- Gonal-f® RFF Redi-ject™ (follitropin alfa injection)
- Gonal-f® Multi-Dose (follitropin alfa for injection)
- Gonal-f® RFF 75 IU (follitropin alfa for injection)
Gonal-f® RFF* Redi-ject®
Enhanced pen ready for an improved patient experience.1
Gonal-f® RFF Redi-ject® is an injection pen that delivers a prescription medicine containing follicle-stimulating hormone (FSH) used in infertile women to:
- Help healthy ovaries develop and release an oocyte
- Cause the ovaries to make multiple (more than 1) oocytes as part of an Assisted Reproductive Technology (ART) program
The only disposable, prefilled, ready-to-use, preassembled FSH pen, designed with patients in mind. After attaching the needle and setting the dose, the pen is ready to inject—no priming needed.
1Ready to use
Ready to use: No priming needed. After attaching the needle and setting the dose, the pen is ready to inject
2Transparent Reservoir
Transparent reservoir: Allows patients to estimate the amount of medicine available in the pen
- It should not replace the dose display
3Smaller increments
Smaller increments: Ability to titrate between approved doses in 12.5 IU increment
- Doses less than 37.5 IU have not been studied in clinical trials and are not recommended
- All 12.5 IU increments are numerically labeled
4Single-dose display
Single-dose display: The only follicle-stimulating hormone pen that shows a single figure in the dose display
5Bidirectional dose dialing
Bidirectional dose dialing:
Allows patients to dial the dose backward and forward without spillage
Available in 300 IU, 450 IU, and 900 IU.
The FSH with proven results in Ovulation Induction (OI) and Assisted Reproduction Technologies (ART).
Ovulation induction was evaluated in a multiple cycle, assessor-blind, multinational, multicenter, active comparator study of oligo-anovulatory infertile women. Women either received Gonal-f® RFF Redi-ject® (n=83) or a comparator (recombinant human FSH). The study was designed to evaluate and compare mean ovulation rates and cumulative clinical pregnancy rates per cycle of treatment.
Gonal-f: Clinically proven results:
Cycle |
Cumulativea Percent Ovulation |
Cumulativea Clinical Pregnancyc Rate |
Cycle 1 |
72%b |
28% c |
Cycle 2 |
89%c |
41% c |
Cycle 3 |
92% c |
45% c |
aCumulative rates were determined per woman over cycles 1, 2, and 3.
bNoninferior to comparator recombinant human FSH based on a two-sided 95% confidence interval, intent-to-treat analysis.
cSecondary efficacy outcomes. The study was not powered to demonstrate differences in these outcomes.
dClinical 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 Human Chorionic Gonadotropin (hCG) administration.
The efficacy of Gonal-f® RFF Redi-ject® was evaluated in a single cycle, assessor-blind, multinational, multicenter, active comparator study of healthy, normal ovulatory, infertile women. Women were randomized to either Gonal-f® RFF Redi-ject® (n=237) or a comparator (recombinant human FSH). Randomization was stratified by insemination technique, (IVF vs ICSI). All women received pituitary down-regulation with a Gonadotropin-releasing hormone (GnRH) agonist before stimulation with recombinant FSH. Efficacy was assessed using the mean number of fertilized oocytes the day after insemination.
IVF=in vitro fertilization.
ICSI=intracytoplasmic sperm injection.
Treatment outcomes for patients on Gonal-f® RFF Redi-ject®:
| Study Outcome | Value (n) |
| Mean number of 2PN oocytes per woman | 6.3 (237)a |
| Mean number of 2PN oocytes per subject receiving IVF | 6.1 (n=88)b |
| Mean number of 2PN oocytes per subject receiving ICSI | 6.5 (n=132)b |
| Clinical pregnancyc rate per attempt | 33.5% (n=218)d |
| Clinical pregnancyc rate per embryo transfer | 35.8% (n=204)d |
| Mean treatment duration in days (range) | 9.7 [3-21] (n=230)d |
aNoninferior to comparator recombinant human FSH based on a two-sided 95% confidence interval, intent-to-treat analysis.
bSubgroup analyses. The study was not powered to demonstrate differences in subgroups.
cA 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.
dSecondary efficacy outcomes. The study was not powered to demonstrate differences in these outcomes.
Ovulation induction was evaluated in a multiple cycle, assessor-blind, multinational, multicenter, active comparator study of oligo-anovulatory infertile women. Women either received Gonal-f® RFF Redi-ject® (n=83) or a comparator (recombinant human FSH). The study was designed to evaluate and compare mean ovulation rates and cumulative clinical pregnancy rates per cycle of treatment.
