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.

Women: Follitropin alfa is indicated for the induction of ovulation and pregnancy in the anovulatory infertile patient in whom the cause of infertility is functional and not due to primary ovarian failure. Follitropin alfa is also indicated for the development of multiple follicles in the ovulatory patient participating in an Assisted Reproductive Technology (ART) program.

Men: Follitropin alfa for injection is indicated for the induction of spermatogenesis in men with primary and secondary hypogonadotropic hypogonadism in whom the cause of infertility is not due to primary testicular failure.

Female infertility: Dose should be individualised. Recommended initial: 75 IU/day; may increase by up to 37.5 IU after 14 days; further increases of the same magnitude may be made every 7 days, if needed. Max: 300 IU/day. If response is appropriate, administer hCG 1 day after the last dose.

Assisted reproductive technologies Initial: 150-225 IU/day for at least 4 days, to be started on day 2 or 3 of cycle, until follicular development is adequate. Adjust dose based on ovarian response. Usual max: 450 IU/day. Once follicular development is adequate, administer hCG to induce final follicular maturation. Withhold hCG if ovaries are abnormally enlarged.

Spermatogenesis induction 150 IU 3 times/week with continued chorionic gonadotrophin for at least 4 mth. Max: 300 IU 3 times/week

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.

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.

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.

Pregnancy & Lactation

Pregnancy category X. Studies in animals or human beings have demonstrated foetal abnormalities or there is evidence of foetal risk based on human experience or both, and the risk of the use of the drug in pregnant women clearly outweighs any possible benefit. The drug is contraindicated in women who are or may become pregnant.