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Human Menopausal Gonadotrophins

(British Approved Name)

Drug Nomenclature

Synonyms: Gonadotropina menopáusica humana; HMG; Human Menopausal Gonadotrophins; Org-31338; Urogonadotrophin
BAN: Human Menopausal Gonadotrophins
ATC code: G03GA02
Read code: y03Y9

Description. A purified extract of human postmenopausal urine containing follicle-stimulating hormone (FSH) and lutein-ising hormone (LH) the relative in-vivo activity is expressed as a ratio. Human menopausal gonadotrophins with a ratio of FSH:LH of 1:1 are known as menotrophin (see below).

Menotrophin

(British Approved Name)

MenotrophinDrug Nomenclature

Synonyms: Menotropiini; Menotropin; Menotropina; Menotropinum
BAN: Menotrophin
USAN: Menotropins
CAS: 9002-68-0

Pharmacopoeias. In British, China, Japan, and US.

British Pharmacopeia 2008 (Menotrophin). A dry preparation containing glycoprotein gonadotrophins possessing follicle-stimulating and luteinising activities. It contains not less than 40 units of follicle-stimulating hormone activity per mg. The ratio of units of luteinising hormone activity to units of follicle-stimulating hormone activity is about 1. The preparation is exclusively or predominantly of pituitary origin and obtained from the urine of postmenopausal women but, when necessary, chorionic gonadotrophin obtained from the urine of pregnant women may be added to achieve the above ratio. An almost white or slightly yellow powder. Soluble in water. Store in airtight containers. Protect from light.

The United States Pharmacopeia 31, 2008 (Menotropins). An extract of human postmenopausal urine containing both follicle-stimulating hormone and luteinising hormone. It has a potency of not less than 40 follicle-stimulating hormone units and not less than 40 luteinising hormone units per mg. The ratio of units is about 1. Chorionic Gonadotropin obtained from the urine of pregnant women may be added to achieve this ratio. Not more than 30% of the luteinising hormone activity is contributed by Chorionic Gonadotropin. Store in airtight containers at 2° to 8°.

Adverse Effects

Human menopausal gonadotrophins may cause dose-related ovarian hyperstimulation varying from mild ovarian enlargement and abdominal discomfort to severe hyperstimulation with marked ovarian enlargement or cyst formation, acute abdominal pain, ascites, pleural effusion, hypovolaemia, shock and thromboembolic disorders. Rupture of ovarian cysts and intraperitoneal haemorrhage has occurred, usually after pelvic examination. Fatalities have been reported.

Hypersensitivity reactions and local reactions at the injection site may occur. Nausea and vomiting, joint pains and fever have been reported gynaecomastia, acne, and weight gain have occurred in men.

Carcinogenicity. In a case-control study of 4575 women with primary invasive breast cancer, an evaluation of risk factors found that, overall, the use of infertility drugs was not associated with an increased risk of breast cancer. However, subgroup analysis of individual drugs found that the use of human menopausal gonadotrophins for at least 6 months or 6 treatment cycles was associated with a risk of breast cancer that was 2 to 3 times greater than for women who had never received any fertility treatment. The authors of this study noted that these results were based on small numbers and that other studies had failed to show an association between fertility treatment and breast cancer.

Effects on the ovary. Ovarian hyperstimulation syndrome after use of human menopausal gonadotrophins in 4 women progressed to acute adnexal torsion. Deep-vein thrombosis has also been a rare complication of ovarian hyperstimulation syndrome associated with the use of human menopausal gonadotrophins plus chorionic gonadotrophin. In another case in which thrombosis followed the use of human menopausal gonadotrophins alone, hereditary activated protein C resistance and smoking may have been contributing factors

Precautions

Human menopausal gonadotrophins should not be given to pregnant patients. Use should be avoided in patients with abnormal genital bleeding, hormone sensitive malignancies such as those of the breast, uterus, prostate, ovaries or testes, or ovarian cysts or enlargement not caused by the polycystic ovary syndrome. Pituitary or hypothalamic lesions, adrenal or thyroid disorders, and hyperprolactinaemia should be treated appropriately to exclude them as causes of infertility before attempting therapy with human menopausal gonadotrophins. Patients who experience ovarian enlargement are at risk of rapture pelvic examinations should be avoided or carried out with care and the recommendation has been made that sexual intercourse should be avoided while there is such a risk. There is a risk of multiple births.

Interactions

In women who show evidence of excessive ovarian stimulation while receiving human menopausal gonadotrophins the use of drugs with luteinising-hormone (LH) activity increases the risk of ovarian hyperstimulation syndrome.

