Acquired, generalized hypoactive sexual desire disorder (HSDD)
Premenopausal women
1.75 mg SC ≥45 min before sexual activity, PRN
1.75 mg SC PRN
1.75 mg per dose
Renal Undefined
Hepatic Undefined
Do not administer more than one dose within 24 hours; >8 doses/month not recommended
Instructions
Inject SC into abdomen or thigh via autoinjector
Administer at least 45 minutes before anticipated sexual activity
No more than one dose within 24 hours; no more than 8 doses per month
Available strengths
inj 1.75 mg/0.3 mL
Contraindications
Uncontrolled hypertension
Known cardiovascular disease
Cautions
Transient increase in blood pressure and decrease in heart rate after each dose — not recommended if high cardiovascular risk
Focal hyperpigmentation (higher risk with darker skin/daily dosing)
Nausea (may require anti-emetic)
Adverse reactions
Nausea
Flushing
Injection site reactions
Headache
Vomiting
Pregnancy May be associated with fetal harm (animal data); pregnancy exposure registry available
Lactation No information on presence in human milk
Cost
Bremelanotide (VYLEESI)
Strength
#/mo
generic $/unit
CostPlus
1.75 mg/0.3 mL
inj
per unit
not offered
NADAC is a voluntary CMS survey of what retail community pharmacies pay for the drugs they stock. Bremelanotide is administered under clinical supervision and dispensed outside retail pharmacies, so it rarely appears on surveyed invoices.
Generic entry2033 est.
NO BOXED WARNINGS
Principal riskNausea in about 40%, and transient blood pressure rise
Legacy pregnancy categoryNot assigned — PLLR-era drug
Defining liabilityGenerally tolerated at therapeutic doses; clinically important risks are agent-specific and increase with interactions or organ impairment.