Gonal-f® RFF 75 IU
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Our first breakthrough innovation in recombinant FSH therapy

Our original offering to induce follicular development1

 

Gonal-f® RFF* (follitropin alfa for injection) is indicated for:

  • 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
  • Development of multiple follicles in the ovulatory patient as part of an Assisted Reproductive Technology (ART) cycle.

 

Prior to treatment complete an evaluation of female and male partners to determine infertility diagnosis and fertility status. Patients with a tubal obstruction should receive Gonal-f® only if enrolled in an in vitro fertilization program.  Primary ovarian failure and pregnancy should be excluded.

stats

As the #1 most prescribed r-hFSH treatment in the world, Gonal-f® has helped bring more than 3 million babies to life.2,3

Clinical trial efficacy in OI and ART1

Ovulation induction (OI) study

Clinical trial

Study design

 

Study 22240 was a phase III, assessor-blind, randomized, comparative, multinational, multicenter study in oligo-anovulatory infertile women undergoing ovulation induction. Patients 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. Efficacy was assessed using the mean ovulation rate in the first cycle of treatment. The cycle 1 ovulation rate (primary outcome) for Gonal-f® RFF* is presented in the table below. Additionally, this table includes cumulative secondary outcome results from cycle 1 through 3. Study 22240 was not powered to demonstrate differences in these secondary outcomes.

 

Results with Gonal-f® RFF* 75 IU

 

Cumulative Ovulation Ratea

Gonal-f® RFF* 75 IU (n=83)

Cycle 1

72%b

Cycle 2

89%c

Cycle 3

92%c

 

a Cumulative rates were determined per woman over cycles 1, 2, and 3.

b Noninferior to comparator recombinant human FSH based on a two-sided 95% confidence interval, intent-to-treat analysis.

c Secondary efficacy outcomes. The study was not powered to demonstrate differences in these outcomes.

Adverse reactions

The following common adverse reactions were reported at ≥2% in one OI clinical trial, Study 22240.

 

Body System
Preferred Term

Gonal-f® RFF* 75 IU Patients (%) Experiencing Events
Treatment cycles=176n=83b

Central and peripheral nervous system

Headache

22 (26.5%)

Dizziness

2 (2.4%)

Migraine

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 flashes

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%)

 

a Up to 3 cycles of therapy.

b Total patients treated with Gonal-f® RFF* 75 IU.

Assisted reproductive technology (ART) study

Clinical trial

Study design

 

Study 21884 was 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 were randomized to either Gonal-f® RFF* (n=237), administered subcutaneously, or a comparator recombinant human FSH. Randomization was stratified by insemination technique [conventional in vitro fertilization (IVF) vs. intra-cytoplasmic sperm injection (ICSI)]. Efficacy was assessed using the mean number of fertilized oocytes the day after insemination. The initial doses of Gonal-f® RFF* were 150 IU a day for patients < 35 years old and 225 IU for patients ≥ 35 years old. The maximal dose allowed for both age groups was 450 IU per day. Treatment outcomes for Gonal-f® RFF* are summarized below.

 

Results with Gonal-f® RFF* 75 IU

 

Study Outcome

Gonal-f® RFF* 75 IU (n=56)

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

 

Clinical pregnancyc rate per embryo transfer

 

35.8% (n=204)d

 

Mean treatment duration in days (range)

 

9.7 (3-21) (n=230)d

 

 

a  Noninferior to comparator recombinant human FSH based on a two-sided 95% confidence interval, intent-to-treat analysis.

b  Study was not powered to demonstrate differences in subgroups.

c  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.

d  Secondary efficacy parameter. Study was not powered to demonstrate differences in this parameter.

Adverse reactions

The following common adverse reactions were reported at ≥2% in one ART clinical trial, Study 21884.

 

Body System
Preferred Term
Gonal-f® RFF* 75 IU Patients (%) Experiencing Events n=237a

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 peripheral 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%)

Intermenstrual bleeding

9 (3.8%)

 

a Total patients treated with Gonal-f® RFF* 75 IU.

