Posology : מינונים

4.2    Posology and method of administration

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

Posology

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

Luveris should be administered concomitantly with follitropin alfa.

A recommended regimen commences at 75 IU of lutropin alfa (i.e. one vial of Luveris) daily with 75 to 150 IU FSH. Treatment should be tailored to the individual patient’s response as assessed by measuring follicle size by ultrasound and estrogen response.

In clinical trials, Luveris has been shown to increase the ovarian sensitivity to follitropin alfa. If an FSH dose increase is deemed appropriate, dose adaptation should preferably be after 7- to 14-day intervals and preferably by 37.5 IU to 75 IU increments. 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 to 48 hours after the last Luveris and FSH injections. 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 (see section 4.4).

Special populations

Elderly
There is no relevant use of Luveris in the elderly population. Safety and efficacy of Luveris in elderly patients have not been established.

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

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

Method of administration
Luveris is intended for subcutaneous use. The first injection of Luveris should be performed under direct medical supervision. The powder should be reconstituted immediately prior to use with the solvent provided. Self-administration of this medicinal product should only be performed by patients who are well-motivated, adequately trained and with access to expert advice.

For instructions on reconstitution of the medicinal product before administration, see section 6.6.