Karma-FSH®

Description

Karma-FSH® contains a purified hormone obtained from Human Menopausal urine having 75 I.U. / 150 I.U. FSH. In patients showing normal or high LH, require preparations without LH activity, this character belongs to FSH.

FSH stimulates both the growth and maturation of follicles, it induces secretion of estrogens and the proliferation of the endometrium.

Karma-FSH® is manufactured in BSV Co. (Bioscience Gmbh) and is developed by Homa Pharmed Co. under the license of Karma pharmatech, Germany.

Labeled Indications

• Woman: Induction of ovulation in patients with Polycystic Ovarian Disease (PCOD) who have an elevated LH / FSH ratio and who have failed to respond to adequate clomiphene citrate therapy sequentially with Human Chorionic Gonadotrophin (HCG).
• Women: Karma-HMG® is indicated for the induction of multiple follicle development and pregnancy in ovulatory women as part of an assisted reproductive technology cycle (ART)
• Men: Karma-HMG® with concomitant Karma-HCG® (Chorionic Gonadotrophin Injection) therapy is indicated for the stimulation of spermatogenesis in men with azoospermia and treatment of secondary hypogonadism.

Administration

Karma-FSH® should be administered by intramuscular or subcutaneous injection. The powder for injection should be reconstituted with the Sodium Chloride Injection immediately before use. Discard any unused portion.

Side effects

Headache, depression, emotional instability, fever, and pain, large ovary, OHSS, breast tenderness, hot flashes, ovarian disorder (pain and cysts), Cramps, big abdomen, abdominal pain, constipation, diarrhea, dehydration, nausea and vomiting, weight gain, High blood pressure, cervical disease, urinary tract infection, pelvic pain, uterine spasms, vaginal discharge, vaginal spotting

Contraindication

Woman:

Hypersensitivity to menotropins or any component of the formulation; primary ovarian failure as indicated by a high follicle-stimulating hormone level; uncontrolled nongonadal endocrinopathies (eg, thyroid, adrenal, pituitary); pituitary or hypothalamic tumors; sex hormone-dependent tumors of the reproductive tract and accessory organs; abnormal uterine bleeding of undetermined origin; ovarian cyst or enlargement not due to polycystic ovary syndrome; pregnancy.

Men:

Patients with elevated endogenous FSH levels indicative of primary testicular failure are usually unresponsive to Karma-HMG® and Karma-HCG® (Chorionic Gonadotrophin Injection) therapy. Appropriate treatment should first be given for hypothyroidism, adrenocortical deficiency, hyperprolactinemia, or pituitary tumor. An acceptable semen analysis should be available before Karma-HMG® treatment.

Warnings

If the ovaries are abnormally enlarged on the last day of karma-FSH® therapy, HCG should not be administered in this course of therapy. This reduces the development of OHSS (Ovarian Hyperstimulation Syndrome).

Storage

Karma-FSH® should be stored between °2C–°8C. Do not freeze. Protect from light.

Reconstituted solution should be used immediately after preparation, any unused portion should be discarded.

Keep away from children.

Pregnancy and Lactation:

Menotropins are used for the induction of ovulation and with assisted reproductive technology (ART); use is contraindicated in women who are already pregnant.

It is not known if menotropins are present in breast milk.

Due to the potential for serious adverse reactions in the breastfed infant, the manufacturer recommends a decision be made to discontinue breastfeeding or to discontinue the drug, considering the importance of treatment to the mother.