Vyleesi (Bremelanotide) – Subcutaneous

What Is Vyleesi?

Vyleesi (bremelanotide) is a prescription injectable medication used to treat hypoactive sexual desire disorder (HSDD) in premenopausal females, a condition characterized by low sexual desire that results in interpersonal difficulty.

Vyleesi is a melanocortin receptor (MCR) agonist and is approved for adults 18 and older.

MCR agonists are neuropeptides that control food intake and sexual function. Neuropeptides are proteins created by neurons (nerve cells that are information messengers) that either increase or decrease the strength of synaptic signaling (the junctions where neurons communicate with one another). As a result, these neuropeptides are used to treat HSDD.

Vyleesi works by increasing the release of certain natural substances in the brain, including dopamine and oxytocin, which can affect the way you think and feel.

Vyleesi contains the active ingredient bremelanotide. However, bremelanotide itself is not available as a generic product.

Vyleesi is administered via a subcutaneous (under the skin) injection.

What Is Vyleesi Used For?

The Food and Drug Administration (FDA) has approved Vyleesi as a medication option to treat HSDD in females who have not gone through menopause (when menstrual cycles have ended for 12 straight months).

Vyleesi may be an appropriate treatment option if you have not had problems with low sexual desire in the past and you experience low sexual desire no matter the sexual activity, situation, or partner.

Vyleesi should not be used if your low sexual desire is due to:

• A medical or mental health problem
• Problems in your relationship
• Side effects from medications or drugs

HSDD affects more than 7 million females in the United States and is one of the most common female sexual disorders.

People with HSDD experience:

• Decreased or no motivation to engage in sexual activity
• Reduced or absent sexual thoughts or fantasies
• Distress as a result of their low sexual desire, which may include feelings of frustration, guilt, incompetence, or sadness

Healthcare providers may recommend one or more treatment options for HSDD, including education, mindfulness therapy, cognitive behavioral therapy (CBT), and prescription medications.

How to Take Vyleesi

Vyleesi is available as a subcutaneous auto-injector. Vyleesi should be injected under your skin at least 45 minutes before you think sexual activity will begin.

Do not inject more than one dose of Vyleesi within 24 hours. Do not inject more than eight doses of Vyleesi in one month.

Follow these steps to ensure you use Vyleesi safely and effectively:

• Before injecting, check the label on the auto-injector to ensure your dose of Vyleesi is not expired.
• Inspect the solution in the view window. The solution should be clear and free of particles. Do not use it if the solution is cloudy, discolored, or contains particles. Do not use it if the view window is purple.
• Check that the clear cap on the auto-injector fits tightly. Do not use it if the cap feels loose or is damaged.
• Following your healthcare provider's instructions, inject your dose of Vyleesi into your stomach area or the front of your thigh. Do not inject Vyleesi within 2 inches of your navel (belly button). Do not inject into irritated, sore, bruised, red, hard, or scarred skin.
• Rotate (change out) the injection site each time you give yourself an injection.
• The auto-injector must be used right after removing the clear cap. If you remove the clear cap but decide not to use Vyleesi, you must throw away the auto-injector. Do not attempt to recap the auto-injector.
• Each auto-injector contains one dose of Vyleesi. Throw away the auto-injector after giving yourself your injection.
• Use an FDA-cleared sharps disposal container to throw away your auto-injector. Do not dispose of it in the trash. If you do not have an FDA-cleared sharps disposal container, you may use a container that is made of heavy-duty plastic, can be closed with a tight-fitting, puncture-resistant lid, and is leak-resistant.
• When your sharps container is almost full, follow local guidelines for the proper way to dispose of the container.
  

Storage

Store your Vyleesi auto-injectors at or below 77 F. Do not freeze the medication. Keep the auto-injectors in their original carton, protected from light.

Keep Vyleesi and all your medicines in a safe location, out of the reach of children and pets.

What Are the Side Effects of Vyleesi?

This is not a complete list of side effects, and others may occur. A healthcare provider can advise you on side effects.

If you experience other effects, contact your pharmacist or a healthcare provider. You may report side effects to the FDA at fda.gov/medwatch or 800-FDA-1088.

Common Side Effects

You may experience side effects while taking Vyleesi. Let your healthcare provider know if you develop any side effects that bother you or don't go away.

Common side effects include:

• Nausea
• Facial flushing
• Injection site reactions, such as pain, redness, bruising, or itching
• Headache
• Vomiting
• Nasal congestion
• Cough
• Fatigue
• Dizziness
  

Severe Side Effects

Vyleesi may cause serious side effects. Contact your healthcare provider right away if you develop any signs of a severe reaction. Call 911 if your symptoms feel life-threatening.