Gonal-f: Clinically proven results:
Cycle |
Cumulativea Percent Ovulation |
Cumulativea Clinical Pregnancyc Rate |
Cycle 1 |
72%b |
28% c |
Cycle 2 |
89%c |
41% c |
Cycle 3 |
92% c |
45% c |
aCumulative rates were determined per woman over cycles 1, 2, and 3.
bNoninferior to comparator recombinant human FSH based on a two-sided 95% confidence interval, intent-to-treat analysis.
cSecondary efficacy outcomes. The study was not powered to demonstrate differences in these outcomes.
dClinical 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 Human Chorionic Gonadotropin (hCG) administration.
The efficacy of Gonal-f® RFF Redi-ject® was evaluated in a single cycle, assessor-blind, multinational, multicenter, active comparator study of healthy, normal ovulatory, infertile women. Women were randomized to either Gonal-f® RFF Redi-ject® (n=237) or a comparator (recombinant human FSH). Randomization was stratified by insemination technique, (IVF vs ICSI). All women received pituitary down-regulation with a Gonadotropin-releasing hormone (GnRH) agonist before stimulation with recombinant FSH. Efficacy was assessed using the mean number of fertilized oocytes the day after insemination.
IVF=in vitro fertilization.
ICSI=intracytoplasmic sperm injection.
Treatment outcomes for patients on Gonal-f® RFF Redi-ject®:
| Study Outcome | Value (n) |
| Mean number of 2PN oocytes per woman | 6.3 (237)a |
| Mean number of 2PN oocytes per subject receiving IVF | 6.1 (n=88)b |
| Mean number of 2PN oocytes per subject receiving ICSI | 6.5 (n=132)b |
| Clinical pregnancyc rate per attempt | 33.5% (n=218)d |
| Clinical pregnancyc rate per embryo transfer | 35.8% (n=204)d |
| Mean treatment duration in days (range) | 9.7 [3-21] (n=230)d |
aNoninferior to comparator recombinant human FSH based on a two-sided 95% confidence interval, intent-to-treat analysis.
bSubgroup analyses. The study was not powered to demonstrate differences in subgroups.
cA 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.
dSecondary efficacy outcomes. The study was not powered to demonstrate differences in these outcomes.
In a clinical trial for ovulation induction, patients experienced the following adverse events:
| System Organ Class/Adverse Reaction | Gonal-f® RFF Redi-ject® N=83a (176 treatment cyclesb) nc(%) |
| 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 Hyerstimulation | 6 (7.2%) |
| Application Site Disorders | |
| Injection Site Pain | 4 (4.8%) |
| Injection Site Inflammation | 2 (2.4%) |
aTotal number of women treated with Gonal-f® RFF Redi-ject®.
bUp to 3 treatment cycle per woman.
cNumber of women with the adverse reaction.
Common adverse reactions reported at a frequency of ≥2% in an assisted reproductive technologies study.
In a clinical trial for ART, patients experienced the following adverse events:
| System Organ Class/Adverse Reactions | Gonal-f® RFF N=237a nb (%) | |
| 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%) | |
aTotal number of women treated with Gonal-f® RFF Redi-ject®
cNumber of women with the adverse reaction.
Reference: 1. Mahony M, Dwyer A, Barkume R, et al. US human factors engineering evaluation of an updated follitropin alpha pen injector (Gonal-f® RFF Redi-ject®) and instructions for use. Expert Opin Drug Deliv. 2018;15(1):5-15.
Gonal-f® Multi-Dose
A follicle-stimulating hormone (FSH) available in multi-dose vials.
Gonal-f® (follitropin alfa for injection) Multi-Dose is indicated for the induction of ovulation and pregnancy in the anovulatory infertile patient in which the cause of infertility is functional and not due to primary ovarian failure. Gonal-f® is also indicated for the development of multiple follicles in the ovulatory patient participating in an Assisted Reproduction Technology (ART) program.
1Prefilled diluent syringe
Prefilled diluent syringe
21050 IU and 450 IU vials
1050 IU and 450 IU vials
3The only FSH available in multidose vials
The only FSH available in multidose vials
The follicle-stimulating hormone with proven results in Ovulation Induction (OI) and Assisted Reproductive Technology (ART)
Gonal-f® Multi-Dose OI Clinical Study Outcomes
Gonal-f® Multi-Dose ART Study Outcomes
In a phase III, open-label, randomized, comparative, multinational, multicenter study in oligo-anovulatory infertile women who failed to ovulate or conceive following adequate clomiphene citrate therapy study of 222 patients, 110 received Gonal-f® Multi-Dose and 112 received urofollitropin. Ovulation rates were similar between Gonal-f® Multi-Dose and urofollitropin treatment groups.
