Posology : מינונים

4.2   Posology and method of administration

Treatment with Pergoveris should be initiated under the supervision of a physician experienced in the treatment of fertility problems.

Posology
In LH and FSH deficient women (hypogonadotrophic hypogonadism), the objective of Pergoveris therapy is to develop a single mature Graafian follicle from which the oocyte will be liberated after the administration of human chorionic gonadotrophin (hCG).
Pergoveris should be given as a course of daily injections. Since these patients are amenorrhoeic and have low endogenous oestrogen secretion, treatment can commence at any time.

Treatment should be tailored to the individual patient’s response as assessed by measuring follicle size by ultrasound and oestrogen response. A recommended regimen commences with one vial of Pergoveris daily. If less than one vial of Pergoveris daily is used, the follicular response may be unsatisfactory because the amount of lutropin alfa may be insufficient (see section 5.1).

If an FSH dose increase is deemed appropriate, dose adaptation should preferably be after 7-14 day intervals and preferably by 37.5-75 IU increments using a licensed follitropin alfa preparation. It may be acceptable to extend the duration of stimulation in any one cycle to up to 5 weeks.

When an optimal response is obtained, a single injection of 250 micrograms of r-hCG or 5,000 IU to 10,000 IU hCG should be administered 24-48 hours after the last Pergoveris injection. The patient is recommended to have coitus on the day of, and on the day following, hCG administration. Alternatively, intrauterine insemination (IUI) may be performed.

Luteal phase support may be considered since lack of substances with luteotrophic activity (LH/hCG) after ovulation may lead to premature failure of the corpus luteum.

If an excessive response is obtained, treatment should be stopped and hCG withheld.
Treatment should recommence in the next cycle at a dose of FSH lower than that of the previous cycle.

Special populations

Older people
There is no relevant indication for the use of Pergoveris in the elderly population. Safety and effectiveness of Pergoveris in elderly patients have not been established.

Renal and hepatic impairment
Safety, efficacy, and pharmacokinetics of Pergoveris in patients with renal or hepatic impairment have not been established.

Paediatric population
There is no relevant use of Pergoveris in the paediatric population.

Method of administration
Pergoveris is intended for subcutaneous administration. The first injection of Pergoveris should be performed under direct medical supervision. The powder should be reconstituted immediately prior to use with the solvent provided. Self-administration of Pergoveris should only be performed by patients who are well motivated, adequately trained and with access to expert advice.
For further instructions on reconstitution of the medicinal product before administration, see section 6.6.