Gonal-f RFF Redi-ject
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The only ready-to-use r-hFSH pen on the US market1

Designed to induce follicle development

 

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

  • 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 and fertility status. Primary ovarian failure and pregnancy should be excluded.

 gonal
gonal

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

Easy to teach, easy to use4†

Clinical trial efficacy in OI and ART1

Ovulation induction (OI)

Clinical trial

Study design

 

Ovulation induction was evaluated in a randomized, assessor-blind, multinational, multicenter, active-controlled, study in oligo-anovulatory infertile women. Women were randomized to either Gonal-f® RFF (n=83), administered subcutaneously, or a comparator recombinant human FSH. The use of insulin-sensitizing agents was allowed during the study. The study was designed to evaluate and compare mean ovulation rates in the first cycle of treatment. Results for Gonal-f® RFF are presented in below. Also presented in this table are secondary outcome results from cycle 1 through cycle 3. The study was not powered to demonstrate differences in any of the secondary outcomes.

 

Results with Gonal-f® RFF* Redi-ject®

 

Cycle

Cumulativea Percent Ovulation

Cumulativea Clinical Pregnancyd Rate

Cycle 1

72%b

28%c

Cycle 2

89%c

41%c

Cycle 3

92%c

45%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.

d 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 Human Chorionic Gonadotropin (hCG) administration.

Adverse reactions

The following common adverse reactions were reported at ≥2% in OI clinical trials.

 

System Organ Class/
Adverse Reactions

Gonal-f® RFF*
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 hyperstimulation

6 (7.2%)

Application site

 

Injection site pain

4 (4.8%)

Injection site inflammation

2 (2.4%)

 

a Total number of women treated with Gonal-f® RFF*.
b Up to 3 treatment cycles per woman.
c Number of women with the adverse reaction.

Assisted reproductive technology (ART)

Clinical trial

Study design

 

The efficacy of Gonal-f® RFF* was evaluated in a randomized, assessor-blind, multinational, multicenter, active controlled study in healthy normal ovulatory, infertile women treated for one cycle with controlled ovarian stimulation, as part of an ART [in vitro fertilization (IVF), or intracytoplasmic sperm injection (ICSI)] cycle. Women were randomized to either Gonal-f® RFF* 16 (n=237), administered subcutaneously, or a comparator recombinant human FSH. Randomization was stratified by insemination technique, (IVF vs. ICSI). All women received pituitary down-regulation with a GnRH agonist before stimulation with recombinant FSH. Efficacy was assessed using the mean number of fertilized oocytes the day after insemination. The initial doses of Gonal-f® RFF* were 150 International Units per day for women less than 35 years of age and 225 International Units per day for women 35 years of age and older. The maximum dose given for both age groups was 450 International Units per day. Treatment outcomes for Gonal-f® RFF* are summarized in the table below.

 

Results with 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

 

a Noninferior to comparator recombinant human FSH based on a two-sided 95% confidence interval, intent-to-treat analysis. 
b Subgroup analyses. The study was not powered to demonstrate differences in subgroups. 
c A clinical pregnancy was defined as a pregnancy during which a fetal sac (with or without heart activity) was visualized by ultrasound on day 35-42 after hCG administration.
d 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 ART clinical trials.

 

System Organ Class/
Adverse Reactions
Gonal-f® RFF* 
N=237anb (%)
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%)

 

a Total number of women treated with Gonal-f® RFF* Redi-ject®.  
b Number of women with the adverse reaction.

Prescribing information

 

 English

 Spanish

 Mandarin

Instructions for use

 

 English

FSH = follicle stimulating hormone; IVF = in vitro fertilization; ICSI = intracytoplasmic sperm injection.

FSH = follicle stimulating hormone; IVF = in vitro fertilization; ICSI = intracytoplasmic sperm injection.

*RFF = revised formulation female

†100% of participants rated the enhanced Redi-ject® as easy to learn how to use and easy to use (n=60). The enhanced Redi-ject® and Instructions for Use were evaluated using a 7-point Likert-type scale: a score of 5-7 indicated a positive result (easy), a score of 1-3 indicated a negative result (difficult), and a score of 4 indicated a neutral result.

‡Patients should always consult with an HCP before initiating treatment

§Doses less than 37.5 IU have not been clinically studied and are not recommended.

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References

1. Gonal-f® RFF* Redi-ject® [Prescribing Information]. Rockland, MA: EMD Serono, Inc.; 2020.

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. 

4. Mahony M, Dwyer A, Barkume R, et al. US human factors engineering evaluation of an updated follitropin alfa pen injector (GONAL-f® RFF Redi-ject®) and instructions for use. Expert Opin Drug Deliv. 2018;15(1)5-15.

