Gonal-F

N/A

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 ... Read moreWomen: 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.

N/A

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.

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.

Other ovulation stimulating agents (eg hCG, clomiphene citrate) may potentiate the follicular response, concurrent use of GnRH agonist-induced pituitary desensitisation may increase the dosage of Gonal-f needed to elicit an adequate ovarian response.

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.

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.

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.