MENOPUR
Clinical safety rating
cautionComprehensive clinical and safety monograph for MENOPUR (MENOPUR).
Comprehensive clinical and safety monograph for MENOPUR (MENOPUR).
Induction of ovulation in patients with polycystic ovary syndrome (PCOS) after failure of clomiphene citrateControlled ovarian hyperstimulation for assisted reproductive technologies (ART) such as in vitro fertilization (IVF)Off-label: Treatment of male hypogonadotropic hypogonadism (in combination with human chorionic gonadotropin)
Headache, Injection site pain, Injection site allergic reaction, Abdominal pain, Abdominal cramp, Nausea, Ovarian hyperstimulation syndrome
Menotropins (MENOPUR) contain follicle-stimulating hormone (FSH) and luteinizing hormone (LH) activity, which stimulate ovarian follicular growth and maturation in women, and spermatogenesis in men with hypogonadotropic hypogonadism.
| Metabolism | Metabolism is not fully characterized; renally excreted as intact protein. |
| Excretion | Primarily renal excretion of unchanged drug and metabolites; approximately 80% of a dose is excreted in urine within 24 hours, with the remainder excreted in feces via biliary elimination. |
| Half-life | The terminal elimination half-life is approximately 30-40 hours for FSH activity, reflecting the prolonged effect on follicular development; clinical dosing is adjusted based on response. |
| Protein binding | Approximately 10-20% bound to plasma proteins, primarily albumin. |
| Volume of Distribution | Approximately 0.5-0.6 L/kg, indicating distribution primarily into extracellular fluid and limited tissue binding. |
| Bioavailability | Subcutaneous or intramuscular: Approximately 70-80% due to partial local degradation; oral bioavailability is negligible (<1%). |
| Onset of Action | Subcutaneous or intramuscular injection: Serum FSH levels rise within 1-2 hours, with follicular growth detectable by ultrasound after 5-7 days of daily administration. |
| Duration of Action | The duration of effect on follicular growth persists for several days after the last injection; clinical monitoring continues until ovulation is induced or cycle is completed. |
| Molecular Weight | 32000 (approx., for FSH and LH subunits; menotropins are a mixture of glycoproteins, primarily FSH ~34 kDa and LH ~30 kDa; average ~32,000 Da) |
| Action Class | Gonadotropins |
| Brand Substitutes | Ovulate-M 75IU Injection, Menovul 75IU Injection, Hmg SP 75IU Injection, Menosar HP 75IU Injection, Menogon Injection |
225 IU subcutaneously or intramuscularly once daily starting on day 2-3 of cycle, adjusted after 5 days based on response; maximum daily dose 450 IU.
| Dosage form | INJECTABLE |
| Renal impairment | No specific guidelines; use with caution in severe renal impairment (GFR <30 mL/min) due to limited data, consider risk of fluid retention. |
| Liver impairment | No specific guidelines; contraindicated in severe hepatic impairment (Child-Pugh class C) as metabolism is hepatic; use with caution in Child-Pugh class B. |
| Pediatric use | Not indicated; no established pediatric dosing. |
| Geriatric use | Not indicated for geriatric patients; no dosing recommendations. |
| 1st trimester | Contraindicated due to risk of fetal harm. Based on animal studies and its mechanism of action, MENOPUR (menotropins) can cause fetal harm when administered to pregnant women. There are no adequate and well-controlled studies in pregnant women. If used inadvertently during pregnancy, it may result in unintended luteinization of the ovaries and potential teratogenic effects from high doses of gonadotropins. Generally, use during the first trimester is not indicated as ovulation induction would not be performed in pregnancy. |
| 2nd trimester | Contraindicated. MENOPUR is not indicated during pregnancy at any trimester. It is used only for ovulation induction or controlled ovarian stimulation prior to assisted reproductive technologies. Use in the second trimester would occur only in the context of inadvertent exposure, which should be avoided. |
| 3rd trimester | Contraindicated. Similar to second trimester, use in third trimester is not indicated and could cause harm to the fetus or mother, including ovarian hyperstimulation syndrome (OHSS) and multiple gestations, though these are typically associated with treatment cycles rather than ongoing pregnancy. No evidence of safety in third trimester. |
Clinical note
Comprehensive clinical and safety monograph for MENOPUR (MENOPUR).
