Prior to initiation of treatment with GONAL-f ® RFF Redi-ject ® : Perform a complete gynecologic and endocrinologic evaluation Exclude primary ovarian failure Exclude the possibility of pregnancy Demonstrate tubal patency Evaluate the fertility status of the male partner Prior to initiation of treatment with GONAL-f ® RFF Redi-ject ® : Perform a complete gynecologic and endocrinologic evaluation, and diagnose the ...
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. GONAL-f ® RFF Redi-ject ® is a pre-filled disposable auto-injection device intended for multiple dose use. GONAL-f ® RFF Redi-ject ® can be set in 12.5 International Units increments. Administer GONAL-f ® RFF Redi-ject ® subcutaneously in the abdomen as des...
GONAL-f ® RFF Redi-ject ® (follitropin alfa) injection is a disposable, prefilled single-patient-use pen containing a clear and colorless to slightly yellow solution. Each Redi-ject ® is supplied in a carton containing 31G × 5/16 inch disposable needles to be used for administration. The following package presentations are available: NDC 44087-1115-1 - One GONAL-f ® RFF Redi-ject ® delivers 300 International Units...
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www.Rediject.comPrior to initiation of treatment with GONAL-f® RFF Redi-ject®:
Prior to initiation of treatment with GONAL-f® RFF Redi-ject®:
The dosing scheme is stepwise and is individualized for each woman [see Clinical Studies (14.1)]. Starting doses less than 37.5 International Units have not been studied in clinical trials and are not recommended.
The dosing scheme follows a stepwise approach and is individualized for each woman.
GONAL-f® RFF Redi-ject is a clear and colorless to slightly yellow solution available as:
| • Injection: | GONAL-f® RFF Redi-ject® 300 International Units per 0.48 mL in prefilled, single-patient-use pen |
| • Injection: | GONAL-f® RFF Redi-ject® 450 International Units per 0.72 mL in prefilled, single-patient-use pen |
| • Injection: | GONAL-f® RFF Redi-ject® 900 International Units per 1.44 mL in prefilled, single-patient-use pen |
GONAL-f® RFF Redi-ject® is contraindicated in women who exhibit:
GONAL-f® RFF Redi-ject® should only be used by physicians who are experienced in infertility treatment. GONAL-f® RFF Redi-ject® contains a gonadotropic substance capable of causing Ovarian Hyperstimulation Syndrome (OHSS) in women with or without pulmonary or vascular complications [see Warnings and Precautions (5.2, 5.3, 5.4, 5.5)] and multiple births [see Warnings and Precautions (5.6)]. Gonadotropin therapy requires the availability of appropriate monitoring facilities [see Warnings and Precautions (5.11)]. The lowest effective dose should be used.
Careful attention should be given to the diagnosis of infertility and the selection of candidates for GONAL-f® RFF Redi-ject® therapy [see Indications and Usage (1.1, 1.2) and Dosage and Administration (2.2, 2.3)].
Serious systemic hypersensitivity reactions, including anaphylaxis, have been reported in the postmarketing experience with GONAL-f® and GONAL-f® RFF. Symptoms have included dyspnea, facial edema, pruritus, and urticaria. If an anaphylactic or other serious allergic reaction occurs, initiate appropriate therapy including supportive measures if cardiovascular instability and/or respiratory compromise occur, and discontinue further use.
In order to minimize the hazards associated with abnormal ovarian enlargement that may occur with GONAL-f® RFF Redi-ject® therapy, treatment should be individualized and the lowest effective dose should be used [see Dosage and Administration (2.2, 2.3)]. Use of ultrasound monitoring of ovarian response and/or measurement of serum estradiol levels is important to minimize the risk of ovarian stimulation [see Warnings and Precautions (5.11)].
If the ovaries are abnormally enlarged on the last day of GONAL-f® RFF Redi-ject® therapy, hCG should not be administered in order to reduce the chance of developing Ovarian Hyperstimulation Syndrome (OHSS) [see Warnings and Precautions (5.3)]. Intercourse should be prohibited in women with significant ovarian enlargement after ovulation because of the danger of hemoperitoneum resulting from rupture of ovarian cysts [see Warnings and Precautions (5.3)].
OHSS is a medical entity distinct from uncomplicated ovarian enlargement and may progress rapidly to become a serious medical event. OHSS is characterized by a dramatic increase in vascular permeability, which can result in a rapid accumulation of fluid in the peritoneal cavity, thorax, and potentially, the pericardium. The early warning signs of development of OHSS are severe pelvic pain, nausea, vomiting, and weight gain. Abdominal pain, abdominal distension, gastrointestinal symptoms including nausea, vomiting and diarrhea, severe ovarian enlargement, weight gain, dyspnea, and oliguria have been reported with OHSS. Clinical evaluation may reveal hypovolemia, hemoconcentration, electrolyte imbalances, ascites, hemoperitoneum, pleural effusions, hydrothorax, acute pulmonary distress, and thromboembolic reactions [see Warnings and Precautions (5.4)]. Transient liver function test abnormalities suggestive of hepatic dysfunction with or without morphologic changes on liver biopsy, have been reported in association with OHSS.
OHSS occurs after gonadotropin treatment has been discontinued and it can develop rapidly, reaching its maximum about seven to ten days following treatment. Usually, OHSS resolves spontaneously with the onset of menses. If there is evidence that OHSS may be developing prior to hCG administration [see Warnings and Precautions (5.2)], the hCG must be withheld. Cases of OHSS are more common, more severe, and more protracted if pregnancy occurs; therefore, women should be assessed for the development of OHSS for at least two weeks after hCG administration.
If serious OHSS occurs, gonadotropins, including hCG, should be stopped and consideration should be given as to whether the woman needs to be hospitalized. Treatment is primarily symptomatic and overall should consist of bed rest, fluid and electrolyte management, and analgesics (if needed). Because the use of diuretics can accentuate the diminished intravascular volume, diuretics should be avoided except in the late phase of resolution as described below. The management of OHSS may be divided into three phases as follows:
Ascitic, pleural, and pericardial fluid should not be removed unless there is the necessity to relieve symptoms such as pulmonary distress or cardiac tamponade.
OHSS increases the risk of injury to the ovary. Pelvic examination or intercourse may cause rupture of an ovarian cyst, which may result in hemoperitoneum, and should therefore be avoided.
