Vyleesi bremelanotide for hypoactive sexual desire disorder

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.

use to improve sexual performance.

use in children.

Do not use Vyleesi if you have:

high blood pressure that is not controlled (uncontrolled hypertension)

known heart (cardiovascular) disease

Before you start treatment, 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.

Pregnancy Registry: There will be a pregnancy registry for women who use Vyleesi during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. Women who can become pregnant should use effective birth control during treatment with Vyleesi. Talk to your healthcare provider about birth control choices that may be right for you during this time. Stop using Vyleesi and tell your healthcare provider right away if you become pregnant or think you might be pregnant during treatment.

are breastfeeding or plan to breastfeed. It is not known if Vyleesi passes into your breast milk. Talk with your healthcare provider about the best way to feed your baby during treatment.

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 vice versa.

Talk to your healthcare provider or pharmacist if you have any questions.

Use Vyleesi exactly as prescribed by your healthcare provider.

Vyleesi comes in an autoinjector that you or your caregiver may use at home to give injections.

Vyleesi is given as an injection under the skin (subcutaneous injection), in your thighs or stomach area (abdomen).

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

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

Do not inject more than 8 doses within a month.

Tell your healthcare provider if your symptoms of HSDD have not improved after you have used Vyleesi for 8 weeks.

Vyleesi side effects

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.

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 treatment.

Nausea. Nausea is common and can also be severe. Nausea most commonly happens after the first injection but can also happen after any dose. The nausea usually lasts for about two 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. Your healthcare provider may prescribe an anti-nausea medicine for you.

The most common side effects include:

flushing

vomiting

hot flush

nasal congestion

injection site reactions

cough

tingling

headache

fatigue

dizziness.

Vyleesi bremelanotide for hypoactive sexual desire disorder

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. use to improve sexual performance. use in children. Do not use Vyleesi if you have: high blood pressure that is not controlled (uncontrolled hypertension) known heart (cardiovascular) disease Before you start treatment, 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. Pregnancy Registry: There will be a pregnancy registry for women who use Vyleesi during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. Women who can become pregnant should use effective birth control during treatment with Vyleesi. Talk to your healthcare provider about birth control choices that may be right for you during this time. Stop using Vyleesi and tell your healthcare provider right away if you become pregnant or think you might be pregnant during treatment. are breastfeeding or plan to breastfeed. It is not known if Vyleesi passes into your breast milk. Talk with your healthcare provider about the best way to feed your baby during treatment. 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 vice versa. Talk to your healthcare provider or pharmacist if you have any questions. Use Vyleesi exactly as prescribed by your healthcare provider. Vyleesi comes in an autoinjector that you or your caregiver may use at home to give injections. Vyleesi is given as an injection under the skin (subcutaneous injection), in your thighs or stomach area (abdomen). Inject Vyleesi at least 45 minutes before you think that you will begin sexual activity. Do not inject more than one dose within 24 hours of your last dose. Do not inject more than 8 doses within a month. Tell your healthcare provider if your symptoms of HSDD have not improved after you have used Vyleesi for 8 weeks. Vyleesi side effects 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. 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 treatment. Nausea. Nausea is common and can also be severe. Nausea most commonly happens after the first injection but can also happen after any dose. The nausea usually lasts for about two 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. Your healthcare provider may prescribe an anti-nausea medicine for you. The most common side effects include: flushing vomiting hot flush nasal congestion injection site reactions cough tingling headache fatigue dizziness.