Important safety information
Compounded PT-141 (bremelanotide) injection is a prescription medication. Compounded medications are prescription medications prepared by state-licensed pharmacies for an individual prescription. They are not FDA-approved, and the FDA does not review compounded medications for safety, effectiveness or quality. Bremelanotide is FDA-approved under the brand name Vyleesi for premenopausal women with acquired, generalized hypoactive sexual desire disorder; the safety information below is drawn from that labeling.
Blood pressure and heart rate. PT-141 causes a temporary increase in blood pressure and a decrease in heart rate after each dose, which usually resolves within 12 hours. Do not use it if you have uncontrolled high blood pressure or known cardiovascular disease, and use no more than one dose in 24 hours and no more than eight doses in a month. Tell your provider before starting if you have heart disease or high blood pressure, and check your blood pressure as your provider directs.
Skin darkening. PT-141 can cause darkening of the skin (focal hyperpigmentation), especially on the face, gums and breasts, which may not go away after stopping. The risk is higher with more than eight doses a month and in people with darker skin. Slowed stomach emptying. PT-141 may slow the absorption of other medications you take by mouth, including some that must work quickly, such as oral naltrexone and indomethacin. Tell your provider about every medication you take.
The most common side effects are nausea (which can be severe and may need treatment), flushing, injection site reactions, headache, vomiting, cough, fatigue, hot flush, tingling, dizziness and nasal congestion. Do not use PT-141 if you have had an allergic reaction to it, or if you are pregnant; women who can become pregnant should use effective contraception. Stop using PT-141 and get medical help right away if you have signs of a serious allergic reaction, such as trouble breathing, swelling of the face or throat, or hives.
This is not a complete list. Talk to your provider about your full medical history and every medication and supplement you take, and tell your provider if you are pregnant, planning to become pregnant or breastfeeding.
