Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. ABILIFY MAINTENA is not approved for the treatment of patients with dementia-related psychosis [see Warnings and Precautions (5.1) ].
ABILIFY MAINTENA (aripiprazole) is indicated: for the treatment of schizophrenia in adults for maintenance monotherapy treatment of bipolar I disorder in adults
For patients who have never taken aripiprazole, establish tolerability with oral aripiprazole prior to initiating treatment with ABILIFY MAINTENA. Due to the half-life of oral aripiprazole (i.e., 75 hours and 94 hours for aripiprazole and dehydro-aripiprazole, respectively), it may take up to 2 weeks to fully assess tolerability. ABILIFY MAINTENA must be administered by intramuscular injection by a healthcare prof...
How Supplied Pre-filled Dual Chamber Syringe: ABILIFY MAINTENA (aripiprazole) pre-filled dual chamber syringe for extended-release injectable suspension in single-dose syringes is available in 300 mg or 400 mg strength syringes. The pre-filled dual chamber syringe consists of a front chamber that contains the lyophilized powder of aripiprazole monohydrate and a rear chamber that contains sterile water for injectio...
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www.ABILIFYMAINTENA.comElderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. ABILIFY MAINTENA is not approved for the treatment of patients with dementia-related psychosis [see Warnings and Precautions (5.1)].
ABILIFY MAINTENA (aripiprazole) is indicated:
For patients who have never taken aripiprazole, establish tolerability with oral aripiprazole prior to initiating treatment with ABILIFY MAINTENA. Due to the half-life of oral aripiprazole (i.e., 75 hours and 94 hours for aripiprazole and dehydro-aripiprazole, respectively), it may take up to 2 weeks to fully assess tolerability.
ABILIFY MAINTENA must be administered by intramuscular injection by a healthcare professional. Do not administer by any other route.
For detailed preparation and administration instructions, [see Dosage and Administration (2.6, 2.7)].
The recommended dose of ABILIFY MAINTENA is 400 mg monthly (no sooner than 26 days after the previous injection).
There are two ways to initiate treatment with ABILIFY MAINTENA in patients receiving oral antipsychotics:
1-day initiation:
14-day initiation:
If there are adverse reactions with the 400 mg dosage, the dosage may be reduced to 300 mg once monthly.
If the second or third doses are missed:
If the fourth or subsequent doses are missed:
Refer to Table 1 and Table 2 for dosage modifications for patients who are CYP2D6 poor metabolizers and/or in patients taking concomitant CYP3A4 inhibitors or CYP2D6 inhibitors for greater than 14 days.
If the CYP3A4 inhibitor or CYP2D6 inhibitor is withdrawn, the ABILIFY MAINTENA dosage may need to be increased to the previous dose [see Dosage and Administration (2.2)].
Avoid the concomitant use of CYP3A4 inducers with ABILIFY MAINTENA for greater than 14 days because the blood levels of aripiprazole are decreased and may be below the effective levels.
Dosage modifications are not recommended for patients with concomitant use of CYP3A4 inhibitors, CYP2D6 inhibitors or CYP3A4 inducers for less than 14 days.
| Factors | Adjusted Dose* |
|---|---|
| CYP2D6 Poor Metabolizers | |
| Known CYP2D6 Poor Metabolizers | 300 mg |
| Known CYP2D6 Poor Metabolizers taking concomitant CYP3A4 inhibitors | Avoid use |
| Concomitant use with CYP Inhibitors and/or Inducers | |
| Strong CYP2D6 or CYP3A4 inhibitors | 300 mg |
| CYP2D6 and CYP3A4 inhibitors | Avoid use |
| CYP3A4 inducers | Avoid use |
* No change for oral dosage required during initiation.
| Factors | Adjusted Dose* |
|---|---|
| CYP2D6 Poor Metabolizers | |
| Known CYP2D6 Poor Metabolizers | 300 mg |
| Known CYP2D6 Poor Metabolizers taking concomitant CYP3A4 inhibitors | 200 mg† |
| Patients Taking 400 mg of ABILIFY MAINTENA | |
| Strong CYP2D6 or CYP3A4 inhibitors | 300 mg |
| CYP2D6 and CYP3A4 inhibitors | 200 mg† |
| CYP3A4 inducers | Avoid use |
| Patients Taking 300 mg of ABILIFY MAINTENA | |
| Strong CYP2D6 or CYP3A4 inhibitors | 200 mg† |
| CYP2D6 and CYP3A4 inhibitors | 160 mg† |
| CYP3A4 inducers | Avoid use |
* No change for oral dosage required during initiation.
† 200 mg and 160 mg dosage adjustment is obtained only by using the 300 mg or 400 mg strength vials.
ABILIFY MAINTENA comes in two types of kits. See instructions for reconstitution/injection/disposal procedures for 1) Pre-filled Dual Chamber Syringe [see Dosage and Administration (2.6)], and 2) Vials [see Dosage and Administration (2.7)].
ABILIFY MAINTENA comes in two types of kits. See instructions for reconstitution/injection/disposal procedures for 1) Pre-filled Dual Chamber Syringe available in 300 mg or 400 mg strength syringes [see Dosage and Administration (2.6)], and 2) Single-dose vials available in 300 mg or 400 mg strength vials [see Dosage and Administration (2.7)].
The 200 mg and 160 mg dosage adjustments are obtained only by using the 300 mg or 400 mg strength vials.
Preparation Prior to Reconstitution
For deep intramuscular deltoid or gluteal injection by healthcare professionals only. Do not administer by any other route. Inject full syringe contents immediately following reconstitution. Administer once monthly.
Lay out and confirm that components listed below are provided in the kit:
Reconstitution of Lyophilized Powder in Pre-filled Dual Chamber Syringe
Reconstitute at room temperature.
Injection Procedure
Use appropriate aseptic techniques throughout injection procedure. For deep intramuscular injection only.
For deltoid administration:
For gluteal administration:
Disposal Procedure
Preparation Prior to Reconstitution
For deep intramuscular injection by healthcare professionals only. Do not administer by any other route. Inject immediately after reconstitution. Administer once monthly.
| 400 mg Vial | 300 mg Vial | ||
|---|---|---|---|
| Dose | Sterile Water for Injection | Dose | Sterile Water for Injection |
| 400 mg | 1.9 mL | 300 mg | 1.5 mL |
Important: There is more Sterile Water for Injection in the vial than is needed to reconstitute ABILIFY MAINTENA (aripiprazole) for extended-release injectable suspension. The vial will have excess Sterile Water for Injection; discard any unused portion.
Reconstitution of Lyophilized Powder in Vial
Preparation Prior to Injection
| 400 mg Vial | 300 mg Vial | ||
|---|---|---|---|
| Dose | Volume to Inject | Dose | Volume to Inject |
| 400 mg | 2 mL | --- | --- |
| 300 mg | 1.5 mL | 300 mg | 1.5 mL |
| 200 mg | 1 mL | 200 mg | 1 mL |
| 160 mg | 0.8 mL | 160 mg | 0.8 mL |
Injection Procedure
For deltoid administration:
For gluteal administration:
Disposal Procedure
For extended-release injectable suspension: 300 mg and 400 mg of lyophilized powder for reconstitution in:
The reconstituted extended-release injectable suspension is a uniform, homogeneous suspension that is opaque and milky-white in color.
ABILIFY MAINTENA is contraindicated in patients with a known hypersensitivity to aripiprazole. Hypersensitivity reactions ranging from pruritus/urticaria to anaphylaxis have been reported in patients receiving aripiprazole [see Adverse Reactions (6.1 and 6.2)].
Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of 17 placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in drug-treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group.
Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear. ABILIFY MAINTENA is not approved for the treatment of patients with dementia-related psychosis.
In placebo-controlled clinical studies (two flexible-dose and one fixed-dose study) of dementia-related psychosis, there was an increased incidence of cerebrovascular adverse reactions (e.g., stroke, transient ischemic attack), including fatalities, in oral aripiprazole-treated patients (mean age: 84 years; range: 78 to 88 years). In the fixed-dose study, there was a statistically significant dose response relationship for cerebrovascular adverse reactions in patients treated with oral aripiprazole. ABILIFY MAINTENA is not approved for the treatment of patients with dementia-related psychosis.
A potentially fatal symptom complex sometimes referred to as Neuroleptic Malignant Syndrome (NMS) may occur with administration of antipsychotic drugs, including ABILIFY MAINTENA. Rare cases of NMS occurred during aripiprazole treatment in the worldwide clinical database.
Clinical manifestations of NMS are hyperpyrexia, muscle rigidity, altered mental status, and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis, and cardiac dysrhythmia). Additional signs may include elevated creatine phosphokinase, myoglobinuria (rhabdomyolysis), and acute renal failure.
The diagnostic evaluation of patients with this syndrome is complicated. In arriving at a diagnosis, it is important to exclude cases where the clinical presentation includes both serious medical illness (e.g., pneumonia, systemic infection) and untreated or inadequately treated extrapyramidal signs and symptoms (EPS). Other important considerations in the differential diagnosis include central anticholinergic toxicity, heat stroke, drug fever, and primary central nervous system pathology.
The management of NMS should include: 1) immediate discontinuation of antipsychotic drugs and other drugs not essential to concurrent therapy; 2) intensive symptomatic treatment and medical monitoring; and 3) treatment of any concomitant serious medical problems for which specific treatments are available. There is no general agreement about specific pharmacological treatment regimens for uncomplicated NMS.
If a patient requires antipsychotic drug treatment after recovery from NMS, the potential reintroduction of drug therapy should be carefully considered. The patient should be carefully monitored, since recurrences of NMS have been reported.
A syndrome of potentially irreversible, involuntary, dyskinetic movements may develop in patients treated with antipsychotic drugs. Although the prevalence of the syndrome appears to be highest among the elderly, especially elderly women, it is impossible to rely upon prevalence estimates to predict, at the inception of antipsychotic treatment, which patients are likely to develop the syndrome. Whether antipsychotic drug products differ in their potential to cause tardive dyskinesia is unknown.
The risk of developing tardive dyskinesia and the likelihood that it will become irreversible are believed to increase as the duration of treatment and the total cumulative dose of antipsychotic drugs administered to the patient increase. However, the syndrome can develop, although much less commonly, after relatively brief treatment periods at low doses.
Tardive dyskinesia may remit, partially or completely, if antipsychotic treatment is withdrawn. Antipsychotic treatment, itself, however, may suppress (or partially suppress) the signs and symptoms of the syndrome and, thereby, may possibly mask the underlying process. The effect of symptomatic suppression on the long-term course of the syndrome is unknown.
Given these considerations, ABILIFY MAINTENA should be prescribed in a manner that is most likely to minimize the occurrence of tardive dyskinesia. Chronic antipsychotic treatment should generally be reserved for patients who suffer from a chronic illness that 1) is known to respond to antipsychotic drugs and 2) for whom alternative, equally effective, but potentially less harmful treatments are not available or appropriate. In patients who do require chronic treatment, the smallest dose and the shortest duration of treatment producing a satisfactory clinical response should be sought. The need for continued treatment should be reassessed periodically.
If signs and symptoms of tardive dyskinesia appear in a patient treated with ABILIFY MAINTENA drug discontinuation should be considered. However, some patients may require treatment with ABILIFY MAINTENA despite the presence of the syndrome.
Atypical antipsychotic drugs have been associated with metabolic changes that include hyperglycemia/diabetes mellitus, dyslipidemia, and weight gain. While all drugs in the class have been shown to produce some metabolic changes, each drug has its own specific risk profile.
Hyperglycemia/Diabetes Mellitus
Hyperglycemia, in some cases extreme and associated with diabetic ketoacidosis, hyperosmolar coma, or death, has been reported in patients treated with atypical antipsychotics. There have been reports of hyperglycemia in patients treated with aripiprazole [see Adverse Reactions (6.1)]. Assessment of the relationship between atypical antipsychotic use and glucose abnormalities is complicated by the possibility of an increased background risk of diabetes mellitus in patients with schizophrenia and the increasing incidence of diabetes mellitus in the general population. Given these confounders, the relationship between atypical antipsychotic use and hyperglycemia-related adverse reactions is not completely understood. However, epidemiological studies suggest an increased risk of hyperglycemia-related adverse reactions in patients treated with the atypical antipsychotics.
Patients with an established diagnosis of diabetes mellitus who are started on atypical antipsychotics should be monitored regularly for worsening of glucose control. Patients with risk factors for diabetes mellitus (e.g., obesity, family history of diabetes), who are starting treatment with atypical antipsychotics should undergo fasting blood glucose testing at the beginning of treatment and periodically during treatment. Any patient treated with atypical antipsychotics should be monitored for symptoms of hyperglycemia including polydipsia, polyuria, polyphagia, and weakness. Patients who develop symptoms of hyperglycemia during treatment with atypical antipsychotics should undergo fasting blood glucose testing. In some cases, hyperglycemia has resolved when the atypical antipsychotic was discontinued; however, some patients required continuation of anti-diabetic treatment despite discontinuation of the atypical antipsychotic drug.
