Complete SPL Sections
WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS; and SUICIDAL THOUGHTS AND BEHAVIORS
BOXED WARNING SECTION
Increased Mortality in Elderly Patients with Dementia-Related Psychosis Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Lurasidone hydrochloride tablet is not approved for the treatment of patients with dementia-related psychosis [see Warnings and Precautions (5.1)] . Suicidal Thoughts and Behaviors Antidepressants increased the risk of suicidal thoughts and behavior in pediatric and young adults in short-term studies. Closely monitor all antidepressant-treated patients for clinical worsening, and for emergence of suicidal thoughts and behaviors [see Warnings and Precautions (5.2)] .
1 INDICATIONS AND USAGE
INDICATIONS & USAGE SECTION
Lurasidone hydrochloride tablet is indicated for: Treatment of adult and adolescent patients (13 to 17 years) with schizophrenia [see Clinical Studies (14.1)]. Monotherapy treatment of adult and pediatric patients (10 to 17 years) with major depressive episode associated with bipolar I disorder (bipolar depression) [see Clinical Studies (14.2)]. Adjunctive treatment with lithium or valproate in adult patients with major depressive episode associated with bipolar I disorder (bipolar depression) [see Clinical Studies (14.2)].
2 DOSAGE AND ADMINISTRATION
DOSAGE & ADMINISTRATION SECTION
3 DOSAGE FORMS AND STRENGTHS
DOSAGE FORMS & STRENGTHS SECTION
Lurasidone hydrochloride tablets are available in the following shape and color (Table 1) with respective one-sided debossing. Table 1: Lurasidone Hydrochloride Tablet Presentations Tablet Strength Tablet Color/Shape Tablet Markings 20 mg white to off-white round 578 40 mg white to off-white round 684 60 mg white to off-white modified capsule shaped 639 80 mg pale green oval 685 120 mg white to off-white oval 579
4 CONTRAINDICATIONS
CONTRAINDICATIONS SECTION
Known hypersensitivity to lurasidone hydrochloride or any components in the formulation. Angioedema has been observed with lurasidone [see Adverse Reactions (6.1)] . Strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin, ritonavir, voriconazole, mibefradil, etc.) [see Drug Interactions (7.1)]. Strong CYP3A4 inducers (e.g., rifampin, avasimibe, St. John’s wort, phenytoin, carbamazepine, etc.) [see Drug Interactions (7.1)].
5 WARNINGS AND PRECAUTIONS
WARNINGS AND PRECAUTIONS SECTION
6 ADVERSE REACTIONS
ADVERSE REACTIONS SECTION
The following adverse reactions are discussed in more detail in other sections of the labeling: Increased Mortality in Elderly Patients with Dementia-Related Psychosis [see Boxed Warning and Warnings and Precautions (5.1)] Suicidal Thoughts and Behaviors [see Boxed Warning and Warnings and Precautions (5.2)] Cerebrovascular Adverse Reactions, Including Stroke, in Elderly Patients with Dementia-related Psychosis [see Warnings and Precautions (5.3)] Neuroleptic Malignant Syndrome [see Warnings and Precautions (5.4)] Tardive Dyskinesia [see Warnings and Precautions (5.5)] Metabolic Changes [see Warnings and Precautions (5.6)] Hyperprolactinemia [see Warnings and Precautions (5.7)] Leukopenia, Neutropenia, and Agranulocytosis [see Warnings and Precautions (5.8)] Orthostatic Hypotension and Syncope [see Warnings and Precautions (5.9)] Falls [see Warnings and Precautions ( 5.10 )] Seizures [see Warnings and Precautions (5.11)] Potential for Cognitive and Motor Impairment [see Warnings and Precautions (5.12)] Body Temperature Dysregulation [see Warnings and Precautions (5.13)] Activation of Mania/Hypomania [see Warnings and Precautions (5.14)] Dysphagia [see Warnings and Precautions (5.15)] Neurological Adverse Reactions in Patients with Parkinson’s Disease or Dementia with Lewy Bodies [see Warnings and Precautions (5.16)]
7 DRUG INTERACTIONS
DRUG INTERACTIONS SECTION
8 USE IN SPECIFIC POPULATIONS
USE IN SPECIFIC POPULATIONS SECTION
9 DRUG ABUSE AND DEPENDENCE
DRUG ABUSE AND DEPENDENCE SECTION
10 OVERDOSAGE
OVERDOSAGE SECTION
11 DESCRIPTION
DESCRIPTION SECTION
Lurasidone hydrochloride is an atypical antipsychotic belonging to the chemical class of benzisothiazol derivatives. Its chemical name is (3a R ,4 S ,7 R ,7a S )-2-{(1 R ,2 R )-2-[4-(1,2-benzisothiazol-3-yl)piperazin-1ylmethyl] cyclohexylmethyl}hexahydro-4,7-methano-2 H -isoindole-1,3-dione hydrochloride. Its molecular formula is C 28 H 36 N 4 O 2 S·HCl and its molecular weight is 529.14. The chemical structure is: Lurasidone hydrochloride is a white to off-white powder. It is very slightly soluble in water, practically insoluble or insoluble in 0.1 N HCl, slightly soluble in ethanol, sparingly soluble in methanol, practically insoluble or insoluble in toluene and very slightly soluble in acetone. Lurasidone hydrochloride tablets are intended for oral administration only. Each tablet contains 20 mg, 40 mg, 60 mg, 80 mg, or 120 mg of lurasidone hydrochloride. Inactive ingredients are mannitol, alginic acid, pregelatinized corn starch, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol and carnauba wax. The 80 mg tablets also contain yellow iron oxide, FD&C Blue#1 aluminum lake and black iron oxide.
