Vyleesi (bremelanotide)

Vyleesi may cause serious side effects including:

• hives,
• difficulty breathing,
• swelling of your face, lips, tongue, or throat,
• temporary increase in blood pressure,
• decrease in heart rate, and
• severe dizziness

Get medical help right away, if you have any of the symptoms listed above.

The most common side effects of Vyleesi include:

• nausea,
• vomiting,
• flushing,
• redness, irritation, or pain at the injection site,
• darkening of the skin (face, gums, and breast),
• headache, and
• dizziness

Tell the doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Vyleesi. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

• The recommended dosage of Vyleesi is 1.75 mg administered subcutaneously in the abdomen or thigh, as needed, at least 45 minutes before anticipated sexual activity. The duration of efficacy after each dose is unknown and the optimal window for Vyleesi administration has not been fully characterized. Patients may decide the optimal time for Vyleesi administration based on how they experience the duration of effect on desire and any adverse reactions such as nausea.
• Patients should not administer more than one dose within 24 hours. The efficacy of consecutive doses within 24 hours has not been established and administering doses close together may increase the risk of additive effects on blood pressure.
• Administering more than 8 doses per month is not recommended. Few patients in the phase 3 program received more than 8 doses per month. Also, more frequent dosing increases the risk for focal hyperpigmentation and the length of time per month when blood pressure is increased.
• Vyleesi is self-administered via a prefilled autoinjector pen. Visually inspect the drug product for particulate matter and discoloration prior to administration, whenever solution and container permit. Discard if the solution is cloudy, discolored, or visible particles are observed.

Discontinuation Of Vyleesi

• Discontinue Vyleesi after 8 weeks if the patient does not report an improvement in her symptoms.

Effect Of Vyleesi On Other Drugs

• Vyleesi may slow gastric emptying and thus has the potential to reduce the rate and extent of absorption of concomitantly administered oral medications.
• Instruct patients to avoid the use of Vyleesi when taking concomitant oral drugs that are dependent on threshold concentrations for efficacy (e.g., antibiotics).
• In addition, patients should consider discontinuing Vyleesi if there is a delayed drug effect of concomitant oral medications when a quick onset of drug effect is desired (e.g. drugs for pain relief such as indomethacin).

Naltrexone

• As Vyleesi may significantly decrease the systemic exposure of orally-administered naltrexone, patients should avoid using Vyleesi with an orally administered naltrexone-containing product that is intended to treat alcohol and opioid addiction due to the severe consequence of naltrexone treatment failure.

• The few pregnancies in women exposed to Vyleesi in clinical trials are insufficient for determining whether there is a drug-associated risk for major birth defects, miscarriage or adverse maternal or fetal outcomes.
• There is no information on the presence of bremelanotide or its metabolites in human milk, the effects on the breastfed infant, or the effects on milk production.
• The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Vyleesi and any potential adverse effects on the breastfed child from Vyleesi or from the underlying maternal condition.