Highly purified menotrophin.
Each vial contains: Menotrophin B.P. equivalent to activity of Follicle stimulating Hormone 75 I.U./150 I.U., Luteinizing Hormone 75 I.U./150 I.U.
Pharmacology: Highly Purified Menotrophin (HUMOG) (Human Menopausal Gonadotropin) is a hormonal substance containing FSH and LH in a ratio of 1:1. In female, Highly Purified Menotrophin (HUMOG) stimulates both the growth and the maturation of follicles, it induces an increase in the oestrogen levels and a proliferation of the endometrium. In the male Highly Purified Menotrophin (HUMOG) stimulates the spermatogenesis by acting on the production of the androgen-binding protein in the seminiferous tubules of the sertoli cells.
Women and Men: Anovulatory women: Highly Purified Menotrophin (HUMOG) can be used to stimulate follicle development in amenorrhoeic patients. Clomiphene (or a similar ovulation inducing agent which influences steroid feed-back mechanisms) is the preferred treatment for women with a variety of menstrual cycle disturbances, including luteal phase insufficiency with anovulatory cycles and with normal prolactin, and also amenorrhoeic patients with evidence of endogenous oestrogen production but normal prolactin and normal gonadotropin levels. Non-responders may then be selected for menotrophin therapy.
Women undergoing superovulation within a medically assisted fertilisation programme: Highly Purified Menotrophin (HUMOG) can be used to induce multiple follicular development in patients undergoing an assisted conception technique such as in-vitro fertilisation (IVF).
Hypogonadotrophic hypogonadism in men: Highly Purified Menotrophin (HUMOG) may be given in combination with human chorionic gonadotropin for the stimulation of spermatogenesis. Patients with primary testicular failure are usually unresponsive.
Anovulatory infertility: Menotrophin is administered to induce follicular maturation and is followed by treatment with chorionic gonadotropin to stimulate ovulation and corpus luteum formation. The dosage and schedule of treatment must be determined according to the needs of each patient. Response is monitored by studying the patient's urinary oestrogen excretion or by ultrasound visualisation of follicles. Menotrophin may be given daily by either intramuscular or subcutaneous injection to provide a dose of 75 to 150 units of FSH and 75 to 150 units of LH, and gradually adjusted if necessary until an adequate response is achieved, followed after 1 or 2 days by chorionic gonadotropin. In menstruating patients, treatment should be started within the first 7 days of the menstrual cycle. The treatment course should be abandoned if no response is seen in 3 weeks. This treatment cycle may be repeated at least twice more if necessary. Alternatively, three equal doses of menotrophin, each providing 225 to 375 units of FSH with 225 to 375 units of LH, may be given on alternate days followed by chorionic gonadotropin one week after the first dose.
In the daily therapy schedule, the dose is gradually increased until oestrogen levels start to rise. The effective dose is then maintained until adequate pre-ovulatory oestrogen levels are reached. If oestrogen levels rise too rapidly, the dose should be decreased.
As a measure of follicle maturity the following values can be taken: total urinary oestrogen: 75-150 micrograms (270-540 nmol)/24 hours; plasma 17 beta-oestradiol: 400-800 picograms/mL (1500-3000 pmol/L).
When adequate pre-ovulatory oestrogen levels have been reached, administration of Highly Purified Menotrophin (HUMOG) is stopped, and ovulation may then be induced by administering human chorionic gonadotropin at a dose of 5000-10000 I.U.
The effect of an overdose is unknown, nevertheless one could expect ovarian hyperstimulation syndrome to occur.
Congenital malformation: The prevalence of congenital malformations after ART may be slightly higher than after spontaneous conceptions. This is thought to be due to differences in parental characteristics (e.g. maternal age, sperm characteristics) and multiple pregnancies.
Thromboembolic events: In women with generally recognised risk factors for thromboembolic events, such as personal or family history, treatment with gonadotropins may further increase the risk. In these women, the benefits of gonadotropin administration need to be weighed against the risks. It should be noted however, that pregnancy itself also carries an increased risk of thromboembolic events.
Effects on ability to drive and use machines: No studies on the effects on ability to drive and use machines have been performed.
Highly Purified Menotrophin (HUMOG) should not be given if pregnancy is suspected or to lactating mothers.
In the female, a local reaction at the injection site, fever and arthralgia have been observed in rare cases. In the male, a combined treatment with Highly Purified Menotrophin (HUMOG) and Chorionic Gonadotropin Injection (HUCOG) may cause gynecomastia.
No drug/drug interaction studies have been conducted with Highly Purified Menotrophin (HUMOG) in humans. Although there is no controlled clinical experience, it is expected that the concomitant use of Highly Purified Menotrophin (HUMOG) and clomiphene citrate may enhance the follicular response. When using GnRH agonist for pituitary desensitization, a higher dose of Highly Purified Menotrophin (HUMOG) may be necessary to achieve adequate follicular response.
Incompatibilities: The product is stable and there is no incompatibility amongst excipients.
Vials of Highly Purified Menotrophin (HUMOG) should be stored between 2°C - 8°C. Do not freeze. Protect from light.
Reconstituted solution of Highly Purified Menotrophin (HUMOG) should be used immediately after preparation. Discard any unused portion.
Shelf life: 36 months.
G03GA02 - human menopausal gonadotrophin ; Belongs to the class of gonadotropins. Used as ovulation stimulants.
Soln for inj (vial + 1 mL amp diluent) 75 IU x 2 mL x 1's. 150 IU x 2 mL x 1's.