Active Ingredient: Lutropin alfa
Lutropin alfa in association with a Follicle Stimulating Hormone (FSH) preparation is recommended for the stimulation of follicular development in adult women with severe Luteinising Hormone (LH) and FSH deficiency. In clinical trials these patients were defined by an endogenous serum LH level <1.2 IU/l.
For this indication, competent medicine agencies globally authorize below treatments:
Subcutaneous
75 - 75 [iU]
From 75 To 75 [iU] once every day
In LH and FSH deficient women, the objective of lutropin alfa 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). Lutropin alfa should be given as a course of daily injections simultaneously with FSH. Since these patients are amenorrhoeic and have low endogenous oestrogen secretion, treatment can commence at any time.
Lutropin alfa should be administered concomitantly with follitropin alfa.
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 at 75 IU of lutropin alfa daily with 75-150 IU FSH.
In clinical trials, lutropin alfa 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 7-14 day intervals and preferably by 37.5 IU-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 microgramsof r-hCG or 5,000 IU to 10,000 IU hCG should be administered 24-48 hours after the last lutropin alfa 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.
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