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 who have HSDD have an imbalance of neurotransmitter (chemical messenger) activity in the brain, resulting in low sexual desire. Vyleesi, which belongs to a group of drugs called melanocortin receptor agonists, is believed to act on certain neurotransmitters, called melanocortins, to help improve sexual desire. The exact way that Vyleesi works isn’t fully known.

This medication comes comes in an autoinjector that you or your caregiver may use at home to give injections under the skin (subcutaneous injection), in your thighs or stomach area (abdomen). Vyleesi hould be taken at least 45 minutes before anticipated sexual activity.

The most common side effects are nausea, flushing, injection site reactions, headache, and vomiting.

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.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Vyleesi. See the "Vyleesi Precautions" section.

The most common side effects of Vyleesi include: 

• flushing
• injection site reactions
• headache
• vomiting
• cough
• fatigue
• hot flush
• tingling
• dizziness
• 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.

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. Especially tell your health care professional if you are taking:

• an antibiotic
• a medication for pain relief
• Naltrexone

This is not a complete list of Vyleesi drug interactions. Ask your doctor or pharmacist for more information.

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 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.

Do not use Vyleesi if you have:

• high blood pressure that is not controlled (uncontrolled hypertension)
• known heart (cardiovascular) disease

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Vyleesi there are no specific foods that you must exclude from your diet when receiving this medication.

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.

Tell your healthcare provider if you are pregnant or planning 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. Talk to your healthcare provider about how you can take part in this registry or call the Vyleesi Pregnancy Exposure Registry at 877- 411-2510.

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 with Vyleesi.

Tell your healthcare provider if you 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 if you use Vyleesi.

See the detailed “Instructions for Use” that comes with Vyleesi for information on how to prepare and inject a dose of Vyleesi. 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 1 dose of Vyleesi within 24 hours of your last dose.
• Do not inject more than 8 doses of Vyleesi within a month.
• Tell your healthcare provider if your symptoms of HSDD have not improved after you have used Vyleesi for 8 weeks.

Take Vyleesi exactly as prescribed by your doctor. Follow the directions on your prescription label carefully. Your doctor will determine the best dose for you.

The recommended dosage:

Inject 1.75 mg subcutaneously via the autoinjector to the abdomen or thigh, as needed, at least 45 minutes before anticipated sexual activity.

• Do not administer more than one dose within 24 hours. 
• More than 8 doses per month is not recommended. 

If you take too much Vyleesi call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

Store at or below 77°F (25°C).
• Do not freeze.
• Protect from light.

Keep Vyleesi and all medicines out of the reach of children.