Vyleesi is used to treat low sexual desire in women who have not gone through menopause and have not had low sexual desire in the past.

Vyleesi should be used only to treat low sexual desire that occurs with any type of sexual activity, in any sexual situation, or with any sexual partner.

Vyleesi should not be used to treat low sexual desire that is caused by relationship problems, health problems, mental illness, or by using certain drugs or medications.

Vyleesi is not for use in men, or in women who have gone through menopause. Bremelanotide should not be used to improve sexual performance.

You should not use Vyleesi if you have heart problems or if you have untreated or uncontrolled high blood pressure.

Use Vyleesi exactly as directed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

Vyleesi is injected under the skin. A healthcare provider may teach you how to properly use the medication by yourself.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you don't understand all instructions.

Use the Vyleesi injection at least 45 minutes before sexual activity.

Do not use more than 1 Vyleesi injection every 24 hours. Do not use more than 8 total injections within 1 month.

Prepare an injection only when you are ready to give it. Do not use if the medicine looks cloudy, has changed colors, or has particles in it. Call your pharmacist for new medicine.

Bremelanotide can cause nausea, which may be severe. You may be given other medication to help prevent nausea. Use this medicine exactly as your doctor has prescribed.

Call your doctor if your symptoms do not improve after 8 weeks.

Store at cool room temperature, away from heat and light. Do not freeze. Keep unused injection pens in their original carton.

Use a prefilled injection pen only once and then place it in a puncture-proof "sharps" container. Follow state or local laws about how to dispose of this container. Keep it out of the reach of children and pets.

Usual Adult Dose for Hypoactive Sexual Desire Disorder:

1.75 mg subcutaneously as needed 45 minutes before anticipated sexual activity

-No more than 1 dose should be administered within 24-hour period
-Administering more than 8 doses/month is not recommended

Comments:
-Hypoactive sexual desire disorder (HSDD) is characterized by low sexual desire that causes marked distress or interpersonal difficulty.
-Acquired HSDD means the patient has previously had no problems with sexual desire.
-Generalized HSDD means the condition occurs regardless of the type of stimulation, situation, or partner.
-This drug is not for the treatment of HSDD in postmenopausal women or in men; it is not indicated to enhance sexual performance.
-This drug should be discontinued if there is no improvement in symptoms after 8 weeks.

Use: For the treatment of acquired, generalized HSDD in premenopausal women not due to a co-existing medical or psychiatric condition, problems with the relationship, or the effects of a medication or drug substance.

You should not use Vyleesi if you are allergic to bremelanotide, or if you have:

• heart disease; or

• untreated or uncontrolled high blood pressure.

Vyleesi is not approved for use by anyone younger than 18 years old.

To make sure this medicine is safe for you, tell your doctor if you have ever had:

• heart problems;

• high blood pressure;

• kidney disease; or

• liver disease.

Bremelanotide may harm an unborn baby. Use effective birth control to prevent pregnancy. Stop using the medicine and tell your doctor right away if you become pregnant.

If you do use Vyleesi during pregnancy, your name may be listed on a pregnancy registry to track the effects of bremelanotide on the baby.

It may not be safe to breastfeed while using this medicine. Ask your doctor about any risk.

Since Vyleesi is used when needed, it does not have a daily dosing schedule.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Get emergency medical help if you have signs of an allergic reaction to Vyleesi: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• severe or ongoing nausea;

• slow heartbeats; or

• high blood pressure - severe headache, blurred vision, pounding in your neck or ears.

Your blood pressure and heart rate should return to normal within 12 hours after an injection. Tell your doctor if these side effects last longer that 12 hours.

Bremelanotide may darken the color of your gums or your skin (especially on the face or breasts). People with darker skin color may be more likely to develop this side effect. These skin changes may be permanent, even after you stop using this medicine. Talk with your doctor about your own risk.

Common Vyleesi side effects may include:

• nausea, vomiting;

• flushing (sudden warmth, redness, or tingly feeling);

• cough, stuffy nose;

• headache, tiredness, dizziness; or

• pain, bruising, redness, itching, bleeding, numbness, or tingling where an injection was given.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Vyleesi can slow your digestion, and it may take longer for your body to absorb any medicines you take by mouth.

Tell your doctor about all your other medicines, especially:

• an antibiotic;

• pain medicine; or

• naltrexone (to treat alcohol or opioid addiction).

This list is not complete. Other drugs may interact with bremelanotide, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.