REPRONEX
Clinical safety rating
cautionComprehensive clinical and safety monograph for REPRONEX (REPRONEX).
Comprehensive clinical and safety monograph for REPRONEX (REPRONEX).
Induction of ovulation in oligo-ovulatory or anovulatory women with functional hypothalamic-pituitary dysfunction (WHO Group II)Controlled ovarian hyperstimulation for assisted reproductive technologies (ART) such as in vitro fertilization (IVF)
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 |
| Molecular Weight | 36,700 Da (for hCG component) |
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 | Contraindicated due to risk of congenital anomalies from gonadotropin stimulation |
| 2nd trimester | Contraindicated due to risk of ovarian hyperstimulation syndrome and fetal harm |
| 3rd trimester | Contraindicated due to risk of ovarian hyperstimulation syndrome and fetal harm |
Clinical note
Comprehensive clinical and safety monograph for REPRONEX (REPRONEX).
| Placental transfer | Likely crosses placenta due to low molecular weight; specifically, human chorionic gonadotropin has been detected in fetal tissues. |
| Breastfeeding | Excretion into breast milk is unknown; due to potential for serious adverse effects, use is not recommended during breastfeeding. |
| Lactation Rating | L5 - Contraindicated |
| 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. |
| 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. |
■ 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 |
PregnancyOvarian cyst or enlargement not due to polycystic ovary syndromeGonadal dysgenesisOvarian malignancyHypersensitivity to drug or components
| 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) |
| Food/Dietary | No specific food interactions documented. Maintain adequate hydration to reduce OHSS risk. Avoid excessive alcohol or caffeine as they may affect fertility. |
| Clinical Pearls | REPRONEX (menotropins) is a gonadotropin preparation containing FSH and LH activity. Monitor estradiol levels and follicular growth via ultrasound to adjust dosing and minimize ovarian hyperstimulation syndrome (OHSS) risk. Avoid use in primary ovarian failure. Administer intramuscularly; rotate injection sites. Concomitant hCG is required for final follicular maturation and ovulation trigger. |
| Patient Advice | Store REPRONEX in the refrigerator and protect from light. · Administer exactly as prescribed; do not change dose or schedule. · You may experience bloating, pelvic discomfort, or mood swings; report severe abdominal pain, nausea, or rapid weight gain (signs of OHSS) immediately. · Multiple pregnancy is possible; discuss risks with your doctor. · Use barrier contraception until instructed to attempt conception. · Do not drive or operate machinery if dizziness or visual disturbances occur. |
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