Bremelanotide
VYLEESI
What it isMelanocortin-4 receptor agonist; acquired generalized hypoactive sexual desire disorder in premenopausal women.
Why this oneOn-demand injection distinguishes it from daily flibanserin and avoids serotonergic or hormonal treatment.
What limits itNausea affects about 40%, blood pressure rises transiently, and repeated use can cause focal hyperpigmentation.
FDA-approved for
- hypoactive sexual desire disorder (2019)
FDA label
Read the full label on DailyMed ↗
| FDA dosing | Population | Start | Target | Max |
|---|---|---|---|---|
| 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
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
NO BOXED WARNINGS
Principal riskNausea in about 40%, and transient blood pressure rise
Cost, est. cash$900–$1,200/4 doses
Generic entry2033 est.
Classes and tags
Clinical profile
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.
Mechanism of action: Bremelanotide ballicule
Open Bremelanotide in the interactive console ↗
Memory aids: mascots and interaction avatars
stimulates melanocytes → may cause tan-like coloration