| Cumulative Ovulation Rate | Gonal-f® Multi-Dose(n=110) | Urofollitropin n=(112) |
| Cycle 1 | 64% | 59% |
| Cycle 2 | 78% | 82% |
| Cycle 3 | 84% | 91% |
In a second randomized, comparative, open-label, multicenter study conducted in 23 U.S. centers, the primary efficacy parameter was ovulation rate. Ovulation rates were similar between Gonal-f® Multi-Dose and urofollitropin treatment groups. 232 patients with oligo-anovulatory infertility received treatment with up to 3 cycles of Gonal-f® Multi-Dose administered subcutaneously (118 patients) or urofollitropin administered intramuscularly (114 patients).
| Cumulative Ovulation Rate | Gonal-f® (n=118) | Urofollitropin (n=114) |
| Cycle 1 | 58% | 68% |
| Cycle 2 | 72% | 86% |
| Cycle 3 | 81% | 93% |
| Cumulative Pregnency* Rate | ||
| Cycle 1 | 13% | 14% |
| Cycle 2 | 25% | 25% |
| Cycle 3 | 37% | 36% |
| Cumulative Pregnency* Rate | Gonal-f® (n=44) | Urofollitropin (n=41) |
| Pregnancies not reaching term | 22.7% | 22% |
| Single Births | 63.6% | 65.9% |
| Multiple Births | 13.7% | 12.2% |
*A 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.
In a phase III, open-label, randomized, comparative, multinational, multicenter study in ovulatory, infertile women undergoing stimulation of multiple follicles for In Vitro Fertilization and Embryo Transfer (IVF/ET) after pituitary down-regulation with a GnRH agonist, Gonal-f® Multi-Dose was shown to offer the same safety and efficacy as urofollitropin. The primary efficacy parameter was the number of mature pre-ovulatory follicles on the day of Human Chorionic Gonadotropin (hCG) administration. There were 60 patients in the Gonal-f® Multi-Dose treatment arm and 63 in the urofollitropin treatment arm.
Treatment outcomes by treatment group in ART:
Cumulative ovulation rate |
Gonal-f® (n=60) |
Urofollitropin (n=63) |
Mean number of follicles ≥14mm in diameter on day of hCG |
7.8 |
9.2 |
Mean number of oocytes recovered per patient |
9.3 |
10.7 |
Mean Serum E2 (pg/mL) on day of hCG |
1576 |
2193 |
Mean treatment duration in days (range) |
9.9 (5-20) |
9.4 (5-14) |
Clinical pregnancy* rate per attempt |
20% |
16% |
Clinical pregnancy* rate per embryo transfer |
24% |
19% |
| For the 22 patients who had a clinical pregnancy (12 in Gonal-f® group; 10 in urofollitropin group), the outcomes of the pregnancy were: | ||
| Pregnancies not reaching term | 25% | 20% |
| Single births | 41.7% | 50% |
| Multiple births | 33.3% | 30% |
*A 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.
In a second randomized, comparative, open-label, multicenter study conducted in 7 US centers, 114 patients with ovulatory infertility undergoing IVF/ET were randomized and received either Gonal-f® Multi-Dose by subcutaneous administration (56 patients) or urofollitropin by intramuscular administration (58 patients) following pituitary down- regulation with a GnRH agonist. The primary efficacy parameter was the number of mature pre-ovulatory follicles on the day of hCG administration.
| Cumulative Ovulation Rate | Gonal-f® (n=56) | Urofollitropin (n=58) |
| Mean number of follicles ≥14mm diameter on day of hCG | 7.2 | 8.3 |
| Mean number of oocytes recovered per patient | 9.3 | 12.3 |
| Mean Serum E2 (pg/mL) on day of hCG | 1236 | 1513 |
| Mean treatment duration in days (range) | 10.1 (5-15) | 9.0 (5-12) |
| Clinical pregnancy* rate per attempt | 21% | 22% |
| Cinical pregnancy* rate per embryo transfer | 26% | 25% |
| For the 25 patients who had a clinical pregnancy (12 in Gonal-f® group; 13 in urofollitropin group), the outcomes of the pregnancy were: | ||
| Pregnancies not reaching term | 33.3% | 30.8% |
| Single births | 41.7% | 38.5% |
| Multiple births | 25% | 30.8% |
*A 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.