Uses and Administration

Human menopausal gonadotrophins possess both follicle-stimulating hormone (FSH) activity and luteinising hormone (LH) activity. Human menopausal gonadotrophins are used in the treatment of male and female infertility due to hypog-onadism. In anovulatory infertility unresponsive to clomifene, human menopausal gonadotrophins are given to induce follicular maturation and are followed by treatment with chorionic gonadotrophin to stimulate ovulation and corpus luteum formation, a topic discussed further.

Human Menopausal GonadotrophinsThe dosage and schedule of treatment for female infertility 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. Human menopausal gonadotrophins may be given daily by intramuscular or subcutaneous injection to provide a dose of 75 to 150 units of FSH and gradually adjusted if necessary until an adequate response is achieved. Treatment is then stopped and followed after 1 or 2 days by single doses of chorionic gonadotrophin 5000 to 10 000 units. In menstruating patients treatment should be started within the first 7 days of the menstrual cycle. In the UK it has been suggested that the treatment course should be abandoned if no response is seen in 3 weeks although in the US the manufacturers recommend that an individual course should not exceed 12 days. This course may be repeated at least twice more if necessary.

An alternative schedule is to give three equal doses by intramuscular or subcutaneous injection, each providing 225 to 375 units of FSH on alternate days followed by chorionic gonadotrophin one week after the first dose.

In IVF and other assisted conception techniques, human menopausal gonadotrophins are used with chorionic gonadotrophin and sometimes also clomifene citrate or a gonadorelin analogue. Stimulation of follicular growth is produced by human menopausal gonadotrophins given by intramuscular or subcutaneous injection, in a dose providing 75 to 300 units of FSH daily, usually beginning on the 2nd or 3rd day of the menstrual cycle. Treatment is continued until an adequate response is obtained and the final injection of human menopausal gonadotrophins is followed 1 to 2 days later with up to 10 000 units of chorionic gonadotrophin. Oocyte retrieval is carried out about 32 to 36 hours later.

In men with infertility due to hypogonadotrophic hypogonadism (see Infertility), spermatogenesis is stimulated with chorionic gonadotrophin and then human menopausal gonadotrophins are added in a dose of 75 or 150 units of FSH two or three times weekly by intramuscular or subcutaneous injection. Treatment should be continued for at least 3 or 4 months.

Infertility. Systematic reviews have not found evidence of a significant difference in efficacy for human menopausal gonadotrophins compared with urinary-derived gonadotrophins in women with anovulatory infertility, or compared with recombinant follicle-stimulating hormone in assisted reproduction cycles. UK guidelines consider that human menopausal gonadotrophins, urinary follicle-stimulating hormone, and recombinant follicle-stimulating hormone are equally effective in achieving pregnancy for women with ovulatory disorders, such as polycystic ovary syndrome, and for IVF treatment.

Preparations

British Pharmacopeia 2008: Menotrophin Injection

The United States Pharmacopeia 31, 2008: Menotropins for Injection

Proprietary Preparations

Argentina: HMG Ferring Lifecell Menopur Pergonal

Australia: Humegon

Austria: Menopur

Belgium: Menopur

Brazil: Menogon Menopur Merional-HMG Pergonal

Canada: Humegon Pergonal Repronex

Chile: Menopur Pergonal

Czech Republic: Humegon Menogon Menopur Merional

Denmark: Menogon Menopur

Finland: Menogon Menopur

France: Menopur

Germany: Humegon Menogon

Greece: Altermon Menogon Menopur Merional Pergogreen Pergonal

Hong Kong: Menogon Menopur Merional Pergonal

Hungary: Menogon Menopur Merional

India: Eventin Pergonal Pregnorm

Ireland: Humegon Menogon Menopur

Israel: Humegon Menogon Menopur Pergonal

Italy: Humegon Menogon Meropur

Japan: Gonadoryl

Mexico: Humegon Merapur HP Merional Pergonal

The Netherlands: Humegon Menogon Menopur Pergonal

Norway: Menopur

Poland: Menopur

Portugal: Humegon

Russia: Menogon Menopur Pergonal

South Africa: Humegon Pergonal

Singapore: Menogon

Spain: HMG Menopur Pergonal

Sweden: Menopur

Switzerland: Menogon Menopur Merional Pergonal

Thailand: IVF-M Menogon

Turkey: Menogon Pergonal

United Kingdom: Menogon Menopur Merional

USA: Humegon Menopur Pergonal Repronex

Venezuela: Pergonal

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