HMG75 IU/vial

HMG is a purified preparation of follicle-stimulating hormone (FSH) and luteinizing hormone (LH) activity, extracted from the urine of postmenopausal women, used in the management of infertility. Its approved and evidence-supported uses include:

• Ovulation induction: In anovulatory infertile women (including those who have not responded adequately to clomiphene citrate), to stimulate follicular development and induce ovulation, typically combined with a subsequent human chorionic gonadotropin (hCG) trigger.
• Controlled ovarian stimulation (COS) for assisted reproductive technology (ART): In women undergoing in vitro fertilization (IVF) or related procedures, to promote development of multiple follicles ahead of oocyte retrieval, used together with hCG.
• Spermatogenesis induction in men: In men with hypogonadotropic hypogonadism, used in combination with hCG (given first to restore intratesticular testosterone) to stimulate sperm production.

HMG is used only under the close supervision of a fertility specialist or reproductive endocrinologist with access to ultrasound and hormone-monitoring facilities; it is not intended for self-directed use.

Human Menopausal Gonadotrophin is a biological product purified from the urine of postmenopausal women, standardized to provide a combination of follicle-stimulating hormone (FSH) and luteinizing hormone (LH) bioactivity, commonly supplied in a 1:1 ratio (e.g., 75 IU FSH and 75 IU LH activity per ampoule/vial). It is presented as a lyophilized (freeze-dried) powder for injection, packaged with a solvent ampoule for reconstitution, for subcutaneous or intramuscular administration.

HMG belongs to the gonadotropin class of hormonal medicines. Unlike single-hormone recombinant FSH products, it supplies both FSH and LH activity, mimicking the combined pituitary signal needed for follicular growth and steroidogenesis in women and for spermatogenesis support in men. It is used only as part of a structured, specialist-supervised fertility treatment cycle, typically combined with hCG and close ultrasound/hormonal monitoring to reduce the risk of over-response.

HMG belongs to the therapeutic class of Gonadotropins, specifically urinary-derived FSH/LH combination preparations used in ovulation induction, assisted reproduction, and male fertility treatment.

Human Menopausal Gonadotrophin supplies both FSH and LH bioactivity, acting on gonadal receptors as follows:

• In women: The FSH component stimulates growth, development, and maturation of ovarian follicles, while the LH component supports theca-cell androgen production (a substrate for follicular estradiol synthesis) and contributes to overall follicular steroidogenesis. Final oocyte maturation and follicular rupture require a subsequent hCG injection.
• In men: When given together with hCG (which maintains intratesticular testosterone via Leydig-cell stimulation), the FSH activity in Human Menopausal Gonadotrophin stimulates Sertoli-cell function and supports spermatogenesis.

Pharmacokinetically, Human Menopausal Gonadotrophin is absorbed after subcutaneous or intramuscular injection, with an elimination half-life in the range of roughly 10-40 hours (varying by component and assay), and serum hormone levels are monitored clinically rather than pharmacokinetically titrated.

HMG is given by intramuscular or subcutaneous injection, either administered by a healthcare professional or self-administered by the patient/caregiver after proper training, using the reconstituted solution prepared from the powder vial and supplied solvent (see Reconstitution). Injection sites should be rotated to reduce local irritation. The reconstituted solution should not be mixed with other medicinal products in the same syringe unless specifically directed by the treating physician. Injections are usually given at approximately the same time each day for consistent hormone exposure.

No formal drug-drug interaction studies have been conducted with HMG. It is routinely and intentionally co-administered with human chorionic gonadotropin (hCG) as part of standard fertility protocols, and is sometimes used together with a GnRH agonist or antagonist to prevent a premature LH surge during controlled ovarian stimulation; these combinations are expected and managed by the treating specialist. Concomitant use of other hormonal medications (e.g., clomiphene citrate) should occur only under specialist guidance, as they may alter ovarian response and the required dose of HMG.

The most common side effects reported with HMG include:

• Headache
• Pelvic or lower abdominal pain/discomfort
• Ovarian enlargement or ovarian cysts
• Nausea and abdominal bloating
• Injection site reactions (redness, pain, bruising)
• Breast tenderness
• In men: gynecomastia, acne, injection site pain

A more serious but less common risk is ovarian hyperstimulation syndrome (OHSS) — see Precautions and Warnings for full detail. Uncommon effects include hypersensitivity reactions (including anaphylaxis) and thromboembolic events.

HMG is contraindicated once pregnancy is confirmed and has no indication for use during an established pregnancy. It is used only to help achieve pregnancy, under specialist supervision, and is stopped once ovulation is triggered (aside from the hCG trigger dose itself). There is no clear evidence that gonadotropin use itself increases the rate of congenital malformations beyond the background population risk, but multiple-pregnancy and ART-related factors can independently increase risk; this should be discussed with the treating physician. It is not known whether HMG passes into human breast milk; a physician should be consulted before use in a breastfeeding woman, weighing the benefit of treatment against the clinical situation.

