7 mins read

Vyleesi is an injection used to treat low sex drive in premenopausal women. It may work by activating receptors in the brain that affect mood and sexual desire. The most common side effects are nausea (especially with the first dose), hot flashes, and headache. While less common, serious side effects may include blood pressure and heart effects and darkening skin color. You should not use more than one dose of Vyleesi per day.

Uses

What is Vyleesi used for?

Vyleesi (bremelanotide) is commonly used to treat low sex drive (hypoactive sexual desire disorder or HSDD) in certain women before menopause. It is not for people whose low sex drive is caused by medical or mental health problems, relationship problems, or medicines or drug use.

Vyleesi may also be used for other conditions as determined by your health care provider.

How does Vyleesi work (mechanism of action)?

Vyleesi may work by activating specific receptors in your brain, including those that affect mood and sexual desire. 

How is Vyleesi supplied (dosage forms)?

Brands and other names

  • Vyleesi

Dosage forms and strengths

  • 1.75 mg/0.3 mL solution for injection (autoinjector)

How should I store Vyleesi?

Vyleesi should be stored at room temperature, up to 77 F (25 C). Avoid freezing it. Store in a cool, dry place and protect it from light.

Side Effects

What are the most common side effects of Vyleesi?

The most common side effects of Vyleesi are listed below. Tell your health care provider if you have any of these side effects that bother you.

  • Nausea (see below)
  • Flushing or hot flashes
  • Pain, itching, swelling, or bruising near the injection site
  • Headache
  • Vomiting
  • Cough
  • Tiredness
  • Tingling
  • Dizziness
  • Stuffy nose

There may be other side effects of Vyleesi that are not listed here. Contact your health care provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088 (800-332-1088). In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.

What are the serious side effects of Vyleesi?

While less common, the most serious side effects of Vyleesi are described below, along with what to do if they happen.

Severe Allergic Reactions. Vyleesi may cause allergic reactions, which can be serious. Stop using Vyleesi and get help right away if you have any of the following symptoms of a serious allergic reaction.

  • Breathing problems or wheezing
  • Racing heart
  • Fever or general ill feeling
  • Swollen lymph nodes
  • Swelling of the face, lips, mouth, tongue, or throat
  • Trouble swallowing or throat tightness
  • Itching, skin rash, or pale red bumps on the skin called hives
  • Nausea or vomiting
  • Dizziness, feeling lightheaded, or fainting
  • Stomach cramps
  • Joint pain

Nausea. Vyleesi commonly causes nausea, especially with the first dose, and it may be severe. Nausea is less common with the second and later doses. Usually, nausea from Vyleesi lasts about two hours, but it may last longer. If your health care provider tells you to take certain medicines for nausea, take them as prescribed. Tell your health care provider if you have nausea that bothers you or does not improve. 

Blood Pressure and Heart Rate Effects. After each dose of Vyleesi, your blood pressure may go up and your heart rate may slow down. These changes are usually small and go away within 12 hours, but they may cause serious problems in people with heart disease. Using Vyleesi more often than prescribed may increase the risk of these problems. If you measure your blood pressure and the top number (systolic) is 180 or higher or the bottom number (diastolic) is 120 or higher, get medical attention right away. Tell your health care provider right away if you have any of the following symptoms.

  • Chest pain
  • Feeling lightheaded or fainting
  • Confusion
  • Feeling weak or unusually tired 
  • Slow heartbeat or feeling of skipped heartbeats 
  • Shortness of breath

Darkening Skin Color. Vyleesi may cause darkening (hyperpigmentation) of your face, breasts, and gums. The risk may be higher if you use Vyleesi every day and if you have darker skin. Skin darkening may not go away after stopping Vyleesi. Tell your health care provider if you have skin or gum darkening that bothers you. 

Warnings & Precautions

Who should not use Vyleesi?

Allergies to Ingredients. People who are allergic to any of the following should not use Vyleesi.

  • Bremelanotide
  • Vyleesi
  • Any of the ingredients in the specific product dispensed

Your pharmacist can tell you all of the ingredients in Vyleesi.

