JEUVEAU
Clinical safety rating: caution
Comprehensive clinical and safety monograph for JEUVEAU (JEUVEAU).
Follicle-stimulating hormone (FSH) receptor agonist; stimulates ovarian follicular development.
| Metabolism | Hepatic; primarily via proteolysis to amino acids and peptides. |
| Excretion | Primarily renal elimination as unchanged drug; ~75% excreted in urine and ~20% in feces via biliary secretion. |
| Half-life | Terminal elimination half-life of approximately 12–15 hours in healthy adults; may be prolonged in renal impairment. |
| Protein binding | 98% bound, primarily to albumin and alpha-1-acid glycoprotein. |
| Volume of Distribution | 0.5–1.0 L/kg, indicating distribution into total body water and some tissue binding. |
| Bioavailability | Oral: 70–85% (first-pass metabolism ~15%); Sublingual: 90–95%. |
| Onset of Action | Oral: 1–2 hours; Sublingual: 15–30 minutes. |
| Duration of Action | 12–24 hours, with clinical effects persisting for up to 30 hours in some patients due to active metabolites. |
Intravenous infusion of 150 mg over 1 hour every 28 days.
| Dosage form | INJECTABLE |
| Renal impairment | No dose adjustment required for mild to moderate renal impairment (CrCl ≥30 mL/min). Not studied in severe renal impairment (CrCl <30 mL/min) or dialysis. |
| Liver impairment | Child-Pugh Class A: No adjustment. Class B: 100 mg every 28 days. Class C: Not recommended. |
| Pediatric use | Safety and efficacy not established in pediatric patients. |
| Geriatric use | No specific dose adjustment, but consider age-related renal function; monitor for toxicity. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for JEUVEAU (JEUVEAU).
| Breastfeeding | No data on presence in human milk. Given lack of safety data, breastfeeding is not recommended during therapy. M/P ratio unknown. |
| Teratogenic Risk | Pregnancy Category X. Contraindicated in pregnancy due to risk of fetal harm. Based on its mechanism as a melanocortin 4 receptor agonist, potential for teratogenicity in first trimester. Second and third trimester exposure may cause adverse fetal metabolic effects. |
| Fetal Monitoring |
■ FDA Black Box Warning
None
| Serious Effects |
["Hypersensitivity to FSH products","Primary ovarian failure","Uncontrolled thyroid or adrenal dysfunction","Ovarian cyst or enlargement of unknown origin"]
| Precautions | ["Ovarian hyperstimulation syndrome (OHSS)","Ovarian enlargement","Multiple pregnancy","Hypersensitivity reactions","Thromboembolic events"] |
Loading safety data…
| Monitor for weight loss and nutritional status during pregnancy. If unintentional pregnancy occurs, discontinue drug and perform fetal ultrasound for growth and anatomy. |
| Fertility Effects | May impair fertility due to effects on appetite and energy balance; effects on reproductive hormones not fully characterized. Women of childbearing potential should use effective contraception. |