follitropin alfa (Rx)

Brand and Other Names:Gonal-f, Gonal-f RFF

Dosing & Uses


Dosage Forms & Strengths

multi-dose vial (Gonal-f)

  • 450 IU/vial (ie, 600 IU/vial delivers 450 IU)
  • 1050 IU/vial (ie, 1200 IU/vial delivers 1050 IU)

single-dose vial (Gonal-f RFF)

  • 75 IU (ie, 82 IU/vial delivers 75 IU)

Redi-ject pen (Gonal-f RFF)

  • 300 IU
  • 450 IU
  • 900 IU

Ovulation Induction

Initial dose of first cycle: 75 IU SC qDay; after 14 days, increase dose by increments of up to 37.5 IU; further dose increases, as necessary every 7 days

Dose based on effect, with lowest effective dose; maximum recommended dose 300 International Units qDay

Treatment maximum of 35 days, unless E2 rise indicates imminent follicular developement

To complete follicular development in absence of endogenous LH surge, give chorionic gonadatropin (hCG)- 5000 units 1 day after last dose

Withhold if serum estradiol >2,000 pg/mL or if abnormal ovarian enlargement/abdominal pain

Advise patient against intercourse

Initial dose in subsequent cycles based on response in previous cycle

Advise daily intercourse beginning on day prior to hCG until ovulation apparent from lab tests

Assisted Reproductive Technologies

Initial dose on cycle day 2 or 3: 150 IU SC qDay until sufficient follicular development; typically does not exceed 10 days

If endogenous gonadotropin levels are suppressed, should be started at 225 IU qDay

Continue until adequate follicular development based on ultrasound and serum estradiol levels; dose adjustments of 75-150 IU may be made q3-5Days

Maximum recommended dose 450 IU qDay

Once adequate follicular development, administer hCG (5,000-10,000 USP); withhold if ovaries abnormally enlarged on last day of treatment

Male Patients with Hypogonadotropic Hypogonadism (Gonal-f Only)

Pretreat with hCG (1,000- 2,250 USP IU 2-3 x/week) until serum testosterone within normal range (may require 3-6 months of treatment)

Treatment consists of Gonal-f 150 IU SC 3 times/week used in conjunction with hCG

hCG 1000 USP Units (or dose to maintain normal serum testosterone levels) 3 x/week

If azoospermia persists, may increase dose to 300 IU 3 x/week

May need to administer for up to 18 months for adequate response

Safety and efficacy not established


Adverse Effects

Frequency Not Defined


  • Intermenstrual bleeding
  • Ovarian hyperstimulation
  • Abdominal pain
  • Acne
  • Flatulence
  • Diarrhea
  • Back pain
  • Emotional lability

Gonal-f RFF Pen

  • Diarrhea
  • Dizziness
  • OHSS (for ovulation induction)
  • Flatulence
  • Acne
  • Toothache
  • Intermenstrual bleeding
  • Breast pain, Injection site reactions, Ovarian cyst, Nausea, Sinusitis

Postmarketing Reports

Asthma exacerbation





Prior hypersensitivity to recombinant FSH preparations

High levels of FSH indicating primary gonadal failure

Presence of uncontrolled non-gonadal endocrinopathies (thyroid, adrenal, or pituitary disorders)

Sex hormone-dependent tumors of the reproductive tract and accessory organs

Tumors of pituitary gland or hypothalamus

Gonal-F: Women with abnormal uterine bleeding of undetermined origin; ovarian cyst or enlargement of undetermined origin


In the postmarketing experience, serious systemic hypersensitivity reactions, including anaphylaxis, reported with use and 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

Ovarian torsion reported after treatment with gonadotropins, including this drug; this may be related to OHSS, pregnancy, previous abdominal surgery, past history of ovarian torsion, previous or current ovarian cyst and polycystic ovaries; early diagnosis and immediate detorsion limit damage to ovary due to reduced blood supply

Multi-fetal gestation and births reported with all gonadotropin therapy, including therapy with this drug; 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; advise the woman and her partner of potential risk of multi-fetal gestation and birth before beginning therapy with this drug

