Class: Ovulation stimulant
- Powder or pellet for injection, lyophilized 75 units FSH activity, 75 units LH activity
- Powder or pellet for injection, lyophilized 75 or 150 units follicle-stimulating hormone (FSH) activity, 75 or 150 units luteinizing hormone (LH) activity
Stimulates ovarian follicular growth in women who do not have primary ovarian failure.
Mean follicle-stimulating hormone (FSH) C max is 8.5 milliunit/mL (subcutaneous) and 7.8 milliunit/mL (IM); mean FSH AUC is 762 milliunit•h/mL (subcutaneous) and 656.1 milliunit•h/mL (IM); median T max is 17.9 h (subcutaneous) and 27.5 h (IM).Repronex
Mean FSH C max is 5.62 milliunit/mL (subcutaneous) and 4.15 milliunit/mL (IM); mean FSH AUC is 385.2 milliunit•h/mL (subcutaneous) and 320.1 milliunit•h/mL (IM); median T max is 12 h (subcutaneous) and 18 h (IM).
Mean FSH t ½ is 11 to 13 h.Repronex
Mean FSH t ½ is 53.7 h (subcutaneous) and 59.2 h (IM).
Indications and UsageMenopur
Subcutaneous administration for the development of multiple follicles and pregnancy in ovulatory patients participating in an assisted reproductive technology (ART) program.Repronex
In conjunction with human chorionic gonadotropin (hCG) for multiple follicular development (controlled ovarian stimulation) and ovulation induction in patients who have previously received pituitary suppression.
High FSH level, which indicates primary ovarian failure; uncontrolled thyroid and adrenal dysfunction; organic intracranial lesion (eg, pituitary tumor); abnormal uterine bleeding of undetermined origin; ovarian cysts or enlargement not caused by polycystic ovary syndrome; pregnancy; prior sensitivity of menotropins; sex hormone-dependent tumors of the reproductive tract and accessory organs ( Menopur only); presence of any cause of infertility other than anovulation, unless patient is a candidate for IVF ( Repronex only).
Dosage and AdministrationART
Subcutaneous/IM Recommended initial dose for patients who have received gonadotropin-releasing hormone (GnRH) agonist or antagonist pituitary suppression is 225 units. Adjust dose based on patient's response and clinical monitoring. Do not make adjustments more frequently than once every 2 days and do not exceed 75 to 150 units/adjustment for Repronex or 150 units/adjustment for Menopur (max, 450 units/day). Do not dose Repronex beyond 12 days or Menopur beyond 20 days. Once adequate follicular development is evident, give 5,000 to 10,000 units hCG 1 day following the last dose of menotropins. Withhold hCG if ovaries are abnormally enlarged on the last day of therapy.Follicular Development and Ovulation Induction ( Repronex )
Subcutaneous/IM Start with 150 units for 5 days then adjust dose based on patient's response. Do not make adjustments more frequently than once every 2 days and do not exceed 75 to 150 units/adjustment (max, 450 units/day). Do not dose beyond 12 days. If response is appropriate, give 5,000 to 10,000 units hCG 1 day following the last dose of menotropins. Withhold hCG if serum estradiol is greater than 2,000 pg/mL, ovaries are abnormally enlarged, or if abdominal pain occurs.
- Administer Repronex only by subcutaneous or IM injection. Not for intradermal, IV, or intra-arterial administration.
- Administer Menopur only by subcutaneous injection. Not for intradermal, IM, IV, or intra-arterial administration.
- Reconstitute contents of 1 to 6 vials of Repronex with 1 to 2 mL sterile saline solution. Gently swirl vial until solution is clear. Do not shake vial during reconstitution.
- Reconstitute contents of 1 to 6 vials of Menopur with 1 mL sterile saline solution. Gently swirl vial until solution is clear. Do not shake vial during reconstitution.
- For single injection of dose requiring multiple vials, up to 6 vials can be reconstituted with initial diluent by drawing contents of first vial into syringe and then injecting contents into second vial and gently swirling until solution is clear. This can be repeated with up to 4 additional vials.
