Gonal-f® Multi-Dose
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Our first major advancement in FSH administration

A flexible approach to dosing1

 

In women, Gonal-f® Multi-Dose (follitropin alfa for injection) is indicated for:

  • Induction of ovulation (OI) and pregnancy in anovulatory women in whom the cause of infertility is functional anxd 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 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.

 

In men, Gonal-f® (follitropin alfa for injection) is 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.

 

Prior to treatment perform thorough medical and endocrinologic evaluation, confirm hypogonadotropic hypogonadism, exclude primary testicular failure and serum testosterone levels should be normalized.

gonal multi dose box

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

A smart choice for appropriate patients

dosing

Gonal-f® Multi-Dose is appropriate for patients who require more precise dosing, for more individualized control

 

Injection syringes provide half-dose increments, allowing for doses of 37.5 IU up to 75 IU

Clinical trial efficacy in OI and ART1

Ovulation induction (OI)

Clinical trial 1

Study design

 

The safety and efficacy of Gonal-f® administered subcutaneously vs. urofollitropin administered intramuscularly were assessed 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 5642).

 

The primary efficacy parameter was the ovulation rate. Two hundred and twenty-two patients entered into the first cycle of treatment, of whom 110 received Gonal-f® and 112 received urofollitropin. Ovulation rates were similar between Gonal-f® and urofollitropin treatment groups. The study results for the 222 patients who received treatment in at least one cycle are summarized below.

 

Results with Gonal-f® Multi-Dose

 

Cumulative Ovulation Rate Gonal-f® Multi-Dose (n=110) Urofollitropin (n=112)
Cycle 1 64% 59%
Cycle 2 78% 82%
Cycle 3 84% 91%
Clinical trial 2

Study design

 

A second randomized, comparative, open-label, multicenter study was conducted in 23 U.S. centers (Study 5727). The primary efficacy parameter was ovulation rate. Ovulation rates were similar between Gonal-f® and urofollitropin treatment groups. Two hundred and thirty-two patients with oligo-anovulatory infertility received treatment with up to three cycles of Gonal-f® administered subcutaneously (118 patients) or urofollitropin administered intramuscularly (114 patients). 

 

The cumulative patient ovulation rate and clinical pregnancy rates by cycle are presented for the 232 patients who received treatment in at least one cycle.

 

Results with Gonal-f® Multi-Dose

 

Cumulative Ovulation Rate Gonal-f® Multi-Dose (n=118) Urofollitropin (n=114)
Cycle 1 58% 68%
Cycle 2 72% 86%
Cycle 3 81% 93%
Cumulative Pregnancya Rate    
Cycle 1
 13% 14%
Cycle 2
 25% 25%
Cycle 3
 37% 36%
Cumulative Pregnancya 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 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.

Adverse reactions

The following common adverse reactions were reported in one OI clinical trial, Study 5727.

 

Body System
Preferred Term

Gonal-f® Multi-Dose Patients (%) Experiencing Events
Treatment cycles=288a (n=188)

Urofollitropin Patients (%) Experiencing Events
Treatment cycles=277a (n=144)

Reproductive, female

 

 

Intermenstrual bleeding

9.3%

4.4%

Breast pain female

4.2%

6.1%

Ovarian hyperstimulation​b

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%

 

a Up to 3 cycles of therapy.

b Severe = 0.8% of 118 patients in study.

Assisted reproductive technology (ART)

Clinical trial 1

Study design

 

The safety and efficacy of Gonal-f® administered subcutaneously vs. urofollitropin administered intramuscularly were assessed 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 (Study 5503). The purpose of the study was to demonstrate that Gonal-f®, administered subcutaneously, was clinically not different in terms of safety and efficacy from urofollitropin, administered intramuscularly. The initial and maximal doses of Gonal-f® were 225 and 450 IU, respectively. The primary efficacy parameter was the number of mature pre-ovulatory follicles on the day of hCG administration. One hundred and twenty-three patients were randomized and received either Gonal-f® (60 patients) or urofollitropin (63 patients).

 

The results summarized below are mean data with Gonal-f® and urofollitropin administered to ovulatory infertile women undergoing multiple follicular development for IVF/ET.

 

Results with Gonal-f® Multi-Dose

 

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 pregnancya rate per attempt

20%

16%

Clinical pregnancya 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 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.

Clinical trial 2

Study design

 

In a second randomized, comparative, open-label, multicenter study conducted in 7 US centers (Study 5533), 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.