In a phase III, open-label, randomized, comparative, multinational, multicenter study in oligo-anovulatory infertile women who failed to ovulate or conceive following adequate clomiphene citrate therapy study of 222 patients, 110 received Gonal-f® Multi-Dose and 112 received urofollitropin. Ovulation rates were similar between Gonal-f® Multi-Dose and urofollitropin treatment groups.
| Cumulative Ovulation Rate | Gonal-f® Multi-Dose(n=110) | Urofollitropin n=(112) |
| Cycle 1 | 64% | 59% |
| Cycle 2 | 78% | 82% |
| Cycle 3 | 84% | 91% |
In a second randomized, comparative, open-label, multicenter study conducted in 23 U.S. centers, the primary efficacy parameter was ovulation rate. Ovulation rates were similar between Gonal-f® Multi-Dose and urofollitropin treatment groups. 232 patients with oligo-anovulatory infertility received treatment with up to 3 cycles of Gonal-f® Multi-Dose administered subcutaneously (118 patients) or urofollitropin administered intramuscularly (114 patients).
| Cumulative Ovulation Rate | Gonal-f® (n=118) | Urofollitropin (n=114) |
| Cycle 1 | 58% | 68% |
| Cycle 2 | 72% | 86% |
| Cycle 3 | 81% | 93% |
| Cumulative Pregnency* Rate | ||
| Cycle 1 | 13% | 14% |
| Cycle 2 | 25% | 25% |
| Cycle 3 | 37% | 36% |
| Cumulative Pregnency* Rate | Gonal-f® (n=44) | Urofollitropin (n=41) |
| Pregnancies not reaching term | 22.7% | 22% |
| Single Births | 63.6% | 65.9% |
| Multiple Births | 13.7% | 12.2% |
*A 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.
In a phase III, open-label, randomized, comparative, multinational, multicenter study in ovulatory, infertile women undergoing stimulation of multiple follicles for In Vitro Fertilization and Embryo Transfer (IVF/ET) after pituitary down-regulation with a GnRH agonist, Gonal-f® Multi-Dose was shown to offer the same safety and efficacy as urofollitropin. The primary efficacy parameter was the number of mature pre-ovulatory follicles on the day of Human Chorionic Gonadotropin (hCG) administration. There were 60 patients in the Gonal-f® Multi-Dose treatment arm and 63 in the urofollitropin treatment arm.
Treatment outcomes by treatment group in ART:
Cumulative ovulation rate |
Gonal-f® (n=60) |
Urofollitropin (n=63) |
Mean number of follicles ≥14mm in diameter on day of hCG |
7.8 |
9.2 |
Mean number of oocytes recovered per patient |
9.3 |
10.7 |
Mean Serum E2 (pg/mL) on day of hCG |
1576 |
2193 |
Mean treatment duration in days (range) |
9.9 (5-20) |
9.4 (5-14) |
Clinical pregnancy* rate per attempt |
20% |
16% |
Clinical pregnancy* rate per embryo transfer |
24% |
19% |
| For the 22 patients who had a clinical pregnancy (12 in Gonal-f® group; 10 in urofollitropin group), the outcomes of the pregnancy were: | ||
| Pregnancies not reaching term | 25% | 20% |
| Single births | 41.7% | 50% |
| Multiple births | 33.3% | 30% |
*A 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.
In a second randomized, comparative, open-label, multicenter study conducted in 7 US centers, 114 patients with ovulatory infertility undergoing IVF/ET were randomized and received either Gonal-f® Multi-Dose by subcutaneous administration (56 patients) or urofollitropin by intramuscular administration (58 patients) following pituitary down- regulation with a GnRH agonist. The primary efficacy parameter was the number of mature pre-ovulatory follicles on the day of hCG administration.
| Cumulative Ovulation Rate | Gonal-f® (n=56) | Urofollitropin (n=58) |
| Mean number of follicles ≥14mm diameter on day of hCG | 7.2 | 8.3 |
| Mean number of oocytes recovered per patient | 9.3 | 12.3 |
| Mean Serum E2 (pg/mL) on day of hCG | 1236 | 1513 |
| Mean treatment duration in days (range) | 10.1 (5-15) | 9.0 (5-12) |
| Clinical pregnancy* rate per attempt | 21% | 22% |
| Cinical pregnancy* rate per embryo transfer | 26% | 25% |
| For the 25 patients who had a clinical pregnancy (12 in Gonal-f® group; 13 in urofollitropin group), the outcomes of the pregnancy were: | ||
| Pregnancies not reaching term | 33.3% | 30.8% |
| Single births | 41.7% | 38.5% |
| Multiple births | 25% | 30.8% |
*A 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.
