Follitropin alfa: Indication, Dosage, Side Effect, Precaution

Generic Medicine Info Patient Medicine Information

This information is not country-specific. Please refer to the local prescribing information.

Generic Medicine Info

Indications and Dosage

Subcutaneous
Female infertility

Adult: Dose should be individualised. Recommended initial dose: 75 IU/day; may increase dose by up to 37.5 IU after 14 days; further increases of the same magnitude can be made, if needed, every 7 days. Max: 300 IU/day. If response is appropriate, hCG (5,000 USP IU) is given 1 day after the last dose. Withhold hCG if serum estradiol is >2000 pg/ml, if the ovaries are abnormally enlarged or if abdominal pain occurs. Generally, therapy should not exceed 35 days.

Subcutaneous
Spermatogenesis induction

Adult: Start treatment with hCG until serum testosterone is in normal range. Initiate with 150 IU 3 times/wk combined with continued chorionic gonadotrophin. Treatment should be given for at least 4 mths and may continue for >18 mth. Max: 300 IU 3 times wkly.

Subcutaneous
Assisted reproductive technologies

Adult: Initially, 150-225 IU/day for at least 4 days, to be started in the early follicular phase (cycle day 2 or 3), until follicular development is adequate. Generally, therapy should not exceed 10 days. In patients ≥35 yr old with suppressed endogenous gonadotropin levels, initiate at 225 IU/day. Continue until follicular development is adequate. Adjust dose based on ovarian response; adjust subsequent doses every 3-5 days by ≤75-150 IU additionally at each adjustment. Adequate follicular development usually occurs within 5-10 days of treatment. Usual max: 450 IU/day.. Once follicular development is adequate, administer hCG to induce final follicular maturation. Withhold hCG if ovaries are abnormally enlarged.

Contraindications

Hypersensitivity. Abnormal genital bleeding of undetermined origin, sex hormone sensitive malignancies of the reproductive tract and accessory organs, an organic intracranial lesion e.g. pituitary tumor, ovarian cysts or enlargement of undetermined origin, high levels of FSH indicating primary gonadal failure, uncontrolled thyroid or adrenal dysfunction, pregnancy, lactation.

Special Precautions

May result in multiple births. Ovarian hyperstimulation syndrome, serious pulmonary conditions and thromboembolic events may occur. Evaluate patients for hypothyroidism, adrenocortical deficiency, hyperprolactinaemia, pituitary and hypothalamic tumors before starting therapy.

Adverse Reactions

Ovarian cysts, mild to severe Inj site reactions, headache, mild to moderate ovarian hyperstimulation syndrome (OHSS), abdominal pain, GI disturbances. Rarely, severe OHSS, ovarian torsion, thromboembolism, mild systemic allergic reactions.

Action

Description: Follitropin alfa is a human FSH preparation of recombinant DNA origin. It stimulates ovarian follicular growth in women who do not have primary ovarian failure and stimulates spermatogenesis in men with hypogonadotrophic hypogonadism.
Onset: Peak effect: Spermatogenesis, median: 165 days (range: 25-327 days). Follicle development: within cycle.
Pharmacokinetics:
Absorption: Bioavailability: About 66-76% in healthy female volunteers.
Excretion: Half-life elimination (healthy female): 50 hr (IM) and 24 hr (SC).

Storage

Store at 2-25°C.

MIMS Class

Trophic Hormones & Related Synthetic Drugs

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