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

  • 600units/mL

single-dose ampules

  • 75units

solution reconstituted

  • 450units
  • 1050units
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Ovulation Induction

Initial dose of first cycle: 75 units SC qDay; after 14 days, increase dose by increments of up to 37.5 International Units; 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 International Units SC qDay until sufficient follicular development. In most cases, therapy should not exceed 10 days

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

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

Maximum recommended dose 450 international units 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 Units 2-3 x/week) until serum testosterone within normal range (may require 3-6 months of treatment)

Treatment- GONAL-f used in conjunction with hCG GONAL-f 150 international units SC 3 x/week

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

If azoospermia persists, may increase GONAL-f to maximum of 300 international units 3 x/week

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

Administration

Gonal-f RFF Pen (Follitropin Alfa) & Follistim AQ (Follitropin Beta) are SC self-injectable pens for women only; check manufacturer's package insert for dosage & administration

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

Follistim AQ

  • Headache
  • Ovarian pain
  • Back pain
  • Constipation
  • OHSS (for ovulation induction)
  • URI
  • Sinusitis
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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 & 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 GONAL-f therapy, do not administer hCG

Pulmonary conditions (atelactasis, ARDS, & asthma exacerbation) have been reported

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

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

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Pregnancy & Lactation

Pregnancy Category: X

Lactation: Excretion in milk unknown; not recommended

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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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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