follitropin alfa (Rx)

Brand and Other Names:Gonal-f, Gonal-f RFF
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Dosing & Uses

AdultPediatric

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

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Adverse Effects

Frequency Not Defined

GONAL-f

  • 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

Thromboembolism

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Warnings

Contraindications

Prior hypersensitivity to recombinant FSH preparations

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 (e.g. pituitary tumor)

Women with abnormal uterine bleeding of undetermined origin; ovarian cyst or enlargement of undetermined origin

Pregnancy

Cautions

May cause ovarian hyperstimulation syndrome (OHSS, dramatic increase in vascular permeability which can result in rapid fluid accumulation in peritoneal cavity, thorax and pericardium; accompanied by severe pelvic pain, nausea, vomiting and weight gain) in women with or without pulmonary or vascular complications

If ovaries are abnormally enlarged on last day of therapy, inform women not to administer hCG and to avoid intercourse

Pulmonary conditions (atelactasis, ARDS, & asthma exacerbation) have been reported; in women with recognized risk factors, the benefits of induction of ovulation and ART need to be weighed against risks; during or after use of drug, monitor for venous or arterial thromboembolic events

Possibility of multiple births (range 12.3%-44.0% live births)

In ovarian torsion, early diagnosis and immediate detorsion limit damage to ovary due to reduced blood supply

A thorough gynecologic & endocrinological evaluation should be conducted prior to treatment to rule out primary ovarian failure, early pregnancy & partner's fertility potential

The rate of multiple births is dependent on number of embryos transferred; advise the woman and her partner of the potential risk of multi-fetal gestation and birth before beginning therapy

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 the presence of an intrauterine pregnancy early by β-hCG testing and transvaginal ultrasound

The risk of spontaneous abortion (miscarriage) is increased with gonadotropin products, however, causality has not been established

Both benign and malignant ovarian neoplasms are reported in women who have had multiple drug therapy for controlled ovarian stimulation, however, causality has not been established

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Pregnancy & Lactation

Pregnancy

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

Lactation

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.

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Pharmacology

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

Pharmacokinetics

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)

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Administration

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

Storage

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

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Images

BRAND FORM. UNIT PRICE PILL IMAGE
Gonal-F subcutaneous
-
1,050 unit vial
Gonal-F subcutaneous
-
450 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
Gonal-f RFF subcutaneous
-
75 unit vial
Gonal-f RFF subcutaneous
-
75 unit vial

Copyright © 2010 First DataBank, Inc.

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Patient Handout

Patient Education
follitropin alfa subcutaneous

FOLLITROPIN ALFA - INJECTION

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

COMMON BRAND NAME(S): Gonal-F RFF

USES: This medication contains follicle-stimulating hormone (FSH) and is used to treat certain fertility problems 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).This medication is not recommended for women whose ovaries no longer make eggs properly (primary ovarian 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. Once mixed, use the liquid right away.Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid.Inject this medication under the skin or into a muscle as directed by your doctor, usually once a day. Your doctor may direct you to use this medication in a treatment cycle (for example, only on certain days each month). Carefully follow your doctor's instructions.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, bloating, redness/pain at the injection site, 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, 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, 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 www.fda.gov/medwatch.In 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), abnormal bleeding from the vagina/uterus, thyroid problems, adrenal gland problems, cancer of the reproductive organs (such as breast, uterus, ovary), 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 medication in the refrigerator or at room temperature. Do not freeze. Do not store in the bathroom. Protect from light. Once mixed, use the liquid right away. Throw away any unused liquid. 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 August 2021. Copyright(c) 2021 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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Formulary

FormularyPatient Discounts

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The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL Quantity Limits
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST Step Therapy
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR Other Restrictions
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.