HMG should only be used under the supervision of a physician experienced in fertility treatment, with access to ultrasound and hormonal monitoring. Key warnings include:

• Ovarian Hyperstimulation Syndrome (OHSS): A potentially life-threatening condition involving rapid ovarian enlargement, fluid shifts, and third-spacing (ascites, pleural effusion). Early warning signs include severe pelvic pain, nausea, vomiting, and rapid weight gain; if these occur, treatment should be stopped and the physician contacted immediately. Risk is reduced by using the lowest effective dose, careful monitoring, and by withholding the hCG trigger if the ovarian response is excessive.
• Multiple pregnancy: Gonadotropin therapy including HMG is associated with an increased risk of twin or higher-order multiple pregnancy — historically somewhat higher with urinary hMG-based ovulation-induction regimens than with natural conception — which carries greater maternal and perinatal risk; careful cycle monitoring and patient counseling before starting treatment are essential.
• Ovarian torsion: A rare but serious complication associated with OHSS and enlarged ovaries; presents with sudden severe abdominal pain and requires urgent evaluation.
• Thromboembolism: Rare cases of venous or arterial thromboembolic events (including deep vein thrombosis, pulmonary embolism, stroke) have been reported, particularly in women with additional risk factors such as obesity or a personal/family history of thrombosis.
• Ectopic pregnancy: Women with a history of tubal disease are at increased risk of ectopic pregnancy following fertility treatment; early ultrasound confirmation of an intrauterine pregnancy is recommended.

Regular specialist monitoring (ultrasound and estradiol levels in women; testosterone and semen analysis in men) is required throughout treatment with HMG.

Specific data on acute overdosage of HMG are limited, though the effects of a single excessive dose are not expected to be clinically significant. Excessive or repeated overdosing over a treatment cycle is expected to increase the risk of ovarian hyperstimulation syndrome and multiple pregnancy in women. If overdose is suspected, discontinue the medicine and seek immediate medical attention or contact emergency services; the treating fertility specialist should be informed promptly so that appropriate monitoring and supportive care can be arranged. No specific antidote exists.

Store HMG (unreconstituted powder) at room temperature, below 25-30°C, protected from light, and do not freeze; check the specific product's pack insert for the exact temperature limit. Once reconstituted with the supplied solvent, use immediately and discard any unused solution — do not store reconstituted solution for later use unless the specific product labeling states otherwise. Keep out of reach of children, and do not use after the expiry date printed on the pack.

Pediatric use: HMG is not indicated for use in children; safety and efficacy in pediatric patients have not been established.

Geriatric use: Not applicable, as this medicine is used within the reproductive age range for its approved indications; clinical studies in patients 65 years and older have not been conducted.

Renal/hepatic impairment: Specific dose-adjustment data in significant renal or hepatic impairment are not well established; use with caution and specialist judgment in such patients.

Body weight: Total drug exposure can vary with body weight and individual ovarian/testicular sensitivity; the treating physician adjusts dosing according to monitored response rather than weight alone.

For ovulation induction and controlled ovarian stimulation, a single treatment cycle with HMG typically lasts about 7 to 14 days, ending with the hCG trigger injection; the number of cycles attempted is decided by the fertility specialist. For spermatogenesis induction in men, treatment is generally continued for a minimum of 3-4 months, as a visible response in sperm production may take up to 12 months or longer; hCG pretreatment for several months often precedes the addition of HMG in men.

HMG is supplied as a lyophilized (freeze-dried) powder in an ampoule or vial with a separate solvent ampoule (usually sterile water or sterile saline for injection) and must be reconstituted immediately before use: inject the provided solvent gently into the powder vial without vigorous shaking, and swirl gently until the powder is fully dissolved into a clear solution. Do not use if the reconstituted solution is cloudy or contains particulate matter. Where more than one powder ampoule is needed for a single dose, the same solvent may be used to dissolve successive ampoules as directed. The reconstituted solution should be used immediately, and any unused portion discarded.

Human Menopausal Gonadotrophin belongs to the drug class of Gonadotropins (Urinary-derived FSH/LH combination preparations), used in the treatment of infertility.

Human Menopausal Gonadotrophin supplies combined FSH and LH bioactivity that binds to and activates FSH and LH receptors on ovarian granulosa and theca cells in women, stimulating follicular growth, development, and estradiol production, and on testicular Sertoli cells in men (via its FSH activity), supporting spermatogenesis when combined with hCG. It reproduces the physiological combined gonadotropin signal normally provided by the pituitary gland.

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HMG has no approved use in pediatric patients. It is indicated only for adults undergoing fertility treatment (women undergoing ovulation induction or assisted reproduction, and adult men with hypogonadotropic hypogonadism). Safety and efficacy in children and adolescents have not been established.