12 CLINICAL PHARMACOLOGY
CLINICAL PHARMACOLOGY SECTION
13 NONCLINICAL TOXICOLOGY
NONCLINICAL TOXICOLOGY SECTION
14 CLINICAL STUDIES
CLINICAL STUDIES SECTION
16 HOW SUPPLIED/STORAGE AND HANDLING
HOW SUPPLIED SECTION
Lurasidone hydrochloride tablets are available as follows: 20 mg: White to off-white, round, film-coated tablet, debossed with '578' on one side and plain on other side. Bottles of 30 with Child Resistant Cap…………………..NDC 47335-578-83 Bottles of 90 with Child Resistant Cap………………..…NDC 47335-578-81 Bottles of 500……………………………………….……NDC 47335-578-13 40 mg: White to off-white, round, film-coated tablet, debossed with '684' on one side and plain on other side. Bottles of 30 with Child Resistant Cap…………………..NDC 47335-684-83 Bottles of 90 with Child Resistant Cap………………..…NDC 47335-684-81 Bottles of 500……………………………………….……NDC 47335-684-13 60 mg: White to off-white, modified capsule shaped, film-coated tablet, debossed with '639' on one side and plain on other side. Bottles of 30 with Child Resistant Cap…………………..NDC 47335-639-83 Bottles of 90 with Child Resistant Cap………………..…NDC 47335-639-81 Bottles of 500……………………………………….……NDC 47335-639-13 80 mg: Pale green colored, oval shaped, film-coated tablet, debossed with '685' on one side and plain on other side. Bottles of 30 with Child Resistant Cap…………………..NDC 47335-685-83 Bottles of 90 with Child Resistant Cap………………..…NDC 47335-685-81 Bottles of 500……………………………………….……NDC 47335-685-13 120 mg: White to off-white, oval shaped, film-coated tablet, debossed with '579' on one side and plain on other side. Bottles of 30 with Child Resistant Cap…………………..NDC 47335-579-83 Bottles of 90 with Child Resistant Cap………………..…NDC 47335-579-81 Bottles of 500……………………………………….……NDC 47335-579-13 Storage Store lurasidone hydrochloride tablets at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature] .