Since infertile women undergoing ART often have tubal abnormalities, the incidence of ectopic pregnancy may be increased in women who become pregnant as result of ART; advise women who become pregnant following ART and have: abdominal/pelvic pain (particularly on one side); shoulder, neck or rectal pain; and nausea and vomiting to seek immediate medical attention; confirm presence of an intrauterine pregnancy early by β-hCG testing and transvaginal ultrasound

The risk of spontaneous abortion (miscarriage) is increased with gonadotropin products, including this drug; however, causality has not been established; the increased risk may be a factor of underlying infertility

There have been infrequent reports of ovarian neoplasms, both benign and malignant, in women who have had multiple drug therapy for controlled ovarian stimulation, however, a causal relationship has not been established

Ovarian hyperstimulation syndrome (OHSS)

  • This syndrome is a medical entity distinct from uncomplicated ovarian enlargement and may progress rapidly to become a serious medical event; OHSS is characterized by a dramatic increase in vascular permeability, which can result in rapid accumulation of fluid in peritoneal cavity, thorax, and potentially, the pericardium
  • The early warning signs of development of OHSS are severe pelvic pain, nausea, vomiting, and weight gain; abdominal pain, abdominal distension, gastrointestinal symptoms including nausea, vomiting and diarrhea, severe ovarian enlargement weight gain, dyspnea, and oliguria have been reported with OHSS
  • Clinical evaluation may reveal hypovolemia, hemoconcentration, electrolyte imbalances, ascites, hemoperitoneum, pleural effusions, hydrothorax, acute pulmonary distress, and thromboembolic reactions
  • Transient liver function test abnormalities suggestive of hepatic dysfunction with or without morphologic changes on liver biopsy, reported in association with OHSS
  • OHSS occurs after gonadotropin treatment discontinued and it can develop rapidly, reaching its maximum about seven to ten days following treatment
  • Usually, OHSS resolves spontaneously with onset of menses; if there is evidence that OHSS may be developing prior to hCG administration withhold hCG; cases of OHSS are more common, more severe, and more protracted if pregnancy occurs; therefore, assess women for development of OHSS for at least two weeks after hCG administration
  • If serious OHSS occurs, stop gonadotropins, including this medication and hCG, and consider whether the woman needs to be hospitalized; treatment is primarily symptomatic and overall consists of bed rest, fluid and electrolyte management, and analgesics (if needed); because the use of diuretics can accentuate the diminished intravascular volume, avoid diuretics exceptin the late phase of resolution as described below
  • The management of OHSS is divided into three phases as follows:
  • Acute phase:
    • Management is directed at preventing hemoconcentration due to loss of intravascular volume to third space and minimizing risk of thromboembolic phenomena and kidney damage
    • Thoroughly assess daily or more often, based on clinical need,fluid intake and output, weight, hematocrit, serum and urinary electrolytes, urine specific gravity, BUN and creatinine, total proteins with albumin: globulin ratio, coagulation studies, electrocardiogram to monitor for hyperkalemia, and abdominal girth
    • Treatment, consisting of limited intravenous fluids, electrolytes, human serum albumin, is intended to normalize electrolytes while maintaining an acceptable but somewhat reduced intravascular volume
    • Full correction of the intravascular volume deficit may lead to an unacceptable increase in the amount of third space fluid accumulation
  • Chronic phase
    • After acute phase is successfully managed as above, excessive fluid accumulation in the third space should be limited by instituting severe potassium, sodium, and fluid restriction
  • Resolution phase
    • As third space fluid returns to intravascular compartment, a fall in hematocrit and increasing urinary output are observed in absence of any increase in intake
    • Peripheral and/or pulmonary edema may result if the kidneys are unable to excrete third space fluid as rapidly as it is mobilized; diuretics may be indicated during resolution phase, if necessary, to combat pulmonary edema
    • Do not remove ascitic, pleural, and pericardial fluid, unless there is necessity to relieve symptoms such as pulmonary distress or cardiac tamponade
  • OHSS increases risk of injury to ovary; avoid pelvic examination or intercourse, as these may cause rupture of an ovarian cyst, which may result in hemoperitoneum
  • If bleeding occurs and requires surgical intervention, control the bleeding and retain as much ovarian tissue as possible; a physician experienced in management of this syndrome, or who is experienced in management of fluid and electrolyte imbalances should be consulted