In a short-term, placebo-controlled randomized trial in adults with schizophrenia, the mean change in fasting glucose was +9.8 mg/dL (N=88) in the ABILIFY MAINTENA-treated patients and +0.7 mg/dL (N=59) in the placebo-treated patients. Table 5 shows the proportion of ABILIFY MAINTENA-treated patients with normal and borderline fasting glucose at baseline and their changes in fasting glucose measurements.
| Category Change (at least once) from Baseline | Treatment Arm | n/N* | % | |
|---|---|---|---|---|
| Fasting Glucose | Normal to High (<100 mg/dL to ≥126 mg/dL) | ABILIFY MAINTENA | 7/88 | 8.0 |
| Placebo | 0/75 | 0.0 | ||
| Borderline to High (≥100 mg/dL and <126 mg/dL to ≥126 mg/dL) | ABILIFY MAINTENA | 1/33 | 3.0 | |
| Placebo | 3/33 | 9.1 |
* N = the total number of subjects who had a measurement at baseline and at least one post-baseline result. n = the number of subjects with a potentially clinically relevant shift.
During a 52-week, open-label bipolar I disorder study in those patients who initiated ABILIFY MAINTENA treatment, 1.1% with normal baseline fasting glucose experienced a shift to high while receiving ABILIFY MAINTENA and 9.8% with borderline fasting glucose experienced a shift to high. Combined, 2.9% of these patients with normal or borderline fasting glucose experienced shifts to high fasting glucose during this trial.
Dyslipidemia
Undesirable alterations in lipids have been observed in patients treated with atypical antipsychotics.
Table 6 shows the proportion of adult patients from one short-term, placebo-controlled randomized trial in adults with schizophrenia taking ABILIFY MAINTENA, with changes in total cholesterol, fasting triglycerides, fasting LDL cholesterol and HDL cholesterol.
| Treatment Arm | n/N* | % | |
|---|---|---|---|
| Total Cholesterol Normal to High (<200 mg/dL to ≥240 mg/dL) | ABILIFY MAINTENA | 3/83 | 3.6 |
| Placebo | 2/73 | 2.7 | |
| Borderline to High (200~<240 mg/dL to ≥240 mg/dL) | ABILIFY MAINTENA | 6/27 | 22.2 |
| Placebo | 2/19 | 10.5 | |
| Any increase (≥40 mg/dL) | ABILIFY MAINTENA | 15/122 | 12.3 |
| Placebo | 6/110 | 5.5 | |
| Fasting Triglycerides Normal to High (<150 mg/dL to ≥200 mg/dL) | ABILIFY MAINTENA | 7/98 | 7.1 |
| Placebo | 4/78 | 5.1 | |
| Borderline to High (150~<200 mg/dL to ≥200 mg/dL) | ABILIFY MAINTENA | 3/11 | 27.3 |
| Placebo | 4/15 | 26.7 | |
| Any increase (≥50 mg/dL) | ABILIFY MAINTENA | 24/122 | 19.7 |
| Placebo | 20/110 | 18.2 | |
| Fasting LDL Cholesterol Normal to High (<100 mg/dL to ≥160 mg/dL) | ABILIFY MAINTENA | 1/59 | 1.7 |
| Placebo | 1/51 | 2.0 | |
| Borderline to High (100~<160 mg/dL to ≥160 mg/dL) | ABILIFY MAINTENA | 5/52 | 9.6 |
| Placebo | 1/41 | 2.4 | |
| Any increase (≥30 mg/dL) | ABILIFY MAINTENA | 17/120 | 14.2 |
| Placebo | 9/103 | 8.7 | |
| HDL Cholesterol Normal to Low (≥40 mg/dL to <40 mg/dL) | ABILIFY MAINTENA | 14/104 | 13.5 |
| Placebo | 11/87 | 12.6 | |
| Any decrease (≥20 mg/dL) | ABILIFY MAINTENA | 7/122 | 5.7 |
| Placebo | 12/110 | 10.9 |
* N = the total number of subjects who had a measurement at baseline and at least one post-baseline result. n = the number of subjects with a potentially clinically relevant shift.
During a 52-week, open-label bipolar I disorder study in those patients who initiated ABILIFY MAINTENA, shifts from baseline in fasting cholesterol from normal to high were reported in 2.1% (total cholesterol) and 2.2% (LDL cholesterol) and shifts from baseline from normal to low were reported in 8.5% (HDL cholesterol). Of these patients with normal baseline triglycerides, 3.6% experienced shifts to high, and 0.0% experienced shifts to very high. Combined, 1.0% of these patients with normal or borderline fasting triglycerides experienced shifts to very high fasting triglycerides during this trial.
Weight Gain
Weight gain has been observed with atypical antipsychotic use. Clinical monitoring of weight is recommended.
In one short-term, placebo-controlled trial in adult patients with schizophrenia with ABILIFY MAINTENA, the mean change in body weight at Week 12 was +3.5 kg (N=99) in the ABILIFY MAINTENA-treated patients and +0.8 kg (N=66) in the placebo-treated patients.
Table 7 shows the percentage of adult patients with schizophrenia with weight gain ≥7% of body weight in a short-term, placebo-controlled trial with ABILIFY MAINTENA.
| Treatment Arm | N* | Patients n (%) | |
|---|---|---|---|
| Weight gain ≥7% of body weight | ABILIFY MAINTENA | 144 | 31 (21.5) |
| Placebo | 141 | 12 (8.5) |
* N = the total number of subjects who had a measurement at baseline and at least one post-baseline result.
During a 52-week, open-label bipolar I disorder study in those patients who initiated ABILIFY MAINTENA, 1.8% discontinued ABILIFY MAINTENA treatment due to weight increase. ABILIFY MAINTENA was associated with mean increase from baseline in weight of 1.0 kg at week 52. In this trial, 21.4% of these patients demonstrated ≥7% increase in body weight and 15.4% demonstrated a ≥7% decrease in body weight.
Post-marketing case reports suggest that patients can experience intense urges, particularly for gambling, and the inability to control these urges while taking aripiprazole. Other compulsive urges, reported less frequently, include: sexual urges, shopping, eating or binge eating, and other impulsive or compulsive behaviors. Because patients may not recognize these behaviors as abnormal, it is important for prescribers to ask patients or their caregivers specifically about the development of new or intense gambling urges, compulsive sexual urges, compulsive shopping, binge or compulsive eating, or other urges while being treated with aripiprazole. It should be noted that impulse-control symptoms can be associated with the underlying disorder. In some cases, although not all, urges were reported to have stopped when the dose was reduced, or the medication was discontinued. Compulsive behaviors may result in harm to the patient and others if not recognized. Consider dose reduction or stopping the medication if a patient develops such urges.
ABILIFY MAINTENA may cause orthostatic hypotension, perhaps due to its α1-adrenergic receptor antagonism. In the short-term, placebo-controlled trial in adults with schizophrenia, the adverse event of presyncope was reported in 1/167 (0.6%) of patients treated with ABILIFY MAINTENA, while syncope and orthostatic hypotension were each reported in 1/172 (0.6%) of patients treated with placebo. During the stabilization phase of the randomized-withdrawal (maintenance) study in adult patients with schizophrenia, orthostasis-related adverse events were reported in 4/576 (0.7%) of patients treated with ABILIFY MAINTENA, including abnormal orthostatic blood pressure (1/576, 0.2%), postural dizziness (1/576, 0.2%), presyncope (1/576, 0.2%) and orthostatic hypotension (1/576, 0.2%).
In the short-term placebo-controlled trial in adults with schizophrenia, there were no patients in either treatment group with a significant orthostatic change in blood pressure (defined as a decrease in systolic blood pressure ≥20 mmHg accompanied by an increase in heart rate ≥25 bpm when comparing standing to supine values). During the stabilization phase of the randomized-withdrawal (maintenance) study in adult patients with schizophrenia, the incidence of significant orthostatic change in blood pressure was 0.2% (1/575).
Antipsychotics, including ABILIFY MAINTENA, may cause somnolence, postural hypotension, motor and sensory instability, which may lead to falls and, consequently, fractures or other injuries. For patients with diseases, conditions, or medications that could exacerbate these effects, complete fall risk assessments when initiating antipsychotic treatment and recurrently for patients on long-term antipsychotic therapy.
In clinical trials and post-marketing experience, leukopenia and neutropenia have been reported temporally related to antipsychotic agents, including ABILIFY MAINTENA. Agranulocytosis has also been reported [see Adverse Reactions (6.1)].
Possible risk factors for leukopenia/neutropenia include pre-existing low white blood cell count (WBC)/absolute neutrophil count (ANC) and a history of drug-induced leukopenia/neutropenia. In patients with a history of a clinically significant low WBC/ANC or drug-induced leukopenia/neutropenia, perform a complete blood count (CBC) frequently during the first few months of therapy. In such patients, consider discontinuation of ABILIFY MAINTENA at the first sign of a clinically significant decline in WBC in the absence of other causative factors.
Monitor patients with clinically significant neutropenia for fever or other symptoms or signs of infection and treat promptly if such symptoms or signs occur. Discontinue ABILIFY MAINTENA in patients with severe neutropenia (absolute neutrophil count <1000/mm3) and follow their WBC counts until recovery.
As with other antipsychotic drugs, use ABILIFY MAINTENA cautiously in patients with a history of seizures or with conditions that lower the seizure threshold. Conditions that lower the seizure threshold may be more prevalent in a population of 65 years or older.
ABILIFY MAINTENA, like other antipsychotics, may impair judgment, thinking, or motor skills. Patients should be cautioned about performing activities that require mental alertness such as operating hazardous machinery, or operating a motor vehicle, until they are reasonably certain that therapy with ABILIFY MAINTENA does not affect them adversely.
Disruption of the body's ability to reduce core body temperature has been attributed to antipsychotic agents. Appropriate care is advised when prescribing ABILIFY MAINTENA for patients who will be experiencing conditions which may contribute to an elevation in core body temperature, (e.g., exercising strenuously, exposure to extreme heat, receiving concomitant medication with anticholinergic activity, or being subject to dehydration).
Esophageal dysmotility and aspiration have been associated with antipsychotic drug use, including ABILIFY MAINTENA. ABILIFY MAINTENA and other antipsychotic drugs should be used cautiously in patients at risk for aspiration pneumonia [see Warnings and Precautions (5.1)].
The following adverse reactions are discussed in more detail in other sections of the labeling:
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Safety Database of ABILIFY MAINTENA and Oral Aripiprazole
Oral aripiprazole has been evaluated for safety in 16,114 adult patients who participated in multiple-dose, clinical trials in schizophrenia and other indications, and who had approximately 8,578 patient-years of exposure to oral aripiprazole. A total of 3,901 patients were treated with oral aripiprazole for at least 180 days, 2,259 patients were treated with oral aripiprazole for at least 360 days, and 933 patients continuing aripiprazole treatment for at least 720 days.
ABILIFY MAINTENA has been evaluated for safety in 2,128 adult patients in clinical trials in schizophrenia, with approximately 2,633 patient-years of exposure to ABILIFY MAINTENA. A total of 1,229 patients were treated with ABILIFY MAINTENA for at least 180 days (at least 7 consecutive injections) and 935 patients treated with ABILIFY MAINTENA had at least 1 year of exposure (at least 13 consecutive injections).
ABILIFY MAINTENA has been evaluated for safety in 804 adult patients in clinical trials in bipolar I disorder, with approximately 530 patient-years of exposure to ABILIFY MAINTENA. A total of 419 patients were treated with ABILIFY MAINTENA for at least 180 days (at least 7 consecutive injections) and 287 patients treated with ABILIFY MAINTENA had at least 1 year of exposure (at least 13 consecutive injections).
The conditions and duration of treatment with ABILIFY MAINTENA included double-blind and open-label studies. The safety data presented below are derived from the 12-week double-blind placebo-controlled study of ABILIFY MAINTENA in adult patients with schizophrenia.
Adverse Reactions with ABILIFY MAINTENA
Most Commonly Observed Adverse Reactions in Double-Blind, Placebo-Controlled Clinical Trials in Schizophrenia
Based on the placebo-controlled trial of ABILIFY MAINTENA in schizophrenia, the most commonly observed adverse reactions associated with the use of ABILIFY MAINTENA in patients (incidence of 5% or greater and aripiprazole incidence at least twice that for placebo) were increased weight (16.8% vs. 7.0%), akathisia (11.4% vs. 3.5%), injection site pain (5.4% vs. 0.6%) and sedation (5.4% vs. 1.2%).