*RFF = revised formulation female.

Prescribing information

 

 English

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Instructions for use

 

 English

Injection training videos

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Patient medication savings

Financial support for eligible patients

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QUESTIONS OR REQUESTS?

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References

1. Gonal-f® RFF* 75 IU (follitropin alfa for injection)  [Prescribing Information]. Rockland, MA: EMD Serono, Inc.; 2018.

2. Data on file. IQVIA Market Data Analysis. December 2019.

3. Longobardi S, Seidler A, Martins J, et al. An evaluation of the use and handling errors of currently available recombinant human follicle-stimulating hormone pen injectors by women with infertility and fertility nurses. Expert Opin Drug Deliv. 2019;16(9):1003-1014.

IMPORTANT RISK INFORMATION & INDICATIONS AND USAGE

Important Risk Information for Gonal-f® RFF* 75 IU (follitropin alfa for injection)

Contraindications:

  • Prior hypersensitivity to rhFSH preparations or 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
  • Organic intracranial lesion such as a pituitary tumor
  • Abnormal uterine bleeding of undetermined origin
  • Ovarian cyst or enlargement of undetermined origin
  • Pregnancy

 

WARNINGS

For use by physicians specializing in fertility treatment or reproductive health and only when appropriate monitoring facilities are available. Gonal-f® is a potent gonadotropic substance capable of causing Ovarian Hyperstimulation Syndrome (OHSS) in women with or without pulmonary or vascular complications. Monitor ovarian response with serum estradiol and vaginal ultrasound on a regular basis. The lowest effective dose should be used.

Overstimulation of the Ovary During FSH Therapy:

  • Ovarian Enlargement:  If the ovaries are abnormally enlarged on the last day of Gonal-f® RFF* therapy, hCG should not be administered in this course of therapy
  • Ovarian Hyperstimulation Syndrome (OHSS): OHSS is a medical event distinct from uncomplicated ovarian enlargement. Severe OHSS may progress rapidly to become a serious medical event. If severe OHSS occurs, treatment must be stopped and the patient should be hospitalized.

Pulmonary and Vascular Complications:

  • Serious pulmonary complications (e.g., atelectasis, acute respiratory distress syndrome and exacerbation of asthma) have been reported. Thromboembolic events both in association with, and separate from OHSS have been reported in women treated with gonadotropins including Gonal-f® RFF*. Sequelae of such events have included venous thrombophlebitis, pulmonary embolism, pulmonary infarction, cerebral vascular occlusion (stroke), and arterial occlusion resulting in loss of limb. In rare cases, pulmonary complications and/or thromboembolic reactions have resulted in death.

Multiple Births

  • In Study 2240 for women receiving Gonal-f® RFF* over three treatment cycles, 20% of live births were multiple births. In Study 21884, 35.1% of live births were multiple births in women receiving Gonal-f® RFF*. The rate of multiple births is dependent on the number of embryos transferred. The patient should be advised of the potential risk of multiple births before starting treatment

PRECAUTIONS

  • General: Careful attention given to the diagnosis of infertility
  • Information for Patients: Inform patients of duration of treatment, required monitoring of their condition, risks of ovarian hyperstimulation syndrome and multiple births
  • Laboratory Tests: 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.
  • Nursing Mothers: It is not known whether this drug is excreted in human milk and because of the potential for serious adverse reactions in the nursing infant, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother

Adverse Reactions:

The most common adverse reactions (≥5%) in OI include: headache, abdominal pain, ovarian hyperstimulation, breast pain, vaginal hemorrhage, sinusitis, pharyngitis and rhinitis. The most common adverse reactions (≥5%) in ART include: abdominal pain, nausea, abdominal enlargement, headache, and injection site reactions (pain, bruising).

Indications and Usage:

  • 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
  • Development of multiple follicles in the ovulatory patient as part of an Assisted Reproductive Technology (ART) cycle.

