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IMPORTANT SAFETY INFORMATION

Do not use VYLEESI if you have:

high blood pressure that is not controlled (uncontrolled hypertension)

known heart (cardiovascular) disease

Before using VYLEESI, tell your healthcare provider about all of your medical conditions, including if you:

have high blood pressure.

have heart problems.

have kidney problems.

have liver problems.

are pregnant or plan to become pregnant. It is not known if VYLEESI will harm your unborn baby. Women who can become pregnant should use effective birth control during treatment with Vyleesi.



Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. VYLEESI may affect the way other medicines work, and other medicines may affect the way VYLEESI works.

How should I use VYLEESI?

Inject Vyleesi at least 45 minutes before you think that you will begin sexual activity.

Do not inject more than 1 dose of VYLEESI within 24 hours of your last dose.

inject more than 1 dose of VYLEESI within 24 hours of your last dose. Do not inject more than 8 doses of VYLEESI within a month.

What are the possible side effects of VYLEESI?

VYLEESI can cause serious side effects, including:

Temporary increase in blood pressure and decrease in heart rate: An increase in blood pressure and decrease in heart rate can happen shortly after you inject VYLEESI. These changes usually go away within 12 hours after your injection. Increases in blood pressure and an increased risk of heart (cardiovascular) problems can happen if you use VYLEESI more often than prescribed by your healthcare provider.

An increase in blood pressure and decrease in heart rate can happen shortly after you inject VYLEESI. These changes usually go away within 12 hours after your injection. Increases in blood pressure and an increased risk of heart (cardiovascular) problems can happen if you use VYLEESI more often than prescribed by your healthcare provider. Darkening of the skin on certain parts of the body (focal hyperpigmentation) including the face, gums (gingiva) and breast . The chance of darkening of the skin is increased in people with darker skin color. The chance of darkening of the skin is higher if VYLEESI is used every day. Darkening of the skin may not go away, even after you stop using VYLEESI.

. The chance of darkening of the skin is increased in people with darker skin color. The chance of darkening of the skin is higher if VYLEESI is used every day. Darkening of the skin may not go away, even after you stop using VYLEESI. Nausea. Nausea is common and can also be severe. Nausea most commonly happens after the first VYLEESI injection but can also happen after any dose of VYLEESI. The nausea usually lasts for about 2 hours but can last longer in some people. The nausea usually goes away by itself. Tell your healthcare provider if you have nausea that is severe or does not go away.

The most common side effects of VYLEESI include: flushing, injection site reactions, headache, vomiting, cough, fatigue, hot flush, tingling, dizziness, and nasal congestion. These are not all the possible side effects of VYLEESI.

Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit fda.gov/medwatch or call 1-800-FDA-1088.

INDICATION

What is VYLEESI?

VYLEESI is a prescription medicine used to treat hypoactive (low) sexual desire disorder (HSDD) in women who have not gone through menopause, who have not had problems with low sexual desire in the past, and who have low sexual desire no matter the type of sexual activity, the situation, or the sexual partner. Women with HSDD have low sexual desire that is troubling to them. Their low sexual desire is not due to:

a medical or mental health problem

problems in the relationship

medicine or other drug use

VYLEESI is not for the treatment of HSDD in women who have gone through menopause or in men.

VYLEESI is not for use to improve sexual performance.

VYLEESI is not for use in children.