Short answer: The Vyleesi label dose is 1.75 mg injected under the skin of the abdomen or thigh, as needed, at least 45 minutes before anticipated sexual activity. No more than one dose should be taken within 24 hours, and more than 8 doses per month is not recommended. The label says to stop Vyleesi after 8 weeks if symptoms have not improved.
This is what the FDA label says. Follow your prescriber. Your prescriber may use a different dose or pace than the label's standard schedule.
What Vyleesi is approved for: Vyleesi is approved for premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD): low sexual desire that causes marked distress or relationship difficulty and is not due to another medical or mental health condition, relationship problems, or a medicine or drug. It is not for postmenopausal women or men, and not to enhance sexual performance (section 1).
Source
VYLEESI (bremelanotide injection), prescribing information and Patient Information. Cosette Pharmaceuticals. DailyMed, version published November 18, 2025. DailyMed setid f1d0c1b5-2f39-4bad-a6a4-0066e3ad5dcf
Vyleesi is self-injected under the skin (subcutaneously) in the abdomen or thigh with a single-dose prefilled autoinjector containing 1.75 mg/0.3 mL (sections 2.1 and 3).
It is used as needed, at least 45 minutes before anticipated sexual activity. The label says how long each dose works is unknown, and patients may choose the best timing based on how they experience the effect on desire and side effects such as nausea (section 2.1).
The solution is checked before use and thrown away if it is cloudy, discolored or has visible particles (section 2.1).
The table below is the label's schedule, from the Dosage and Administration section. Numbers are copied exactly; the section is in brackets.
| Rule | What the label says |
|---|---|
| Dose | 1.75 mg |
| Route and site | Subcutaneous, in the abdomen or thigh |
| When | As needed, at least 45 minutes before anticipated sexual activity |
| Limit per 24 hours | Should not administer more than one dose within 24 hours |
| Limit per month | Administering more than 8 doses per month is not recommended |
| When to stop | Discontinue after 8 weeks if the patient does not report an improvement in her symptoms (section 2.2) |
The label says: "Patients should not administer more than one dose within 24 hours." The effect of back-to-back doses within 24 hours has not been established, and doses close together may add to the blood pressure effect.
The label says: "Administering more than 8 doses per month is not recommended." Few patients in the phase 3 program used more than 8 doses a month, and more frequent dosing raises the risk of skin darkening and the time each month that blood pressure is raised.
The duration of effect after each dose is unknown, and the best window for taking Vyleesi has not been fully characterized.
Vyleesi is discontinued after 8 weeks if the patient does not report an improvement in her symptoms.
Before starting and periodically during treatment, the label says to consider cardiovascular risk and make sure blood pressure is well controlled.
In the trials, most patients used Vyleesi two to three times per month and no more than once a week.
Vyleesi is taken as needed, so the label gives no missed-dose instruction. Its limits are no more than one dose within 24 hours and no more than 8 doses per month.
In Dose Track you set up Vyleesi as a protocol with the dose and schedule your prescriber gave you. A protocol can hold dose steps, each with its own dose and length in days or weeks, so a step-up plan like the one on the label can be entered once and the app moves to the next step on its own. Reminders follow the schedule, and every dose is logged with the date and time, so you can see which step you are on and when your last dose was. The app follows what you enter; it does not choose or change a dose.
This page is what the FDA label says, in plain words. It is not medical advice. Follow your prescriber, and ask them or your pharmacist about anything here.