Follitropin Alfa + Lutropin Alfa

Indications

Follitropin Alfa + Lutropin Alfa is an injection used to stimulate follicular development in adult women who have severe LH and FSH deficiency. In the clinical trials, these women were identified by an endogenous serum LH level below 1.2 IU/L.

⚠️ Always consult a registered physician before taking any medicine.

Pharmacology

This injection contains recombinant human follicle stimulating hormone (follitropin alfa, r-hFSH) and recombinant human luteinising hormone (lutropin alfa, r-hLH). Both are made in Chinese hamster ovary (CHO) cells by recombinant DNA technology. Clinical trials have shown that the combination of follitropin alfa and lutropin alfa works in women with hypogonadotropic hypogonadism.

When follicular development is stimulated in anovulatory women who lack LH and FSH, the main effect of giving lutropin alfa is a rise in oestradiol secretion by the follicles. FSH stimulates the growth of these follicles. In the clinical trials, patients with severe FSH and LH deficiency were defined as those with an endogenous serum LH level below 1.2 IU/L, measured in a central laboratory. LH measurements can vary from one laboratory to another, so this should be taken into account. In these trials the ovulation rate per cycle was 70-75%.

Pregnancy & Breastfeeding

This injection has no use during pregnancy. A limited number of pregnancies have been exposed to follitropin alfa and lutropin alfa after controlled ovarian stimulation, and those data show no adverse effect on the pregnancy, on the development of the embryo or foetus, on delivery, or on development after birth. Animal studies have not reported any teratogenic effect of these gonadotropins. Still, if exposure happens during pregnancy, the clinical data are not enough to rule out a teratogenic effect of this injection. It is also not indicated during breast-feeding.

⚠️ Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.

Dosage Reference

⚠️ Reference ranges from official sources only. Consult your doctor for personalized dosing.

Adults: In women who lack LH and FSH (hypogonadotrophic hypogonadism), the aim of this injection is to develop a single mature Graafian follicle. The oocyte is released from that follicle after human chorionic gonadotrophin (hCG) is given. The injection is given as a course of daily injections. These women have no periods (amenorrhoeic) and produce little oestrogen of their own, so treatment can start at any time. The treatment should be adjusted to each patient's response, which is checked by measuring follicle size on ultrasound and by the oestrogen response. A recommended regimen starts with one vial of this injection daily. If less than one vial a day is used, the follicles may not respond well, because the amount of lutropin alfa may not be enough. If a higher FSH dose is thought to be appropriate, the dose should preferably be changed after intervals of 7 to 14 days, and preferably in steps of 37.5 to 75 IU, using a licensed follitropin alfa preparation. It may be acceptable to extend the stimulation in any one cycle to up to 5 weeks. When the response is optimal, a single injection of 250 micrograms of r-hCG, or 5,000 IU to 10,000 IU of hCG, should be given 24 to 48 hours after the last injection of this medicine. The patient is advised to have intercourse on the day of hCG and on the day after. Intrauterine insemination (IUI) may be done instead. Luteal phase support may be considered, because a lack of substances with luteotrophic activity (LH/hCG) after ovulation may lead to early failure of the corpus luteum. If the response is excessive, treatment should be stopped and hCG withheld. In the next cycle, treatment should start again at a lower FSH dose than the one used in the previous cycle.

Side Effects & Interactions

Side Effects

No side-effect data recorded yet.

Key Interactions

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Follitropin Alfa