HUMEGON
Clinical safety rating: caution
Comprehensive clinical and safety monograph for HUMEGON (HUMEGON).
HUMEGON (menotropins) is a purified preparation of gonadotropins (follicle-stimulating hormone, FSH, and luteinizing hormone, LH) extracted from the urine of postmenopausal women. It acts by stimulating ovarian follicular growth and maturation in women and spermatogenesis in men via binding to FSH and LH receptors on target cells.
| Metabolism | The metabolic pathway of menotropins is not fully characterized; however, it is likely degraded via proteolysis into smaller peptides and amino acids in the liver and kidneys. |
| Excretion | Primarily renal (90-95% as intact hormone and metabolites); biliary/fecal excretion minor (<5%). |
| Half-life | Terminal half-life approximately 23-24 hours (range 20-30 h) for FSH and LH activity; clinical significance: once-daily dosing achieves steady-state in 4-5 half-lives (approx. 5 days). |
| Protein binding | Approximately 30-40% bound to serum albumin; no specific binding proteins identified. |
| Volume of Distribution | Approximately 0.3-0.5 L/kg (total body water); indicates distribution primarily into extracellular fluid. |
| Bioavailability | IM/SC: Approximately 80-90% absolute bioavailability (due to first-pass hepatic metabolism with oral route being ineffective). |
| Onset of Action | IM/SC: Increased serum estradiol measurable within 6-12 hours; follicular growth detectable by ultrasound in 5-7 days. |
| Duration of Action | Duration of pharmacodynamic effect (elevated estradiol, follicular growth) persists 7-10 days post last dose; clinical note: daily dosing required throughout follicular phase. |
75 to 150 IU subcutaneously or intramuscularly once daily for 7 to 12 days, adjusted based on follicular response.
| Dosage form | INJECTABLE |
| Renal impairment | No specific dose adjustment guidelines; use caution in severe renal impairment. |
| Liver impairment | No specific dose adjustment guidelines; use caution in severe hepatic impairment. |
| Pediatric use | Not indicated for use in pediatric patients. |
| Geriatric use | Not indicated for use in geriatric patients. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for HUMEGON (HUMEGON).
| Breastfeeding | It is not known whether menotropins are excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when administered to a nursing woman. No M/P ratio is available. |
| Teratogenic Risk | HUMEGON (menotropins) is not indicated for use during pregnancy. Human menopausal gonadotropin is used for ovulation induction and may result in multiple gestations. No teratogenic effects have been reported from inadvertent exposure during early pregnancy, but fetal risks include increased incidence of multiple births and associated prematurity, low birth weight, and perinatal morbidity. Avoid use during pregnancy. |
■ FDA Black Box Warning
HUMEGON should only be used by physicians who are experienced in infertility treatment and familiar with the potential risks. The drug has been associated with serious pulmonary and vascular events, including thromboembolism, ovarian hyperstimulation syndrome (OHSS), and multiple pregnancies. Female patients should be advised of the risk of OHSS and multiple gestations.
| Serious Effects |
["High levels of FSH indicating primary ovarian failure","Uncontrolled thyroid or adrenal dysfunction","Pituitary tumor","Abnormal uterine bleeding of undetermined origin","Ovarian cyst or enlargement not due to polycystic ovary syndrome (PCOS)","Sex hormone-dependent tumors (e.g., breast, uterus, ovary, prostate)","Pregnancy","Hypersensitivity to menotropins or any component"]
| Precautions | ["Risk of Ovarian Hyperstimulation Syndrome (OHSS): may progress to severe form with ascites, pleural effusion, oliguria, and thromboembolic events.","Thromboembolic events: increased risk especially in patients with predisposing factors.","Ovarian torsion: reported in post-treatment period.","Multiple pregnancies: high incidence, especially with higher doses.","Ovarian enlargement: may be asymptomatic or cause abdominal pain.","Ectopic pregnancy: increased risk in patients with tubal disease.","Congenital malformations: incidence may be slightly higher than spontaneous pregnancies.","Monitoring: requires ultrasound and estradiol levels to minimize risks."] |
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| Fetal Monitoring | Monitor ovarian response via ultrasound and serum estradiol levels to prevent ovarian hyperstimulation syndrome (OHSS). Monitor for multiple pregnancy. During pregnancy, standard obstetric surveillance is recommended. |
| Fertility Effects | HUMEGON is used to induce ovulation in anovulatory women and to stimulate multifollicular development in assisted reproductive technology (ART). It does not adversely affect fertility; rather, it is a fertility treatment. |