Pharmacotherapeutic group: gonadotrophins.
Pharmacology: Pharmacodynamics: FOLISAN (r-hFSH) is a preparation of follicle stimulating hormone produced by genetically engineered Chinese Hamster Ovary (CHO) cells. In women, the most important effect resulting from parenteral administration of FSH is the development of mature Graafian follicles. Patients with severe FSH and LH deficiency were defined by an endogenous serum LH level <1.2 IU/l as measured in laboratory. However, it should be taken into account that there are variations between LH measurements performed in different laboratories.
Pharmacokinetics: Following intravenous administration, FOLISAN (r-hFSH) is distributed to the extra cellular fluid space with an initial half-life of around 2 hours and eliminated from the body with a terminal half-life of about one day. The steady state volume of distribution and total clearance are 10 l and 0.6 l/h, respectively. One eighth of the FOLISAN (r-hFSH) dose is excreted in the urine. Following subcutaneous administration, the absolute bioavailability is about 70%. Following repeated administration, FOLISAN (r-hFSH) accumulates 3-fold achieving a steady state within 3-4 days. In women whose endogenous gonadotrophin secretion is suppressed, FOLISAN (r-hFSH) has nevertheless been shown to effectively stimulate follicular development and steroidogenesis, despite un-measurable LH levels.