Commonly Reported Adverse Reactions in Double-Blind, Placebo-Controlled Clinical Trials in Schizophrenia
The following findings are based on the double-blind, placebo-controlled trial that compared ABILIFY MAINTENA 400 mg or 300 mg to placebo in patients with schizophrenia. Table 8 lists the adverse reactions reported in 2% or more of ABILIFY MAINTENA-treated subjects and at a greater proportion than in the placebo group.
| Percentage of Patients Reporting Reaction* | ||
|---|---|---|
| ABILIFY MAINTENA | Placebo | |
| Preferred Term | (n=167) | (n=172) |
| Gastrointestinal Disorders | ||
| Constipation | 10 | 7 |
| Dry Mouth | 4 | 2 |
| Diarrhea | 3 | 2 |
| Vomiting | 3 | 1 |
| Abdominal Discomfort | 2 | 1 |
| General Disorders and Administration Site Conditions | ||
| Injection Site Pain | 5 | 1 |
| Infections and Infestations | ||
| Upper Respiratory Tract Infection | 4 | 2 |
| Investigations | ||
| Increased Weight | 17 | 7 |
| Decreased Weight | 4 | 2 |
| Musculoskeletal and Connective Tissue Disorders | ||
| Arthralgia | 4 | 1 |
| Back Pain | 4 | 2 |
| Myalgia | 4 | 2 |
| Musculoskeletal Pain | 3 | 1 |
| Nervous System Disorders | ||
| Akathisia | 11 | 4 |
| Sedation | 5 | 1 |
| Dizziness | 4 | 2 |
| Tremor | 3 | 1 |
| Respiratory, Thoracic and Mediastinal | ||
| Nasal Congestion | 2 | 1 |
* This table does not include adverse reactions which had an incidence equal to or less than placebo.
Other Adverse Reactions Observed During the Clinical Trial Evaluation of ABILIFY MAINTENA
The following listing does not include reactions: 1) already listed in previous tables or elsewhere in labeling, 2) for which a drug cause was remote, 3) which were so general as to be uninformative, 4) which were not considered to have significant clinical implications, or 5) which occurred at a rate equal to or less than placebo.
Reactions are categorized by body system according to the following definitions: frequent adverse reactions are those occurring in at least 1/100 patients; infrequent adverse reactions are those occurring in 1/100 to 1/1000 patients; rare reactions are those occurring in fewer than 1/1000 patients:
Demographic Differences
An examination of population subgroups was performed across demographic subgroup categories for adverse reactions experienced by at least 5% of ABILIFY MAINTENA subjects at least twice rate of the placebo (i.e., increased weight, akathisia, injection site pain, and sedation) in the double-blind placebo-controlled trial. This analysis did not reveal evidence of differences in safety differential adverse reaction incidence on the basis of age, gender, or race alone; however, there were few subjects ≥65 years of age.
Injection Site Reactions of ABILIFY MAINTENA
In the data from the short-term, double-blind, placebo-controlled trial with ABILIFY MAINTENA in patients with schizophrenia, the percent of patients reporting any injection site-related adverse reaction (all reported as injection site pain) was 5.4% for patients treated with gluteal administered ABILIFY MAINTENA and 0.6% for placebo. The mean intensity of injection pain reported by subjects using a visual analog scale (0=no pain to 100=unbearably painful) approximately one hour after injection was 7.1 (SD 14.5) for the first injection and 4.8 (SD 12.4) at the last visit in the double-blind, placebo-controlled phase.
In an open-label study comparing bioavailability of ABILIFY MAINTENA administered in the deltoid or gluteal muscle, injection site pain was observed in both groups at approximately equal rates.
Extrapyramidal Symptoms (EPS)
In the short-term, placebo-controlled trial of ABILIFY MAINTENA in adults with schizophrenia, the incidence of reported EPS-related events, excluding events related to akathisia, for ABILIFY MAINTENA-treated patients was 9.6% vs. 5.2% for placebo. The incidence of akathisia-related events for ABILIFY MAINTENA-treated patients was 11.5% vs. 3.5% for placebo.
Dystonia
Symptoms of dystonia, prolonged abnormal contractions of muscle groups, may occur in susceptible individuals during the first few days of treatment. Dystonic symptoms include: spasm of the neck muscles, sometimes progressing to tightness of the throat, swallowing difficulty, difficulty breathing, and/or protrusion of the tongue. While these symptoms can occur at low doses, they occur more frequently and with greater severity with high potency and at higher doses of first-generation antipsychotic drugs. An elevated risk of acute dystonia is observed in males and younger age groups. In the short-term, placebo-controlled trial of ABILIFY MAINTENA in adults with schizophrenia, the incidence of dystonia was 1.8% for ABILIFY MAINTENA vs. 0.6% for placebo.
Neutropenia
In the short-term, placebo-controlled trial of ABILIFY MAINTENA in adults with schizophrenia, the incidence of neutropenia (absolute neutrophil count ≤1.5 thous/mcL) for ABILIFY MAINTENA-treated patients was 5.7% vs. 2.1% for placebo. An absolute neutrophil count of <1 thous/mcL (i.e., 0.95 thous/mcL) was observed in only one patient on ABILIFY MAINTENA and resolved spontaneously without any associated adverse events [see Warnings and Precautions (5.9)].
Adverse Reactions Reported in Clinical Trials with Oral Aripiprazole
The following is a list of additional adverse reactions that have been reported in clinical trials with oral aripiprazole and not reported above for ABILIFY MAINTENA:
The following adverse reactions have been identified during post-approval use of oral aripiprazole or ABILIFY MAINTENA. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure: occurrences of allergic reaction (anaphylactic reaction, angioedema, laryngospasm, pruritus/urticaria, or oropharyngeal spasm), pathological gambling, hiccups, blood glucose fluctuation, drug reaction with eosinophilia and systemic symptoms (DRESS), and fecal incontinence.
| Concomitant Drug Name or Drug Class | Clinical Rationale | Clinical Recommendation |
|---|---|---|
| Strong CYP3A4 Inhibitors (e.g., ketoconazole) or strong CYP2D6 inhibitors (e.g., paroxetine, fluoxetine) | The concomitant use of oral aripiprazole with strong CYP3A4 or CYP2D6 inhibitors increased the exposure of aripiprazole [see Clinical Pharmacology (12.3)]. | With concomitant use of ABILIFY MAINTENA with a strong CYP3A4 inhibitor or CYP2D6 inhibitor for more than 14 days, reduce the ABILIFY MAINTENA dosage [see Dosage and Administration (2.4)]. |
| Strong CYP3A4 Inducers (e.g., carbamazepine) | The concomitant use of oral aripiprazole and carbamazepine decreased the exposure of aripiprazole [see Clinical Pharmacology (12.3)]. | Avoid use of ABILIFY MAINTENA in combination with carbamazepine and other inducers of CYP3A4 for greater than 14 days [see Dosage and Administration (2.4)]. |
| Antihypertensive Drugs | Due to its alpha-adrenergic antagonism, aripiprazole has the potential to enhance the effect of certain antihypertensive agents. | Monitor blood pressure and adjust dose accordingly [see Warnings and Precautions (5.7)]. |
| Benzodiazepines (e.g., lorazepam) | The intensity of sedation was greater with the combination of oral aripiprazole and lorazepam as compared to that observed with aripiprazole alone. The orthostatic hypotension observed was greater with the combination as compared to that observed with lorazepam alone [see Warnings and Precautions (5.7)]. | Monitor sedation and blood pressure. Adjust dose accordingly. |
Based on pharmacokinetic studies with oral aripiprazole, no dosage adjustment of ABILIFY MAINTENA is required when administered concomitantly with famotidine, valproate, lithium, lorazepam [see Clinical Pharmacology (12.3)].
In addition, no dosage adjustment is necessary for substrates of CYP2D6 (e.g., dextromethorphan, fluoxetine, paroxetine, or venlafaxine), CYP2C9 (e.g., warfarin), CYP2C19 (e.g., omeprazole, warfarin), or CYP3A4 (e.g., dextromethorphan) when coadministered with ABILIFY MAINTENA. Additionally, no dosage adjustment is necessary for valproate, lithium, lamotrigine, lorazepam, or sertraline when coadministered with ABILIFY MAINTENA. [See Clinical Pharmacology (12.3)].
Pregnancy Exposure Registry
There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ABILIFY MAINTENA during pregnancy. For more information contact the National Pregnancy Registry for Atypical Antipsychotics at 1-866-961-2388 or visit womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry.
Risk Summary
Neonates exposed to antipsychotic drugs, including ABILIFY MAINTENA, during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery (see Clinical Considerations). Overall available data from published epidemiologic studies of pregnant women exposed to aripiprazole have not established a drug-associated risk of major birth defects, miscarriage, or adverse maternal outcomes. There are risks to the mother associated with untreated schizophrenia or bipolar I disorder and with exposure to antipsychotics, including ABILIFY MAINTENA, during pregnancy (see Clinical Considerations). Aripiprazole exposure during pregnancy may decrease milk supply in the post-partum period [see Use in Specific Populations (8.2)].
In animal reproduction studies, oral and intravenous aripiprazole administration during organogenesis in rats and/or rabbits at doses 10 and 11 times, respectively, the maximum recommended human dose (MRHD) produced fetal death, decreased fetal weight, undescended testicles, delayed skeletal ossification, skeletal abnormalities, and diaphragmatic hernia. Oral and intravenous aripiprazole administration during the pre- and post-natal period in rats at doses 10 times the MRHD produced prolonged gestation, stillbirths, decreased pup weight, and decreased pup survival (see Data).
The background risk of major birth defects and miscarriage for the indicated population are unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.
Clinical Considerations
Disease-associated maternal and/or embryo/fetal risk
There is a risk to the mother from untreated schizophrenia or bipolar I disorder, including increased risk of relapse, hospitalization, and suicide. Schizophrenia and bipolar I disorder are associated with increased adverse perinatal outcomes, including preterm birth. It is not known if this is a direct result of the illness or other comorbid factors.
Fetal/Neonatal Adverse Reactions
Extrapyramidal and/or withdrawal symptoms, including agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress and feeding disorder have been reported in neonates who were exposed to antipsychotic drugs (including oral aripiprazole) during the third trimester of pregnancy. These symptoms have varied in severity. Some neonates recovered within hours or days without specific treatment; others required prolonged hospitalization. Monitor neonates exhibiting extrapyramidal and/or withdrawal symptoms and manage symptoms appropriately.
Data
Animal Data
In animal studies, aripiprazole demonstrated developmental toxicity, including possible teratogenic effects in rats and rabbits.
Pregnant rats were treated with oral doses of 3, 10, and 30 mg/kg/day which are approximately 1 to 10 times the MRHD of 30 mg/day on a mg/m2 basis of aripiprazole during the period of organogenesis. Treatment at the highest dose caused a slight prolongation of gestation and delay in fetal development, as evidenced by decreased fetal weight and undescended testes. Delayed skeletal ossification was observed at 3 and 10 times the oral MRHD on mg/m2 basis.
At 3 and 10 times the oral MRHD on a mg/m2 basis, delivered offspring had decreased body weights. Increased incidences of hepatodiaphragmatic nodules and diaphragmatic hernia were observed in offspring from the highest dose group (the other dose groups were not examined for these findings). Postnatally, delayed vaginal opening was seen at 3 and 10 times the oral MRHD on a mg/m2 basis and impaired reproductive performance (decreased fertility rate, corpora lutea, implants, live fetuses, and increased post-implantation loss, likely mediated through effects on female offspring) along with some maternal toxicity were seen at the highest dose; however, there was no evidence to suggest that these developmental effects were secondary to maternal toxicity.
In pregnant rats treated with aripiprazole intravenously at doses of 3, 9, and 27 mg/kg/day, which are 1 to 9 times the oral MRHD on mg/m2 basis, during the period of organogenesis, decreased fetal weight and delayed skeletal ossification were seen at the highest dose which also caused maternal toxicity.
In pregnant rabbits treated with oral doses of 10, 30, and 100 mg/kg/day which are 2 to 11 times human exposure at the oral MRHD based on AUC and 6 to 65 times the oral MRHD of aripiprazole on mg/m2 basis during the period of organogenesis, decreased maternal food consumption and increased abortions were seen at the highest dose as well as increased fetal mortality. Decreased fetal weight and increased incidence of fused sternebrae were observed at 3 and 11 times the MRHD based on AUC.
In pregnant rabbits receiving aripiprazole injection intravenously at doses of 3, 10, and 30 mg/kg/day, which are 2 to 19 times the oral MRHD on mg/m2 basis during the period of organogenesis, the highest dose caused pronounced maternal toxicity that resulted in decreased fetal weight, increased fetal abnormalities (primarily skeletal), and decreased fetal skeletal ossification. The fetal no-effect dose was 5 times the human exposure at the oral MRHD based on AUC and is 6 times the oral MRHD on mg/m2 basis.