Pulmonary vascular complications

  • Serious pulmonary conditions (for example, atelectasis, acute respiratory distress syndrome, and exacerbation of asthma) reported in women treated with gonadotropins, including this medication
  • In addition, thromboembolic events both in association with, and separate from OHSS reported in women treated with gonadotropins, including this medication
  • Intravascular thrombosis and embolism, which may originate in venous or arterial vessels, can result in reduced blood flow to critical organs or extremities
  • 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 ovulation induction and assisted reproductive technology (ART) need to be weighed against risks; it should be noted that pregnancy also carries an increased risk of thrombosis

Abnormal ovarian enlargement

  • In order to minimize hazards associated with abnormal ovarian enlargement that may occur with therapy, individualize treatment and use lowest effective dose; use of ultrasound monitoring of ovarian response and/or measurement of serum estradiol levels is important to minimize risk of ovarian stimulation
  • If ovaries are abnormally enlarged on last day of therapy, do not administer hCG in order to reduce chance of developing OHSS; prohibit intercourse for women with significant ovarian enlargement after ovulation because of danger of hemoperitoneum resulting from rupture of ovarian cysts

Embryofetal toxicity

  • .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 (eg, maternal age, maternal and paternal genetic background, sperm characteristics) and to higher incidence of multi-fetal gestations after IVF or ICSI; there are no indications that the use of gonadotropins during IVF or ICSI is associated with an increased risk of congenital malformations.

Pregnancy & Lactation


Drug not indicated in pregnant women

The incidence of congenital malformations after some assisted reproductive technology, specifically in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI)], maybe slightly higher than that after spontaneous conception; this slightly higher incidence is thought to be related to differences in parental characteristics (eg, maternal age, maternal and paternal genetic background, sperm characteristics) and to a higher incidence of multi-fetal gestations after IVF or ICSI; there is no human data that the use of gonadotropins (including drug alone or as part of IVF or ICSI cycles, increases risk of congenital malformations

Risk of spontaneous abortion (miscarriage) is increased in women who have used gonadotropins products (including GONAL-F) to achieve pregnancy

Verify a negative pregnancy test before administering drug

Animal data

  • In animal studies, the continuous administration of recombinant human FSH during pregnancy resulted in a decrease in number of viable fetuses and difficult and prolonged delivery; no teratogenic effect observed


There are no data on presence of drug in human milk, effects on breastfed infant, or on milk production; because secretion of prolactin during lactation can result in inadequate response to ovarian stimulation, advise women not to breastfeed during treatment

Pregnancy Categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.



Mechanism of Action

Recombinant follicle stimulating hormone (FSH); stimulate ovarian follicular growth in women who do not have primary ovarian failure;

Stimulates spermatogenesis in men with hypogonadotrophic hypogonadism


Onset: 2.7-18 months (spermatogenesis); within cycle (females)

Vd: 10 L

Bioavailability: 66-76% (healthy female volunteers)

Half-life: 50 hr (IM in healthy female volunteers); 24 hr (SC in healthy female volunteers)

Peak plasma time: 8-16 hr (SC in females); 25 hr (IM in females); 11-20 hr (IM in males)



SC Administration

Gonal-f RFF Pen is a SC self-injectable pen for women

Remove pen from refridgerator at least 30 min before injection to warm to room temperature

Inject SC in abdomen


Pharmacy: Store the Gonal-f RFF Redi-ject refrigerated 2-8°C (36-46°F) until dispensed

Upon dispensing, store refrigerated 2-8°C (36-46°F) until the expiration date, or at room temperature 20-25°C (68-77°F) for up to 3 months or until the expiration date, whichever occurs first

After the first injection, store refrigerated 2-8°C (36-46°F) or at room temperature 20-25°C (68-77°F) for up to 28 days

Protect from light

Do not freeze

Once opened or stored at room temperature, discard unused material after 28 days



Gonal-F subcutaneous
1,050 unit vial
Gonal-F subcutaneous
450 unit vial
Gonal-f RFF subcutaneous
75 unit vial
Gonal-f RFF subcutaneous
75 unit vial
Gonal-F RFF Redi-Ject subcutaneous
900/1.5 unit/mL injection
Gonal-F RFF Redi-Ject subcutaneous
450/0.75 unit/mL injection
Gonal-F RFF Redi-Ject subcutaneous
300/0.5 unit/mL injection

Copyright © 2010 First DataBank, Inc.