If bleeding occurs and requires surgical intervention, the clinical objective should be to control the bleeding and retain as much ovarian tissue as possible. A physician experienced in the management of this syndrome, or who is experienced in the management of fluid and electrolyte imbalances should be consulted.
During clinical trials with GONAL-f® RFF, OHSS occurred in 7.2% of 83 women and 4.6% of 237 women treated with GONAL-f® RFF for ovulation induction and during Assisted Reproductive Technology, respectively.
Serious pulmonary conditions (e.g., atelectasis, acute respiratory distress syndrome and exacerbation of asthma) have been reported in women treated with gonadotropins. In addition, thromboembolic events both in association with, and separate from OHSS have been reported in women treated with gonadotropins including GONAL-f® RFF. Intravascular thrombosis and embolism, which may originate in venous or arterial vessels, can result in reduced blood flow to critical organs or the extremities. Women with generally recognized risk factors for thrombosis, such as personal or family history, severe obesity, or thrombophilia, may have an increased risk of venous or arterial thromboembolic events, during or following treatment with gonadotropins. Sequelae of such reactions have included venous thrombophlebitis, pulmonary embolism, pulmonary infarction, cerebral vascular occlusion (stroke), and arterial occlusion resulting in loss of limb and rarely in myocardial infarctions. In rare cases, pulmonary complications and/or thromboembolic reactions have resulted in death. In women with recognized risk factors, the benefits of ovulation induction and assisted reproductive technology need to be weighed against the risks. It should be noted that pregnancy also carries an increased risk of thrombosis.
Ovarian torsion has been reported after treatment with gonadotropins. This may be related to OHSS, pregnancy, previous abdominal surgery, past history of ovarian torsion, previous or current ovarian cyst and polycystic ovaries. Damage to the ovary due to reduced blood supply can be limited by early diagnosis and immediate detorsion.
Multi-fetal gestation and births have been reported with all gonadotropin therapy including therapy with GONAL-f® RFF.
During clinical trials with GONAL-f® RFF, multiple births occurred in 20% of live births in women receiving therapy for ovulation induction and 35.1 % of live births in women undergoing ART.
The woman and her partner should be advised of the potential risk of multi-fetal gestation and birth before beginning therapy with GONAL-f® RFF Redi-ject®.
The incidence of congenital malformations after some ART [specifically in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI)] may be slightly higher than after spontaneous conception. This slightly higher incidence is thought to be related to differences in parental characteristics (e.g., maternal age, maternal and paternal genetic background, sperm characteristics) and to the higher incidence of multi-fetal gestations after IVF or ICSI. There are no indications that the use of gonadotropins during IVF or ICSI is associated with an increased risk of congenital malformations.
Since infertile women undergoing ART often have tubal abnormalities, the incidence of ectopic pregnancy may be increased. Early confirmation of intrauterine pregnancy should be determined by β-hCG testing and transvaginal ultrasound.
The risk of spontaneous abortion (miscarriage) is increased with gonadotropin products. However, causality has not been established. The increased risk may be a factor of the underlying infertility.
There have been infrequent reports of ovarian neoplasms, both benign and malignant, in women who have had multiple drug therapy for controlled ovarian stimulation, however, a causal relationship has not been established.
In most instances, treatment of women with GONAL-f® RFF Redi-ject® will result only in follicular growth and maturation. In the absence of an endogenous LH surge, hCG is given when monitoring of the woman indicates that sufficient follicular development has occurred. This may be estimated by ultrasound alone or in combination with measurement of serum estradiol levels. The combination of both ultrasound and serum estradiol measurement are useful for monitoring follicular growth and maturation, timing of the ovulatory trigger, detecting ovarian enlargement and minimizing the risk of the OHSS and multiple gestation.
The clinical confirmation of ovulation is obtained by direct or indirect indices of progesterone production as well as sonographic evidence of ovulation.
Direct or indirect indices of progesterone production:
Sonographic evidence of ovulation:
The following serious adverse reactions are discussed elsewhere in 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 trial of another drug and may not reflect the rates observed in practice.
The safety of GONAL-f® RFF was examined in two clinical studies (one ovulation induction study and one ART study).
Ovulation Induction
In a multiple cycle (3), assessor-blind, multinational, multicenter, active comparator study vs. a recombinant FSH comparator, a total of 83 oligo-anovulatory infertile women were randomized and underwent ovulation induction with GONAL-f® RFF. Adverse reactions occurring in at least 2.0% of women receiving GONAL-f® RFF are listed in Table 1.
| System Organ Class/Adverse Reactions | GONAL-f® RFF N=83* (176 treatment cycles†) n‡ (%) |
|---|---|
| Central and Peripheral Nervous System | |
| Headache | 22 (26.5%) |
| Gastrointestinal System | |
| Abdominal Pain | 10 (12.0%) |
| Nausea | 3 (3.6%) |
| Flatulence | 3 (3.6%) |
| Diarrhea | 3 (3.6%) |
| Neoplasm | |
| Ovarian Cyst | 3 (3.6%) |
| Reproductive, Female | |
| Ovarian Hyperstimulation | 6 (7.2%) |
| Application Site | |
| Injection Site Pain | 4 (4.8%) |
| Injection Site Inflammation | 2 (2.4%) |
Assisted Reproductive Technology
In a single cycle, assessor-blind, multinational, multicenter, active comparator study vs. a recombinant FSH comparator, a total of 237 normal ovulatory infertile women were randomized and received GONAL-f® RFF as part of an ART [in vitro fertilization (IVF) or intracytoplasmic sperm injection cycle (ICSI)] cycle. All women received pituitary down-regulation with gonadotropin releasing hormone (GnRH) agonist before stimulation. Adverse Reactions occurring in at least 2.0% of women are listed in Table 2.
| System Organ Class/Adverse Reactions | GONAL-f® RFF N=237* n† (%) |
|---|---|
| Gastrointestinal System | |
| Abdominal Pain | 55 (23.2%) |
| Nausea | 19 (8.0%) |
| Body as a Whole- General | |
| Abdomen Enlarged | 33 (13.9%) |
| Central and Peripheral Nervous System | |
| Headache | 44 (18.6%) |
| Application Site Disorders | |
| Injection Site Bruising | 23 (9.7%) |
| Injection Site Pain | 13 (5.5%) |
| Injection Site Inflammation | 10 (4.2%) |
| Injection Site Reaction | 10 (4.2%) |
| Application Site Edema | 6 (2.5%) |
| Reproductive, Female | |
| Ovarian Hyperstimulation | 11 (4.6%) |
The following adverse reactions have been reported during postmarketing use of GONAL-f® RFF. Because these reactions were reported voluntarily from a population of uncertain size, the frequency or a causal relationship to GONAL-f® RFF cannot be reliably determined.