In rats treated with oral doses of 3, 10, and 30 mg/kg/day, which are 1 to 10 times the oral MRHD of aripiprazole on a mg/m2 basis, peri- and post-natally (from Day 17 of gestation through Day 21 postpartum), slight maternal toxicity and slightly prolonged gestation were seen at the highest dose. An increase in stillbirths and decreases in pup weight (persisting into adulthood) and survival were also seen at this dose.
In rats treated with aripiprazole intravenously at doses of 3, 8, and 20 mg/kg/day which are 1 to 6 times the oral MRHD on mg/m2 basis from Day 6 of gestation through Day 20 postpartum, increased stillbirths were seen at 3 and 6 times the MRHD on mg/m2 basis, and decreases in early postnatal pup weight and survival were seen at the highest dose; these doses produced some maternal toxicity. There were no effects on postnatal behavioral and reproductive development.
Risk Summary
Aripiprazole is present in human breast milk. Based on published case reports and pharmacovigilance reports, aripiprazole exposure during pregnancy and/or the postpartum period may lead to clinically relevant decreases in milk supply which may be reversible with discontinuation of the drug. There are also reports of aripiprazole exposure during pregnancy and no maternal milk supply in the post-partum period. Effects on milk supply may be mediated through decreases in prolactin levels, which have been observed [see Adverse Reactions (6.1)]. Monitor the breastfed infant for dehydration and lack of appropriate weight gain. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for ABILIFY MAINTENA and any potential adverse effects on the breastfed infant from ABILIFY MAINTENA or from the underlying maternal condition.
ABILIFY MAINTENA has not been studied in children 18 years of age or younger. However, juvenile animal studies have been conducted in rats and dogs.
Juvenile Animal Studies
Aripiprazole in juvenile rats caused mortality, CNS clinical signs, impaired memory and learning, and delayed sexual maturation when administered at oral doses of 10, 20, 40 mg/kg/day from weaning (21 days old) through maturity (80 days old). At 40 mg/kg/day, mortality, decreased activity, splayed hind limbs, hunched posture, ataxia, tremors and other CNS signs were observed in both genders. In addition, delayed sexual maturation was observed in males. At all doses and in a dose-dependent manner, impaired memory and learning, increased motor activity, and histopathology changes in the pituitary (atrophy), adrenals (adrenocortical hypertrophy), mammary glands (hyperplasia and increased secretion), and female reproductive organs (vaginal mucification, endometrial atrophy, decrease in ovarian corpora lutea) were observed. The changes in female reproductive organs were considered secondary to the increase in prolactin serum levels. A No Observed Adverse Effect Level (NOAEL) could not be determined and, at the lowest tested dose of 10 mg/kg/day, there is no safety margin relative to the systemic exposures (AUC0-24) for aripiprazole or its major active metabolite in adolescents at the maximum recommended pediatric dose of 15 mg/day. All drug-related effects were reversible after a 2-month recovery period, and most of the drug effects in juvenile rats were also observed in adult rats from previously conducted studies.
Aripiprazole in juvenile dogs (2 months old) caused CNS clinical signs of tremors, hypoactivity, ataxia, recumbency and limited use of hind limbs when administered orally for 6 months at 3, 10, 30 mg/kg/day. Mean body weight and weight gain were decreased up to 18% in females in all drug groups relative to control values. A NOAEL could not be determined and, at the lowest tested dose of 3 mg/kg/day, there is no safety margin relative to the systemic exposures (AUC0-24) for aripiprazole or its major active metabolite in adolescents at the maximum recommended pediatric dose of 15 mg/day. All drug-related effects were reversible after a 2-month recovery period.
Clinical studies of oral aripiprazole did not include sufficient numbers of subjects aged 65 years and over to determine whether they respond differently from younger subjects. Other reported clinical experience and pharmacokinetic data have not identified differences in responses between the elderly and younger patients [see Clinical Pharmacology (12.3)]. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
In single-dose and multiple-dose pharmacokinetic studies, there was no detectable age effect in the population pharmacokinetic analysis of oral aripiprazole in schizophrenia patients [see Clinical Pharmacology (12.3)]. No dosage adjustments are recommended based on age alone. ABILIFY MAINTENA is not approved for the treatment of patients with dementia-related psychosis [see also Boxed Warning and Warnings and Precautions (5.1)].
Dosage adjustment is recommended in known CYP2D6 poor metabolizers due to high aripiprazole concentrations. Approximately 8% of Caucasians and 3% to 8% of Black/African Americans cannot metabolize CYP2D6 substrates and are classified as poor metabolizers (PM) [see Dosage and Administration (2.4)].
Human Experience
The largest known case of acute ingestion with a known outcome involved 1260 mg of oral aripiprazole (42 times the maximum recommended daily dose) in a patient who fully recovered.
Common adverse reactions (reported in at least 5% of all overdose cases) reported with oral aripiprazole overdosage (alone or in combination with other substances) include vomiting, somnolence, and tremor. Other clinically important signs and symptoms observed in one or more patients with aripiprazole overdoses (alone or with other substances) include acidosis, aggression, aspartate aminotransferase increased, atrial fibrillation, bradycardia, coma, confusional state, convulsion, blood creatine phosphokinase increased, depressed level of consciousness, hypertension, hypokalemia, hypotension, lethargy, loss of consciousness, QRS complex prolonged, QT prolonged, pneumonia aspiration, respiratory arrest, status epilepticus, and tachycardia.
Management of Overdosage
In case of overdosage, call the Poison Control Center immediately at 1-800-222-1222.
Aripiprazole is an atypical antipsychotic which is present in ABILIFY MAINTENA as its monohydrate polymorphic form. Aripiprazole monohydrate is 7-[4-[4-(2,3-dichlorophenyl)-1-piperazinyl] butoxy]-3,4 dihydrocarbostyril monohydrate. The empirical formula is C23H27Cl2N3O2∙H2O and its molecular weight is 466.40. The chemical structure is:
ABILIFY MAINTENA (aripiprazole) is an extended-release injectable suspension available in 400 mg or 300 mg strength pre-filled dual chamber syringes and 400 mg or 300 mg strength vials. The labeled strengths are calculated based on the anhydrous form (aripiprazole). Inactive ingredients (per administered dose) for 400 mg and 300 mg strength products, respectively, include carboxymethyl cellulose sodium (16.64 mg and 12.48 mg), mannitol (83.2 mg and 62.4 mg), sodium phosphate monobasic monohydrate (1.48 mg and 1.11 mg) and sodium hydroxide (pH adjuster).
The mechanism of action of aripiprazole in the treatment of schizophrenia and bipolar I disorder is unknown.
The efficacy of aripiprazole could be mediated through a combination of partial agonist activity at dopamine D2 and serotonin 5-HT1A receptors and antagonist activity at 5-HT2A receptors.
Aripiprazole exhibits high affinity for dopamine D2 and D3 (Kis 0.34 and 0.8 nM, respectively), serotonin 5-HT1A and 5-HT2A receptors (Kis 1.7 and 3.4 nM, respectively), moderate affinity for dopamine D4, serotonin 5-HT2C and 5-HT7, alpha1-adrenergic and histamine H1 receptors (Kis of 44 nM, 15 nM, 39 nM, 57 nM, and 61 nM, respectively), and moderate affinity for the serotonin reuptake site (Ki=98 nM). Aripiprazole has no appreciable affinity for cholinergic muscarinic receptors (IC50>1000 nM). Actions at receptors other than D2, 5-HT1A, and 5-HT2A could explain some of the other adverse reactions of aripiprazole (e.g., the orthostatic hypotension observed with aripiprazole may be explained by its antagonist activity at adrenergic alpha1 receptors).
Alcohol
There was no significant difference between oral aripiprazole coadministered with ethanol and placebo coadministered with ethanol on performance of gross motor skills or stimulus response in healthy subjects. As with most psychoactive medications, patients should be advised to avoid alcohol while taking ABILIFY MAINTENA.
ABILIFY MAINTENA activity is presumably primarily due to the parent drug, aripiprazole, and to a lesser extent, to its major metabolite, dehydro-aripiprazole, which has been shown to have affinities for D2 receptors similar to the parent drug.
Steady-state concentrations for the typical subject were attained by the fourth dose for both sites of administration. Approximate dose-proportional increases in aripiprazole and dehydro-aripiprazole exposure were observed after every four-week ABILIFY MAINTENA injections of 300 mg and 400 mg.
Absorption
Aripiprazole absorption into the systemic circulation is slow and prolonged following intramuscular injection due to low solubility of aripiprazole particles. Following a single-dose administration of ABILIFY MAINTENA in the deltoid and gluteal muscle, the extent of absorption (AUCtau, AUCinf) of aripiprazole was similar for both injection sites, but the rate of absorption (Cmax) was 31% higher following administration to the deltoid compared to the gluteal site. However, at steady state, AUCtau and Cmax were similar for both sites of injection. Following multiple intramuscular doses, the plasma concentrations of aripiprazole gradually rise to maximum plasma concentrations at a median Tmax of 5 to 7 days for the gluteal muscle and 4 days for the deltoid muscle.
Distribution
Based on results from trials with oral administration of aripiprazole, aripiprazole is widely distributed throughout the body with an apparent volume of distribution of 4.9 L/kg, indicating extensive extravascular distribution. At therapeutic concentrations, aripiprazole and dehydro-aripiprazole are greater than 99% bound to serum proteins, binding primarily to albumin.
Elimination
Following single dose administration of ABILIFY MAINTENA, the mean apparent terminal elimination half-life of aripiprazole was 17.8 and 21 days, for deltoid and gluteal injections, respectively.
After multiple gluteal administrations, the mean apparent terminal elimination half-life of aripiprazole was 29.9 days and 46.5 days for every 4-week injection of ABILIFY MAINTENA 300 mg and 400 mg, respectively.
Metabolism
Aripiprazole is metabolized primarily by three biotransformation pathways: dehydrogenation, hydroxylation, and N-dealkylation. Based on in vitro studies, CYP3A4 and CYP2D6 enzymes are responsible for dehydrogenation and hydroxylation of aripiprazole, and N-dealkylation is catalyzed by CYP3A4. Aripiprazole is the predominant drug moiety in the systemic circulation. Dehydro aripiprazole represents about 29% of the parent drug AUC in plasma.
Excretion
Following a single oral dose of [14C]-labeled aripiprazole, approximately 25% and 55% of the administered radioactivity was recovered in the urine and feces, respectively. Less than 1% of unchanged aripiprazole was excreted in the urine and approximately 18% of the oral dose was recovered unchanged in the feces.
Studies in Specific Populations
No specific pharmacokinetic studies have been performed with ABILIFY MAINTENA in specific populations. All the information is obtained from studies with oral aripiprazole.
Exposures of aripiprazole and dehydro-aripiprazole in specific populations are summarized in Figure 19 and Figure 20, respectively. In addition, in pediatric patients (10 to 17 years of age) administered with oral aripiprazole (20 mg to 30 mg), the body weight corrected aripiprazole clearance was similar to the adults.
Figure 19: Effects of intrinsic factors on aripiprazole pharmacokinetics
Figure 20: Effects of intrinsic factors on dehydro-aripiprazole pharmacokinetics:
Drug Interaction Studies
No specific drug interaction studies have been performed with ABILIFY MAINTENA. The information below is obtained from studies with oral aripiprazole.
Effects of other drugs on the exposures of aripiprazole and dehydro-aripiprazole are summarized in Figure 21 and Figure 22, respectively. Based on simulation, a 4.5-fold increase in mean Cmax and AUC values at steady-state is expected when extensive metabolizers of CYP2D6 are administered with both strong CYP2D6 and CYP3A4 inhibitors. After oral administration, a 3-fold increase in mean Cmax and AUC values at steady-state is expected in poor metabolizers of CYP2D6 administered with strong CYP3A4 inhibitors.
Figure 21: The effects of other drugs on aripiprazole pharmacokinetics
Figure 22: The effects of other drugs on dehydro-aripiprazole pharmacokinetics
The effects of oral aripiprazole on the exposures of other drugs are summarized in Figure 23. A population PK analysis in patients with major depressive disorder showed no substantial change in plasma concentrations of fluoxetine (20 mg/day or 40 mg/day), paroxetine CR (37.5 mg/day or 50 mg/day), or sertraline (100 mg/day or 150 mg/day) dosed to steady-state. The steady-state plasma concentrations of fluoxetine and norfluoxetine increased by about 18% and 36%, respectively, and concentrations of paroxetine decreased by about 27%. The steady-state plasma concentrations of sertraline and desmethylsertraline were not substantially changed when these antidepressant therapies were coadministered with aripiprazole.
