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bremelanotide

Pronunciation: BRE me LAN oh tide

Brand: Vyleesi

What is the most important information I should know about bremelanotide?

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

What is bremelanotide?

Bremelanotide 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.

This medicine 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.

Bremelanotide 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.

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

Bremelanotide may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before using bremelanotide?

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

  • heart disease; or
  • untreated or uncontrolled high blood pressure.

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

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 bremelanotide 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.

How should I use bremelanotide?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Bremelanotide 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 bremelanotide injection at least 45 minutes before sexual activity.

Do not use more than 1 bremelanotide 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.

What happens if I miss a dose?

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

What happens if I overdose?

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

What should I avoid while using bremelanotide?

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

What are the possible side effects of bremelanotide?

Get emergency medical help if you have signs of an allergic reaction: 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 bremelanotide. Talk with your doctor about your own risk.

Common side effects may include:

  • nausea, vomiting;
  • hot flashes or flushing (sudden warmth, redness, or tingly feeling);
  • cough, stuffy nose;
  • headache, tiredness, dizziness;
  • tingly feeling; 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.

What other drugs will affect bremelanotide?

Bremelanotide 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 affect bremelanotide, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Where can I get more information?

Your pharmacist can provide more information about bremelanotide.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2019 Cerner Multum, Inc. Version: 1.01. Revision date: 8/13/2019.

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