Menotropins

A to Z Drug Facts

 Action Stimulates ovarian follicular growth in women who do not have primary ovarian failure.

 Indications

Women: In conjunction with human chorionic gonadotropin (hCG), for multiple follicular development and ovulation induction in patients who have previously received pituitary suppression.

Men: In conjunction with hCG for stimulation of spermatogenesis in primary or secondary hypogonadotropic hypogonadism caused by a congenital factor or prepubertal hypophysectomy and in secondary hypogonadotropic hypogonadism caused by hypophysectomy, craniopharyngioma, cerebral aneurysm, or chromophobe adenoma.

 Contraindications Women who have high follicle stimulating hormone (FSH) level indicating primary ovarian failure; uncontrolled thyroid and adrenal dysfunction; organic intracranial lesion (eg, pituitary tumor); presence of any cause of infertility other than anovulation unless patient is candidate for in vitro fertilization; abnormal bleeding of undetermined origin; ovarian cysts or enlargement not caused by polycystic ovary syndrome; pregnancy; prior hypersensitivity to menotropins. Men (Pergonal) who have normal gonadotropin levels indicating normal pituitary function; elevated gonadotropin levels indicating primary testicular failure; infertility disorders other than hypogonadotropic hypogonadism.

 Route/Dosage

Follicular Development and Ovulation Induction

ADULT (WOMEN): Repronex: SC/IM Start with 150 IU for 5 days, then based on patient response, adjust dose. Do not make adjustments more frequently than once every 2 days and do not exceed 75 to 150 IU per adjustment (max, 450 IU/day). Do not dose beyond 12 days. If response is appropriate, give hCG 5000 to 10,000 U 1 day following the last dose of menotropins. Withhold hCG if serum estradiol is greater than 2000 pg/mL. Pergonal: IM Start with 75 IU FSH/75 IU luteinizing hormone (LH) daily for 7 to 12 days, followed by 5000 to 10,000 U hCG 1 day after the last dose of menotropins. Do not exceed 12 days of menotropins administration. Repeat dose: If there is evidence of ovulation, but no pregnancy, repeat the regimen for at least 2 more courses before increasing the dose to 150 IU FSH/150 IU LH/day for 7 to 12 days, followed by 5000 to 10,000 U hCG 1 day after the last dose of menotropins. If there is evidence of ovulation, but no pregnancy, repeat the same dose for 2 more courses.

Stimulation of Spermatogenesis

ADULTS (MEN): Pretreat with hCG alone (5000 U 3 times/wk). Continue hCG for a period sufficient to achieve serum testosterone levels within normal range and masculinization (ie, appearance of secondary sex characteristics), which may take 4 to 6 mo. IM (Pergonal only): 75 IU FSH/75 IU LH 3 times/wk and hCG 2000 U twice weekly for at least 4 mo to ensure spermatozoa in ejaculate. If patient has not responded with increased spermatogenesis at the end of 4 mo continue treatment with 75 IU FSH/75 IU LH 3 times/wk or increase the dose to 150 IU FSH/150 IU LH 3 times/wk, with the hCG dose unchanged.

 Interactions None well documented.

 Lab Test Interferences None well documented.

 Adverse Reactions

CV: Vascular complications (eg, stroke); tachycardia. CNS: Dizziness; headache. DERM: Rash; swelling and irritation at injection site; body rashes. GI: Nausea; vomiting; diarrhea; abdominal cramps; bloating; enlarged abdomen. GU: Mild to moderate ovarian enlargement; ovarian cysts; ectopic pregnancy; congenital abnormalities; ovarian hyperstimulation syndrome; vaginal hemorrhage; ovarian disease; pelvic pain; breast tenderness; gynecomastia (men). RESP: Pulmonary complications (eg, thrombolic events); dyspnea; tachypnea. OTHER: Hemoperitoneum; adnexal torsion; abdominal pain; hypersensitivity; flu-like symptoms; pain; injection site edema; infection.

 Precautions

Pregnancy: Category X. Lactation: Undetermined. Children: Safety and efficacy not established. Elderly: Safety and efficacy not established. Multiple births: Multiple pregnancies have occurred. Health care professional use: Menotropins should be used only by health care professionals thoroughly familiar with infertility problems and their management. Ovarian enlargement: Mild to moderate uncomplicated ovarian enlargement may occur in approximately 20% treated and generally regresses without treatment with 2 to 3 wk. Ovarian hyperstimulation syndrome: Warning signs include pelvic pain, nausea, vomiting, distention, and weight gain. May progress within 24 hr to several days to become a serious medical event. Pulmonary and vascular complications: May occur, resulting in intravascular thrombosis and embolism, which reduce blood flow to critical organs (may result in pulmonary infarct) or extremities (which may cause loss of limbs).

 Administration/Storage

• Follow manufacturer's instructions for reconstituting the Powder or Pellet for Injection. Administer prescribed dose immediately after reconstitution.
• Reconstitute by dissolving contents of 1 or more ampules in ½ to 1 mL of Sterile Water for Injection. Administer prescribed dose immediately after reconstitution.
• Do not administer if particulate matter or discoloration noted.
• Administer Repronex only by SC or IM injection. Not for intradermal or IV administration.
• Administer Pergonal only by IM injection. Not for intradermal, SC, or IV administration.
• With patient lying down or sitting, administer drug by SC or IM injection. Rotate injection sites.
• To minimize bleeding do not rub site after injection.
• Discard any unused reconstituted material.
• Store ampules and vials in refrigerator or at controlled room temperature 3° to 25°C (37° to 77°F). Protect from light.

 Assessment/Interventions

• Obtain patient history, including drug history and any known allergies.
• Review patient's health history for any condition that could contraindicate menotropins (eg, previous allergic reaction to menotropins, high levels of FSH, uncontrolled thyroid or adrenal dysfunction, intracranial lesion, sex hormone dependent tumors, and in women, abnormal uterine bleeding of undetermined origin, ovarian cyst or enlargement of undetermined origin, pregnancy).
• Ensure that women have had a thorough gynecological and endocrinological evaluation before starting therapy.
• Ensure that men have had a thorough medical and endocrinological evaluation before starting therapy.
• Monitor women for signs of overstimulation of the ovary (eg, difficulty breathing, severe pelvic pain, nausea, vomiting, weight gain, stomach pain or bloating, diarrhea, infrequent urination) and report to health care provider immediately if noted.

 Patient/Family Education

• Explain name, dose, action, and potential side effects of drug. Review the treatment regimen including duration and monitoring that will be required.
• If patient will be administering at home, teach patient how to store, prepare, and administer the dose, and dispose of used equipment and supplies.
• Remind women that drug is administered to promote follicular growth and egg production, and that hCG will need to be administered to induce ovulation.
• Encourage patient receiving drug for infertility to have intercourse daily, beginning on the day prior to administration of hCG until ovulation has become apparent.
• Warn women that close monitoring for overstimulation of the ovary is required and to report any of the following immediately to health care provider: difficulty breathing, severe pelvic pain, nausea, vomiting, weight gain, stomach pain or bloating, diarrhea, infrequent urination.
• Remind men that drug is administered to promote sperm development and that hCG also will need to be administered to normalize testosterone levels.
• Advise patient that follow-up visits and laboratory tests will be required to monitor therapy and to keep appointments.

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Copyright © 2003 Facts and Comparisons
David S. Tatro
A to Z Drug Facts