| Body System (Preferred Term) | Gonal-f® Multi-Dose Patients (%) Experiencing Events Treatment cycles=288* n=188 |
Urofollitropin Patients (%) Experiencing Events Treatment cycles=277* n=144 |
| Reproductive, Female | ||
| Intermenstrual Bleeding | 9.3% | 4.4% |
| Breast Pain Female | 4.2% | 6.1% |
| Ovarian Hyperstimulation† | 6.8% | 3.5% |
| Dysmenorrhea | 2.5% | 6.1% |
| Ovarian Disorder | 1.7% | 2.6% |
| Cervix Lesion | 2.5% | 0.9% |
| Menstrual Disorder | 2.5% | 0.9% |
| Gastrointestinal System | ||
| Abdominal Pain | 9.3% | 12.3% |
| Nausea | 13.6% | 3.5% |
| Flatulence | 6.8% | 8.8% |
| Diarrhea | 7.6% | 3.5% |
| Vomiting | 2.5% | 2.6% |
| Dyspepsia | 1.7% | 3.5% |
| Central and Peripheral Nervous System | ||
| Headache | 22.0% | 20.2% |
| Dizziness | 2.5% | 0.0% |
| Neoplasm | ||
| Ovarian Cyst | 15.3% | 28.9% |
| Body as a Whole - General | ||
| Pain | 5.9% | 6.1% |
| Back Pain | 5.1% | 1.8% |
| Influenza-like Symptoms | 4.2% | 2.6% |
| Fever | 4.2% | 1.8% |
| Respiratory System | ||
| Upper Respiratory Tract Infection | 11.9% | 7.9% |
| Sinusitis | 5.1% | 5.3% |
| Pharyngitis | 2.5% | 3.5% |
| Coughing | 1.7% | 2.6% |
| Rhinitis | 0.8% | 2.6% |
| Skin and Appendages | ||
| Acne | 4.2% | 2.6% |
| Psychiatric | ||
| Emotional Liability | 5.1% | 2.6% |
| Urinary System | ||
| Urinary Tract Infection | 1.7% | 4.4% |
| Resistance Mechanism | ||
| Moniliasis Genital | 2.5% | 0.9% |
| Application Site | ||
| Injection Site Pain | 2.5% | 0.9% |
*Up to 3 cycles of therapy.
†Severe = 0.8% of 118 patients in Study 5727.
| Body System (Preferred Term) | Gonal-f® Patients (%) Experiencing Events n=59 | Urofollitropin Patients (%) Experiencing Events n=61 |
| Reproductive, Female | ||
| Intermenstrual Bleeding | 3.6% | 5.2% |
| Leukorrhea | 1.7% | 3.4% |
| Vaginal Hemorrhage | 3.6% | 3.4% |
| Gastrointestinal System | ||
| Nausea | 5.4% | 1.7% |
| Flatulence | 3.6% | 0.0% |
| Central and Peripheral Nervous System | ||
| Headache | 12.5% | 3.4% |
| Body as a Whole - General | ||
| Abdominal Pain | 8.9% | 3.4% |
| Pelvic Pain Female | 7.1% | 1.7% |
| Respiratory System | ||
| Upper Respiratory Tract Infection | 3.6% | 1.7% |
| Metabolic and Nutritional | ||
| Weight increase | 3.6% | 0.0% |
Gonal-f® RFF 75 IU
A follicle-stimulating hormone (FSH) that you can tailor to each of your patient’s needs.
Gonal-f® RFF 75 IU is indicated for the induction of ovulation and pregnancy in the oligo-anovulatory infertile patient in whom the cause of infertility is functional and not due to primary ovarian failure. Gonal-f® RFF is also indicated for the development of multiple follicles in the ovulatory patient participating in an Assisted Reproductive Technology (ART) program.
- 1Prefilled diluent syringe
- 2Also available in 10-vial pack
The follicle–stimulating hormone with proven results in Ovulation Induction (OI) and Assisted Reproduction Technology (ART).
In a phase III, assessor-blind, randomized, comparative, multinational, multicenter study in oligo-anovulatory infertile women undergoing ovulation induction, patients either received Gonal-f® RFF 75 IU (n=83) or a comparator (recombinant human FSH). Efficacy was assessed using the mean ovulation rate in the first cycle of treatment.
The cumulative ovulation rates for Gonal-f® RFF 75 IU are presented below:
Cumulative percent ovulation ratesa |
Gonal-f® (n=83) |
Cycle 1 |
72%b |
Cycle 2 |
89%c |
Cycle 3 |
92% c |
aCumulative rates were determined per woman over cycles 1, 2, and 3.
bNoninferior to comparator recombinant human FSH based on a two-sided 95% confidence interval, intent-to-treat analysis.
cSecondary efficacy outcomes. The study was not powered to demonstrate differences in these outcomes.