Body as a Whole - General: hypersensitivity reactions including anaphylactoid reactions [see Warnings and Precautions (5.1)]
Respiratory System: asthma
Vascular disorders: thromboembolism [see Warnings and Precautions (5.4)]
No drug-drug interaction studies have been performed.
Risk Summary
GONAL-f® RFF Redi-ject® is not indicated in pregnant women.
The incidence of congenital malformations after some Assisted Reproductive Technology (ART), procedures, specifically in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI)], may be slightly higher than after spontaneous conception. This slightly higher incidence is thought to be related to differences in parental characteristics (e.g., maternal age, maternal and paternal genetic background, sperm characteristics) and to a higher incidence of multi-fetal gestations after IVF or ICSI. There is no human data that the use of gonadotropins (including GONAL-f® RFF Redi-ject®), alone or as part of IVF or ICSI cycles, increases the risk of congenital malformations.
The risk of spontaneous abortion (miscarriage) is increased in women who have used gonadotropins products (including GONAL-f® RFF Redi-ject®) to achieve pregnancy.
In animal studies, the continuous administration of recombinant human FSH during pregnancy resulted in a decrease in the number of viable fetuses and difficult and prolonged delivery. No teratogenic effect has been observed.
In the US general population, the estimated background risk of major birth defects and miscarriage after spontaneous clinically recognized pregnancies, is 2% to 4% and 15% to 20%, respectively.
Data
Human Data
Data on a limited number of exposed pregnancies indicate no adverse reactions of gonadotropins on pregnancy, embryonal or fetal development, parturition or postnatal development following controlled ovarian stimulation.
Animal Data
Embryofetal development studies with recombinant human FSH in rats, where dosing occurred during organogenesis, showed a dose dependent increase in difficult and prolonged parturition in dams, and dose dependent increases in resorptions, pre- and post-implantation losses, and stillborn pups at doses representing 5 and 41 times the lowest clinical dose of 75 IU based on body surface area. Pre-/post-natal development studies with recombinant human FSH in rats, where dosing occurred from mid-gestation through lactation, showed difficult and prolonged parturition in all dams dosed at 41 times the lowest clinical dose of 75 IU based on body surface area, along with maternal death and stillborn pups associated with the difficult and prolonged parturition. This toxicity was not observed in dams and offspring dosed at a level 5 times the lowest clinical dose of 75 IU based on body surface area.
There are no data on the presence of GONAL-F RFF in human milk, the effects on the breastfed infant, or the effects on milk production. Because the secretion of prolactin during lactation can result in inadequate response to ovarian stimulation, advise women not to breast feed during treatment with GONAL-f® RFF Redi-ject®.
Since GONAL-f® RFF Redi-ject® is not indicated in pregnant women, verify a negative pregnancy test before administering GONAL-f® RFF Redi-ject® to a woman [see Dosage and Administration (2.2, 2.3)].
Safety and effectiveness in pediatric patients have not been established.
Safety, efficacy, and pharmacokinetics of GONAL-f® RFF Redi-ject® in women with renal or hepatic insufficiency have not been established.
Aside from possible OHSS [see Warnings and Precautions (5.3)] and multiple gestations [see Warnings and Precautions (5.6)], there is no additional information on the consequences of acute overdosage with GONAL-f® RFF Redi-ject®.
Follitropin alfa, a gonadotropin [human follicle stimulating hormone (hFSH)], is a glycoprotein hormone produced by recombinant DNA technology in a Chinese Hamster Ovary (CHO) cell line. It has a dimeric structure consisting of two glycoprotein subunits (alpha and beta). The alpha and beta subunits have 92 and 111 amino acids, respectively, and their primary and tertiary structures are indistinguishable from those of human follicle stimulating hormone. The molecular weight is approximately 31 kDa (14 kDa for alpha subunit and 17 kDa for beta subunit).
GONAL-f® RFF Redi-ject® (follitropin alfa) injection is a sterile, clear and colorless to slightly yellow solution in disposable, prefilled single-patient-use pen intended for the subcutaneous use.
Each GONAL-f® RFF Redi-ject® pen delivers 300 International Units (22 mcg) follitropin alfa in 0.48 mL and the inactive ingredients: dibasic sodium phosphate (0.43 mg), m-cresol (1.47 mg), methionine (0.05 mg), monobasic sodium phosphate (0.19 mg), poloxamer (0.05 mg), sucrose (29.47 mg) and Water for Injection USP. Phosphoric acid and/or sodium hydroxide may be used to adjust the pH to 7.
Each GONAL-f® RFF Redi-ject® pen delivers 450 International Units (33 mcg) follitropin alfa in 0.72 mL and the inactive ingredients: dibasic sodium phosphate (0.65 mg), m-cresol (2.21 mg), methionine (0.07 mg), monobasic sodium phosphate (0.29 mg), poloxamer (0.07 mg), sucrose (44.20 mg) and Water for Injection USP. Phosphoric acid and/or sodium hydroxide may be used to adjust the pH to 7.
Each GONAL-f® RFF Redi-ject® pen delivers 900 International Units (66 mcg) follitropin alfa in 1.44 mL and the inactive ingredients: dibasic sodium phosphate (1.3 mg), m-cresol (4.42 mg), methionine (0.15 mg), monobasic sodium phosphate (0.58 mg), poloxamer (0.15 mg), sucrose (88.41 mg) and Water for Injection USP. Phosphoric acid and/or sodium hydroxide may be used to adjust the pH to 7.
Under current storage conditions, GONAL-f® RFF Redi-ject® may contain up to 10% of oxidized follitropin alfa.
Follicle stimulating hormone (FSH), the active component in GONAL-f® RFF Redi-ject®, is required for normal follicular growth, follicular maturation, and gonadal steroid production. The level of FSH is critical for the onset and duration of follicular development, and consequently for the timing and number of follicles reaching maturity.
