(British Approved Name, US Adopted Name, rINN)
35 units of human pituitary luteinising hormone are contained in about 5.8 micrograms (with 1 mg of human albumin, 5 mg of mannitol, and 1 mg of sodium chloride) in one ampoule of the second International Standard (1988).
10 units of the alpha subunit of human pituitary luteinising hormone are contained in about 10 micrograms (with 0.5 mg of human albumin, 2.5 mg of lactose, and 45 micrograms of sodium chloride) in one ampoule of the first International Standard (1984).
10 units of the beta subunit of human pituitary luteinising hormone are contained in 10 micrograms (with 0.5 mg of human albumin, 2.5 mg of lactose, and 45 micrograms of sodium chloride) in one ampoule of the first International Standard (1984). 189 units of recombinant human luteinising hormone are contained in about 8.8 micrograms (with 2 mg of human albumin, 10 mg of lactose, and 8.9 mg of sodium chloride) in one ampoule of the first International Standard (2003).
Adverse Effects and Precautions
As for Human Menopausal Gonadotrophins.
The absolute bioavailability of lutropin alfa after subcutaneous doses is about 60%, and the terminal half-life is at least 10 to 12 hours.
Uses and Administration
Luteinising hormone (LH) is secreted with follicle-stimulating hormone (FSH), another gonadotrophin, by the anterior pituitary lobe.
These gonadotrophins stimulate the normal functioning of the gonads and the secretion of sex hormones in both men and women. In women, follicle-stimulating hormone stimulates the development and maturation of the follicles and ova. As the follicle develops it produces oestrogen in increasing amounts which at mid-cycle stimulates the release of LH. This causes rupture of the follicle with ovulation and converts the follicle into the corpus luteum which secretes progesterone. In men, luteinising hormone stimulates the interstitial cells of the testis to secrete testosterone, which in turn has a direct effect on the seminiferous tubules.
Gonadotrophic substances with luteinising or follicle-stimulating activity or both are used in the treatment of infertility, chiefly in females but also in males. Such substances include chorionic gonadotrophin which possesses LH activity and human menopausal gonadotrophins which possess both LH and FSH activity.
Lutropin alfa is a recombinant human luteinising hormone used to induce ovulation in women with severe deficiency of luteinising and follicle-stimulating hormones. It is used at the same time as a preparation with follicle-stimulating activity, usually folli-tropin alfa. The dosage and schedule of treatment must be determined according to the needs of each patient it is usual to monitor response by studying the patient’s urinary oestrogen excretion or by ultrasonic visualisation of follicles or both. Treatment is usually begun with 75 units of lutropin alfa daily by subcutaneous injection for 7 to 14 days, accompanied by FSH. If there is no response, the FSH dosage may be increased at 7- or 14-day intervals until an adequate but not excessive response is achieved. A treatment cycle of up to 5 weeks may be needed. Treatment is then stopped and followed after 1 or 2 days by a single dose of chorionic gonadotrophin 5000 to 10 000 units to induce ovulation. These patients are generally amenorrhoeic and treatment may be started at any time.
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