Karma-HMG®

Description

Karma-HMG® is a highly purified preparation of human menopausal gonadotropin (hMG) containing follicle-stimulating hormone (FSH) and luteinizing hormone (LH) in a 1:1 ratio, extracted from the urine of postmenopausal women.

In women, Karma-HMG® stimulates the growth and maturation of ovarian follicles, increases estrogen levels, and promotes proliferation of the endometrium. In men, it stimulates spermatogenesis by acting on Sertoli cells to enhance production of androgen-binding protein.

Karma-HMG® is supplied as a pack containing three vials of sterile lyophilized powder and three 1 mL ampules of 0.9% Sodium Chloride Injection B.P. as solvent.

Karma-HMG® is manufactured by BSV BioScience GmbH (Germany) and developed/produced by Homa Pharmed Co. under license from Karma Pharmatech GmbH (Germany).

Indications

In women:

– Induction of multiple follicular development in ovulatory women as part of an assisted reproductive technology (ART) program.

– Stimulation of follicular growth in anovulatory women (including polycystic ovary syndrome) who have failed to respond to clomiphene citrate.

In men:

– Stimulation of spermatogenesis in patients with hypogonadotropic hypogonadism (secondary hypogonadism), in combination with hCG (e.g., Karma-HCG®).

Administration

Karma-HMG® should be administered by intramuscular (IM) or subcutaneous (SC) injection under the supervision of a healthcare professional experienced in fertility treatment.

The powder should be reconstituted immediately before use with the provided 0.9% Sodium Chloride solvent. Gently swirl to dissolve; do not shake vigorously. Use the reconstituted solution immediately and discard any unused portion.

Side Effects

All medicines can cause side effects, although not everybody experiences them. Contact your doctor if any side effects are severe, persist, or if you experience any other symptoms.

Common side effects may include:

– Injection site reactions (pain, redness, swelling)

– Headache

– Abdominal pain or bloating

– Breast tenderness

– Fatigue

– Fever

– Joint pain (arthralgia)

In men: Gynecomastia (breast enlargement).

Serious risks include Ovarian Hyperstimulation Syndrome (OHSS) in women and the possibility of multiple pregnancy.

Contraindications

– Hypersensitivity to menotropins or any component of the formulation

– Primary ovarian failure (high endogenous FSH levels)

– Uncontrolled thyroid, adrenal, or pituitary disorders

– Tumors of the pituitary or hypothalamus

– Hormone-dependent tumors of the reproductive tract or accessory organs

– Undiagnosed abnormal uterine bleeding

– Ovarian cysts or enlargement not due to polycystic ovary syndrome

– Pregnancy

In men:

Treatment is unlikely to be effective in primary testicular failure (elevated endogenous FSH levels). Underlying conditions such as hypothyroidism, adrenocortical deficiency, hyperprolactinemia, or pituitary tumors should be treated before initiating therapy. A baseline semen analysis is recommended.

Storage

– Store Karma-HMG® refrigerated at 2–8°C.

– Protect from light.

– Do not freeze.

– The reconstituted solution should be used immediately; discard any unused portion.

– Keep out of the reach of children.

Pregnancy and Lactation

Karma-HMG® is indicated for induction of ovulation and use in assisted reproductive technology (ART). It is contraindicated in women who are already pregnant.

It is unknown whether menotropins are excreted in human breast milk. Due to the potential for serious adverse reactions in a breastfed infant, a decision must be made whether to discontinue breastfeeding or discontinue the drug, taking into account the importance of the treatment to the mother. This decision should be made in consultation with a physician.