GONAL-f® RFF Redi-ject® stimulates ovarian follicular growth in women who do not have primary ovarian failure. In order to effect the final phase of follicle maturation, resumption of meiosis, and rupture of the follicle in the absence of an endogenous LH surge, human chorionic gonadotropin (hCG) must be given following treatment with GONAL-f® RFF Redi-ject® when monitoring of the woman indicates that appropriate follicular development parameters have been achieved. There is inter-woman variability in response to FSH administration.
Single-dose pharmacokinetics of follitropin alfa were determined following subcutaneous administration of 300 International Units of GONAL-f® RFF Redi-ject® to 21 pre-menopausal healthy female volunteers who were pituitary down-regulated with a GnRH agonist.
The descriptive statistics for the pharmacokinetic parameters are presented in Table 3.
| Parameter | Healthy Volunteers (N=21) | ||||
|---|---|---|---|---|---|
| Mean | % CV | ||||
| Abbreviations are: Cmax: peak concentration (above baseline) tmax: time of Cmax t1/2: elimination half life | |||||
| AUClast (IU hr/L) | 884 | 20% | |||
| Cmax (IU/L) | 9.83 | 23% | |||
| tmax (hr) | 15.5 | 43% | |||
| t1/2 (hr) | 53 | 52% | |||
Absorption
The absorption rate of GONAL-f® RFF Redi-ject® following subcutaneous administration is slower than the elimination rate. Hence, the pharmacokinetics of GONAL-f® RFF Redi-ject® are absorption rate-limited.
Distribution
Human tissue or organ distribution of FSH has not been determined for GONAL-f® RFF Redi-ject®.
Metabolism/Excretion
FSH metabolism and excretion following administration of GONAL-f® RFF Redi-ject® have not been studied in humans.
Long-term studies in animals have not been performed to evaluate the carcinogenic potential of GONAL-f® RFF Redi-ject®. However, follitropin alfa showed no mutagenic activity in a series of tests performed to evaluate its potential genetic toxicity including, bacterial and mammalian cell mutation tests, a chromosomal aberration test and a micronucleus test.
Impaired fertility has been reported in rats, exposed to pharmacological doses of follitropin alfa (greater than or equal to 40 International Units per kg per day, greater than or equal to 5 times the lowest clinical dose of 75 International Units) for extended periods, through reduced fecundity.
The safety and efficacy of GONAL-f® RFF were examined in two clinical studies (one ovulation induction study and one ART study).
Ovulation induction was evaluated in a randomized, assessor-blind, multinational, multicenter, active-controlled, study in oligo-anovulatory infertile women. Women were randomized to either GONAL-f® RFF (n=83), administered subcutaneously, or a comparator recombinant human FSH. The use of insulin-sensitizing agents was allowed during the study. The study was designed to evaluate and compare mean ovulation rates in the first cycle of treatment. Results for GONAL-f® RFF are presented in Table 4. Also presented in this table are secondary outcome results from cycle 1 through cycle 3. The study was not powered to demonstrate differences in any of the secondary outcomes.
| Cycle | GONAL-f® RFF (n=83) | |||
|---|---|---|---|---|
| Cumulative* Percent Ovulation | Cumulative* Clinical Pregnancy† Rate | |||
| Cycle 1 | 72%‡ | 28%§ | ||
| Cycle 2 | 89%§ | 41%§ | ||
| Cycle 3 | 92%§ | 45%§ | ||
* Cumulative rates were determined per woman over cycles 1, 2, and 3.
† Clinical pregnancy was defined as a pregnancy for which a fetal sac (with or without heart activity) was visualized by ultrasound on day 34-36 after hCG administration.
‡ Non-inferior to comparator recombinant human FSH based on a two-sided 95% confidence interval, intent-to-treat analysis.
§ Secondary efficacy outcomes. The study was not powered to demonstrate differences in these outcomes.
The efficacy of GONAL-f® RFF was evaluated in a randomized, assessor-blind, multinational, multicenter, active controlled study in healthy normal ovulatory, infertile women treated for one cycle with controlled ovarian stimulation, as part of an ART [in vitro fertilization (IVF), or intracytoplasmic sperm injection (ICSI)] cycle. Women were randomized to either GONAL-f® RFF (n=237), administered subcutaneously, or a comparator recombinant human FSH. Randomization was stratified by insemination technique, (IVF vs. ICSI). All women received pituitary down-regulation with a GnRH agonist before stimulation with recombinant FSH. Efficacy was assessed using the mean number of fertilized oocytes the day after insemination. The initial doses of GONAL-f® RFF were 150 International Units per day for women less than 35 years of age and 225 International Units per day for women 35 years of age and older. The maximum dose given for both age groups was 450 International Units per day. Treatment outcomes for GONAL-f® RFF are summarized in Table 5.
| Study Outcome | value (n) |
|---|---|
| Mean number of 2PN oocytes per woman | 6.3 (237)* |
| Mean number of 2PN oocytes per subject receiving IVF | 6.1 (88)† |
| Mean number of 2PN oocytes per subject receiving ICSI | 6.5 (132)† |
| Clinical pregnancy‡ rate per attempt | 33.5% (218)§ |
| Clinical pregnancy‡ rate per embryo transfer | 35.8% (204)§ |
| Mean treatment duration in days (range) | 9.7 [3-21] (230)§ |
* Non-inferior to comparator recombinant human FSH based on a two-sided 95% confidence interval, intent-to-treat analysis.
† Subgroup analyses. The study was not powered to demonstrate differences in subgroups.
‡ A clinical pregnancy was defined as a pregnancy during which a fetal sac (with or without heart activity) was visualized by ultrasound on day 35-42 after hCG administration.
§ Secondary efficacy outcomes. The study was not powered to demonstrate differences in these outcomes.
GONAL-f® RFF Redi-ject® (follitropin alfa) injection is a disposable, prefilled single-patient-use pen containing a clear and colorless to slightly yellow solution. Each Redi-ject® is supplied in a carton containing 31G × 5/16 inch disposable needles to be used for administration.