17 PATIENT COUNSELING INFORMATION
INFORMATION FOR PATIENTS SECTION
Advise the patient to read the FDA-approved patient labeling (Medication Guide). Suicidal Thoughts and Behavior Advise patients and caregivers to look for the emergence of suicidality, especially early during treatment and when the dosage is adjusted up or down and instruct them to report such symptoms to the healthcare provider [see Boxed Warning, Warnings and Precautions (5.2)] . Neuroleptic Malignant Syndrome Counsel patients about a potentially fatal adverse reaction referred to as Neuroleptic Malignant Syndrome (NMS). Advise patients, family members, or caregivers to contact the healthcare provider or to report to the emergency room if they experience signs and symptoms of NMS [see Warnings and Precautions (5.4)] . Tardive Dyskinesia Counsel patients on the signs and symptoms of tardive dyskinesia and to contact their healthcare provider if these abnormal movements occur [see Warnings and Precautions (5.5)] . 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 [ s ee Warnings and Precautions (5.6)] . Hyperprolactinemia Counsel patients on signs and symptoms of hyperprolactinemia that may be associated with chronic use of lurasidonehydrochloride tablets. Advise them to seek medical attention if they experience any of the following: amenorrhea or galactorrhea in females, erectile dysfunction or gynecomastia in males [see Warnings and Precautions (5.7) ]. Leukopenia/Neutropenia Advise patients with a preexisting low WBC or a history of drug-induced leukopenia/neutropenia that they should have their CBC monitored while taking lurasidone hydrochloride tablets [ s ee Warnings and Precautions (5.8)] . Orthostatic Hypotension Educate patients about the risk of orthostatic hypotension, particularly at the time of initiating treatment, re-initiating treatment, or increasing the dose [see Warnings and Precautions (5.9)] . Interference with Cognitive and Motor Performance Caution patients about performing activities requiring mental alertness, such as operating hazardous machinery or operating a motor vehicle, until they are reasonably certain that lurasidonehydrochloride tablets therapy does not affect them adversely [see Warnings and Precautions (5.12)] . Heat Exposure and Dehydration Educate patients regarding appropriate care in avoiding overheating and dehydration [see Warnings and Precautions (5.13)]. Activation of Mania or Hypomania Advise patients and their caregivers to observe for signs of activation of mania/hypomania [ see Warnings and Precautions (5.14) ]. Concomitant Medication Advise patients to inform their physicians if they are taking, or plan to take, any prescription or over-the-counter drugs, because there is a potential for drug interactions [see Drug Interactions (7)] . Pregnancy Advise patients that lurasidonehydrochloride tablets may cause extrapyramidal and/or withdrawal symptoms in a neonate. Advise patients to notify their healthcare provider with a known or suspected pregnancy [see Use in Specific Populations (8.1)] . Advise patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to lurasidone hydrochloride tablets during pregnancy [see Use in Specific Populations (8.1)] . Manufactured by: Sun Pharmaceutical Industries Ltd. Survey No. 1012, Dadra-396 193, U.T. of D & NH and Daman & Diu, India. Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512
SPL MEDGUIDE SECTION
SPL MEDGUIDE SECTION
Dispense with Medication Guide available at: https://www.sunpharma.com/usa/products Medication Guide Lurasidone Hydrochloride (loo-RAS-i-done HYE-droe-KLOR-ide) Tablets What is the most important information I should know about lurasidone hydrochloride tablets? Lurasidone hydrochloride tablets may cause serious side effects, including: • Increased risk of death in elderly people with dementia-related psychosis. Medicines like lurasidone hydrochloride can raise the risk of death in elderly people who have lost touch with reality (psychosis) due to confusion and memory loss (dementia). Lurasidone hydrochloride tablet is not approved for the treatment of people with dementia-related psychosis. Increased risk of suicidal thoughts or actions in children and young adults. Antidepressant medicines may increase suicidal thoughts or actions in some children and young adults within the first few months of treatment and when the dose is changed. o Depression and other serious mental illnesses are the most important causes of suicidal thoughts and actions. Some people may have a particularly high risk of having suicidal thoughts or actions. These include people who have (or have a family history of) depression, bipolar illness (also called manic-depressive illness), or a history of suicidal thoughts or actions. How can I watch for and try to prevent suicidal thoughts and actions in myself or a family member? Pay close attention to any changes, especially sudden changes in mood, behaviors, thoughts, or feelings. This is very important when an antidepressant medicine is started or when the dose is changed. Call the healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings. Keep all follow-up visits with the healthcare provider as scheduled. Call the healthcare provider between visits as needed, especially if you have concerns about symptoms. Call a healthcare provider right away if you or your family member has any of the following symptoms, especially if they are new, worse, or worry you: • thoughts about suicide or dying • attempts to commit suicide • new or worse depression • new or worse anxiety • feeling very agitated or restless • panic attacks • trouble sleeping (insomnia) • new or worse irritability • acting aggressive, being angry, or violent • acting on dangerous impulses • an extreme increase in activity and talking (mania) • other unusual changes in behavior or mood What is lurasidone hydrochloride tablet? Lurasidone hydrochloride tablet is a prescription medicine used: • To treat people 13 years of age or older with