| Placental transfer | Menotropins are proteins with molecular weight of approximately 2,000–34,000 Da (primarily FSH and LH, each ~32,000 Da). These hormones do not readily cross the placenta due to their size; however, animal studies have shown potential for fetal harm, possibly via effects on maternal hormones or indirect effects. In humans, no specific placental transfer data are available, but caution is warranted. |
| Breastfeeding | It is not known whether menotropins are excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from MENOPUR, a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother. MENOPUR is not indicated for use during breastfeeding. The low molecular weight and potential for excretion suggest potential transfer, but no specific data exist. |
| Lactation Rating | L5 (Contraindicated) |
| Teratogenic Risk | Menopur (menotropins) is a gonadotropin preparation used for ovulation induction. Fetal risk in the first trimester is associated with an increased incidence of neural tube defects, congenital heart defects, and multiple anomalies, likely related to the underlying infertility and assisted reproductive technology rather than direct teratogenicity. Second and third trimester risks include preterm labor, low birth weight, and perinatal mortality due to multiple gestation and ovarian hyperstimulation syndrome (OHSS). |
| Fetal Monitoring | Monitor for ovarian hyperstimulation syndrome (OHSS) via ultrasound and estradiol levels. Assess multiple gestation with early ultrasound. During pregnancy, monitor for signs of OHSS, ectopic pregnancy, and spontaneous abortion. Fetal monitoring includes serial ultrasounds for growth and anatomy, and consider prenatal diagnostic testing for neural tube defects and chromosomal anomalies. |
| Fertility Effects | Menopur is used for ovulation induction in women undergoing assisted reproductive technology. It increases the risk of multiple gestation (up to 20%), ovarian hyperstimulation syndrome, ectopic pregnancy, and spontaneous abortion. It does not have known long-term adverse effects on fertility, but underlying conditions may persist. |
■ FDA Black Box Warning
MENOPUR should only be used by physicians who are experienced in infertility diagnosis and management. Use may cause ovarian hyperstimulation syndrome (OHSS), which can be severe and result in pulmonary embolism, stroke, ovarian torsion, or death. Use should be avoided in women with a high baseline FSH level indicating primary ovarian failure.
| Serious Effects |
High levels of FSH indicating primary ovarian failureUncontrolled thyroid or adrenal dysfunctionAn organic intracranial lesion (e.g., pituitary tumor)Abnormal uterine bleeding of undetermined originOvarian, uterine, or mammary carcinomaPregnancy or suspected pregnancyKnown hypersensitivity to menotropins or any excipients
| Precautions | Ovarian Hyperstimulation Syndrome (OHSS) - risk minimized by monitoring estradiol levels and ultrasound; discontinue if severe., Multiple pregnancy - high risk; counseling is required., Ovarian enlargement - usually resolves without treatment., Pulmonary embolism and arterial thromboembolism - especially in severe OHSS., Ovarian torsion - consider in patients with severe OHSS., Ectopic pregnancy - increased risk in patients with tubal disease., Congenital malformations - incidence similar to natural conception., Ovarian neoplasms - no definitive causal link, but caution. |
| Food/Dietary | No clinically relevant food interactions have been reported. Patients should maintain a normal balanced diet. Grapefruit and grapefruit juice are not known to interact with menotropins. No restriction on caffeine or dairy products. |
| Clinical Pearls | MENOPUR (menotropins) is a purified preparation of follicle-stimulating hormone (FSH) and luteinizing hormone (LH) used for ovulation induction and controlled ovarian stimulation. Monitor ovarian response with ultrasound and estradiol levels to minimize risk of ovarian hyperstimulation syndrome (OHSS). Adjust dose based on antral follicle count and prior response. For IVF, concomitant gonadotropin-releasing hormone (GnRH) antagonist or agonist is typically used to prevent premature LH surge. Administer intramuscularly or subcutaneously; reconstitute immediately before use. Multifetal pregnancy rates are high; counsel patients accordingly. |
| Patient Advice | MENOPUR is a hormone injection used to help your ovaries produce multiple eggs. It is given as a shot under the skin or into a muscle. Your doctor will show you how to prepare and inject the medication. Do not shake the vial after mixing. Use each vial only once and discard any unused medicine. · Common side effects include injection site reactions (pain, redness, swelling), ovarian enlargement, abdominal discomfort, and mood swings. Serious risks include ovarian hyperstimulation syndrome (OHSS) with symptoms like sudden severe abdominal pain, nausea, vomiting, and rapid weight gain. Notify your doctor immediately if you experience these. · You will have frequent blood tests and vaginal ultrasounds to monitor your response. Stick to the schedule and do not change doses without consulting your doctor. · There is a high chance of multiple pregnancy (twins, triplets, etc.). Discuss the risks and implications with your doctor. · Avoid alcohol and smoking during treatment. No specific food restrictions, but maintain a balanced diet to support overall health. |
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