- Administer immediately after reconstituting solution. Discard any unused reconstituted solution. Do not save for future use.
- Do not administer if reconstituted solution is cloudy, discolored, or contains particulate matter.
- To minimize bleeding, do not rub site after injection.
- Administer subcutaneous doses in lower abdomen, alternating sides.
Store vials in refrigerator (36° to 46°F) or at room temperature not exceeding 77°F. Protect from light.
None well documented.
Laboratory Test Interactions
None well documented.
Tachycardia, vascular complications.
Headache (34%); dizziness, malaise (3%); migraine (2%).
Flushing (2%); body rashes.
Nausea (12%); abdominal pain (10%); abdominal fullness (9%); abdominal cramping (7%); enlarged abdomen (6%); vomiting (4%); diarrhea (3%); constipation (2%); bloating.
Ovarian hyperstimulation syndrome (OHSS) (13%); vaginal hemorrhage (at least 8%); ovarian disease (8%); postretrieval pain (6%); pelvic cramps, uterine spasm (4%); breast tenderness, hot flashes, menstrual disorder, pelvic disorder, pelvic pain (3%); ectopic pregnancy (1%); adnexal torsion as a complication of ovarian enlargement; mild to moderate ovarian enlargement; ovarian cysts.
Sensitivity including febrile reactions, flu-like symptoms (eg, chills, fever, musculoskeletal aches, joint pains, nausea, headaches, malaise).
Injection site edema or reaction (12%); irritation, pain, rash, swelling.
Back pain (3%).
Respiratory disorder (6%); increased cough (3%); dyspnea (2%); pulmonary and respiratory complications; tachypnea.
Elevated estradiol (2%); flu syndrome, pain (3%); infection (1%); hemoperitoneum.
Before treatment, a thorough gynecologic and endocrinologic evaluation must be performed. Evaluate estradiol levels and ultrasonography results for monitoring growth and development of follicles, timing of hCG administration, and minimizing risk of OHSS and multiple gestation. Monitor patient for signs of excessive ovarian stimulation (eg, abdominal pain or distension, diarrhea, dyspnea, nausea, oliguria, rapid weight gain, severe pelvic pain, vomiting). Monitor patient for signs and symptoms of thromboembolic events (eg, arterial occlusion, pulmonary embolism, pulmonary infarction, stroke, venous thrombophlebitis).
Category X .
Safety and efficacy not established.
Hypersensitivity/anaphylactic reactions have been reported in some patients.
Multiple pregnancies have occurred.
To minimize hazards associated with abnormal ovarian enlargement, use lowest effective dose.
May occur. Warning signs include abdominal distention, nausea, oliguria, pelvic pain, vomiting, weight gain. May progress within 24 h to several days to become a serious medical reaction.
Serious pulmonary conditions (eg, acute respiratory distress syndrome, atelectasis) have been reported.
Intravascular thrombosis may occur, resulting in intravascular thrombosis and embolism, which can reduce blood flow to vital organs (resulting in pulmonary infarction or stroke) or extremities (resulting in loss of limbs).
- Explain name, action, and potential adverse reactions of the treatment regimen, including risk of multiple births. Review the treatment regimen, including duration of treatment 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. Advise patient to review the patient information leaflet before starting therapy and with each refill.
- Caution patient not to change the dose or stop taking unless advised by health care provider.
- Caution patient that if a dose is missed not to double the dose to catch up. Advise patient to contact health care provider for further instructions.
- Remind patient that drug is administered to promote follicular growth and egg production, and that hCG will need to be administered to induce ovulation.
- Encourage women receiving drug for infertility to have intercourse daily, beginning on the day prior to administration of hCG and until ovulation has become apparent.
- Warn patient 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, rapid weight gain, stomach pain or bloating, diarrhea, infrequent urination.
- Advise patient to inform health care provider of any adverse reactions, symptoms, or physical changes, or bothersome injection site reactions.
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