Figure 23: The effects of oral aripiprazole on pharmacokinetics of other drugs
In vitro
Aripiprazole is not a substrate of CYP1A1, CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, or CYP2E1 enzymes. Aripiprazole also does not undergo direct glucuronidation.
Carcinogenesis
Lifetime carcinogenicity studies were conducted in ICR mice, Sprague-Dawley (SD) rats, and F344 rats. Aripiprazole was administered for 2 years in the diet at doses of 1, 3, 10, and 30 mg/kg/day to ICR mice and 1, 3, and 10 mg/kg/day to F344 rats (0.2 to 5 times and 0.3 to 3 times the maximum recommended human dose [MRHD] based on mg/m2, respectively). In addition, SD rats were dosed orally for 2 years at 10, 20, 40, and 60 mg/kg/day (3 to 19 times the MRHD based on mg/m2). Aripiprazole did not induce tumors in male mice or male rats. In female mice, the incidences of pituitary gland adenomas and mammary gland adenocarcinomas and adenoacanthomas were increased at dietary doses of 3 to 30 mg/kg/day (0.1 to 0.9 times human exposure at MRHD based on AUC and 0.5 to 5 times the MRHD based on mg/m2). In female rats, the incidence of mammary gland fibroadenomas was increased at a dietary dose of 10 mg/kg/day (0.1 times human exposure at MRHD based on AUC and 3 times the MRHD based on mg/m2); and the incidences of adrenocortical carcinomas and combined adrenocortical adenomas/carcinomas were increased at an oral dose of 60 mg/kg/day (14 times human exposure at MRHD based on AUC and 19 times the MRHD based on mg/m2).
Proliferative changes in the pituitary and mammary gland of rodents have been observed following chronic administration of other antipsychotic agents and are considered prolactin-mediated. Serum prolactin was not measured in the aripiprazole carcinogenicity studies. However, increases in serum prolactin levels were observed in female mice in a 13-week dietary study at the doses associated with mammary gland and pituitary tumors. Serum prolactin was not increased in female rats in 4-week and 13-week dietary studies at the dose associated with mammary gland tumors. The relevance for human risk of the findings of prolactin-mediated endocrine tumors in rodents is unknown.
Mutagenesis
The mutagenic potential of aripiprazole was tested in the in vitro bacterial reverse-mutation assay, the in vitro bacterial DNA repair assay, the in vitro forward gene mutation assay in mouse lymphoma cells, the in vitro chromosomal aberration assay in Chinese hamster lung (CHL) cells, the in vivo micronucleus assay in mice, and the unscheduled DNA synthesis assay in rats. Aripiprazole and a metabolite (2,3-DCPP) were clastogenic in the in vitro chromosomal aberration assay in CHL cells with and without metabolic activation. The metabolite, 2,3-DCPP, produced increases in numerical aberrations in the in vitro assay in CHL cells in the absence of metabolic activation. A positive response was obtained in the in vivo micronucleus assay in mice; however, the response was due to a mechanism not considered relevant to humans.
Impairment of Fertility
Female rats were treated with oral doses of 2, 6, and 20 mg/kg/day (0.6, 2, and 6 times the MRHD on a mg/m2 basis) of aripiprazole from 2 weeks prior to mating through Day 7 of gestation. Estrus cycle irregularities and increased corpora lutea were seen at all doses, but no impairment of fertility was seen. Increased pre-implantation loss was seen at 6 and 20 mg/kg/day and decreased fetal weight was seen at 20 mg/kg/day.
Male rats were treated with oral doses of 20, 40, and 60 mg/kg/day (6, 13, and 19 times the MRHD on mg/m2 basis) of aripiprazole from 9 weeks prior to mating through mating. Disturbances in spermatogenesis were seen at 60 mg/kg and prostate atrophy was seen at 40 and 60 mg/kg, but no impairment of fertility was seen.
Oral Aripiprazole
Aripiprazole produced retinal degeneration in albino rats in a 26-week chronic toxicity study at a dose of 60 mg/kg and in a 2-year carcinogenicity study at doses of 40 and 60 mg/kg. The 40 and 60 mg/kg/day doses are 13 and 19 times the MRHD based on mg/m2 and 7 to 14 times human exposure at MRHD based on AUC. Evaluation of the retinas of albino mice and of monkeys did not reveal evidence of retinal degeneration. Additional studies to further evaluate the mechanism have not been performed. The relevance of this finding to human risk is unknown.
Intramuscular Aripiprazole
The toxicological profile for aripiprazole administered to experimental animals by intramuscular injection is generally similar to that seen following oral administration at comparable plasma levels of the drug. With intramuscular injection, however, injection-site tissue reactions are observed that consist of localized inflammation, swelling, scabbing and foreign-body reactions to deposited drug. These effects gradually resolved with discontinuation of dosing.
After 26 weeks of treatment in rats, the no-observed-adverse-effect level (NOAEL) was 50 mg/kg in male rats and 100 mg/kg in female rats, which are approximately 1 and 2 times, respectively, the maximum recommended human 400-mg dose of aripiprazole extended-release injectable suspension on a mg/m2 body surface area. At the NOAEL in rats, the AUC7d values were 14.4 mcg∙h/mL in males and 104.1 mcg∙h/mL in females. In dogs at 52 weeks of treatment at the NOAEL of 40 mg/kg, which is approximately 3 times the MRHD (400 mg) on a mg/m2 body surface area, the AUC7d values were approximately 59 mcg∙h/mL in males and 44 mcg∙h/mL in females. In patients at the MRHD of 400 mg, the AUCτ (0-28 days) was 163 mcg∙h/mL. For comparison to this human AUC, extrapolating the animal AUC7d values to an AUC28d results in AUC28d values of approximately 58 and 416 mcg∙h/mL for male and female rats, respectively, and 236 and 175 mcg∙h/mL for male and female dogs, respectively.
The efficacy of ABILIFY MAINTENA for treatment of schizophrenia was established in:
Short-Term Efficacy
In the short-term (12-week), randomized, double-blind, placebo-controlled trial in acutely relapsed adults (Study 1), the primary measure used for assessing psychiatric signs and symptoms was the Positive and Negative Syndrome Scale (PANSS). The PANSS is a 30-item scale that measures positive symptoms of schizophrenia (7 items), negative symptoms of schizophrenia (7 items), and general psychopathology (16 items), each rated on a scale of 1 (absent) to 7 (extreme); total PANSS scores range from 30 to 210. The primary endpoint was the change from baseline in PANSS total score to week 10.
The inclusion criteria for this short-term trial included adult inpatients who met DSM-IV-TR criteria for schizophrenia. In addition, all patients entering the trial must have experienced an acute psychotic episode as defined by both PANSS Total Score ≥80 and a PANSS score of >4 on each of four specific psychotic symptoms (conceptual disorganization, hallucinatory behavior, suspiciousness/persecution, unusual thought content) at screening and baseline. The key secondary endpoint was the change from baseline in Clinical Global Impression-Severity (CGI-S) assessment scale to week 10. The CGI-S rates the severity of mental illness on a scale of 1 (normal) to 7 (among the most extremely ill) based on the total clinical experience of the rater in treating patients with schizophrenia. Patients had a mean PANSS total score of 103 (range 82 to 144) and a CGI-S score of 5.2 (markedly ill) at entry.
In this 12-week study (n=339) comparing ABILIFY MAINTENA (n=167) to placebo (n=172), patients were administered ABILIFY MAINTENA 400 mg or placebo on Days 0, 28, and 56. The dose could be adjusted down and up within the range of 400 to 300 mg on a one-time basis. ABILIFY MAINTENA was superior to placebo in improving the PANSS total score at the end of week 10 (see Table 10).
| Study Number | Treatment Group | Primary Efficacy Measure: PANSS Total Score | ||
|---|---|---|---|---|
| Mean Baseline Score (SD) | LS Mean Change from Baseline (SE) | Placebo-subtracted Difference*
(95% CI) | ||
| SD: standard deviation; SE: standard error; LS Mean: least-squares mean; CI: unadjusted confidence interval. | ||||
| Study 1 | ABILIFY MAINTENA (400 to 300 mg) | 102.4 (11.4) | -26.8 (1.6) | -15.1 (-19.4, -10.8) |
| Placebo | 103.4 (11.1) | -11.7 (1.6) | -- | |
* Difference (drug minus placebo) in least-squares mean change from baseline.
The change in PANSS total score by week is shown in Figure 24. ABILIFY MAINTENA also showed improvement in symptoms represented by CGI-S score mean change from baseline to week 10. The results of exploratory subgroup analyses by gender, race, age, ethnicity, and BMI were similar to the results of the overall population.
| Figure 24: Weekly PANSS Total Score-Change in the 12-Week, Placebo-Controlled Study with ABILIFY MAINTENA |
 |
n = the number of patients remaining in the respective study arm at each time point
Longer-Term Efficacy
The efficacy of ABILIFY MAINTENA in maintaining symptomatic control in schizophrenia was established in a double-blind, placebo-controlled, randomized-withdrawal trial in adult patients (Study 2) who met DSM-IV-TR criteria for schizophrenia and who were being treated with at least one antipsychotic medication. Patients had at least a 3-year history of illness and a history of relapse or symptom exacerbation when not receiving antipsychotic treatment.
In addition to the PANSS and CGI-S, clinical ratings during this trial included the:
This trial included:
The primary efficacy endpoint was time from randomization to relapse. Relapse was defined as the first occurrence of one or more of the following criteria:
A pre-planned interim analysis demonstrated a statistically significantly longer time to relapse in patients randomized to the ABILIFY MAINTENA group compared to placebo-treated patients and the trial was subsequently terminated early because maintenance of efficacy was demonstrated. The final analysis demonstrated a statistically significantly longer time to relapse in patients randomized to the ABILIFY MAINTENA group than compared to placebo-treated patients. The Kaplan-Meier curves of the cumulative proportion of patients with relapse during the double-blind treatment phase for ABILIFY MAINTENA and placebo groups are shown in Figure 25.
| Figure 25: Kaplan-Meier Estimation of Cumulative Proportion of Patients with Relapse* |
|
* This figure is based on a total of 80 relapse events.
The key secondary efficacy endpoint, percentage of subjects meeting the relapse criteria, was statistically significantly lower in patients randomized to the ABILIFY MAINTENA group (10%) than in the placebo group (40%).
The efficacy of ABILIFY MAINTENA for the maintenance treatment of bipolar I disorder was established in a 52-week, double-blind, placebo-controlled, randomized withdrawal trial in adult patients who were experiencing a manic episode at trial entry, met DSM-IV-TR criteria for bipolar I disorder, and had a history of at least one previous manic or mixed episode with manic symptoms of sufficient severity to require one of the following interventions: hospitalization and/or treatment with a mood stabilizer, and/or treatment with an antipsychotic agent.
Clinical ratings during this trial included:
This trial included:
The primary efficacy endpoint was time from randomization to recurrence of any mood episode. Recurrence was defined as the first occurrence of one or more of the following criteria:
Analysis demonstrated a statistically significantly longer time to recurrence of any mood episode in subjects randomized to the ABILIFY MAINTENA group than compared to placebo-treated subjects. The Kaplan-Meier curves of the time of recurrence to any mood episode during the double-blind treatment phase for ABILIFY MAINTENA and placebo groups are shown in Figure 26.
| Figure 26: Kaplan-Meier Estimation of Cumulative Recurrence Rate for Any Mood Episode* |
 |
* This figure is based on a total of 103 recurrence events.
Analysis by type of mood recurrence demonstrated a statistically significantly longer time to recurrence for both manic and mixed mood episodes in subjects treated with ABILIFY MAINTENA compared to those treated with placebo. There was no substantial difference between treatment groups in delaying time to recurrence of depressive mood episodes.
An examination of subgroups did not reveal any clear evidence of differential responsiveness on the basis of age, sex, or race.
How Supplied
Pre-filled Dual Chamber Syringe:
ABILIFY MAINTENA (aripiprazole) pre-filled dual chamber syringe for extended-release injectable suspension in single-dose syringes is available in 300 mg or 400 mg strength syringes. The pre-filled dual chamber syringe consists of a front chamber that contains the lyophilized powder of aripiprazole monohydrate and a rear chamber that contains sterile water for injection.
| 300 mg kit (NDC 59148-045-80) |
|
| 400 mg kit (NDC 59148-072-80) |
|
Single-Dose Vial:
ABILIFY MAINTENA (aripiprazole) extended-release injectable suspension in single-dose vials is available in 300 mg or 400 mg strength vials.
| 300 mg kit (NDC 59148-232-12) |
|
| 400 mg kit (NDC 59148-245-12) |
|
Storage
Pre-filled dual chamber syringe:
Store below 30°C [86°F]. Do not freeze. Protect the syringe from light by storing in the original package until time of use.
