Karma-FSH®

Description

Karma-FSH® is a highly purified follicle-stimulating hormone (FSH; urofollitropin) extracted from the urine of postmenopausal women. It contains 75 IU of FSH activity per vial, with negligible luteinizing hormone (LH) content. This makes it particularly suitable for patients with normal or elevated endogenous LH levels who require a preparation with minimal LH activity.

FSH promotes the growth and maturation of ovarian follicles, induces estrogen secretion, and supports proliferation of the endometrium.

Karma-FSH® 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 ovulation in patients with polycystic ovary syndrome (PCOS) who have an elevated LH/FSH ratio and have not responded to adequate clomiphene citrate therapy, followed by human chorionic gonadotropin (hCG) to trigger ovulation.

– Development of multiple follicles in ovulatory women undergoing assisted reproductive technology (ART) procedures (e.g., IVF).

In men:

– Stimulation of spermatogenesis in hypogonadotropic hypogonadism (with concomitant hCG therapy).

Administration

Karma-FSH® 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 solvent (0.9% Sodium Chloride). 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:

– Headache

– Emotional instability or mood changes (including depression)

– Breast tenderness

– Hot flushes

– Abdominal pain, bloating, or cramps

– Nausea, vomiting, constipation, or diarrhea

– Weight gain

– Injection site reactions (pain, redness, or swelling)

– Ovarian enlargement, pain, or cysts

– Pelvic pain

– Vaginal spotting or discharge

– Fatigue or fever

Serious but less common side effects include:

– Ovarian Hyperstimulation Syndrome (OHSS) – symptoms may include severe abdominal pain/distension, nausea, vomiting, diarrhea, dehydration, weight gain, shortness of breath, or reduced urine output, High blood pressure, Urinary tract infection

Contraindications

In women:

Karma-FSH® is contraindicated in the presence of:

– Hypersensitivity to urofollitropin, menotropins, or any component of the formulation

– Primary ovarian failure (indicated by high endogenous FSH levels)

– Uncontrolled thyroid, adrenal, or pituitary disorders

– Tumors of the pituitary gland 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:

Karma-FSH® (in combination with hCG) is unlikely to be effective and should not be used in:

– Primary testicular failure (indicated by elevated endogenous FSH levels)

Underlying conditions such as hypothyroidism, adrenocortical deficiency, hyperprolactinemia, or pituitary tumors should be appropriately treated before initiating therapy. A baseline semen analysis is recommended prior to treatment.

Warnings

To reduce the risk of Ovarian Hyperstimulation Syndrome (OHSS), human chorionic gonadotropin (hCG) should not be administered if the ovaries are abnormally enlarged on the last day of Karma-FSH® therapy.

Patients should be monitored closely for signs of OHSS (e.g., severe abdominal pain, bloating, nausea, vomiting, weight gain, or shortness of breath) during and after treatment.

Storage

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

– Do not freeze.

– Protect from light.

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

– Keep out of the reach of children.

Pregnancy and Lactation

Karma-FSH® is indicated for induction of ovulation and use in assisted reproductive technology (ART) procedures. It is contraindicated in women who are already pregnant, as it may cause harm to the fetus.

It is unknown whether urofollitropin is 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.