schizophrenia. • Alone to treat people 10 years of age and older with depressive episodes that happen with Bipolar I Disorder (bipolar depression). • With the medicine lithium or valproate to treat adults with depressive episodes that happen with Bipolar I Disorder (bipolar depression). It is not known if lurasidone hydrochloride tablets are safe and effective in children: • less than 13 years of age with schizophrenia. • less than 10 years of age with bipolar depression. • for the treatment of irritability associated with autistic disorder. Do not take lurasidone hydrochloride tablets if you are: • allergic to lurasidone hydrochloride or any of the ingredients in lurasidone hydrochloride tablets. See the end of this Medication Guide for a complete list of ingredients in lurasidone hydrochloride tablets. • taking certain other medicines called CYP3A4 inhibitors or inducers including ketoconazole, clarithromycin, ritonavir, voriconazole, mibefradil, rifampin, avasimibe, St. John’s wort, phenytoin, or carbamazepine. Ask your healthcare provider if you are not sure if you are taking any of these medicines. Before taking lurasidone hydrochloride tablets, tell your healthcare provider about all of your medical conditions, including if you: have or have had heart problems or stroke have or have had low or high blood pressure have or have had diabetes or high blood sugar, or have a family history of diabetes or high blood sugar. have or have had high levels of total cholesterol or triglycerides have or have had high prolactin levels have or have had low white blood cell count have or have had seizures have or have had kidney or liver problems are pregnant or plan to become pregnant. It is not known if lurasidone hydrochloride tablets will harm your unborn baby. Talk to your healthcare provider about the risk to your unborn baby if you take lurasidone hydrochloride tablets during pregnancy. o Tell your healthcare provider if you become pregnant or think you are pregnant during treatment with lurasidone hydrochloride tablets. o If you become pregnant during treatment with lurasidone hydrochloride tablets, talk to your healthcare provider about registering with the National Pregnancy Registry for Atypical Antipsychotics. You can register by calling 1-866-961-2388 or go to http://womensmentalhealth.org/clinical-and-researchprograms/pregnancyregistry/. are breastfeeding or plan to breastfeed. It is not known if lurasidone hydrochloride passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment with lurasidone hydrochloride tablets. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Lurasidone hydrochloride tablets and other medicines may affect each other causing possible serious side effects. Lurasidone hydrochloride tablets may affect the way other medicines work, and other medicines may affect how lurasidone hydrochloride tablets work. Your healthcare provider can tell you if it is safe to take Lurasidone hydrochloride tablets with your other medicines. Do not start or stop any other medicines during treatment with lurasidone hydrochloride tablets without talking to your healthcare provider first. Know the medicines you take. Keep a list of your medicines to show your healthcare provider and pharmacist when you get a new medicine. How should I take lurasidone hydrochloride tablets? Take lurasidone hydrochloride tablets exactly as your healthcare provider tells you to take it. Do not change the dose or stop taking lurasidone hydrochloride tablets without first talking to your healthcare provider. Take lurasidone hydrochloride tablets by mouth, with food (at least 350 calories). If you take too many lurasidone hydrochloride tablets, call your healthcare provider or poison control center or go to the nearest hospital emergency room right away. What should I avoid while taking lurasidone hydrochloride tablets? Do not drive, operate heavy machinery, or do other dangerous activities until you know how lurasidone hydrochloride tablet affects you. Lurasidone hydrochloride tablets may make you drowsy. Avoid eating grapefruit or drinking grapefruit juice during treatment with lurasidone hydrochloride tablets. Grapefruit and grapefruit juice may affect the amount of lurasidone hydrochloride tablets in your blood. Do not become too hot or dehydrated during treatment with lurasidone hydrochloride tablets. Do not exercise too much. In hot weather, stay inside in a cool place if possible. Stay out of the sun. Do not wear too much clothing or heavy clothing. Drink plenty of water. What are the possible side effects of lurasidone hydrochloride tablets? Lurasidone hydrochloride tablets may cause serious side effects, including: See “What is the most important information I should know about lurasidone hydrochloride tablets?” Stroke (cerebrovascular problems) in elderly people with dementia-related psychosis that can lead to death. Neuroleptic malignant syndrome (NMS) a serious condition that can lead to death. Call your healthcare provider or go to the nearest hospital emergency room right away if you have some or all of the following signs and symptoms of NMS: high fever stiff muscles confusion increased sweating changes in your breathing, heart rate, and bl...
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 47335-578-83 Lurasidone Hydrochloride Tablets 20 mg PHARMACIST: Dispense with Medication Guide to each patient. Rx only 30 Tablets SUN PHARMA NDC 47335-684-83 Lurasidone Hydrochloride Tablets 40 mg PHARMACIST: Dispense with Medication Guide to each patient. Rx only 30 Tablets SUN PHARMA NDC 47335-639-83 Lurasidone Hydrochloride Tablets 60 mg PHARMACIST: Dispense with Medication Guide to each patient. Rx only 30 Tablets SUN PHARMA NDC 47335-685-83 Lurasidone Hydrochloride Tablets 80 mg PHARMACIST: Dispense with Medication Guide to each patient. Rx only 30 Tablets SUN PHARMA NDC 47335-579-83 Lurasidone Hydrochloride Tablets 120 mg PHARMACIST: Dispense with Medication Guide to each patient. Rx only 30 Tablets SUN PHARMA