Follitropin Alfa / Lutropin Alfa

What it is and how it works

Follitropin alfa (recombinant FSH) stimulates recruitment and growth of ovarian follicles. Lutropin alfa (recombinant LH) stimulates theca cells to produce androgens that granulosa cells aromatise to oestradiol, supporting FSH-induced follicular development. The combination replaces both gonadotrophins in women with profound deficiency.

Indications

Stimulation of follicular development in adult women with severe LH and FSH deficiency (hypogonadotrophic hypogonadism).

Dosage and administration (summary)

Subcutaneous injection, usually starting with follitropin alfa 150 IU and lutropin alfa 75 IU once daily, with dose and duration adjusted by the fertility specialist according to ultrasound and oestradiol monitoring, followed by hCG to trigger ovulation.

Contraindications

Ovarian enlargement or cyst not due to polycystic ovary syndrome, tumours of the ovary, uterus, breast, hypothalamus or pituitary, gynaecological bleeding of unknown cause, primary ovarian failure, and malformations of the reproductive organs or fibroid tumours incompatible with pregnancy.

Warnings and precautions

Ovarian hyperstimulation syndrome (OHSS) may occur and can be severe; careful monitoring of follicular response is required, and hCG should be withheld if excessive response occurs. Multiple pregnancy, ectopic pregnancy, miscarriage and thromboembolic events are increased; thyroid, adrenal and pituitary disorders should be excluded or corrected before treatment.

Pregnancy

Not indicated during pregnancy.

Storage and supply

Store refrigerated at 2–8 °C; do not freeze; protect from light (some presentations may be kept at up to 25 °C for a limited period as stated by the manufacturer).

Source: reference summary prepared from the EU SmPC/EPAR, BNF and WHO Model Formulary. The approved product information in Iran governs.