Prior to treatment complete an evaluation of female and male partners to determine infertility diagnosis and fertility status. Patients with a tubal obstruction should receive Gonal-f® only if enrolled in an in vitro fertilization program.  Primary ovarian failure and pregnancy should be excluded.

 For more information, please see the full Prescribing Information and Instructions for Use for Gonal-f® RFF* 75 IU

* RFF: Revised Formulation Female

IMPORTANT RISK INFORMATION & INDICATIONS AND USAGE

Important Risk Information for Gonal-f® RFF* 75 IU (follitropin alfa for injection)

Contraindications:

  • Prior hypersensitivity to rhFSH preparations or 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
  • Organic intracranial lesion such as a pituitary tumor
  • Abnormal uterine bleeding of undetermined origin
  • Ovarian cyst or enlargement of undetermined origin
  • Pregnancy

 

WARNINGS

For use by physicians specializing in fertility treatment or reproductive health and only when appropriate monitoring facilities are available. Gonal-f® is a potent gonadotropic substance capable of causing Ovarian Hyperstimulation Syndrome (OHSS) in women with or without pulmonary or vascular complications. Monitor ovarian response with serum estradiol and vaginal ultrasound on a regular basis. The lowest effective dose should be used.

Overstimulation of the Ovary During FSH Therapy:

  • Ovarian Enlargement:  If the ovaries are abnormally enlarged on the last day of Gonal-f® RFF* therapy, hCG should not be administered in this course of therapy
  • Ovarian Hyperstimulation Syndrome (OHSS): OHSS is a medical event distinct from uncomplicated ovarian enlargement. Severe OHSS may progress rapidly to become a serious medical event. If severe OHSS occurs, treatment must be stopped and the patient should be hospitalized.

Pulmonary and Vascular Complications:

  • Serious pulmonary complications (e.g., atelectasis, acute respiratory distress syndrome and exacerbation of asthma) have been reported. Thromboembolic events both in association with, and separate from OHSS have been reported in women treated with gonadotropins including Gonal-f® RFF*. Sequelae of such events have included venous thrombophlebitis, pulmonary embolism, pulmonary infarction, cerebral vascular occlusion (stroke), and arterial occlusion resulting in loss of limb. In rare cases, pulmonary complications and/or thromboembolic reactions have resulted in death.

Multiple Births

  • In Study 2240 for women receiving Gonal-f® RFF* over three treatment cycles, 20% of live births were multiple births. In Study 21884, 35.1% of live births were multiple births in women receiving Gonal-f® RFF*. The rate of multiple births is dependent on the number of embryos transferred. The patient should be advised of the potential risk of multiple births before starting treatment

PRECAUTIONS

  • General: Careful attention given to the diagnosis of infertility
  • Information for Patients: Inform patients of duration of treatment, required monitoring of their condition, risks of ovarian hyperstimulation syndrome and multiple births
  • Laboratory Tests: 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.
  • Nursing Mothers: It is not known whether this drug is excreted in human milk and because of the potential for serious adverse reactions in the nursing infant, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother

Adverse Reactions:

The most common adverse reactions (≥5%) in OI include: headache, abdominal pain, ovarian hyperstimulation, breast pain, vaginal hemorrhage, sinusitis, pharyngitis and rhinitis. The most common adverse reactions (≥5%) in ART include: abdominal pain, nausea, abdominal enlargement, headache, and injection site reactions (pain, bruising).

Indications and Usage:

  • 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
  • Development of multiple follicles in the ovulatory patient as part of an Assisted Reproductive Technology (ART) cycle.

Prior to treatment complete an evaluation of female and male partners to determine infertility diagnosis and fertility status. Patients with a tubal obstruction should receive Gonal-f® only if enrolled in an in vitro fertilization program.  Primary ovarian failure and pregnancy should be excluded.

 For more information, please see the full Prescribing Information and Instructions for Use for Gonal-f® RFF* 75 IU

* RFF: Revised Formulation Female

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