Bremelanotide (bre-me-LAN-oh-tide)

Treats low sexual desire disorder in premenopausal women.

Brand Name(s):

Vyleesi

When This Medicine Should Not Be Used:

How to Use This Medicine:

Injectable

• Your doctor will prescribe your exact dose and tell you how often it should be given. This medicine is given as a shot under your skin. Inject this medicine at least 45 minutes before a sexual activity.
• Do not use more than one dose of this medicine within 24 hours. Do not use more than 8 doses per month.
• A nurse or other health provider will give you this medicine.
• You may be taught how to give your medicine at home. Make sure you understand all instructions before giving yourself an injection. Do not use more medicine or use it more often than your doctor tells you to.
• You will be shown the body areas where this shot can be given. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas.
• Check the liquid in the autoinjector pen. It should be clear or colorless. Do not use the medicine if the liquid is cloudy, discolored, or has particles in it.
• Use a new needle and syringe each time you inject your medicine.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• If you store this medicine at home, keep it at room temperature, away from heat, moisture, and direct light.
• Throw away used needles in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how bremelanotide works. Tell your doctor if you are using naltrexone, medicine to relieve pain (including indomethacin), or medicine to treat an infection.

Warnings While Using This Medicine:

• It is not safe to take this medicine during pregnancy. It could harm an unborn baby. Tell your doctor right away if you become pregnant.
• Tell your doctor if you are breastfeeding, or if you have kidney disease, liver disease, or stomach or bowel problems.
• This medicine may cause high blood pressure and a slow heartbeat.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Dizziness, lightheadedness, or fainting
• Severe or continuing nausea
• Slow heartbeat

If you notice these less serious side effects, talk with your doctor:

• Darkening of the face, gums, or breasts
• Feeling of warmth, redness of the skin
• Headache
• Pain, itching, burning, swelling, or a lump under your skin where the shot was given

If you notice other side effects that you think are caused by this medicine, tell your doctor

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