Vial:
Store at 25°C (77°F), excursions permitted between 15°C and 30°C (59°F to 86°F) [see USP Controlled Room Temperature].
Advise the patient to read the FDA-approved patient labeling (Medication Guide)
Neuroleptic Malignant Syndrome
Counsel patients about a potentially fatal adverse reaction, Neuroleptic Malignant Syndrome (NMS) that has been reported in association with administration of antipsychotic drugs. Advise patients, family members, or caregivers to contact a health care provider or report to the emergency room if they experience signs and symptoms of NMS [see Warnings and Precautions (5.3)].
Tardive Dyskinesia
Counsel patients on the signs and symptoms of tardive dyskinesia and to contact their health care provider if these abnormal movements occur [see Warnings and Precautions (5.4)].
Metabolic Changes
Educate patients about the risk of metabolic changes, how to recognize symptoms of hyperglycemia and diabetes mellitus, and the need for specific monitoring, including blood glucose, lipids, and weight [see Warnings and Precautions (5.5)].
Pathological Gambling and Other Compulsive Behaviors
Advise patients and their caregivers of the possibility that they may experience compulsive urges to shop, increased urges to gamble, compulsive sexual urges, binge eating and/or other compulsive urges and the inability to control these urges while taking aripiprazole. In some cases, but not all, the urges were reported to have stopped when the dose was reduced or stopped [see Warnings and Precautions (5.6)].
Orthostatic Hypotension and Syncope
Educate patients about the risk of orthostatic hypotension and syncope especially early in treatment, and also at times of re-initiating treatment or increases in dosage [see Warnings and Precautions (5.7)].
Leukopenia/Neutropenia
Advise patients with a pre-existing low WBC count or a history of drug-induced leucopenia/neutropenia that they should have their CBC monitored while receiving ABILIFY MAINTENA [see Warnings and Precautions (5.9)].
Potential for Cognitive and Motor Impairment
Inform patients that ABILIFY MAINTENA has the potential to impair judgment, thinking, or motor skills. Caution patients about performing activities requiring mental alertness, such as operating hazardous machinery, or operating a motor vehicle, until they are reasonably certain that ABILIFY MAINTENA therapy does not affect them adversely [see Warnings and Precautions (5.11)].
Heat Exposure and Dehydration
Educate patients regarding appropriate care in avoiding overheating and dehydration [see Warnings and Precautions (5.12)].
Concomitant Medication
Advise patients to inform their health care providers of any changes to their current prescription or over-the-counter medications since there is a potential for clinically significant interactions [see Drug Interactions (7)].
Pregnancy
Advise patients to notify their healthcare provider if they become pregnant or intend to become pregnant during treatment with ABILIFY MAINTENA. Advise patients that ABILIFY MAINTENA may cause extrapyramidal and/or withdrawal symptoms (agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, and feeding disorder) in a neonate. Advise patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ABILIFY MAINTENA during pregnancy [see Use in Specific Populations (8.1)].
Lactation
ABILIFY MAINTENA use during pregnancy may affect milk supply. Advise the lactating patient to discuss any plans for breastfeeding with their healthcare provider, and to monitor the breastfed infant for dehydration and lack of appropriate weight gain [see Use in Specific Populations (8.2)].
Distributed and marketed by Otsuka America Pharmaceutical, Inc., Rockville, MD 20850 USA
Marketed by Lundbeck, Deerfield, IL 60015 USA
ABILIFY MAINTENA is a trademark of Otsuka Pharmaceutical Co., Ltd.
©2026, Otsuka Pharmaceutical Co., Ltd., Tokyo, 101-8535 Japan
| This Medication Guide has been approved by the U.S. Food and Drug Administration. | Revised: 03/2025 | ||
| MEDICATION GUIDE ABILIFY MAINTENA® (a-BIL-i-fy main-TEN-a) (aripiprazole) for extended-release injectable suspension, for intramuscular use | |||
| What is the most important information I should know about ABILIFY MAINTENA? ABILIFY MAINTENA may cause serious side effects, including:
| |||
| What is ABILIFY MAINTENA? ABILIFY MAINTENA is a prescription medicine given by injection by a healthcare provider:
| |||
| Who should not receive ABILIFY MAINTENA? Do not receive ABILIFY MAINTENA if you are allergic to aripiprazole or any of the ingredients in ABILIFY MAINTENA. See the end of this Medication Guide for a complete list of ingredients in ABILIFY MAINTENA. | |||
Before receiving ABILIFY MAINTENA, tell your healthcare provider about all of your medical conditions, including if you:
ABILIFY MAINTENA and other medicines may affect each other causing possible serious side effects. ABILIFY MAINTENA may affect the way other medicines work, and other medicines may affect how ABILIFY MAINTENA works. Your healthcare provider can tell you if it is safe to receive ABILIFY MAINTENA with your other medicines. Do not start or stop any medicines during treatment with ABILIFY MAINTENA without talking to your healthcare provider first. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine. | |||
How should I receive ABILIFY MAINTENA?
| |||
What should I avoid while receiving ABILIFY MAINTENA?
| |||
| What are the possible side effects of ABILIFY MAINTENA? ABILIFY MAINTENA may cause serious side effects, including:
| |||
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These are not all the possible side effects of ABILIFY MAINTENA. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. | |||
| General information about the safe and effective use of ABILIFY MAINTENA. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about ABILIFY MAINTENA that is written for healthcare professionals. | |||
| What are the ingredients in ABILIFY MAINTENA? Active ingredient: aripiprazole monohydrate Inactive ingredients: carboxymethylcellulose sodium, mannitol, sodium phosphate monobasic monohydrate and sodium hydroxide ABILIFY MAINTENA is a trademark of Otsuka Pharmaceutical Co., Ltd. ©2025, Otsuka Pharmaceutical Co., Ltd., Tokyo, 101-8535 Japan For more information, go to www.ABILIFYMAINTENA.com or call 1-800-441-6763. | |||
For deltoid or
gluteal intramuscular
injection only
NDC 59148-045-80
Rx only
Abilify Maintena®
(aripiprazole) for extended release injectable suspension
300 mg PER PRE-FILLED
DUAL CHAMBER SYRINGE
Must be administered by a healthcare professional.
Single-Dose Injection. Discard unused portion.
Attention: Dispense an enclosed
Medication Guide to each patient.
For deltoid or
gluteal intramuscular
injection only
NDC 59148-072-80
Rx only
Abilify Maintena®
(aripiprazole) for extended release injectable suspension
400 mg PER PRE-FILLED
DUAL CHAMBER SYRINGE
Must be administered by a healthcare professional.
Single-Dose Injection. Discard unused portion.
Attention: Dispense an enclosed
Medication Guide to each patient.
NDC 59148-245-12
Single-Dose Injection. Discard Unused Portion.
400 mg
per vial
Abilify Maintena®
(aripiprazole) for extended release injectable suspension
FOR DELTOID OR GLUTEAL INTRAMUSCULAR INJECTION ONLY
Must Be Administered by a Healthcare Professional
Attention: Dispense Enclosed Medication Guide to Each Patient
Rx only
NOT FOR SALE OR REIMBURSEMENT
Single-Dose Injection. Discard Unused Portion.
Abilify Maintena®
(aripiprazole) for extended release injectable suspension
400 mg
per vial
FOR DELTOID OR GLUTEAL INTRAMUSCULAR INJECTION ONLY
Must Be Administered by a Healthcare Professional
Attention: Dispense Enclosed Medication Guide to Each Patient
Rx only
NDC 59148-232-12
Single-Dose Injection. Discard Unused Portion.
300 mg
per vial
Abilify Maintena®
(aripiprazole) for extended release injectable suspension
FOR DELTOID OR GLUTEAL INTRAMUSCULAR INJECTION ONLY
Must Be Administered by a Healthcare Professional
Attention: Dispense Enclosed Medication Guide to Each Patient
Rx only
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1659818 | Abilify Maintena 300 MG Extended Release Injection | PSN | 27 |
| 1602604 | Abilify Maintena 300 MG Extended Release Prefilled Syringe | PSN | 27 |
| 1659814 | Abilify Maintena 400 MG Extended Release Injection | PSN | 27 |
| 1602607 | Abilify Maintena 400 MG Extended Release Prefilled Syringe | PSN | 27 |
| 1659816 | ARIPiprazole 300 MG Extended Release Injection | PSN | 27 |
| 1602163 | ARIPiprazole 300 MG Extended Release Prefilled Syringe | PSN | 27 |
| 1659812 | ARIPiprazole 400 MG Extended Release Injection | PSN | 27 |
| 1602171 | ARIPiprazole 400 MG in 2 ML Extended Release Prefilled Syringe | PSN | 27 |
| 1602604 | 1.5 ML aripiprazole 200 MG/ML Prefilled Syringe [Abilify] | SBD | 27 |
| 1602607 | 2 ML aripiprazole 200 MG/ML Prefilled Syringe [Abilify] | SBD | 27 |
| 1659818 | aripiprazole 300 MG Injection [Abilify] | SBD | 27 |
| 1659814 | aripiprazole 400 MG Injection [Abilify] | SBD | 27 |
| 1602163 | 1.5 ML aripiprazole 200 MG/ML Prefilled Syringe | SCD | 27 |
| 1602171 | 2 ML aripiprazole 200 MG/ML Prefilled Syringe | SCD | 27 |
| 1659816 | aripiprazole 300 MG Injection | SCD | 27 |
| 1659812 | aripiprazole 400 MG Injection | SCD | 27 |
| 1602604 | 1.5 ML Abilify 200 MG/ML Prefilled Syringe | SY | 27 |
| 1602604 | 1.5 ML Abilify Maintena 200 MG/ML Prefilled Syringe | SY | 27 |
| 1602607 | 2 ML Abilify 200 MG/ML Prefilled Syringe | SY | 27 |
| 1602607 | 2 ML Abilify Maintena 200 MG/ML Prefilled Syringe | SY | 27 |
| 1659818 | Abilify 300 MG Injection | SY | 27 |
| 1659814 | Abilify 400 MG Injection | SY | 27 |
| 1602604 | Abilify Maintena 300 MG extended release Prefilled Syringe | SY | 27 |
| 1659818 | Abilify Maintena 300 MG Injection | SY | 27 |
| 1602604 | Abilify Maintena 300 MG per 1.5 ML extended release Prefilled Syringe | SY | 27 |
| 1602607 | Abilify Maintena 400 MG extended release Prefilled Syringe | SY | 27 |
| 1659814 | Abilify Maintena 400 MG Injection | SY | 27 |
| 1602607 | Abilify Maintena 400 MG per 2 ML extended release Prefilled Syringe | SY | 27 |
| 1602163 | aripiprazole 300 MG extended release Prefilled Syringe | SY | 27 |
| 1602163 | aripiprazole 300 MG per 1.5 ML extended release Prefilled Syringe | SY | 27 |
| 1602171 | aripiprazole 400 MG extended release Prefilled Syringe | SY | 27 |
| 1602171 | aripiprazole 400 MG per 2 ML extended release Prefilled Syringe | SY | 27 |
| Class | Version | Type | Effective |
|---|---|---|---|
| ARIPIPRAZOLE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 915afeb5-0b22-42c0-86ea-77abf1c5fe15 | Product name | 1 | 20250307 |
| 726062af-1135-4707-a1d7-57256991bbf9 | Product name | 2 | 20250226 |
| 51c1e9bf-32c5-4a7b-b010-f93a90af7b6e | Product name | 1 | 20231010 |
| 34645f32-2ac4-41bf-9c61-8107e4764a26 | Product name | 1 | 20181210 |
| f8ff9e17-cd6c-4547-98c3-f5db0d1fc25d | Product name | 1 | 20180110 |
| 14eaf619-f285-4cd0-9f39-d9dd8f3d9c02 | Product name | 1 | 20170824 |
| 8223ef47-de85-24dd-a9c7-5a041d2634a2 | Product name | 9 | 20170223 |
| 19c71a3d-ed9c-166b-a7e5-38c250c35631 | Product name | 1 | 20140508 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 59148-045-80 | ABILIFY MAINTENA | 1 in 1 CARTON | KIT | 1 | 27 | |
| 59148-072-80 | ABILIFY MAINTENA | 1 in 1 CARTON | KIT | 1 | 27 | |
| 59148-072-92 | ABILIFY MAINTENA | 1 in 1 CARTON | KIT | 1 | 27 | |
| 59148-232-12 | ABILIFY MAINTENA | 1 in 1 CARTON | KIT | 1 | 27 | |
| 59148-235-70 | ABILIFY MAINTENA | 1.5 mL in 1 VIAL, SINGLE-USE | INJECTION, SUSPENSION, EXTENDED | 1.5 mL | 300 mg in 1.5mL | 27 |
| 59148-238-90 | ABILIFY MAINTENA | 1.9 mL in 1 VIAL, SINGLE-USE | INJECTION, SUSPENSION, EXTENDED | 1.9 mL | 400 mg in 1.9mL | 27 |
| 59148-245-12 | ABILIFY MAINTENA | 1 in 1 CARTON | KIT | 1 | 27 |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 59148-045-80 | EA - Each | 59148-045 | 439a4dd9-8d8f-42cf-a041-b01d4348dd40 | 1 | 2015-02-02 |
| 59148-072-80 | EA - Each | 59148-072 | 466278b8-2d6e-4ec0-b59c-fb32e3fdbeac | 1 | 2015-02-02 |
| 59148-072-92 | EA - Each | 59148-072 | dc3a9d01-9e16-4523-9551-76c6deb394eb | 1 | 2023-03-13 |
| 59148-245-12 | EA - Each | 59148-245 | dd78d7a7-003c-4529-92f7-0753725c27e4 | 1 | 2025-05-14 |
| 59148-232-12 | EA - Each | 59148-232 | 31a786fd-c651-49c9-96d7-f267b715dda3 | 1 | 2025-05-14 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| aripiprazole | ACTIVE INGREDIENT | 82VFR53I78 | 9 | |
| aripiprazole | ACTIVE MOIETY | 82VFR53I78 | 9 | |
| carboxymethylcellulose sodium | INACTIVE INGREDIENT | K679OBS311 | 9 | |
| mannitol | INACTIVE INGREDIENT | 3OWL53L36A | 9 | |
| sodium hydroxide | INACTIVE INGREDIENT | 55X04QC32I | 9 | |
| sodium phosphate, monobasic, monohydrate | INACTIVE INGREDIENT | 593YOG76RN | 9 | |
| Water | INACTIVE INGREDIENT | 059QF0KO0R | 9 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 59148-045 | 59148-045-80 |
| 59148-072 | 59148-072-80, 59148-072-92 |
| 59148-245 | 59148-245-12 |
| 59148-238 | 59148-238-90 |
| 59148-100 | 59148-100-12 |
| 59148-232 | 59148-232-12 |
| 59148-235 | 59148-235-70 |
Every source-derived ingredient row is available through these pages.
