REPRONEX
Clinical safety rating: caution
Comprehensive clinical and safety monograph for REPRONEX (REPRONEX).
REPRONEX (urofollitropin) is a purified preparation of follicle-stimulating hormone (FSH) that stimulates ovarian follicular growth in women who do not have primary ovarian failure. It acts by binding to FSH receptors on granulosa cells, increasing cAMP and promoting follicular development and estrogen synthesis.
| Metabolism | REPRONEX is a glycoprotein hormone that is cleared primarily by the liver and kidneys. The metabolic pathways involve proteolytic degradation. The terminal half-life is approximately 4-12 hours after subcutaneous administration. |
| Excretion | Renal (approximately 80% as parent drug and metabolites); biliary/fecal (<5%) |
| Half-life | Terminal elimination half-life: 24-30 hours (menotropins); clinically, it supports daily dosing during ovarian stimulation |
| Protein binding | Approximately 10%; mainly albumin |
| Volume of Distribution | 0.2-0.5 L/kg; reflects distribution primarily in extracellular fluid |
| Bioavailability | SC/IM: nearly 100% |
| Onset of Action | SC/IM: Follicular growth detectable by ultrasound and estradiol rise within 5-7 days |
| Duration of Action | Duration of action: 10-14 days for follicular stimulation; multiple doses required |
Men: 1000-2500 IU subcutaneously 3 times weekly for 6-12 months. Women: 75-300 IU subcutaneously or intramuscularly daily for 7-12 days.
| Dosage form | INJECTABLE |
| Renal impairment | No dose adjustment required for mild to moderate renal impairment. Contraindicated in severe renal impairment (eGFR <30 mL/min/1.73 m²). |
| Liver impairment | Child-Pugh A: no adjustment. Child-Pugh B: reduce dose by 50%. Child-Pugh C: contraindicated. |
| Pediatric use | Not recommended for use in pediatric patients (safety and efficacy not established). |
| Geriatric use | No specific dose adjustment; use with caution due to potential for decreased renal function and increased risk of thromboembolic events. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for REPRONEX (REPRONEX).
| Breastfeeding | It is unknown whether menotropins are excreted in human milk. Due to the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother. No M/P ratio is available. |
| Teratogenic Risk | REPRONEX (menotropins) is classified as FDA Pregnancy Category X. Studies have shown that menotropins can cause fetal harm when administered to a pregnant woman. There is no indication for use during pregnancy, as it is used for ovulation induction in infertility. If used inadvertently, there is a risk of multiple gestations and potential for congenital anomalies, but no specific teratogenic pattern has been established. Use is contraindicated in pregnant women. |
■ FDA Black Box Warning
REPRONEX should only be used by physicians who are experienced in infertility treatment and capable of monitoring ovarian response. Ovarian hyperstimulation syndrome (OHSS) may occur, which can be severe and potentially fatal. Multiple births have been reported.
| Serious Effects |
["High levels of FSH indicating primary ovarian failure","Uncontrolled thyroid or adrenal dysfunction","An organic intracranial lesion (e.g., pituitary tumor)","Abnormal uterine bleeding of undetermined origin","Ovarian cyst or enlargement of unknown etiology","Pregnancy","Hypersensitivity to urofollitropin or any component"]
| Precautions | ["Risk of ovarian hyperstimulation syndrome (OHSS), which can be severe","Risk of multiple gestation","Thromboembolic events","Ovarian torsion","Pulmonary complications (e.g., atelectasis, adult respiratory distress syndrome)"] |
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| Fetal Monitoring | During treatment, monitor ovarian response with serial ultrasound and serum estradiol levels to assess follicular development and risk of ovarian hyperstimulation syndrome (OHSS). Monitor for signs of OHSS, including pelvic pain, distension, nausea, vomiting, and rapid weight gain. If pregnancy occurs, monitor for multiple gestation and ectopic pregnancy. No specific fetal monitoring is required beyond standard prenatal care. |
| Fertility Effects | REPRONEX is used to induce ovulation in women with infertility due to anovulation. It stimulates ovarian follicular growth and development. Ovarian enlargement may occur, and there is an increased risk of multiple pregnancy. Ovarian hyperstimulation syndrome is a known risk. Long-term use may be associated with an increased risk of ovarian tumors, though causality is not established. |