The following package presentations are available:
NDC 44087-1115-1 - One GONAL-f® RFF Redi-ject® delivers 300 International Units per 0.48 mL and 5 single-use disposable 31G × 5/16" needles
NDC 44087-1116-1 - One GONAL-f® RFF Redi-ject® delivers 450 International Units per 0.72 mL and 7 single-use disposable 31G × 5/16" needles
NDC 44087-1117-1 - One GONAL-f® RFF Redi-ject® delivers 900 International Units per 1.44 mL and 14 single-use disposable 31G × 5/16" needles
Pharmacy Storage: Refrigerate at 2°C to 8°C (36°F to 46°F) until dispensed.
Patient Storage: Refrigerate at 2°C to 8°C (36°F to 46°F) until the expiration date, or store at room temperature at 20° to 25°C (68°F to 77°F) for up to three months or until the expiration date, whichever occurs first. Store pen in the original carton to protect from light. After the first injection, store refrigerated at 2°C to 8°C (36°F to 46°F) or at room temperature at 20°C to 25°C (68°F to 77°F) for up to 28 days. Keep the cap on the pen to protect from light. Do not freeze. Discard unused material after 28 days.
See FDA-approved patient labeling (Patient Information and Instructions for Use)
Instruct women on the correct usage and dosing of GONAL-f® RFF Redi-ject® [see Dosage and Administration (2.2, 2.3)]. Instruct women to view the dose display in bright light and to adjust the position of the GONAL-f® RFF Redi-ject® to minimize dose window glare. Caution women not to change the dosage or the schedule of administration unless she is told to do so by her healthcare provider. Instruct women to remove the GONAL-f® RFF Redi-ject® from the refrigerator at least 30 minutes prior to use in order to allow GONAL-f® RFF Redi-ject® to warm to room temperature and avoid the discomfort of a cold injection.
Prior to beginning therapy with GONAL-f® RFF Redi-ject®, inform women about the time commitment and monitoring procedures necessary for treatment [see Dosage and Administration (2.2, 2.3) and Warnings and Precautions (5.11)].
Inform the woman that if she misses or forgets to take a dose of GONAL-f® RFF Redi-ject®, the next dose should not be doubled and she should call her healthcare provider for further dosing instructions.
Inform women regarding the risks of OHSS [see Warnings and Precautions (5.3)] and OHSS-associated symptoms including lung and blood vessel problems [see Warnings and Precautions (5.4)] and ovarian torsion [see Warnings and Precautions (5.5)] with the use of GONAL-f® RFF Redi-ject®.
Inform women regarding the risk of multi-fetal gestation and birth with the use of GONAL-f® RFF Redi-ject® [see Warnings and Precautions (5.6)]
Manufactured by: EMD Serono, Inc., Boston, MA 02210 U.S.A.
U.S. License number: 1773
| PATIENT INFORMATION GONAL-f® RFF Redi-ject® (gon-AL-eff ar-eff-eff REH dee-jekt) (follitropin alfa) injection, for subcutaneous use | |
|---|---|
| This Patient Information has been approved by the U.S. Food and Drug Administration | Revised: 03/2025 |
| GONAL-f RFF* Redi-ject (follitropin alfa) injection for subcutaneous use Read this Patient Information before you start using GONAL-f RFF Redi-ject and each time you get a prescription refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment. | |
| What is GONAL-f RFF Redi-ject? GONAL-f RFF Redi-ject is an injection Pen that delivers a prescription medicine containing follicle-stimulating hormone (FSH) used in infertile women to:
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Who should not use GONAL-f RFF Redi-ject? Do not use the GONAL-f RFF Redi-ject if you:
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| What should I tell my healthcare provider before using GONAL-f RFF Redi- ject? Before you use GONAL-f RFF Redi-ject, tell your healthcare provider if you:
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 use GONAL-f RFF Redi-ject?
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| What are the possible side effects of GONAL-f RFF Redi-ject GONAL-f RFF Redi-ject may cause serious side effects, including:
Tell your healthcare provider if you have any side effect that bothers you or that does not go away. Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. | |
How should I store GONAL-f RFF Redi-ject?
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| General Information about the safe and effective use of GONAL-f RFF Redi- ject. Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use GONAL-f RFF Redi-ject for a condition for which it was not prescribed. Do not give GONAL-f RFF Redi-ject to other people, even if they have the same condition that you have. It may harm them. This Patient Information leaflet summarizes the most important patient information about GONAL-f RFF Redi-ject. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about GONAL-f RFF Redi-ject that is written for health professionals. | |
| What are the ingredients in GONAL-f RFF Redi-ject? Active ingredient: follitropin alfa Inactive ingredients: dibasic sodium phosphate, m-cresol, methionine, monobasic sodium phosphate, poloxamer, sucrose and Water for Injection. Phosphoric acid and/or sodium hydroxide may be used for pH adjustment. For more information, go to www.fertilitylifelines.com, or call 1-866-538-7879.Manufactured by: EMD Serono, Inc. Boston, MA 02210 U.S. License Number: 1773 | |
GONAL-f® RFF Redi-ject®
(follitropin alfa) injection
for subcutaneous use
GONAL-f® RFF Redi-ject®
(follitropin alfa) injection
Important Information
Do not reuse needles.
Do not share your pen or needles with anyone, because doing so can cause an infection.
Do not use the GONAL-f RFF Redi-ject if it has been dropped, or if the pen is cracked or damaged. This can cause an injury.
Gather your supplies
Do not use a microwave or other heating element to warm up the pen.
Step 1 Get ready
Do not shake the pen. If you shake the pen, air bubbles may appear in the medicine.
Do not use any tools (such as a knife, scissors or box cutters) to take the pen out of the carton because they may damage the pen.
Do not use an expired pen. Get a new pen from your healthcare provider.
Step 2 Choose and prepare your injection site
Note: Your healthcare provider should show you the injection sites to use around your stomach area.
Do not blow on or touch the injection site after cleaning.
Step 3 Attach your needle
Do not use the needle if it is damaged, expired or if the outer needle cap or peel-off seal tab is damaged or loose. This can lead to an infection. Throw it away in a sharps disposal container and get a new needle.
Do not attach the needle too tightly, the needle could be difficult to remove after the injection.
Do not recap the needle with the inner needle shield, or you could get a needle stick injury.
| Important | |
| If | Then |
| Using a new pen | Check for a droplet of liquid at the tip of the needle. |
|
|
| |
| Re-using a pen | You do not have to check for droplets of liquid at the tip of the needle. Go to Step 4 Dial your dose. |
Step 4 Dial your dose
Note: Call your healthcare provider if you are unsure of today's intended dose.