In a phase III, assessor-blind, randomized, comparative, multinational, multicenter study in ovulatory, infertile women undergoing stimulation of multiple follicles for Assisted Reproductive Technologies (ART) after pituitary down-regulation with a GnRH agonist, patients either received Gonal-f® RFF (n=237) or a comparator (recombinant human FSH).
Treatment outcomes for Gonal-f® RFF were:
| Gonal-f® (n=237) | |
| Mean number of 2PN oocytes per patient | 6.3 (n=237)a |
| Mean number of 2PN oocytes per patient receiving IVF | 6.1 (n=88)b |
| Mean number of 2PN oocytes per patient receiving ICSI | 6.5 (n=132)b |
| Clinical pregnancyc rate per attempt | 33.5% (n=218)d |
| The clinical pregnancyc rate per embryo transfer | 35.8% (n=204)d |
| Mean treatment duration in days (range) | 9.7 (3-21) (n=230)d |
aNoninferior to comparator recombinant human FSH based on a two-sided 95% confidence interval, intent-to-treat analysis.
bStudy 21884 was not powered to demonstrate differences in subgroups.
cClinical 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.
dSecondary efficacy parameter. Study 21884 was not powered to demonstrate differences in this parameter.
In a phase III, assessor-blind, randomized, comparative, multinational, multicenter study in oligo-anovulatory infertile women undergoing ovulation induction, patients either received Gonal-f® RFF 75 IU (n=83) or a comparator (recombinant human FSH). Efficacy was assessed using the mean ovulation rate in the first cycle of treatment.
The cumulative ovulation rates for Gonal-f® RFF 75 IU are presented below:
Cumulative percent ovulation ratesa |
Gonal-f® (n=83) |
Cycle 1 |
72%b |
Cycle 2 |
89%c |
Cycle 3 |
92% c |
aCumulative rates were determined per woman over cycles 1, 2, and 3.
bNoninferior to comparator recombinant human FSH based on a two-sided 95% confidence interval, intent-to-treat analysis.
cSecondary efficacy outcomes. The study was not powered to demonstrate differences in these outcomes.
In a phase III, assessor-blind, randomized, comparative, multinational, multicenter study in ovulatory, infertile women undergoing stimulation of multiple follicles for Assisted Reproductive Technologies (ART) after pituitary down-regulation with a GnRH agonist, patients either received Gonal-f® RFF (n=237) or a comparator (recombinant human FSH).
Treatment outcomes for Gonal-f® RFF were:
| Gonal-f® (n=237) | |
| Mean number of 2PN oocytes per patient | 6.3 (n=237)a |
| Mean number of 2PN oocytes per patient receiving IVF | 6.1 (n=88)b |
| Mean number of 2PN oocytes per patient receiving ICSI | 6.5 (n=132)b |
| Clinical pregnancyc rate per attempt | 33.5% (n=218)d |
| The clinical pregnancyc rate per embryo transfer | 35.8% (n=204)d |
| Mean treatment duration in days (range) | 9.7 (3-21) (n=230)d |
aNoninferior to comparator recombinant human FSH based on a two-sided 95% confidence interval, intent-to-treat analysis.
bStudy 21884 was not powered to demonstrate differences in subgroups.
cClinical 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.
dSecondary efficacy parameter. Study 21884 was not powered to demonstrate differences in this parameter.
| Body System (Preferred Term) |
Gonal-f® RFF 75 IU Patients (%) Experiencing Events Treatment cycles=176* n=83† |
|
| Central and Peripheral Nervous System | ||
| Headache | 22 (26.5%) | |
| Dizziness | 2(2.4%) | |
| Migrane | 3(3.6%) | |
| Gastrointestinal System | ||
| Abdominal Pain | 10 (12.0%) | |
| Nausea | 3 (3.6%) | |
| Flatulence | 3 (3.6%) | |
| Diarrhea | 3 (3.6%) | |
| Toothache | 3 (3.6%) | |
| Dyspepsia | 2 (2.4%) | |
| Constipation | 2 (2.4%) | |
| Stomatitis Ulcerative | 2 (2.4%) | |
| Neoplasm | ||
| Ovarian Cyst | 3 (3.6%) | |
| Reproductive, Female | ||
| Ovarian Hyperstimulation | 6 (7.2%) | |
| Breast Pain Female | 5 (6.0%) | |
| Vaginal Hemorrhage | 5 (6.0%) | |
| Gynecological-related pain | 2 (2.4%) | |
| Uterine Hemorrhage | 2 (2.4%) | |
| Respiratory System | ||
| Sinusitis | 5 (6.0%) | |
| Pharyngitis | 6 (7.2%) | |
| Rhinitis | 6 (7.2%) | |
| Coughing | 2 (2.4%) | |
| Application Site | ||
| Injection Site Pain | 4 (4.8%) | |
| Injection Site Inflammation | 2 (2.4%) | |
| Body as a Whole-General | ||
| Back Pain | 3 (3.6%) | |
| Pain | 2 (2.4%) | |
| Fever | 2 (2.4%) | |
| Hot Flushes | 2 (2.4%) | |
| Malaise | 2 (2.4%) | |
| Skin and Appendages | ||
| Acne | 3 (3.6%) | |
| Urinary System | ||
| Micturition Frequency | 2 (2.4%) | |
| Cystitis | 2 (2.4%) | |
| Resistance Mechanism | ||
| Infection Viral | 2 (2.4%) | |
*Up to 3 cycles of therapy.
