Safety
Not for people with uncontrolled high blood pressure or known heart disease. Each dose briefly raises blood pressure (by up to 6/3 mmHg) and lowers heart rate, usually for up to 12 hours. In trials, 40% of women had nausea (vs 1.3% on placebo), 20% flushing and 11% headache; 1% developed darker patches of skin, more often with frequent use. It can sharply lower levels of oral naltrexone.
Talk to a licensed clinician about your health history and every medication you take before you start.
Legal status
Prescription only; the ingredient has an FDA-approved form, but compounded versions are not FDA-approved. Bremelanotide (PT-141) is prepared by a compounding pharmacy for an individual prescription. Compounded products are not FDA-approved, and the FDA does not review them for safety, effectiveness or quality. Bremelanotide is a component of an FDA-approved drug (Vyleesi), so a licensed 503A pharmacy may compound it for an individual prescription, as long as it isn’t essentially a copy of Vyleesi made regularly or in large amounts. Use in men, and nasal or troche forms, is off-label.
What bremelanotide (PT-141) is
Vyleesi was approved on June 21, 2019. Its label says it is not for postmenopausal women or men, and not for enhancing sexual performance. Compounded PT-141 is not Vyleesi and not a generic of it; a compounding pharmacy prepares it, and it isn’t FDA-approved.
Brand-name Vyleesi only: acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women.
Dosing
Injection under the skin; compounded versions also come as a nasal spray or troche, at least 45 minutes before sex; the Vyleesi label allows no more than 1 dose in 24 hours and 8 doses a month. Vyleesi: 1.75 mg by autoinjector under the skin of the abdomen or thigh, as needed. Stop after 8 weeks if desire hasn’t improved. Compounded doses and forms are set by the prescriber.
How well it works
In two 24-week trials of premenopausal women with HSDD, the desire score rose 0.5 and 0.6 points on Vyleesi vs 0.2 on placebo, and distress about low desire fell more. The number of satisfying sexual events did not differ from placebo. The FDA has not reviewed any trial in men. Individual results vary.
Bremelanotide (PT-141) cost
None of the providers we track publishes a monthly price for compounded PT-141.