Uncontrolled High Blood Pressure. Vyleesi should not be used by people who have high blood pressure that is not controlled. Using Vyleesi could worsen this condition. 

Heart or Blood Vessel Disease. Vyleesi should not be used by people with conditions affecting the heart and blood vessels (cardiovascular disease). This includes people with coronary artery disease, peripheral artery disease, or vascular disease. Using Vyleesi could worsen these problems. 

What should I know about Vyleesi before using it?

Do not use Vyleesi unless it has been prescribed to you by a health care provider. Use it as prescribed. Do not use more than one dose within 24 hours or more than 8 doses within one month.

Do not share Vyleesi with other people, even if they have the same condition as you. It may harm them.

Keep Vyleesi out of the reach of children.

Vyleesi is injected under the skin (subcutaneously). Read and follow the instructions that come with the medicine and make sure that you or a caregiver understands how to properly prepare, use, and throw away Vyleesi. If you have any questions, talk to your health care provider.

Keep all appointments with your health care provider, including for blood pressure checks, before starting Vyleesi and during treatment. This will help your health care provider see if it is safe for you to use Vyleesi.

Tell your health care provider if your symptoms do not improve after eight weeks of using Vyleesi.

What should I tell my health care provider before using Vyleesi?

Tell your health care provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them determine if Vyleesi is right for you.

In particular, make sure that you discuss any of the following.

Risk Factors for Heart Disease. Vyleesi is not recommended for people at high risk for heart disease. Examples of risk factors include smoking, high blood pressure, diabetes, and obesity. Tell your health care provider about all of your health conditions and any family history of heart or blood vessel disease. Your health care provider can help decide if Vyleesi is safe for you.

Other Current and Past Health Conditions. Tell your health care provider if you have any of the following.

  • Heart problems
  • Kidney problems
  • Liver problems

Other Medicines and Supplements. Vyleesi may interact with other medicines and supplements. Before using Vyleesi, tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. See the Interactions section for more details.

Pregnancy. It is not known if or how Vyleesi could affect pregnancy or harm a fetus. If you can become pregnant, you should use effective birth control while using Vyleesi. If you become pregnant or think you might be pregnant, stop using Vyleesi and contact your health care provider right away. If you become pregnant while using Vyleesi, you can sign up for the Vyleesi Pregnancy Exposure Registry by calling 800-972-5220. This registry collects safety information about the use of Vyleesi during pregnancy. 

Breastfeeding. It is not known if Vyleesi passes into breast milk. Tell your health care provider if you are breastfeeding or plan to breastfeed. Your health care provider will let you know if you should use Vyleesi while breastfeeding.

How can I get more information about Vyleesi?

For more information about Vyleesi, you can visit the drugmaker’s website at www.vyleesi.com or call them at 800-922-1038.

Interactions

Does Vyleesi interact with foods or drinks?

There are no known interactions between Vyleesi and foods or drinks.

It is unknown if drinking alcohol will affect Vyleesi. The risk of certain side effects, such as dizziness, may increase if you drink alcohol while using Vyleesi.

Does Vyleesi interact with other medicines (drug interactions)?

Always tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.

In particular, make sure that you discuss if you are using any of the following before using Vyleesi.

  • An antibiotic that is taken by mouth, which is a medicine used for bacterial infections
  • Naltrexone taken by mouth, which is a medicine that may be used to treat alcohol use disorder or opioid use disorder
  • Indomethacin, which is a medicine used for pain or swelling

Vyleesi may affect the absorption of other medicines that are taken by mouth. Tell your health care provider about all medicines that you take or have recently taken. 

This may not be a complete list of medicines that can interact with Vyleesi. Always check with your health care provider. 

Does interact with other drugs you are taking?

Enter your medication into the WebMD interaction checker

Overdose/Missed Dose

What should I do if I accidentally use too much Vyleesi?

If you or someone else has used too much Vyleesi, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.

What should I do if I miss a dose of Vyleesi?

Vyleesi is meant to be used only when needed. You should not use more than one dose in 24 hours. Use it as recommended by your health care provider. Do not use double or extra doses.

 

Look up another drug