 

Results with Gonal-f® Multi-Dose

 

Cumulative ovulation rate

Gonal-f® (n=56)

Urofollitropin (n=58)

Mean number of follicles ≥14mm in 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 pregnancya rate per attempt

21%

22%

Clinical pregnancya 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%

 

aA 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.

Adverse reactions

Study design

 

The following common adverse reactions were reported in one ART clinical trial, Study 5533.

 

Body System
Preferred Term		 Gonal-f® Multi-Dose
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%

Prescribing information

 

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Instructions for use

 

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References

1. Gonal-f® Multi-Dose (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® Multi-Dose (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® 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®. 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 ovulation induction trials, 12.3% of live births were multiple births in women receiving Gonal-f® and 14.5% in women receiving urofollitropin. In IVF/ET clinical trials, 44% of live births in women receiving Gonal-f® and 41% in women receiving urofollitropin and 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:
Women - Adverse events occurring in more than 5% of women were headache, ovarian cyst, nausea, and upper respiratory infection intermenstrual bleeding, abdominal pain, diarrhea, flatulence, ovarian hyperstimulation, Pain, Back pain sinusitis and emotional lability in the U.S. ovulation induction trial. In the U.S. ART trial, adverse event occurring in more than 5% of women were headache, abdominal pain, pelvic pain and nausea.
Men – In Study 5844 events occurring in more than one patient were varicocele (4) and injection site reactions (4), serious adverse reactions were testicular surgery for cryptorchidism, which existed pre-study, hemoptysis, an infection pilonidal cyst, and lymphadenopathy associated with an Epstein-Barr viral infection. In study 4610 3 adverse events were reported in 2 of 8 patients (24%) and one serious event of surgery for gynecomastia which existed at baseline. In the interim analysis of Study 6793, 18 of 22 patients (81.8%) reported a total of 99 events. The most common in more than 2 patients were acne, breast pain, fatigue, gynecomastia and injection site pain. Two serious adverse events (hospitalization for drug abuse and depression) were reported by a single patient.

Indications and Usage:
Women

  • Induction of ovulation (OI) and pregnancy in anovulatory women in whom the cause of infertility is functional anxd 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 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.

Men

  • Induction of spermatogenesis in men with primary and secondary hypogonadotropic hypogonadism in whom the cause of infertility is not due to primary testicular failure.

Prior to treatment perform thorough medical and endocrinologic evaluation, confirm hypogonadotropic hypogonadism, exclude primary testicular failure and serum testosterone levels should be normalized.

 

 For more information, please see the full Prescribing Information and Instructions for Use for Gonal-f® Multi-Dose

IMPORTANT RISK INFORMATION & INDICATIONS AND USAGE

Important Risk Information for Gonal-f® Multi-Dose (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® 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®. 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 ovulation induction trials, 12.3% of live births were multiple births in women receiving Gonal-f® and 14.5% in women receiving urofollitropin. In IVF/ET clinical trials, 44% of live births in women receiving Gonal-f® and 41% in women receiving urofollitropin and 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:
Women - Adverse events occurring in more than 5% of women were headache, ovarian cyst, nausea, and upper respiratory infection intermenstrual bleeding, abdominal pain, diarrhea, flatulence, ovarian hyperstimulation, Pain, Back pain sinusitis and emotional lability in the U.S. ovulation induction trial. In the U.S. ART trial, adverse event occurring in more than 5% of women were headache, abdominal pain, pelvic pain and nausea.
Men – In Study 5844 events occurring in more than one patient were varicocele (4) and injection site reactions (4), serious adverse reactions were testicular surgery for cryptorchidism, which existed pre-study, hemoptysis, an infection pilonidal cyst, and lymphadenopathy associated with an Epstein-Barr viral infection. In study 4610 3 adverse events were reported in 2 of 8 patients (24%) and one serious event of surgery for gynecomastia which existed at baseline. In the interim analysis of Study 6793, 18 of 22 patients (81.8%) reported a total of 99 events. The most common in more than 2 patients were acne, breast pain, fatigue, gynecomastia and injection site pain. Two serious adverse events (hospitalization for drug abuse and depression) were reported by a single patient.

Indications and Usage:
Women

  • Induction of ovulation (OI) and pregnancy in anovulatory women in whom the cause of infertility is functional anxd 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 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.

Men

  • Induction of spermatogenesis in men with primary and secondary hypogonadotropic hypogonadism in whom the cause of infertility is not due to primary testicular failure.

Prior to treatment perform thorough medical and endocrinologic evaluation, confirm hypogonadotropic hypogonadism, exclude primary testicular failure and serum testosterone levels should be normalized.

 

 For more information, please see the full Prescribing Information and Instructions for Use for Gonal-f® Multi-Dose

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