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| carboxymethylcellulose sodium | CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | SOLUTION/ DROPS / OPHTHALMIC | 2 mg | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, SUSPENSION / INTRAVITREAL | ADJ PH | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | SOLUTION / TOPICAL | 39 mg | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / SUBMUCOSAL | ADJ PH | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / INTRAPLEURAL | ADJ PH | ||
| sodium phosphate, monobasic, monohydrate | SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE | 593YOG76RN | INJECTION, SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | 30 mg | ||
| mannitol | MANNITOL | 3OWL53L36A | INJECTION, SOLUTION / SUBMUCOSAL | 2.94 %w/v | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | FILM, EXTENDED RELEASE / TRANSDERMAL | 0.85 mg | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | SOLUTION/ DROPS / AURICULAR (OTIC) | ADJ PH | ||
| mannitol | MANNITOL | 3OWL53L36A | TABLET, ORALLY DISINTEGRATING / ORAL | 4364 mg | ||
| mannitol | MANNITOL | 3OWL53L36A | INJECTION, SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | 105 mg | ||
| carboxymethylcellulose sodium | CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | INJECTION, SUSPENSION / INTRAMUSCULAR | 30 mg | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | FILM, SOLUBLE / ORAL | 11 mg | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, SOLUTION / SUBMUCOSAL | ADJ PH | ||
| mannitol | MANNITOL | 3OWL53L36A | INJECTION, SOLUTION / SUBMUCOSAL | 2.94 %w/v | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | SOLUTION / IRRIGATION | ADJ PH | ||
| mannitol | MANNITOL | 3OWL53L36A | CONCENTRATE / INTRAVENOUS | 220 mg | ||
| carboxymethylcellulose sodium | CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | TABLET, FILM COATED / ORAL | 50 mg | ||
| carboxymethylcellulose sodium | CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | SOLUTION / TOPICAL | NA | ||
| carboxymethylcellulose sodium | CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | POWDER, FOR SUSPENSION / INTRAMUSCULAR | 0.7 %w/v | ||
| mannitol | MANNITOL | 3OWL53L36A | POWDER, FOR SUSPENSION / ORAL | 7093 mg | ||
| carboxymethylcellulose sodium | CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | INJECTION / INTRASYNOVIAL | 0.1 %w/v | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / SUBMUCOSAL | ADJ PH | ||
| carboxymethylcellulose sodium | CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | TABLET / ORAL | 280 mg | ||
| sodium phosphate, monobasic, monohydrate | SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE | 593YOG76RN | SUSPENSION / OPHTHALMIC | 0.04 %w/w | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, POWDER, FOR SOLUTION / INTRADERMAL | ADJ PH | ||
| carboxymethylcellulose sodium | CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | INJECTION, SUSPENSION / SOFT TISSUE | 15 mg | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | SOLUTION / INTRATHECAL | ADJ PH | ||
| mannitol | MANNITOL | 3OWL53L36A | SUSPENSION/ DROPS / TOPICAL | 0.3 %w/v | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | SOLUTION / PERIODONTAL | ADJ PH | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | SUSPENSION / AURICULAR (OTIC) | ADJ PH | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / INTRASPINAL | ADJ PH | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | SOLUTION, CONCENTRATE / INTRAVENOUS | ADJ PH | ||
| sodium phosphate, monobasic, monohydrate | SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE | 593YOG76RN | LOTION / TOPICAL | 8 mg | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | SOLUTION / AURICULAR (OTIC) | 0.8 %w/w | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | ENEMA / RECTAL | 0.44 %v/v | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / SUBMUCOSAL | ADJ PH | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS | ADJ PH | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | SPONGE / TOPICAL | ADJ PH | ||
| mannitol | MANNITOL | 3OWL53L36A | INJECTION, SOLUTION / SUBMUCOSAL | 2.94 %w/v | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | SUSPENSION / SUBCUTANEOUS | ADJ PH | ||
| sodium phosphate, monobasic, monohydrate | SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE | 593YOG76RN | INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR | 1.84 mg | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | GEL, METERED / TRANSDERMAL | 350 mg | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRATHECAL | ADJ PH | ||
| mannitol | MANNITOL | 3OWL53L36A | SUSPENSION/ DROPS / OPHTHALMIC | 3.3 %w/v | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / EXTRACORPOREAL | ADJ PH | ||
| carboxymethylcellulose sodium | CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | AEROSOL, FOAM / VAGINAL | 0.2 %w/w | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS | NA | ||
| carboxymethylcellulose sodium | CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | SOLUTION/ DROPS / OPHTHALMIC | 2 mg | ||
| sodium phosphate, monobasic, monohydrate | SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE | 593YOG76RN | INJECTION, SUSPENSION / INTRALESIONAL | 13 mg | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | GEL / TOPICAL | 70 mg | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | POWDER / INTRAVENOUS | ADJ PH | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / INTRA-ARTICULAR | ADJ PH | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | SOLUTION / INTRA-ARTERIAL | ADJ PH | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | SOLUTION / EPIDURAL | ADJ PH | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, SUSPENSION / INTRA-ARTICULAR | ADJ PH | ||
| mannitol | MANNITOL | 3OWL53L36A | WAFER / ORAL | 642 mg | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | GEL, METERED / TRANSDERMAL | 350 mg | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / SUBMUCOSAL | ADJ PH | ||
| sodium phosphate, monobasic, monohydrate | SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE | 593YOG76RN | INJECTION / INTRAVASCULAR | 0.15 mg |
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N202971-001 | ABILIFY MAINTENA KIT | ARIPIPRAZOLE | 300MG/VIAL | FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD | 2013-02-28 | |
| N202971-002 | ABILIFY MAINTENA KIT | ARIPIPRAZOLE | 400MG/VIAL | FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD, RS | 2013-02-28 | |
| N202971-003 | ABILIFY MAINTENA KIT | ARIPIPRAZOLE | 300MG | FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD | 2014-09-29 | |
| N202971-004 | ABILIFY MAINTENA KIT | ARIPIPRAZOLE | 400MG | FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD, RS | 2014-09-29 |
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N202971-001 | 10980803 | 2033-09-24 | U-1632 | 2021-05-19 | |
| N202971-001 | 10980803 | 2033-09-24 | U-543 | 2021-05-19 | |
| N202971-001 | 11154553 | 2033-09-24 | U-1632 | 2021-11-17 | |
| N202971-001 | 11154553 | 2033-09-24 | U-3245 | 2021-11-17 | |
| N202971-001 | 11154553 | 2033-09-24 | U-814 | 2021-11-17 | |
| N202971-001 | 11344547 | 2033-09-24 | U-1632 | 2022-06-24 | |
| N202971-001 | 11344547 | 2033-09-24 | U-3245 | 2022-06-24 | |
| N202971-001 | 11344547 | 2033-09-24 | U-814 | 2022-06-24 | |
| N202971-001 | 11400087 | 2033-09-24 | U-1632 | 2022-08-29 | |
| N202971-001 | 11400087 | 2033-09-24 | U-3245 | 2022-08-29 | |
| N202971-001 | 11400087 | 2033-09-24 | U-814 | 2022-08-29 | |
| N202971-001 | 10525057 | 2034-03-08 | U-1632 | 2020-01-31 | |
| N202971-001 | 10525057 | 2034-03-08 | U-2723 | 2020-01-31 | |
| N202971-001 | 10525057 | 2034-03-08 | U-543 | 2020-01-31 | |
| N202971-001 | 11648347 | 2034-04-06 | Drug product | 2023-06-15 | |
| N202971-001 | 12691056 | 2041-04-01 | U-3245 | 2026-08-26 | |
| N202971-001 | 12691056 | 2041-04-01 | U-814 | 2026-08-26 | |
| N202971-002 | 10980803 | 2033-09-24 | U-1632 | 2021-05-19 | |
| N202971-002 | 10980803 | 2033-09-24 | U-543 | 2021-05-19 | |
| N202971-002 | 11154553 | 2033-09-24 | U-1632 | 2021-11-17 | |
| N202971-002 | 11154553 | 2033-09-24 | U-3245 | 2021-11-17 | |
| N202971-002 | 11154553 | 2033-09-24 | U-814 | 2021-11-17 | |
| N202971-002 | 11344547 | 2033-09-24 | U-1632 | 2022-06-24 | |
| N202971-002 | 11344547 | 2033-09-24 | U-3245 | 2022-06-24 | |
| N202971-002 | 11344547 | 2033-09-24 | U-814 | 2022-06-24 | |
| N202971-002 | 11400087 | 2033-09-24 | U-1632 | 2022-08-29 | |
| N202971-002 | 11400087 | 2033-09-24 | U-3245 | 2022-08-29 | |
| N202971-002 | 11400087 | 2033-09-24 | U-814 | 2022-08-29 | |
| N202971-002 | 10525057 | 2034-03-08 | U-1632 | 2020-01-31 | |
| N202971-002 | 10525057 | 2034-03-08 | U-2723 | 2020-01-31 | |
| N202971-002 | 10525057 | 2034-03-08 | U-543 | 2020-01-31 | |
| N202971-002 | 11648347 | 2034-04-06 | Drug product | 2023-06-15 | |
| N202971-002 | 12691056 | 2041-04-01 | U-3245 | 2026-08-26 | |
| N202971-002 | 12691056 | 2041-04-01 | U-814 | 2026-08-26 | |
| N202971-003 | 10980803 | 2033-09-24 | U-1632 | 2021-05-19 | |
| N202971-003 | 10980803 | 2033-09-24 | U-543 | 2021-05-19 | |
| N202971-003 | 11154553 | 2033-09-24 | U-1632 | 2021-11-17 | |
| N202971-003 | 11154553 | 2033-09-24 | U-3245 | 2021-11-17 | |
| N202971-003 | 11154553 | 2033-09-24 | U-814 | 2021-11-17 | |
| N202971-003 | 11344547 | 2033-09-24 | U-1632 | 2022-06-24 | |
| N202971-003 | 11344547 | 2033-09-24 | U-3245 | 2022-06-24 | |
| N202971-003 | 11344547 | 2033-09-24 | U-814 | 2022-06-24 | |
| N202971-003 | 11400087 | 2033-09-24 | U-1632 | 2022-08-29 | |
| N202971-003 | 11400087 | 2033-09-24 | U-3245 | 2022-08-29 | |
| N202971-003 | 11400087 | 2033-09-24 | U-814 | 2022-08-29 | |
| N202971-003 | 10525057 | 2034-03-08 | U-1632 | 2020-01-31 | |
| N202971-003 | 10525057 | 2034-03-08 | U-2723 | 2020-01-31 | |
| N202971-003 | 10525057 | 2034-03-08 | U-543 | 2020-01-31 | |
| N202971-003 | 11648347 | 2034-04-06 | Drug product | 2023-06-15 | |
| N202971-003 | 12691056 | 2041-04-01 | U-3245 | 2026-08-26 | |
| N202971-003 | 12691056 | 2041-04-01 | U-814 | 2026-08-26 | |
| N202971-004 | 10980803 | 2033-09-24 | U-1632 | 2021-05-19 | |
| N202971-004 | 10980803 | 2033-09-24 | U-543 | 2021-05-19 | |
| N202971-004 | 11154553 | 2033-09-24 | U-1632 | 2021-11-17 | |
| N202971-004 | 11154553 | 2033-09-24 | U-3245 | 2021-11-17 | |
| N202971-004 | 11154553 | 2033-09-24 | U-814 | 2021-11-17 | |
| N202971-004 | 11344547 | 2033-09-24 | U-1632 | 2022-06-24 | |
| N202971-004 | 11344547 | 2033-09-24 | U-3245 | 2022-06-24 | |
| N202971-004 | 11344547 | 2033-09-24 | U-814 | 2022-06-24 | |
| N202971-004 | 11400087 | 2033-09-24 | U-1632 | 2022-08-29 | |
| N202971-004 | 11400087 | 2033-09-24 | U-3245 | 2022-08-29 | |
| N202971-004 | 11400087 | 2033-09-24 | U-814 | 2022-08-29 | |
| N202971-004 | 10525057 | 2034-03-08 | U-1632 | 2020-01-31 | |
| N202971-004 | 10525057 | 2034-03-08 | U-2723 | 2020-01-31 | |
| N202971-004 | 10525057 | 2034-03-08 | U-543 | 2020-01-31 | |
| N202971-004 | 11648347 | 2034-04-06 | Drug product | 2023-06-15 | |
| N202971-004 | 12691056 | 2041-04-01 | U-3245 | 2026-08-26 | |
| N202971-004 | 12691056 | 2041-04-01 | U-814 | 2026-08-26 |