Do not push or pull the dose knob while you turn it to avoid damaging it.
Note: You can turn the dose knob backward if you turn it past your intended dose.
Step 5 Inject your dose
Important
Example: If your intended dose is 150 IU, confirm that the Dose Information Display reads "150".
You might bend the needle if you do not insert the needle straight in at a 90° angle.
Do not release the dose knob until you remove the needle from your skin. Hold the dose knob down for a slow count of 5 before you remove the needle from your skin. Then release the dose knob after removal of the needle from your skin.
If the Dose Information Display does not show "0", you did not complete your dose.
Step 6 Remove and throw away your needle
You must remove the needle from the pen and throw it away after each injection to avoid risk of infection.
Step 7 Record your injection
Important
Note: The pen contains extra medicine to ensure that you receive the full amount indicated on the pen (300 IU, 450 IU, or 900 IU).
Appendix A: Completing an incomplete dose
Appendix B: How to create a droplet of liquid
Appendix C: How to throw away used needles and empty pens
Do not throw away loose needles and pens in your household trash.
www.fda.gov/safesharpsdisposal.www.fda.gov/safesharpsdisposal.Appendix D: How to store your pen
For more information, call 1-866-538-7879.
To view the Instructions for Use video, please visit www.Rediject.com.
EMD Serono, Inc
Boston, MA 02210
US License number: 1773
This Instructions for Use has been approved by the U.S. Food and Drug Administration.
Revised: 03/2025
NDC 44087-1115-1
GONAL-f® RFF Redi-ject® 300 IU/0.48 mL
(follitropin alfa) injection
For subcutaneous injection
Do not shake
Rx only
1 Gonal-f® RFF Redi-ject®
5 needles for injection (31 gauge)
EMD
SERONO
NDC 44087-1116-1
GONAL-f® RFF Redi-ject® 450 IU/0.72 mL
(follitropin alfa) injection
For subcutaneous injection
Do not shake
Rx only
1 Gonal-f® RFF Redi-ject®
7 needles for injection (31 gauge)
EMD
SERONO
NDC 44087-1117-1
GONAL-f® RFF Redi-ject® 900 IU/1.44 mL
(follitropin alfa) injection
For subcutaneous injection
Do not shake
Rx only
1 Gonal-f® RFF Redi-ject®
14 needles for injection (31 gauge)
EMD
SERONO
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1654171 | follitropin alfa 300 UNT in 0.48 ML Pen Injector | PSN | 13 |
| 1654179 | follitropin alfa 450 UNT in 0.72 ML Pen Injector | PSN | 13 |
| 1654184 | follitropin alfa 900 UNT in 1.44 ML Pen Injector | PSN | 13 |
| 1594432 | GONAL-f RFF Pen 300 UNT in 0.48 ML Pen Injector | PSN | 13 |
| 1594418 | GONAL-f RFF Pen 450 UNT in 0.72 ML Pen Injector | PSN | 13 |
| 1594334 | GONAL-f RFF Pen 900 UNT in 1.44 ML Pen Injector | PSN | 13 |
| 1594432 | 0.48 ML follitropin alfa 625 UNT/ML Pen Injector [Gonal F] | SBD | 13 |
| 1594418 | 0.72 ML follitropin alfa 625 UNT/ML Pen Injector [Gonal F] | SBD | 13 |
| 1594334 | 1.44 ML follitropin alfa 625 UNT/ML Pen Injector [Gonal F] | SBD | 13 |
| 1654171 | 0.48 ML follitropin alfa 625 UNT/ML Pen Injector | SCD | 13 |
| 1654179 | 0.72 ML follitropin alfa 625 UNT/ML Pen Injector | SCD | 13 |
| 1654184 | 1.44 ML follitropin alfa 625 UNT/ML Pen Injector | SCD | 13 |
| 1594432 | 0.48 ML Gonal F 625 UNT/ML Pen Injector | SY | 13 |
| 1594418 | 0.72 ML Gonal F 625 UNT/ML Pen Injector | SY | 13 |
| 1594334 | 1.44 ML Gonal F 625 UNT/ML Pen Injector | SY | 13 |
| 1654171 | follitropin alfa 300 UNT per 0.48 ML Pen Injector | SY | 13 |
| 1654179 | follitropin alfa 450 UNT per 0.72 ML Pen Injector | SY | 13 |
| 1654184 | follitropin alfa 900 UNT per 1.44 ML Pen Injector | SY | 13 |
| 1594418 | Gonal F 450 UNT per 0.72 ML Pen Injector | SY | 13 |
| 1594432 | Gonal F RFF 300 UNT per 0.48 ML Pen Injector | SY | 13 |
| 1594334 | Gonal F RFF Pen 900 UNT per 1.44 ML Pen Injector | SY | 13 |
| 1594432 | Gonal F RFF Redi-ject 300 UNT per 0.48 ML Pen Injector | SY | 13 |
| 1594418 | Gonal F RFF Redi-ject 450 UNT per 0.72 ML Pen Injector | SY | 13 |
| 1594334 | Gonal F RFF Redi-ject 900 UNT per 1.44 ML Pen Injector | SY | 13 |
| Class | Version | Type | Effective |
|---|---|---|---|
| FOLLITROPIN Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20180813 |
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 726062af-1135-4707-a1d7-57256991bbf9 | Product name | 2 | 20250226 |
| 19306eca-07d9-869e-c7a4-1581f31ccc9a | Product name | 2 | 20200323 |
| 568cb8c1-4b4c-2263-a98f-4f62151e332f | Product name | 2 | 20200323 |
| 79651c92-221b-ba7b-52e2-f902ea49889d | Product name | 2 | 20200323 |
| 0ca1d589-929b-4b33-bc5b-1d84abdafa6a | Product name | 1 | 20150324 |
