Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2017 Publisher: IBSA Farmaceutici Italia S.r.l, Via Martiri di Cefalonia 2, 26900 Lodi Italy
Pharmacotherapeutic group: Gonadotropins
ATC CODE: G03GA04
The active substance in Fostimon is highly purified Follicle Stimulating Hormone (FSH), obtained from human Menopausal Gonadotropin (HMG). The main effect of a FSH injection is the development and maturation of de Graaf follicles.
After subcutaneous injection of 300 IU of Fostimon, Cmax is 5.74 ± 0.95 IU/l, and Tmax is 21.33 ± 9.18 hours. AUC0-∞ is 541.22 ± 113.83 IU/l×hour, which is approximately the double of that described in the literature after intramuscular administration of 150 IU uFSH: 258.6 ± 47.9 IU/lxhour (measurements of FSH plasmatic contents by RIA assays).
Elimination half-life is about 50 hours.
After intramuscular injection, literature reports that the bioavailability of FSH is about 70%.
The pharmacokinetics of FSH in patients with renal or hepatic impairment has not been investigated.
Non-clinical data reveal no special hazard for humans based on conventional studies of repeated dose toxicity, with recombinant FSH.
The Ames test did not show any mutagenic activity of FSH.
No carcinogenicity study has been performed.
In a fertility study, high doses of recombinant FSH exerted marked pharmacological effects on the ovary and other genital organs resulting in impaired fertility and increased embryo-fetal mortality in the rat and in the rabbit.
Fostimon was well tolerated locally after subcutaneous administration in a study performed in rabbits.
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