PERGONAL
Clinical safety rating: caution
Comprehensive clinical and safety monograph for PERGONAL (PERGONAL).
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. |
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 | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for PERGONAL (PERGONAL).
| Breastfeeding | No data available on excretion into breast milk. Pergonal is not indicated during breastfeeding. The M/P ratio is unknown. Due to the hormonal nature and potential for adverse effects in infants, breastfeeding is not recommended during therapy. |
| 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. |
■ 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 |
["High levels of FSH indicating primary ovarian failure","Uncontrolled thyroid or adrenal dysfunction","Pituitary tumor","Ovarian cyst or enlargement of unknown origin","Abnormal vaginal bleeding of undetermined cause","Pregnancy","Sex 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)"] |
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| 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. |