Urofollitropin

Strength: Fostimon 75 IU powder and solvent; each vial contains 75 IU of urofollitropin (FSH), and 1 ml of reconstituted solution contains 75, 150, 225, 300, 375 or 450 IU when 1, 2, 3, 4, 5 or 6 vials are reconstituted in 1 ml of solvent (SPC section 2). Doses are in IU of FSH. Indicated in women only (sterility in women, SPC 4.1); the SPC gives no dose for men. Treatment must be initiated under the supervision of a physician experienced in the treatment of infertility; there are great inter- and intra-individual variations in ovarian response, so a uniform dosage scheme is impossible and ultrasonography (and possibly oestradiol monitoring) is required. Anovulation regimen: if the number of responding follicles is too high or oestradiol rises more than a daily doubling for two or three consecutive days, decrease the daily dose; if multiple pre-ovulatory follicles exceed 14 mm, withhold hCG and avoid pregnancy (barrier contraception or abstain from coitus until the next menstrual bleeding); recommence the next cycle at a lower dose. If there is no adequate response after 4 weeks the cycle should be abandoned and the next started at a higher initial dose. Once the ideal response is obtained, a single injection of 5 000 IU to 10 000 IU of hCG is given 24 to 48 hours after the last Fostimon injection (in ART oocyte retrieval is performed 34-35 hours later). Reconstitute immediately before use with the solvent provided; alternate the subcutaneous injection site to prevent lipo-atrophy; self-injection only by motivated, trained and well-informed patients, the first injection under direct medical supervision. Concomitant clomifene citrate may enhance the follicular response (section 4.5).