Patient Handout

Patient Education
follitropin alfa subcutaneous


(FOL-i-TROE-pin AL-fa)


USES: This medication contains follicle-stimulating hormone (FSH) and is used to treat certain fertility problems in women and men. In women, follitropin alfa helps stimulate healthy ovaries to produce eggs. This medication is usually used in combination with another hormone (hCG) to bring about the growth and release of a mature egg (ovulation). In men, this medication helps stimulate healthy testes to produce sperm. It is also used in combination with hCG.This medication is not recommended for women whose ovaries no longer make eggs properly (primary ovarian failure) or for men whose testes no longer make sperm properly (primary testicular failure).

HOW TO USE: Read the Patient Information Leaflet if available from your pharmacist before you start using follitropin alfa and each time you get a refill. If you have any questions, ask your doctor or pharmacist.Learn all preparation and usage instructions from your health care professional and the product package. Follow the instructions for adding the mixing liquid to the medication. Do not shake the vial.Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid.If the medication is stored in the refrigerator, allow the medication to warm to room temperature before use.Inject this medication under the skin or into a muscle as directed by your doctor.Before injecting each dose, clean the injection site with rubbing alcohol. Change the injection site each time to lessen injury under the skin.The dosage is based on your medical condition, response to treatment, and lab tests.Use this medication exactly as directed by your doctor to get the most benefit from it. Do not increase your dose or use this drug more often or for longer than prescribed.Learn how to store and discard needles and medical supplies safely.

SIDE EFFECTS: Headache, mild stomach/abdominal pain, diarrhea, bloating, redness/pain at the injection site, acne, or breast tenderness/pain may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor right away if you have any serious side effects, including: bleeding from the vagina/uterus, flu-like symptoms (such as fever, chills, muscle ache, tiredness), swelling of ankles/hands/feet.Get medical help right away if you have any very serious side effects, including: shortness of breath/rapid breathing, chest/jaw/left arm pain, unusual sweating, confusion, sudden dizziness/fainting, pain/swelling/warmth in the groin/calf, sudden severe headache, trouble speaking, weakness on one side of the body, sudden vision changes.This medication may cause a condition known as ovarian hyperstimulation syndrome (OHSS). This condition may occur during or after treatment. Rarely, serious OHSS causes fluid to suddenly build up in the stomach, chest, and heart area. Get medical help right away if you develop the following side effects: severe pain or swelling in the lower abdominal (pelvic) area, severe nausea/vomiting, sudden/rapid weight gain, or decreased urination.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using this medication, tell your doctor or pharmacist if you are allergic to it; or to other products containing follicle-stimulating hormone (FSH); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: other fertility problems (such as primary ovarian failure or testicular failure), abnormal bleeding from the vagina/uterus, thyroid problems, adrenal gland problems, cancer of the reproductive organs (such as breast, uterus, ovary, testis), tumor in the brain (such as pituitary tumor), ovarian cysts or enlarged ovaries, blood clots, stroke, certain heart diseases (such as angina, heart attack), lung problems (such as asthma).Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).Multiple births may occur as a result of this treatment. Consult your doctor for more details.Stop using this medication when you become pregnant. This medication must not be used during pregnancy. If you think you may be pregnant, tell your doctor right away.It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.A product that may interact with this drug is: gonadorelin.

OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

NOTES: Do not share this medication with others.Lab and/or medical tests (such as vaginal ultrasound, hormone levels, liver tests) may be done while you are using this medication. Keep all medical and lab appointments. Consult your doctor for more details.

MISSED DOSE: If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule. Do not double the dose to catch up.

STORAGE: Before mixing, store the unused vial in the refrigerator or at room temperature away from light. Do not freeze. Once mixed, the vial may be refrigerated or stored at room temperature. Discard any unused portion after 28 days. Protect from light. Do not store in the bathroom. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Information last revised January 2022. Copyright(c) 2023 First Databank, Inc.

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.



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