Vyleesi prescribing information describes an as-needed bremelanotide injection for distressing low sexual desire in certain women before menopause. The label uses 1.75 mg, no more than once within 24 hours. More than eight doses per month is not recommended. Uncontrolled high blood pressure and known heart or blood-vessel disease rule out the branded medicine.
Bremelanotide is also known as PT-141. Vyleesi's label describes the branded injection; a compounded prescription has its own directions, and the prescriber sets the actual dose.
Which Vyleesi prescribing information is current?
The current DailyMed prescribing information reads “Revised: 3/2024.” A website refresh date can be different from the document's revision date.
The numbered sections below match that document. They separate the intended use, dose, exclusions, side effects, medicine interactions, and packaging.
Section 1: Who Vyleesi is indicated for
An indication is a use written into a medicine's label. Vyleesi's is acquired, generalized hypoactive sexual desire disorder, or HSDD: low desire that causes marked distress or relationship difficulty.
“Acquired” means desire problems developed after a period without them. “Generalized” means they occur across situations, stimulation, or partners. The indication covers women before menopause whose low desire isn't explained by another medical or psychiatric condition, relationship problems, or a drug.
The label excludes men, women after menopause, and sexual-performance enhancement from its indicated uses.
The two 24-week RECONNECT trials studied this defined group. They found modest average improvements in desire and related distress, without a significant increase in satisfying-event counts (Kingsberg et al., Obstetrics & Gynecology, 2019). The PT-141 clinical trials walkthrough explains those results.
Section 2: The dose and eight-week checkpoint
The label describes 1.75 mg injected under the skin of the abdomen or thigh through a prefilled autoinjector, a device containing one dose. Its timing is at least 45 minutes before anticipated sexual activity.
It limits dosing to once within 24 hours and recommends no more than eight doses per month. Closer doses may add to blood-pressure effects; more frequent use increases the risk of skin darkening.
The duration of benefit is unknown, and the best timing window hasn't been fully worked out. Section 2.2 calls for stopping after eight weeks if symptoms haven't improved. These are brand-label facts, not directions for a compounded PT-141 preparation.
Vyleesi and Addyi labels both call for reassessment after eight weeks without symptom improvement.
Section 4: Contraindications
A contraindication is a reason a medicine must not be used. Vyleesi lists uncontrolled hypertension, meaning high blood pressure, and known cardiovascular disease, meaning disease of the heart or blood vessels.
Controlled blood pressure isn't the same exclusion. However, the label calls for reviewing heart and blood-vessel risk before treatment and periodically afterward. It also does not recommend Vyleesi for people at high risk of cardiovascular disease.
Section 5: Blood pressure, skin darkening, and nausea
Each dose can temporarily raise blood pressure and lower heart rate. The label reports peak increases of up to 6 mmHg in the upper pressure number and 3 in the lower number. These are the units on a blood-pressure reading. Changes peaked two to four hours after dosing and usually resolved within 12 hours.
Focal hyperpigmentation means patches of darker skin. About 1 in 100 participants using up to eight monthly doses reported it, including on the face, gums, or breasts. Risk was higher with darker skin and daily dosing. The patches may not fully clear after treatment stops.
Nausea affected about 2 in 5 treated participants. Thirteen percent received medicine for nausea, and 8% stopped because of it. The label describes persistent or severe nausea as a reason to reconsider treatment with the prescriber.
Section 6: The adverse-reactions table
Adverse reactions are side effects recorded in the studies. These figures come from Table 1 of the label: 627 women received Vyleesi and 620 received placebo, an inactive comparison treatment.
| Reaction | Vyleesi | Placebo |
|---|---|---|
| Nausea | 40.0% | 1.3% |
| Flushing, a feeling of warmth or redness | 20.3% | 0.3% |
| Injection-site reactions, grouped together | 13.2% | 8.4% |
| Headache | 11.3% | 1.9% |
| Vomiting | 4.8% | 0.2% |
The injection-site row combines pain, redness, bruising, itching, and other local reactions. Overall, side effects led 18% of Vyleesi participants to stop, versus 2% with placebo.
The label also reports that ondansetron, an anti-nausea medicine, given 30 minutes beforehand did not reduce nausea in a 228-woman study. That finding concerns that specific pretreatment, not every way of treating nausea. The broader PT-141 side-effects guide covers the safety context.
Section 7: Oral medicines and naltrexone
Vyleesi may slow gastric emptying, meaning how quickly food and medicine leave the stomach. That can change how oral medicines reach the blood, especially medicines needing reliable levels or a quick effect.
The label calls for avoiding Vyleesi with oral naltrexone products used to treat alcohol or opioid addiction. Bremelanotide can substantially reduce the amount of naltrexone reaching the blood, risking treatment failure. The development-program analysis also identified interactions lowering blood levels of naltrexone and indomethacin, a pain medicine (Clayton et al., Journal of Women's Health, 2022).
Section 8: Pregnancy, breastfeeding, age, kidneys, and liver
Human pregnancy data are too limited to establish risk, and animal studies found potential harm to developing offspring. The label calls for effective contraception and stopping Vyleesi if pregnancy is suspected.
It reports no information about bremelanotide in human breast milk, effects on a breastfed infant, or milk production. Safety and effectiveness haven't been established in children or older adults.
The label recommends no dose adjustment for mild or moderate kidney or liver impairment, meaning reduced organ function. Severe impairment calls for caution because nausea and vomiting may be worse; severe liver impairment hasn't been studied.
Section 16: What comes in the box
Each disposable Vyleesi autoinjector contains 1.75 mg in 0.3 mL of solution. The label describes cartons of two or four devices. Its storage conditions are at or below 25°C (77°F), protected from light and never frozen.
As of September 30, 2026, the day this article was written, an August 20, 2026 laboratory study in Analytical Methods adds context to those storage precautions. Researchers deliberately stressed bremelanotide and identified eight breakdown products, with particular sensitivity to oxidation, damage from chemical reactions involving oxygen. Breakdown also occurred under heat and light. This wasn't a patient study and doesn't establish storage times for a compounded prescription.
What the label means for compounded PT-141
Promise's PT-141 is dispensed as a compounded medication, which is different from an FDA-approved product: the formulation offered here is not FDA-approved. Vyleesi is the branded product. Its label doesn't establish another preparation's concentration, container, storage, or results. The FDA's compounding explanation describes the difference in review.
The PT-141 product page shows what Promise currently offers. Vyleesi's injection label doesn't establish a nasal preparation's dose or effects.
As of September 30, 2026, the day this article was written, an FDA warning letter dated August 24, 2026 names an online seller's PT-141 among unapproved drugs. A prescribed route adds a clinician, an identifiable licensed pharmacy, dispensing records, and a contact for problems. The September PT-141 update covers those letters.
A licensed provider may still prescribe a compounded formulation; that decision is between you and your doctor. At Promise, a licensed provider reviews every request and may prescribe or decline; not everyone qualifies.
