• 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.

 

Gonal-f pen all pieces

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.

Patient Resources

Instructions for Use 

 

Prescribing Information

 

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.

 

Imagery of Gonal-F multi-dose pieces

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%

Patient Resources

Instructions for Use 

 

Prescribing Information

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.

 

Gonal-f RFF 450 IU/.75mL
  • 1
    Prefilled diluent syringe
  • 2
    Also 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.

Patient Resources

Instructions for Use 

 

Prescribing Information

 

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IMPORTANT RISK INFORMATION Expand+
  • 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)