IMPORTANT RISK INFORMATION & INDICATIONS AND USAGE

Important Risk Information for Gonal-f® RFF* Redi-ject® (follitropin alfa injection)

Contraindications:

  • Prior hypersensitivity to rhFSH preparations or excipients
  • high levels of FSH indicating primary gonadal failure
  • pregnancy – apprise women of the potential hazard to the fetus if administered during pregnancy
  • 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 of undetermined origin
  • 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® contains a gonadotropic substance capable of causing Ovarian Hyperstimulation Syndrome (OHSS) in women with or without pulmonary or vascular complications. Careful selection should be given to the diagnosis of infertility and the selection so candidates for therapy. The lowest effective dose should be used.
  • Hypersensitivity Reactions and Anaphylaxis: Serious systemic hypersensitivity reactions, including anaphylaxis, have been reported in post-marketing 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.
  • Abnormal Ovarian Enlargement: Treatment should be individualized and the lowest effective dose should be used. Use of ultrasound monitoring of ovarian response and/or measurement of serum estradial levels is important to minimize the risk of ovarian stimulation. If the ovaries are enlarged on the last day of therapy, hCG should not be administered to reduce the risk of developing OHSS. Prohibit intercourse in women with significant ovarian enlargement.
  • Ovarian Hyperstimulation Syndrome (OHSS): OHSS occurs after gonadotropin treatment discontinuation and can develop rapidly. If there is evidence that OHSS may be developing prior to hCG administration, hCG must be withheld. If serious OHSS occurs, gonadotropins, including hCG, should be stopped and consider if hospitalization is needed.
  • Pulmonary and Vascular Complications: Serious pulmonary complications (e.g., atelectasis, acute respiratory distress syndrome and exacerbation of asthma) have been reported in women treated with gonadotropins. Thromboembolic events both in association with, and separate from OHSS have been reported in women treated with gonadotropins including Gonal-f® RFF*. 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.
  • Ovarian torsion: has been reported after treatment with gonadotropins. This may be related to OHSS, pregnancy, previous abdominal surgery, past history of ovarian torsion, previous or current ovarian cyst and polycystic ovaries. Damage to the ovary due to reduced blood supply can be limited by early diagnosis and immediate detorsion.
  • Multi-fetal Gestation and Birth: 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 woman and her partner should be advised of the potential risk of multi-fetal gestation and birth before beginning therapy with Gonal-f® RFF* Redi-ject®.
  • Congenital Malformations: 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.
  • Ectopic Pregnancy: Since women undergoing ART often have tubal abnormalities, the incidence of ectopic pregnancy may be increased.
  • Spontaneous Abortion: The incidence of spontaneous abortion (miscarriage) may be increased. However, causality has not been established. This may be a factor of the underlying infertility.
  • Ovarian Neoplasms: Both benign and malignant ovarian neoplasms have been infrequently reported in women who have had multiple drug therapy for controlled ovarian stimulation; causality has not been established.
  • 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.

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 Healthcare Provider about questions.

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 and fertility status. 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* Redi-ject®

 

* RFF: Revised Formulation Female

IMPORTANT RISK INFORMATION & INDICATIONS AND USAGE

Important Risk Information for Gonal-f® RFF* Redi-ject® (follitropin alfa injection)

Contraindications:

  • Prior hypersensitivity to rhFSH preparations or excipients
  • high levels of FSH indicating primary gonadal failure
  • pregnancy – apprise women of the potential hazard to the fetus if administered during pregnancy
  • 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 of undetermined origin
  • 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® contains a gonadotropic substance capable of causing Ovarian Hyperstimulation Syndrome (OHSS) in women with or without pulmonary or vascular complications. Careful selection should be given to the diagnosis of infertility and the selection so candidates for therapy. The lowest effective dose should be used.
  • Hypersensitivity Reactions and Anaphylaxis: Serious systemic hypersensitivity reactions, including anaphylaxis, have been reported in post-marketing 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.
  • Abnormal Ovarian Enlargement: Treatment should be individualized and the lowest effective dose should be used. Use of ultrasound monitoring of ovarian response and/or measurement of serum estradial levels is important to minimize the risk of ovarian stimulation. If the ovaries are enlarged on the last day of therapy, hCG should not be administered to reduce the risk of developing OHSS. Prohibit intercourse in women with significant ovarian enlargement.
  • Ovarian Hyperstimulation Syndrome (OHSS): OHSS occurs after gonadotropin treatment discontinuation and can develop rapidly. If there is evidence that OHSS may be developing prior to hCG administration, hCG must be withheld. If serious OHSS occurs, gonadotropins, including hCG, should be stopped and consider if hospitalization is needed.
  • Pulmonary and Vascular Complications: Serious pulmonary complications (e.g., atelectasis, acute respiratory distress syndrome and exacerbation of asthma) have been reported in women treated with gonadotropins. Thromboembolic events both in association with, and separate from OHSS have been reported in women treated with gonadotropins including Gonal-f® RFF*. 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.
  • Ovarian torsion: has been reported after treatment with gonadotropins. This may be related to OHSS, pregnancy, previous abdominal surgery, past history of ovarian torsion, previous or current ovarian cyst and polycystic ovaries. Damage to the ovary due to reduced blood supply can be limited by early diagnosis and immediate detorsion.
  • Multi-fetal Gestation and Birth: 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 woman and her partner should be advised of the potential risk of multi-fetal gestation and birth before beginning therapy with Gonal-f® RFF* Redi-ject®.
  • Congenital Malformations: 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.
  • Ectopic Pregnancy: Since women undergoing ART often have tubal abnormalities, the incidence of ectopic pregnancy may be increased.
  • Spontaneous Abortion: The incidence of spontaneous abortion (miscarriage) may be increased. However, causality has not been established. This may be a factor of the underlying infertility.
  • Ovarian Neoplasms: Both benign and malignant ovarian neoplasms have been infrequently reported in women who have had multiple drug therapy for controlled ovarian stimulation; causality has not been established.
  • 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.

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 Healthcare Provider about questions.

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 and fertility status. 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* Redi-ject®

 

* RFF: Revised Formulation Female

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