Follitropin alfa with lutropin alfa

Indication in the fetched SPC: LH and FSH deficient women, to promote follicular development followed by final maturation after hCG. Treatment must be initiated under the supervision of a physician experienced in fertility disorders. If the patient is amenorrhoeic and has low endogenous oestrogen secretion, treatment can commence at any time. SPC §4.2 verbatim caution: 'If less than one vial daily is used, the follicular response may be unsatisfactory because the amount of lutropin alfa may be insufficient.' Tailor to the individual patient's response, assessed by follicle size on ultrasound and oestrogen response. If an FSH dose increase is deemed appropriate, adapt preferably after 7 to 14 day intervals and preferably by 37.5 to 75 IU increments USING A LICENSED FOLLITROPIN ALFA PREPARATION (i.e. added as separate FSH, not by increasing the number of combination vials). It may be acceptable to extend the duration of stimulation in any one cycle to up to 5 weeks. FINAL MATURATION: when an optimal response is obtained, a single injection of 250 micrograms r-hCG or 5 000 IU to 10 000 IU hCG should be administered 24 to 48 hours after the last Pergoveris injection; coitus is recommended on the day of and the day following hCG, or intrauterine insemination / another medically assisted reproduction procedure may be performed. Luteal phase support may be considered, since lack of luteotrophic activity (LH/hCG) after ovulation may lead to premature failure of the corpus luteum. If an excessive response is obtained, stop treatment and withhold hCG; recommence in the next cycle at a lower FSH dose. ADMINISTRATION: the powder should be reconstituted immediately prior to use with the solvent provided; the first injection should be performed under direct medical supervision; self-administration only by patients who are well motivated, adequately trained and with access to expert advice. No relevant indication in the elderly; no relevant use in the paediatric population.