follitropin alfa

REMS

Induction of ovulation in anovulatory patients whose infertility is not due to primary ovarian failure (Gonal-F and Gonal-F RFF).
Stimulation of multiple oocytes in ovulatory patients undergoing assisted reproduction technology (ART) (Gonal-F and Gonal-F RFF).
Induction of spermatogenesis in men with primary and secondary hypogonadotropic hypogonadism whose infertility is not due to primary testicular failure (Gonal-F only).

Contraind./Precautions ⬆ ⬇

Contraindicated in:

Hypersensitivity;
Primary ovarian or testicular failure;
OB: Pregnancy
Uncontrolled thyroid, adrenal, or pituitary dysfunction;
Abnormal uterine bleeding;
Intracranial or hormone-dependent tumors;
Ovarian cyst/enlargement not due to polycystic ovarian syndrome.

Use Cautiously in:

Adv. Reactions/Side Effects ⬆ ⬇

CV: THROMBOEMBOLIC EVENTS

Derm: acne

EENT: pharyngitis, rhinitis

Endo: breast pain

GI: constipation, diarrhea, dyspepsia, flatulence

GU: abdominal/pelvic pain, dysmenorrhea, irregular bleeding, ovarian enlargement, OVARIAN HYPERSTIMULATION SYNDROME, ovarian torsion

Local: injection site reactions

Neuro: dizziness, headache

Resp: cough

Misc: ANAPHYLAXIS, flu-like symptoms, multiple births

Interactions ⬆ ⬇

Drug-drug:

Unknown.

Availability ⬆ ⬇

Powder for injection: 75 IU/vial (Gonal-F RFF); 450 IU/vial (Gonal-F); 1050 IU/vial (Gonal-F)
Pre-filled multidose pen (Gonal-F RFF Redi-ject): 300 IU/pen; 450 IU/pen; 900 IU/pen

Route/Dosage ⬆ ⬇

Female infertility

SC (Adults ): 75 IU/day for 14 days, then increased by 37.5 IU at weekly intervals as needed by assessment (up to 300 IU/day); followed by hCG.

Assisted Reproduction Technologies

SC (Adults ): 150 IU/day starting on day 2 or 3 of cycle until follicles develop sufficiently; if needed may be increased by 75–150 IU/day every 3–5 days (not to exceed 10 days or 450 IU/day); followed by hCG.

Male Patients with Hypogonadotropic Hypogonadism (Gonal-F only)

SC (Adults ): After normal serum testosterone levels are achieved with hCG, Gonal–F can be initiated at 150 IU 3 times weekly (must be given with hCG). If azoospermia persists, dose can be increased up to 300 IU 3 times weekly; may be given for up to 18 mo.

US Brand Names ⬆ ⬇

Gonal-F, Gonal-F RFF

Action ⬆ ⬇

Stimulates follicle recruitment, growth and maturation.
Induces spermatogenesis.

Therapeutic effects:

Ovulation.
Improved production/harvest of oocytes in patients undergoing ART.
Spermatogenesis.

Classifications ⬆ ⬇

Therapeutic Classification: hormones (ovulation stimulant)

Pharmacokinetics ⬆ ⬇

Absorption: Well absorbed following SUBQ administration.

Distribution: Unknown.

Metabolism/Excretion: Unknown.

Half-Life: 24 hr.

Time/Action Profile ⬆ ⬇

ROUTE	ONSET	PEAK	DURATION
SUBQ	unknown	unknown	unknown

Patient/Family Teaching ⬆ ⬇

Prior to initiation of therapy discuss with patient the duration of therapy, required monitoring, potential adverse reactions, and risk of multiple births.
Encourage couple to have intercourse daily, beginning on the day prior to administration of hCG until ovulation becomes apparent based on indices to determine progestational activity. Care should be taken to ensure insemination.

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Indications ⬇