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Bremelanotide

Brand names: Vyleesi

What is bremelanotide used for?

  • Bremelanotide is used in some women to raise interest in sex.

Before taking bremelanotide, tell your doctor:

  • If you are allergic to bremelanotide; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
  • If you have any of these health problems: Heart disease or high blood pressure.
  • If you are taking naltrexone.
  • If you are pregnant or may be pregnant. Do not take bremelanotide if you are pregnant.

This is not a list of all drugs or health problems that interact with bremelanotide.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take bremelanotide with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take bremelanotide?

  • Tell all of your health care providers that you take bremelanotide. This includes your doctors, nurses, pharmacists, and dentists.
  • High blood pressure and slow heartbeat have happened with bremelanotide. Most of the time, these effects go away within 12 hours after a dose. If you have questions, talk with your doctor.
  • Darkened skin on the face, gums, and breast has happened with bremelanotide. The risk is higher in people with darker skin color. The risk is higher if used every day. Do not take more than 8 doses in a month. Darkened skin may not go back to normal even after bremelanotide is stopped. If you have questions or concerns, talk with your doctor.
  • This medicine may cause harm to an unborn baby. Women must use birth control while taking bremelanotide. If you get pregnant, call your doctor right away.
  • Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

How is bremelanotide best taken?

Use bremelanotide as ordered by your doctor. Read all information given to you. Follow all instructions closely.

  • It is given as a shot into the fatty part of the skin on the top of the thigh or the belly area.
  • If you will be giving yourself the shot, your doctor or nurse will teach you how to give the shot.
  • Take a dose at least 45 minutes before you think you will have sex. If it does not seem to be working well, talk with your doctor. You may need to take bremelanotide at a different time.
  • Do not use if the solution is cloudy, leaking, or has particles.
  • Do not use if solution changes color.
  • Throw away needles in a needle/sharp disposal box. Do not reuse needles or other items. When the box is full, follow all local rules for getting rid of it. Talk with a doctor or pharmacist if you have any questions.

What do I do if I miss a dose?

  • This medicine is taken on an as needed basis. Do not take more often than every 24 hours unless told to do so by your doctor.

What are the side effects of bremelanotide that I need to call my doctor about immediately?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of high blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
  • Slow heartbeat.

What are some other side effects of bremelanotide?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Upset stomach. Most of the time, this happens after the first dose but can happen after any dose. This usually lasts for about 2 hours. If upset stomach is severe or does not go away, talk with your doctor.
  • Flushing.
  • Irritation where the shot is given.
  • Headache.
  • Throwing up.
  • Stuffy nose.
  • Cough.
  • Tingling.
  • Feeling dizzy, tired, or weak.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If overdose is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out bremelanotide?

  • Store at room temperature. Do not freeze.
  • Protect from light.
  • Store in a dry place. Do not store in a bathroom.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Consumer information use and disclaimer

  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else's drugs.
  • Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about bremelanotide, please talk with your doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take bremelanotide or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to bremelanotide. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Source: Wolters Kluwer Health. Last updated April 5, 2023.