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N202971-001 | ABILIFY MAINTENA KIT | 300MG/VIAL | FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD | 2013-02-28 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N202971-002 | ABILIFY MAINTENA KIT | 400MG/VIAL | FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD, RS | 2013-02-28 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N202971-003 | ABILIFY MAINTENA KIT | 300MG | FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD | 2014-09-29 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N202971-004 | ABILIFY MAINTENA KIT | 400MG | FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD, RS | 2014-09-29 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N202971-001 | ABILIFY MAINTENA KIT | 300MG/VIAL | FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD | 2013-02-28 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N202971-002 | ABILIFY MAINTENA KIT | 400MG/VIAL | FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD, RS | 2013-02-28 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N202971-003 | ABILIFY MAINTENA KIT | 300MG | FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD | 2014-09-29 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N202971-004 | ABILIFY MAINTENA KIT | 400MG | FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD, RS | 2014-09-29 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202971-001 | ABILIFY MAINTENA KIT | 300MG/VIAL | FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD | 2013-02-28 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202971-002 | ABILIFY MAINTENA KIT | 400MG/VIAL | FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD, RS | 2013-02-28 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202971-003 | ABILIFY MAINTENA KIT | 300MG | FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD | 2014-09-29 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202971-004 | ABILIFY MAINTENA KIT | 400MG | FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD, RS | 2014-09-29 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N202971-001 | ABILIFY MAINTENA KIT | 300MG/VIAL | FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD | 2013-02-28 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N202971-002 | ABILIFY MAINTENA KIT | 400MG/VIAL | FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD, RS | 2013-02-28 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N202971-003 | ABILIFY MAINTENA KIT | 300MG | FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD | 2014-09-29 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N202971-004 | ABILIFY MAINTENA KIT | 400MG | FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD, RS | 2014-09-29 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N202971-001 | ABILIFY MAINTENA KIT | 300MG/VIAL | FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD | 2013-02-28 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N202971-002 | ABILIFY MAINTENA KIT | 400MG/VIAL | FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD, RS | 2013-02-28 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N202971-003 | ABILIFY MAINTENA KIT | 300MG | FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD | 2014-09-29 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N202971-004 | ABILIFY MAINTENA KIT | 400MG | FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD, RS | 2014-09-29 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N202971-001 | ABILIFY MAINTENA KIT | 300MG/VIAL | FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD | 2013-02-28 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N202971-002 | ABILIFY MAINTENA KIT | 400MG/VIAL | FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD, RS | 2013-02-28 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N202971-003 | ABILIFY MAINTENA KIT | 300MG | FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD | 2014-09-29 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N202971-004 | ABILIFY MAINTENA KIT | 400MG | FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD | 2014-09-29 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N202971-001 | ABILIFY MAINTENA KIT | 300MG/VIAL | FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD | 2013-02-28 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N202971-002 | ABILIFY MAINTENA KIT | 400MG/VIAL | FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD, RS | 2013-02-28 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N202971-003 | ABILIFY MAINTENA KIT | 300MG | FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD | 2014-09-29 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N202971-004 | ABILIFY MAINTENA KIT | 400MG | FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD | 2014-09-29 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N202971-001 | ABILIFY MAINTENA KIT | 300MG/VIAL | FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | AP | RLD | 2013-02-28 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N202971-002 | ABILIFY MAINTENA KIT | 400MG/VIAL | FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | AP | RLD, RS | 2013-02-28 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N202971-003 | ABILIFY MAINTENA KIT | 300MG | FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD | 2014-09-29 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N202971-004 | ABILIFY MAINTENA KIT | 400MG | FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD | 2014-09-29 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N202971-001 | ABILIFY MAINTENA KIT | 300MG/VIAL | FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | AP | RLD | 2013-02-28 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N202971-002 | ABILIFY MAINTENA KIT | 400MG/VIAL | FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | AP | RLD, RS | 2013-02-28 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N202971-003 | ABILIFY MAINTENA KIT | 300MG | FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD | 2014-09-29 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N202971-004 | ABILIFY MAINTENA KIT | 400MG | FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD | 2014-09-29 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N202971-001 | ABILIFY MAINTENA KIT | 300MG/VIAL | FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD | 2013-02-28 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N202971-002 | ABILIFY MAINTENA KIT | 400MG/VIAL | FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD, RS | 2013-02-28 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N202971-003 | ABILIFY MAINTENA KIT | 300MG | FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD | 2014-09-29 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N202971-004 | ABILIFY MAINTENA KIT | 400MG | FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | RLD | 2014-09-29 | 5bbf6a4d5a75… |
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N202971-001 | AP | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N202971-002 | AP | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N202971-001 | AP | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N202971-002 | AP | 1 | 2680178bc6a6… |
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N202971-001 | 10980803 | 2033-09-24 | U-543 | 2021-05-19 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N202971-001 | 10980803 | 2033-09-24 | U-1632 | 2021-05-19 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N202971-001 | 11154553 | 2033-09-24 | U-1632 | 2021-11-17 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N202971-001 | 11154553 | 2033-09-24 | U-814 | 2021-11-17 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N202971-001 | 11154553 | 2033-09-24 | U-3245 | 2021-11-17 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N202971-001 | 11344547 | 2033-09-24 | U-1632 | 2022-06-24 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N202971-001 | 11344547 | 2033-09-24 | U-3245 | 2022-06-24 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N202971-001 | 11344547 | 2033-09-24 | U-814 | 2022-06-24 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N202971-001 | 11400087 | 2033-09-24 | U-3245 | 2022-08-29 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N202971-001 | 11400087 | 2033-09-24 | U-814 | 2022-08-29 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N202971-001 | 11400087 | 2033-09-24 | U-1632 | 2022-08-29 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N202971-001 | 10525057 | 2034-03-08 | U-543 | 2020-01-31 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N202971-001 | 10525057 | 2034-03-08 | U-1632 | 2020-01-31 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N202971-001 | 10525057 | 2034-03-08 | U-2723 | 2020-01-31 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N202971-001 | 11648347 | 2034-04-06 | Drug product | 2023-06-15 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N202971-001 | 12691056 | 2041-04-01 | U-814 | 2026-08-26 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N202971-001 | 12691056 | 2041-04-01 | U-3245 | 2026-08-26 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N202971-002 | 10980803 | 2033-09-24 | U-543 | 2021-05-19 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N202971-002 | 10980803 | 2033-09-24 | U-1632 | 2021-05-19 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N202971-002 | 11154553 | 2033-09-24 | U-1632 | 2021-11-17 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N202971-002 | 11154553 | 2033-09-24 | U-814 | 2021-11-17 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N202971-002 | 11154553 | 2033-09-24 | U-3245 | 2021-11-17 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N202971-002 | 11344547 | 2033-09-24 | U-1632 | 2022-06-24 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N202971-002 | 11344547 | 2033-09-24 | U-3245 | 2022-06-24 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N202971-002 | 11344547 | 2033-09-24 | U-814 | 2022-06-24 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N202971-002 | 11400087 | 2033-09-24 | U-814 | 2022-08-29 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N202971-002 | 11400087 | 2033-09-24 | U-3245 | 2022-08-29 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N202971-002 | 11400087 | 2033-09-24 | U-1632 | 2022-08-29 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N202971-002 | 10525057 | 2034-03-08 | U-2723 | 2020-01-31 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N202971-002 | 10525057 | 2034-03-08 | U-1632 | 2020-01-31 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N202971-002 | 10525057 | 2034-03-08 | U-543 | 2020-01-31 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N202971-002 | 11648347 | 2034-04-06 | Drug product | 2023-06-15 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N202971-002 | 12691056 | 2041-04-01 | U-814 | 2026-08-26 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N202971-002 | 12691056 | 2041-04-01 | U-3245 | 2026-08-26 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N202971-003 | 10980803 | 2033-09-24 | U-543 | 2021-05-19 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N202971-003 | 10980803 | 2033-09-24 | U-1632 | 2021-05-19 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N202971-003 | 11154553 | 2033-09-24 | U-1632 | 2021-11-17 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N202971-003 | 11154553 | 2033-09-24 | U-814 | 2021-11-17 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N202971-003 | 11154553 | 2033-09-24 | U-3245 | 2021-11-17 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N202971-003 | 11344547 | 2033-09-24 | U-1632 | 2022-06-24 | 84e616aacf4f… |
| Captured | Edition | Application-product | Exclusivity code | Expiration | Source SHA-256 |
|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | N202971-001 | I-746 | 2020-07-27 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N202971-002 | I-746 | 2020-07-27 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N202971-003 | I-746 | 2020-07-27 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N202971-004 | I-746 | 2020-07-27 | 74a2ff9319b5… |
| 2020-12-22 03:56 UTC | 2020-12 | N202971-001 | I-746 | 2020-07-27 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | N202971-002 | I-746 | 2020-07-27 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | N202971-003 | I-746 | 2020-07-27 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | N202971-004 | I-746 | 2020-07-27 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | N202971-001 | I-746 | 2020-07-27 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | N202971-002 | I-746 | 2020-07-27 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | N202971-003 | I-746 | 2020-07-27 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | N202971-004 | I-746 | 2020-07-27 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | N202971-001 | I-746 | 2020-07-27 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | N202971-002 | I-746 | 2020-07-27 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | N202971-003 | I-746 | 2020-07-27 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | N202971-004 | I-746 | 2020-07-27 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | N202971-001 | I-746 | 2020-07-27 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | N202971-002 | I-746 | 2020-07-27 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | N202971-003 | I-746 | 2020-07-27 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | N202971-004 | I-746 | 2020-07-27 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | N202971-001 | I-746 | 2020-07-27 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | N202971-002 | I-746 | 2020-07-27 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | N202971-003 | I-746 | 2020-07-27 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | N202971-004 | I-746 | 2020-07-27 | ea99ee380514… |
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| ABILIFY MAINTENA | ARIPIPRAZOLE | Otsuka America Pharmaceutical, Inc. | ee49f3b1-1650-47ff-9fb1-ea53fe0b92b6 | 2026-03-24 | Boxed warning, Warnings, Adverse reactions | 59148-232-12 59148-245-12 59148-100-12 59148-072-92 59148-238-90 59148-045-80 59148-072-80 59148-235-70 59148-072 59148-232 59148-245 59148-045 59148023570 59148024512 59148007280 59148007292 59148023212 59148010012 59148004580 59148023890 30e40a02-9942-4914-8d84-cf5a8058cec6 ee49f3b1-1650-47ff-9fb1-ea53fe0b92b6 |
Adverse event summaries are temporarily unavailable. Other product information remains available.
