Repronex (menotropins for injection, USP) is a purified preparation of gonadotropins extracted from the urine of postmenopausal women. Each vial of Repronex (menotropins for injection, USP) contains 75 International Units (IU) or 150 IU of follicle-stimulating hormone (FSH) activity and 75 IU or 150 IU of luteinizing hormone (LH) activity, respectively, plus 20 mg lactose monohydrate in a sterile, lyophilized form. The final product may contain sodium phosphate buffer (sodium phosphate tribasic and phosphoric acid). Repronex (menotropins for injection, USP) is administered by subcutaneous or intramuscular injection. Human Chorionic Gonadotropin (hCG), a naturally occurring hormone in post-menopausal urine, is detected in Repronex (menotropins for injection, USP).
Repronex (menotropins for injection, USP) is biologically standardized for FSH and LH (ICSH) gonadotropin activities in terms of the Second International Reference Preparation for Human Menopausal Gonadotropins established in September, 1964 by the Expert Committee on Biological Standards of the World Health Organization.
Both FSH and LH are glycoproteins that are acidic and water soluble.
Repronex is a drug that should only be used by physicians who are thoroughly familiar with infertility problems. It is a potent gonadotropic substance capable of causing mild to severe adverse reactions in women. Gonadotropin therapy requires a certain time commitment by physicians and supportive health professionals, and its use requires the availability of appropriate monitoring facilities (see PRECAUTIONS - Laboratory Tests). In female patients it must be used with a great deal of care.
The following Repronex side effects,were reported during menotropins therapy, are listed in decreasing order of potential severity:
Pulmonary and vascular complications
Ovarian Hyperstimulation Syndrome
Adnexal torsion (as a complication of ovarian enlargement)
Mild to moderate ovarian enlargement
Sensitivity to menotropins (Febrile reactions suggestive of Repronex side effects have been reported following the administration of menotropins. Reports of Repronex side effects like flu-like symptoms including fever, chills, musculoskeletal aches, joint pains, nausea, headaches, and malaise have also been reported).
Gastrointestinal symptoms (nausea, vomiting, diarrhea, abdominal cramps, bloating)
Pain, rash, swelling and/or irritation at the site of injection
Dizziness, tachycardia, dyspnea, tachypnea
The following Repronex side effects have been reported subsequent to pregnancies resulting from menotropins therapy:
With menotropin therapy congenital abnormalities have been reported. One infant was shown to have multiple congenital anomalies consisting of aplasia of the sigmoid colon, cecovesicle fistula, bifid scrotum, meningocele, bilateral internal tibial torsion, and right metatarsus adductus. Other reported Repronex side effects include imperforate anus, congenital heart lesions, supernumerary digits, hypospadias, extrophy of the bladder, Down's syndrome and hydrocephalus. The incidence of congenital abnormalities does not exceed that found in the general population.
There have been infrequent reports of Repronex side effects like ovarian neoplasms, both benign and malignant, in women who have undergone multiple drug regimens for ovulation induction; however, a causal relationship has not been established.
Repronex is contraindicated in women who have: A high FSH level indicating primary ovarian failure, Uncontrolled thyroid and adrenal dysfunction, An organic intracranial lesion such as a pituitary tumor, the presence of any cause of infertility other than anovulation unless they are candidates for in vitro fertilization, Abnormal bleeding of undetermined origin, Ovarian cysts or enlargement not due to polycystic ovary syndrome.
Prior hypersensitivity to menotropins. Repronex is not indicated in women who are pregnant. There are limited human data on the Repronex side effects when administered during pregnancy.