| fc363c46-397b-4476-ac0f-70e43e8e4592 | Product name | 1 | 20150324 |
| 19c71a3d-ed9c-166b-a7e5-38c250c35631 | Product name | 1 | 20140508 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 44087-1115-1 | Gonal-f RFF Redi-ject | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | 13 | |
| 44087-1115-1 | Gonal-f RFF Redi-ject | 0.5 mL in 1 PACKAGE | INJECTION, SOLUTION | 0.5 | 13 | |
| 44087-1116-1 | Gonal-f RFF Redi-ject | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | 13 | |
| 44087-1116-1 | Gonal-f RFF Redi-ject | 0.75 mL in 1 PACKAGE | INJECTION, SOLUTION | 0.75 | 13 | |
| 44087-1117-1 | Gonal-f RFF Redi-ject | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | 13 | |
| 44087-1117-1 | Gonal-f RFF Redi-ject | 1.5 mL in 1 PACKAGE | INJECTION, SOLUTION | 1.5 | 13 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 44087-1115 | GONAL-F RFF REDI-JECT (FOLLITROPIN) INJECTION, SOLUTION [EMD SERONO, INC.] | 13 | Current NDC, Legacy NDC, 2 package rows | 20250406_b6d11c45-b502-478e-bb28-2ff596ea259c.zip |
| 44087-1116 | GONAL-F RFF REDI-JECT (FOLLITROPIN) INJECTION, SOLUTION [EMD SERONO, INC.] | 13 | Current NDC, Legacy NDC, 2 package rows | 20250406_b6d11c45-b502-478e-bb28-2ff596ea259c.zip |
| 44087-1117 | GONAL-F RFF REDI-JECT (FOLLITROPIN) INJECTION, SOLUTION [EMD SERONO, INC.] | 13 | Current NDC, Legacy NDC, 2 package rows | 20250406_b6d11c45-b502-478e-bb28-2ff596ea259c.zip |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 44087-1115-1 | ML - Milliliter | 44087-1115 | d9867994-433e-4d5c-b166-febe59c660d5 | 1 | 2014-09-03 |
| 44087-1116-1 | ML - Milliliter | 44087-1116 | 4cead4a7-e144-4cd0-b33b-685cf001e7f5 | 1 | 2014-09-03 |
| 44087-1117-1 | ML - Milliliter | 44087-1117 | 0770dba9-5888-4ed0-a40f-a727aed4586e | 1 | 2014-09-03 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| FOLLITROPIN | ACTIVE INGREDIENT | 076WHW89TW | 3 | |
| FOLLITROPIN | ACTIVE MOIETY | 076WHW89TW | 3 | |
| METACRESOL | INACTIVE INGREDIENT | GGO4Y809LO | 3 | |
| METHIONINE | INACTIVE INGREDIENT | AE28F7PNPL | 3 | |
| POLOXAMER 188 | INACTIVE INGREDIENT | LQA7B6G8JG | 3 | |
| SODIUM PHOSPHATE, DIBASIC, DIHYDRATE | INACTIVE INGREDIENT | 94255I6E2T | 3 | |
| SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE | INACTIVE INGREDIENT | 593YOG76RN | 3 | |
| SUCROSE | INACTIVE INGREDIENT | C151H8M554 | 3 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 44087-1115 | 44087-1115-1 |
| 44087-1116 | 44087-1116-1 |
| 44087-1117 | 44087-1117-1 |
| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|---|---|---|---|---|
| 021684 | Gonal-f RFF RediJect | follitropin alfa | 351(a) | Rx | 2026-09-01 |
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 |
|---|---|---|---|---|---|---|
| POLOXAMER 188 | POLOXAMER 188 | LQA7B6G8JG | CAPSULE / ORAL | 151 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | INJECTION / SUBCUTANEOUS | 47.75 mg | ||
| POLOXAMER 188 | POLOXAMER 188 | LQA7B6G8JG | INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS | 2.2 mg | ||
| METHIONINE | METHIONINE | AE28F7PNPL | SUSPENSION / SUBCUTANEOUS | 0.15 %w/v | ||
| POLOXAMER 188 | POLOXAMER 188 | LQA7B6G8JG | SUSPENSION, EXTENDED RELEASE / ORAL | 6 mg | ||
| POLOXAMER 188 | POLOXAMER 188 | LQA7B6G8JG | CAPSULE / ORAL | 151 mg | ||
| SODIUM PHOSPHATE, DIBASIC, DIHYDRATE | SODIUM PHOSPHATE, DIBASIC, DIHYDRATE | 94255I6E2T | INJECTION, SOLUTION / SUBCUTANEOUS | 0.14 %w/v | ||
| POLOXAMER 188 | POLOXAMER 188 | LQA7B6G8JG | CONCENTRATE / ORAL | 3 mg | ||
| SODIUM PHOSPHATE, DIBASIC, DIHYDRATE | SODIUM PHOSPHATE, DIBASIC, DIHYDRATE | 94255I6E2T | INJECTION, SOLUTION / SUBCUTANEOUS | 0.14 %w/v | ||
| SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE | SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE | 593YOG76RN | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / SUBCUTANEOUS | 2 mg | ||
| POLOXAMER 188 | POLOXAMER 188 | LQA7B6G8JG | TABLET / ORAL | 100 mg | ||
| POLOXAMER 188 | POLOXAMER 188 | LQA7B6G8JG | INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS | 2.2 mg | ||
| POLOXAMER 188 | POLOXAMER 188 | LQA7B6G8JG | POWDER, FOR SUSPENSION / INTRAMUSCULAR | 0.2 %w/v | ||
| POLOXAMER 188 | POLOXAMER 188 | LQA7B6G8JG | POWDER, FOR SOLUTION / ORAL | 500 mg | ||
| SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE | SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE | 593YOG76RN | SUSPENSION / SUBCUTANEOUS | 0.07 %w/v | ||
| POLOXAMER 188 | POLOXAMER 188 | LQA7B6G8JG | SOLUTION / ORAL | 1800 mg | ||
| POLOXAMER 188 | POLOXAMER 188 | LQA7B6G8JG | CAPSULE, DELAYED RELEASE / ORAL | 18 mg | ||
| POLOXAMER 188 | POLOXAMER 188 | LQA7B6G8JG | CREAM / TOPICAL | 1 %w/w | ||