†Total patients treated with Gonal-f® RFF.
Body System (Preferred Term) |
Gonal-f® RFF Patients (%) Experiencing Events n=237† | |
| Gastrointestinal System | ||
| Abdominal Pain | 55 (23.2%) | |
| Nausea | 19 (8.0%) | |
| Body as a Whole-General | ||
| Abdomen Enlarged | 33 (13.9%) | |
| Pain | 7 (3.0%) | |
| Central and Pheripheral Nervous System | ||
| Headache | 44 (18.6%) | |
| Dizziness | 5 (2.1%) | |
| 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%) | |
| Intermentrual Bleeding | 9 (3.8%) | |
†Total patients treated with Gonal-f® RFF 75 IU.
INDICATIONS AND USAGE:
- Induction of ovulation (OI) and pregnancy in oligo-anovulatory women in whom the cause of infertility is functional and not due to primary ovarian failure
- Development of multiple follicles in ovulatory women as part of an Assisted Reproductive Technology (ART) cycle.
- Prior to treatment, complete an evaluation of female and male partners to determine infertility diagnosis. Primary ovarian failure and potential pregnancy should be excluded.
CONTRAINDICATIONS:
- hypersensitivity to rhFSH preparations or excipients
- high levels of FSH indicating primary gonadal failure
- pregnancy (Pregnancy Category X)
- uncontrolled non-gonadal endocrinopathies (thyroid, adrenal, pituitary disorders)
- sex hormone dependent tumors of the reproductive tract and accessory organs
- tumors of pituitary gland or hypothalamus
- abnormal uterine bleeding, and ovarian cyst or enlargement of undetermined origin, not due to polycystic ovary syndrome.
WARNINGS AND PRECAUTIONS:
- For use by physicians specializing in fertility treatment or reproductive health and only when appropriate monitoring facilities are available.
- Gonal-f® RFF Redi-ject® is a potent gonadotropin. The lowest effective dose should be used given risk of abnormal ovarian enlargement and Ovarian Hyperstimulation Syndrome (OHSS). Ultrasound monitoring of ovarian response and/or measurement of estradiol levels are important to minimize risks. If symptoms of OHSS (severe pelvic or abdominal pain and distension, nausea, vomiting, diarrhea, severe ovarian enlargement, weight gain, dyspnea, oliguria) develop, all gondotropin treatment should be stopped, hCG should be withheld, and intercourse should be prohibited. OHSS can be severe and requires hospitalization and treatment of fluid and electrolyte imbalances. OHSS may occur with or without pregnancy. Women should be assessed for the development of OHSS for at least two weeks after hCG administration.
- Serious systemic hypersensitivity reactions, including anaphylaxis, have been reported in the postmarketing experience. Symptoms have included dyspnea, facial edema, pruritis, 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.
- Thromboembolic events both in association with, and separate from OHSS have been reported in women treated with gonadotropins. 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 OI and ART need to be weighed against the risks.
- Serious pulmonary conditions (e.g., atelectasis, acute respiratory distress syndrome and exacerbation of asthma) have been reported in women treated with gonadotropins.
- 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.
- The couple should be advised of the potential risk of multi-fetal gestation and birth before beginning therapy. During clinical trials, 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 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.
- Since women undergoing ART often have tubal abnormalities, the incidence of ectopic pregnancy may be increased
- The incidence of spontaneous abortion may be increased. However, causality has not been established. This may be a factor of the underlying infertility.
- Both benign and malignant ovarian neoplasms have been infrequently reported; causality has not been established.
- Both ultrasound and serum estradiol measurement should be used to monitor follicular growth and maturation, timing of the ovulatory trigger, detecting ovarian enlargement, and minimizing the risk of the OHSS and multiple gestation.
ADVERSE REACTIONS:
The most common adverse reactions (≥5%) in OI include: headache, abdominal pain, and ovarian hyperstimulation. The most common adverse reactions (≥5%) in ART include: abdominal pain, nausea, abdominal enlargement, headache, and injection site reactions (pain, bruising).
