PERGONAL
Clinical safety rating
cautionComprehensive clinical and safety monograph for PERGONAL (PERGONAL).
Comprehensive clinical and safety monograph for PERGONAL (PERGONAL).
Induction of ovulation in patients with polycystic ovary disease or anovulatory infertility not due to primary ovarian failureStimulation of multiple follicular development in ovulatory patients undergoing assisted reproductive technologies (ART)Induction of spermatogenesis in men with hypogonadotropic hypogonadism (in combination with hCG)
Pergonal (menotropins) is a purified preparation of gonadotropins (follicle-stimulating hormone, FSH, and luteinizing hormone, LH) extracted from postmenopausal urine. It stimulates ovarian follicular growth and maturation in women and spermatogenesis in men by acting on specific gonadal receptors.
| Metabolism | Menotropins are metabolized via proteolytic degradation in the liver and kidneys. The metabolic pathways involve hydrolysis into amino acids and smaller peptides. |
| Excretion | Primarily renal: 70-80% as unchanged drug and metabolites within 24 hours; biliary/fecal excretion accounts for <5%. |
| Half-life | Terminal elimination half-life approximately 24-36 hours; clinical context: supports daily dosing in ovulation induction protocols. |
| Protein binding | Approximately 10-15% bound to serum albumin. |
| Volume of Distribution | Vd approximately 0.5-0.6 L/kg, indicating distribution limited to extracellular fluid. |
| Bioavailability | Intramuscular: approximately 100% bioavailability; subcutaneous: approximately 80-90% relative to IM. |
| Onset of Action | After intramuscular administration, increased serum estradiol levels detectable within 5-8 hours; follicular growth evident by ultrasound within 3-5 days. |
| Duration of Action | Duration of pharmacodynamic effect 24-36 hours, with repeated daily injections required to maintain sustained follicular stimulation. |
| Molecular Weight | Menotropins (mixture of FSH and LH) - FSH alpha subunit ~14 kDa, FSH beta subunit ~18 kDa; LH alpha subunit ~14 kDa, LH beta subunit ~15 kDa. Average molecular weight ~30-35 kDa. |
Intramuscular administration: 75 IU daily for 7-12 days, then 5,000-10,000 IU hCG 24 hours after last dose.
| Dosage form | INJECTABLE |
| Renal impairment | No specific guidelines; use with caution in renal impairment as drug excretion may be reduced. |
| Liver impairment | No specific Child-Pugh based modifications; use with caution in severe hepatic impairment. |
| Pediatric use | Not indicated for pediatric use; no weight-based guidelines established. |
| Geriatric use | Not typically used in elderly; consider age-related decline in ovarian response and increased risk of adverse events. |
| 1st trimester | Pergonal is contraindicated in pregnancy; use during organogenesis may cause fetal harm. Animal studies show reproductive toxicity. |
| 2nd trimester | Contraindicated; risk of fetal harm continues. |
| 3rd trimester | Contraindicated; no therapeutic indication during late pregnancy. |
Clinical note
Comprehensive clinical and safety monograph for PERGONAL (PERGONAL).
| Placental transfer | Crosses placenta; detected in fetal serum at levels comparable to maternal. |
| Breastfeeding | Excreted in human milk; potential for serious adverse reactions in nursing infants, including hormonal effects. Decision to discontinue breastfeeding or drug should be based on importance of drug to mother. |
| Lactation Rating | L5 - Contraindicated |
| Teratogenic Risk | Pergonal (menotropins) is a gonadotropin used for ovulation induction. In vitro studies show no evidence of teratogenicity; however, there is a risk of multiple gestation (20% twinning rate, higher order multiples less common). No specific fetal malformations are attributed to the drug. First trimester exposure is not associated with major congenital anomalies. Second and third trimester risks are minimal as the drug is not continued after pregnancy is achieved. |
| Fetal Monitoring | Monitor ovarian response via ultrasound and serum estradiol levels to assess follicle development and prevent ovarian hyperstimulation syndrome (OHSS). Monitor for signs of OHSS (abdominal distension, pain, nausea, vomiting, weight gain). In pregnant patients, monitor for multiple gestation and potential complications such as preterm labor and gestational hypertension. |
| Fertility Effects | Pergonal is used for ovulation induction in anovulatory infertility. It stimulates follicular growth and maturation, restoring fertility in patients with hypothalamic-pituitary dysfunction. However, it may cause ovarian hyperstimulation syndrome (OHSS) and multiple gestations. |
■ FDA Black Box Warning
Pergonal should only be used by physicians who are experienced in fertility disorders and in settings where monitoring of estradiol levels and follicular development through ultrasound is possible. Ovarian hyperstimulation syndrome (OHSS) may occur, which can be severe and is characterized by sudden ovarian enlargement, ascites, pleural effusion, oliguria, and thromboembolic events. Multiple births are increased.
| Serious Effects |
PregnancyHypersensitivity to menotropins or any componentHigh levels of FSH indicating primary ovarian failureUncontrolled thyroid or adrenal dysfunctionTumor of pituitary or hypothalamusOvarian cyst or enlargement of unknown originAbnormal uterine bleeding of undetermined originSex hormone dependent tumors (e.g., breast, uterus)
| Precautions | Ovarian hyperstimulation syndrome (OHSS), Thromboembolic events, Ovarian torsion, Ovarian enlargement, Multiple gestation, Ectopic pregnancy, Spontaneous abortion, Ovarian neoplasms (long-term use), Pulmonary complications (atelectasis, acute respiratory distress syndrome) |
| Food/Dietary | No known food interactions. Maintain adequate hydration to help reduce the risk of OHSS; avoid excessive alcohol or caffeine as they may contribute to dehydration. |
| Clinical Pearls | Pergonal (menotropins) is a human menopausal gonadotropin used for ovulation induction. Monitor estradiol levels and follicular growth via ultrasound to minimize ovarian hyperstimulation syndrome (OHSS) and multiple gestation. Administer IM only; do not use if solution is cloudy or contains particles. Concomitant use with GnRH agonists may require dose adjustments. Discontinue if severe ovarian enlargement or pain occurs. |
| Patient Advice | This medication is injected into a muscle; your healthcare provider will show you how to prepare and give the injection. · You will need frequent blood tests and ultrasound exams to monitor your response to the medication and reduce risks. · The most common serious side effects are ovarian hyperstimulation syndrome (OHSS) and multiple pregnancy. Notify your doctor immediately if you experience severe pelvic pain, bloating, nausea, vomiting, or rapid weight gain. · Store unused vials in the refrigerator; do not freeze. Protect from light. Discard any unused portion after opening. · Do not use if you are already pregnant or have ovarian cysts, abnormal vaginal bleeding, thyroid or adrenal disorders, or pituitary tumors. |
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