| SODIUM PHOSPHATE, DIBASIC, DIHYDRATE | SODIUM PHOSPHATE, DIBASIC, DIHYDRATE | 94255I6E2T | INJECTION, SOLUTION / SUBCUTANEOUS | 0.14 %w/v | ||
| SUCROSE | SUCROSE | C151H8M554 | INJECTION, SOLUTION / INTRAVENOUS | NA | ||
| POLOXAMER 188 | POLOXAMER 188 | LQA7B6G8JG | TABLET, COATED / ORAL | 3 mg | ||
| POLOXAMER 188 | POLOXAMER 188 | LQA7B6G8JG | TABLET / ORAL | 100 mg | ||
| METHIONINE | METHIONINE | AE28F7PNPL | INJECTION, SOLUTION / INTRAVENOUS | 0.16 %w/v | ||
| POLOXAMER 188 | POLOXAMER 188 | LQA7B6G8JG | GRANULE, FOR SOLUTION / ORAL | 624 mg | ||
| SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE | SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE | 593YOG76RN | SUSPENSION / SUBCUTANEOUS | 0.07 %w/v | ||
| SUCROSE | SUCROSE | C151H8M554 | INJECTION, SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS | 1 mg | ||
| POLOXAMER 188 | POLOXAMER 188 | LQA7B6G8JG | SUSPENSION, EXTENDED RELEASE / ORAL | 6 mg | ||
| METHIONINE | METHIONINE | AE28F7PNPL | INJECTION, SUSPENSION / SUBCUTANEOUS | 0.15 %w/v | ||
| POLOXAMER 188 | POLOXAMER 188 | LQA7B6G8JG | SOLUTION / OPHTHALMIC | 0.1 %w/v | ||
| POLOXAMER 188 | POLOXAMER 188 | LQA7B6G8JG | CREAM / TOPICAL | 1 %w/w | ||
| SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE | SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE | 593YOG76RN | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / SUBCUTANEOUS | 2 mg | ||
| POLOXAMER 188 | POLOXAMER 188 | LQA7B6G8JG | TABLET, DELAYED RELEASE / ORAL | 6 mg | ||
| POLOXAMER 188 | POLOXAMER 188 | LQA7B6G8JG | TABLET, DELAYED RELEASE / ORAL | 6 mg | ||
| POLOXAMER 188 | POLOXAMER 188 | LQA7B6G8JG | CAPSULE, DELAYED RELEASE / ORAL | 18 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | INJECTION / SUBCUTANEOUS | 47.75 mg | ||
| POLOXAMER 188 | POLOXAMER 188 | LQA7B6G8JG | POWDER, FOR SOLUTION / ORAL | 500 mg | ||
| POLOXAMER 188 | POLOXAMER 188 | LQA7B6G8JG | INJECTION / INTRAVENOUS | 6 mg | ||
| POLOXAMER 188 | POLOXAMER 188 | LQA7B6G8JG | GRANULE, FOR SOLUTION / ORAL | 624 mg | ||
| POLOXAMER 188 | POLOXAMER 188 | LQA7B6G8JG | SOLUTION / OPHTHALMIC | 0.1 %w/v | ||
| POLOXAMER 188 | POLOXAMER 188 | LQA7B6G8JG | TABLET, FILM COATED / ORAL | 3 mg | ||
| POLOXAMER 188 | POLOXAMER 188 | LQA7B6G8JG | TABLET, COATED / ORAL | 3 mg | ||
| POLOXAMER 188 | POLOXAMER 188 | LQA7B6G8JG | CAPSULE, DELAYED RELEASE / ORAL | 18 mg | ||
| POLOXAMER 188 | POLOXAMER 188 | LQA7B6G8JG | TABLET, DELAYED RELEASE / ORAL | 6 mg | ||
| POLOXAMER 188 | POLOXAMER 188 | LQA7B6G8JG | GRANULE, FOR SOLUTION / ORAL | 624 mg | ||
| POLOXAMER 188 | POLOXAMER 188 | LQA7B6G8JG | GRANULE / ORAL | 81 mg | ||
| POLOXAMER 188 | POLOXAMER 188 | LQA7B6G8JG | GRANULE / ORAL | 81 mg | ||
| METHIONINE | METHIONINE | AE28F7PNPL | INJECTION, SOLUTION / INTRAVENOUS | 0.16 %w/v | ||
| POLOXAMER 188 | POLOXAMER 188 | LQA7B6G8JG | CONCENTRATE / ORAL | 3 mg | ||
| POLOXAMER 188 | POLOXAMER 188 | LQA7B6G8JG | SUSPENSION, EXTENDED RELEASE / ORAL | 6 mg | ||
| SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE | SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE | 593YOG76RN | INJECTION, SOLUTION / INTRAVENOUS | 27 mg | ||
| POLOXAMER 188 | POLOXAMER 188 | LQA7B6G8JG | SUSPENSION / ORAL | 1600 mg | ||
| SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE | SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE | 593YOG76RN | INJECTION, SOLUTION / INTRAVENOUS | 27 mg | ||
| POLOXAMER 188 | POLOXAMER 188 | LQA7B6G8JG | GEL / PERIODONTAL | 55 mg | ||
| POLOXAMER 188 | POLOXAMER 188 | LQA7B6G8JG | TABLET, COATED / ORAL | 3 mg | ||
| POLOXAMER 188 | POLOXAMER 188 | LQA7B6G8JG | TABLET, EXTENDED RELEASE / ORAL | 37 mg | ||
| METHIONINE | METHIONINE | AE28F7PNPL | INJECTION, SUSPENSION / SUBCUTANEOUS | 0.15 %w/v | ||
| POLOXAMER 188 | POLOXAMER 188 | LQA7B6G8JG | POWDER, FOR SUSPENSION / ORAL | 30 mg | ||
| METHIONINE | METHIONINE | AE28F7PNPL | INJECTION, SOLUTION / INTRAVENOUS | 0.16 %w/v | ||
| POLOXAMER 188 | POLOXAMER 188 | LQA7B6G8JG | GEL / PERIODONTAL | 55 mg | ||
| POLOXAMER 188 | POLOXAMER 188 | LQA7B6G8JG | GRANULE / ORAL | 81 mg |
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 |
|---|---|---|---|---|---|---|
| Gonal-f RFF Redi-ject | FOLLITROPIN | EMD Serono, Inc. | b6d11c45-b502-478e-bb28-2ff596ea259c | 2025-04-03 | Warnings, Adverse reactions | 44087-1116-1 44087-1117-1 44087-1115-1 44087-1117 44087-1115 44087-1116 44087111501 44087111701 44087111601 657d712c-ea55-4e2b-9111-ed8dc792887b b6d11c45-b502-478e-bb28-2ff596ea259c |
Adverse event summaries are temporarily unavailable. Other product information remains available.