PATIENT COUNSELING:
In addition to advising patients about the proper use of treatment, the duration and necessity of monitoring, handling of missed doses, OHSS, and multi-fetal gestation and birth, patients should be advised to review the Patient Information Leaflet which contains risk information, follow the Instructions for Use for the Gonal-f® RFF Redi-ject®, not share the device or reuse needles, and to ask their HCP about questions.
Please click here for Full Prescribing Information for Gonal-F® RFF Redi-ject®.
*RFF, Revised Formulation Female
INDICATIONS AND USAGE:
For women, Gonal-f® (follitropin alfa for injection) and Gonal-f® RFF* (follitropin alfa injection) are indicated for 1) the induction of ovulation and pregnancy in the anovulatory infertile patient in whom the cause of infertility is functional and not due to primary ovarian failure and 2) for the development of multiple follicles in the ovulatory patient participating in an ART program.
Gonal-f® is also indicated for the induction of spermatogenesis in men with primary and secondary hypogonadotropic hypogonadism in whom the cause of infertility is not due to primary testicular failure.
IMPORTANT RISK INFORMATION:
These products should only be prescribed by physicians specializing in fertility or reproductive health. Use of Gonal-f® or Gonal-f® RFF by women can result in multiple births. Gonal-f® and Gonal-f® RFF are potent gonadotropins capable of causing mild to severe adverse reactions, including Ovarian Hyperstimulation Syndrome (OHSS) in women with or without pulmonary complications. Gonal-f® and Gonal-f® RFF are contraindicated in women and men who exhibit prior hypersensitivity to recombinant FSH preparations or one of their excipients, high levels of FSH indicating primary gonadal failure, uncontrolled thyroid or adrenal dysfunction, sex hormone dependent tumors of the reproductive tract and accessory organs, and an organic intracranial lesion such as a pituitary tumor. Additionally, Gonal-f® and Gonal-f® RFF should not be given to women with abnormal bleeding, presence or enlargement of an ovarian cyst of undetermined origin, or who are pregnant or nursing. The most common side effects reported in women using Gonal-f® and Gonal-f® RFF include headache, abdominal pain, enlarged abdomen, ovarian cysts, nausea, and upper respiratory infections.
Men using Gonal-f® have commonly reported acne, breast pain and growth, fatigue. Injection site reactions have been reported.
Please click here for Full Prescribing Information for Gonal-f® RFF Multi-Dose.
*RFF, Revised Formulation Female
INDICATIONS AND USAGE:
For women, Gonal-f® (follitropin alfa for injection) and Gonal-f® RFF* (follitropin alfa injection) are indicated for 1) the induction of ovulation and pregnancy in the anovulatory infertile patient in whom the cause of infertility is functional and not due to primary ovarian failure and 2) for the development of multiple follicles in the ovulatory patient participating in an ART program.
Gonal-f® is also indicated for the induction of spermatogenesis in men with primary and secondary hypogonadotropic hypogonadism in whom the cause of infertility is not due to primary testicular failure.
IMPORTANT RISK INFORMATION:
These products should only be prescribed by physicians specializing in fertility or reproductive health. Use of Gonal-f® or Gonal-f® RFF by women can result in multiple births. Gonal-f® and Gonal-f® RFF are potent gonadotropins capable of causing mild to severe adverse reactions, including Ovarian Hyperstimulation Syndrome (OHSS) in women with or without pulmonary complications. Gonal-f® and Gonal-f® RFF are contraindicated in women and men who exhibit prior hypersensitivity to recombinant FSH preparations or one of their excipients, high levels of FSH indicating primary gonadal failure, uncontrolled thyroid or adrenal dysfunction, sex hormone dependent tumors of the reproductive tract and accessory organs, and an organic intracranial lesion such as a pituitary tumor. Additionally, Gonal-f® and Gonal-f® RFF should not be given to women with abnormal bleeding, presence or enlargement of an ovarian cyst of undetermined origin, or who are pregnant or nursing. The most common side effects reported in women using Gonal-f® and Gonal-f® RFF include headache, abdominal pain, enlarged abdomen, ovarian cysts, nausea, and upper respiratory infections.
Men using Gonal-f® have commonly reported acne, breast pain and growth, fatigue. Injection site reactions have been reported.
Please click here for Full Prescribing information for Gonal-f® RFF 75 IU.
*revised formulation female
-
Gonal-f® RFF Redi-ject®
(follitropin alfa injection)
-
Gonal-f® RFF Multi-Dose
(follitropin alfa for injection)
-
Gonal-f® RFF 75 IU
(follitropin alfa for injection)