REPRONEX SUMMARY
Repronex® (menotropins for injection, USP) is a purified preparation of gonadotropins extracted from the urine of postmenopausal women. Each vial of Repronex® 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® is administered by subcutaneous or intramuscular injection. Human Chorionic Gonadotropin (hCG), a naturally occurring hormone in post-menopausal urine, is detected in Repronex®.
Repronex®, in conjunction with hCG, is indicated for multiple follicular development (controlled ovarian stimulation) and ovulation induction in patients who have previously received pituitary suppression.
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Before treatment with Repronex® is instituted, a thorough gynecologic and endocrinologic evaluation must be performed. Except for those patients enrolled in an
in vitro
fertilization program, this should include a hysterosalpingogram (to rule out uterine and tubal pathology) and documentation of anovulation by means of basal body temperature, serial vaginal smears, examination of cervical mucus, determination of serum (or urine) progesterone, urinary pregnanediol and endometrial biopsy. Patients with tubal pathology should receive menotropins only if enrolled in an
in vitro
fertilization program.
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Primary ovarian failure should be excluded by the determination of gonadotropin levels.
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Careful examination should be made to rule out the presence of an early pregnancy.
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Patients in late reproductive life have a greater predilection to endometrial carcinoma as well as a higher incidence of anovulatory disorders. Cervical dilation and curettage should always be done for diagnosis before starting Repronex® therapy in such patients who demonstrate abnormal uterine bleeding or other signs of endometrial abnormalities.
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Evaluation of the husband's fertility potential should be included in the workup.
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