Serious side effects and their symptoms include:

• Temporary increase in blood pressure or decrease in heart rate shortly after injection: Changes in blood pressure or heart rate typically go away within 12 hours after injecting Vyleesi. Taking Vyleesi more often than prescribed can increase your risk. Your healthcare provider will likely not prescribe Vyleesi if you have uncontrolled hypertension (high blood pressure) or heart disease.
• Darkening of the skin on certain parts of the body: This includes on the face, gums, and breasts. People with darker skin may be at increased risk of developing this side effect. Skin darkening may be permanent, even after you stop taking Vyleesi.
• Nausea that can be severe: Nausea commonly occurs after the first injection but can occur after any dose. Symptoms typically last for two hours, but some people may feel nauseous for longer. Nausea should go away on its own, but your healthcare provider may prescribe an antiemetic (antinausea) medicine to help.
  

Dosage: How Much Vyleesi Should I Take?

Modifications

The following modifications (changes) should be kept in mind when using Vyleesi:

Severe allergic reaction: Avoid using Vyleesi if you have a known allergy to it or any of its ingredients. Ask your healthcare provider for a complete list of the ingredients if you're unsure.

Pregnancy: Vyleesi is not recommended to treat people who are pregnant. In animal studies, Vyleesi was found to cause harm to the fetus. People who can become pregnant must use an effective form of birth control while taking Vyleesi. Stop using Vyleesi and contact your healthcare provider if you think you may be pregnant.

Breastfeeding: Not enough is known about the safety of Vyleesi in human breast milk and nursing babies. Talk with your healthcare provider if you plan to breastfeed and discuss the benefits and risks of taking Vyleesi while nursing and the different ways available to feed your baby.

Adults over 65: The safety and effectiveness of using Vyleesi in adults over 65 have not been studied.

Children: Vyleesi is not approved to treat people under the age of 18.

Kidney or liver problems: Individuals with kidney or liver problems may not be able to clear the medication from their bodies as easily as people with healthy organs. This means the medicine stays in the body longer and can have increased side effects. For this reason, if you have severe kidney or liver impairment, your healthcare provider will monitor you closely for side effects, including nausea and vomiting.

Missed Dose

Vyleesi is only taken as needed, not every day. If you forget to take Vyleesi before a sexual encounter, skip that dose, and wait until you anticipate having sex again.

Try to find ways to help yourself remember to routinely keep your appointments and take your medication. If you miss too many doses, Vyleesi might be less effective at treating your condition.

Overdose: What Happens If I Take Too Much Vyleesi?

There is limited information available about a Vyleesi overdose, but symptoms may include nausea and increased blood pressure. You may be more likely to develop skin darkening if you take more Vyleesi than your healthcare provider has prescribed.

If you think that you're experiencing an overdose or life-threatening symptoms, seek immediate medical attention.

Precautions

What Are Reasons I Shouldn’t Take Vyleesi?

Do not take Vyleesi if you:

• Have uncontrolled high blood pressure
• Have heart disease
• Have gone through menopause
• Are allergic to any of the ingredients present in Vyleesi, particularly bremelanotide

What Other Medications Interact With Vyleesi?

Use caution when taking Vyleesi with the following medications:

• Antibiotic medications, such as Keflex (cephalexin) or Flagyl (metronidazole)
• Indocin (indomethacin)
• Vivitrol (naltrexone)
  

Vyleesi may interact with other medicines.

Be sure to let your healthcare provider and pharmacist know about all the medicines you take, including over-the-counter (OTC), nonprescription products, vitamins, and herbal supplements.

What Medications Are Similar?

Vyleesi works by increasing levels of certain naturally occurring brain chemicals.

Another medication that works similarly to Vyleesi and is FDA-approved to treat HSDD is Addyi (flibanserin).

Addyi is an oral medication taken daily, whereas Vyleesi is injected only when needed.

Choosing between treatment options may depend on your other medical conditions, the medicines you take, and your preference for an oral vs. injectable therapy.

You and your healthcare provider will work together to choose the best treatment for you.

How Can I Stay Healthy While Taking Vyleesi?

If you have hypoactive sexual desire disorder (HSDD), you likely understand how frustrating it can be for both you and your partner.

While living with HSDD does have its challenges, there are ways to help improve your health and experience fulfilling sex.

Refer below for some general tips to support your quality of life:

• Take HSDD-related medications as recommended by your healthcare provider.
• Limit your stress and ensure you're getting enough sleep, eating right, and exercising.
• Maintain open communication with your partner.
• Discuss different psychotherapy options with your healthcare provider, including cognitive behavioral therapy (CBT) and mindfulness therapy.
• Consider participating in couples counseling or working with a sex therapist.