Vyleesi
Vyleesi (bremelanotide) treats low sex drive that causes negative emotions in people who haven't gone through menopause yet. This medication belongs to the drug class called melanocortin receptor agonists. Vyleesi (bremelanotide) is an autoinjector that you use to inject the medication under the skin. It's injected as needed at least 45 minutes before sex. Common side effects include nausea, flushing of the skin, and injection site reactions.
What is Vyleesi (bremelanotide)?
What is Vyleesi (bremelanotide) used for?
- Low sexual desire in people who haven't gone through menopause yet
How Vyleesi (bremelanotide) works
Vyleesi (bremelanotide) is a melanocortin receptor agonist. The medication attaches to proteins in the brain called melanocortin receptors. Though unclear, it's thought that the melanocortin system in the body plays a role in regulating sexual behavior.
Drug facts
More on Vyleesi (bremelanotide) essentials
Side effects of Vyleesi (bremelanotide)
The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.
Common Side Effects
- Nausea (40%)
- Flushing of the skin (20%)
- Injection site reactions (e.g., pain, redness, itching, bruising; 13%)
- Headache (11%)
Less Common Side Effects
- Vomiting
- Tiredness
- Dizziness
- "Pins and needles" feeling in the arms and legs
- Hot flush
- Cough
- Stuffy nose
The following Vyleesi (bremelanotide) side effects have also been reported
Side effects that you should report to your care team as soon as possible:
- Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
- Change in skin color
- Increase in blood pressure
- Slow heartbeat—dizziness, feeling faint or lightheaded, confusion, trouble breathing, unusual weakness or fatigue
Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):
Pros and cons of Vyleesi (bremelanotide)
Pros
- One of the few medications approved for low sex drive in people who haven't gone through menopause yet
- Can take when you need it (at least 45 minutes before sex)
- Less limitations for drinking alcohol than Addyi (flibanserin)
- Available by prescription from many healthcare professionals
Cons
- Must inject under the skin
- Not for low sexual desire caused by a medical or mental health condition, relationship problems, or side effects from another medication or substance
- Not proven to improve sexual performance
- Not available as a lower-cost generic
Pharmacist tips for Vyleesi (bremelanotide)
- Use Vyleesi (bremelanotide) when you need it, at least 45 minutes before sex. Don't take more than one dose in a day.
- It's common to feel nauseous after the first time you use Vyleesi (bremelanotide), but it should improve with each dose you take. The nausea usually lasts for a few hours. Stay hydrated and try ginger or peppermint to relieve your nausea. Let your prescriber know if the nausea is too bothersome.
- Talk to your prescriber if you don't notice any improvement in your sex drive after 2 months of using Vyleesi (bremelanotide). Your prescriber can suggest other ways to help improve your sex drive, like therapy.
- Tell your prescriber about all of the medications you're taking. Vyleesi (bremelanotide) can slow down how long it takes for medications to get absorbed into your body. This might affect how well certain medications work for you.
- Keep the Vyleesi (bremelanotide) autoinjectors at or below room temperature (77 degrees Fahrenheit). Be sure to protect the medication from light and don't freeze it.
How to use Vyleesi (bremelanotide):
- Before you take Vyleesi (bremelanotide), carefully read the instructions on how to properly inject the medication. Each autoinjector contains enough medication for one dose.
- Before using the Vyleesi (bremelanotide) autoinjector, check the view window to make sure the medication is clear and colorless without any solid pieces floating around. Otherwise, don't use the autoinjector. It might mean that the medication has broken down or has germs in it, and it won't be safe for you to use.
- Also check the Vyleesi (bremelanotide) autoinjector to see that the medication is in one half of the view window and part of the gray tip is in the other half. The autoinjector won't work if the view window is purple, so you'll need to use a new one if this happens.
- Inject Vyleesi (bremelanotide) into the skin on the front of your thigh or on your stomach area (2 inches away from your belly button). Make sure to choose a different area to inject the medication into every time to lower your risk for skin irritation. Also avoid injecting into skin that's sore, bruised, red, hard, or scarred.
- When you're ready to use Vyleesi (bremelanotide), take off the clear cap and use it right away. Place the purple tip flat against your skin with the view window facing you. Press down and hold the autoinjector against your skin. You'll hear a click at the start of the injection and another click after about 2 seconds. Keep holding the autoinjector against your skin for about 5 more seconds. Then, check that the view window is mostly purple; this means that you got the full dose. Lift the autoinjector off your skin.
- Throw away the Vyleesi (bremelanotide) autoinjector into a sharps disposal container right after you use it. This prevents accidental needle sticks and injury.
Common questions about Vyleesi
In general, everyone's sex drive is different. So, how long it takes for Vyleesi to work for each person can be different. This medication is given at least 45 minutes before sex. So, it might start working to improve sex drive around that time. In studies, some people noticed overall improvements in sex desire and mood after about 4 weeks of using Vyleesi as needed. Since everyone's experience is different, talk to a healthcare professional if you have questions about how long it's taking to work for you.
It's not known how long the effects of Vyleesi last after each injection. Each person can have a different experience after they use Vyleesi and each person's sex drive is different. Speak with a healthcare professional if you have questions about how long Vyleesi can help with your sex drive and mood.
It's recommended to inject Vyleesi at least 45 minutes before sex. We don't know how long it takes for Vyleesi to work for you after each injection since everyone's sex drive is different. As long as you inject Vyleesi at least 45 minutes before sex, you can adjust this time frame based on your experience with how well the medication works for you and on any side effects you might have after your first injection.
It's common to feel nauseous after your Vyleesi injection. Typically, nausea starts about 30 minutes after your injection, but it should go away in 2 hours or so. This means that you might feel nauseous while you're having sex. You can try eating or drinking something with ginger or peppermint to relieve your nausea before you have sex. Other common side effects include having flushed skin (a warm feeling of the skin and skin redness), pain or itching where you injected the medication, and sometimes headache. Let your prescriber know if you have any of these side effects and if they're too bothersome.
In clinical studies, people had significant improvements in their test scores evaluating for sex desire and related mood in as early as 4 weeks after they started taking Vyleesi as needed before sex. These improvements stayed consistent during the following 5 months of treatment. Talk to your prescriber if you don't notice any improvement in your sex drive or mood after 2 months of using Vyleesi. Your prescriber can recommend other ways to improve your sex drive, such as therapy and tips to focus on your sexuality.
Weight gain wasn't a side effect that people who took Vyleesi reported during clinical studies. Talk to a healthcare professional if you notice unusual or concerning weight gain over the course of your treatment with Vyleesi. The healthcare professional can discuss your concerns with you.
It isn't recommended to take Vyleesi if you're pregnant. Based on animal studies, this medication has a potential risk of harm to an unborn baby during pregnancy. But there's not enough data to know whether this risk applies to humans. Stop using Vyleesi if you become pregnant during treatment. It's encouraged that you enroll in the Vyleesi Pregnancy Exposure Registry by calling 1-800-972-5220 if you're pregnant and you've been taking Vyleesi. This registry helps researchers learn about the risks to your health and your baby's health when the medication is taken during pregnancy.
Vyleesi and Addyi (flibanserin) are both used to treat low sex drive in people who haven't gone through menopause yet. Vyleesi is an injection that you give to yourself under your skin when you need it before sex. On the other hand, Addyi is a pill that's swallowed every day. In addition, there are alcohol limitations you need to follow when you're taking Addyi because alcohol can heighten the medication's risk for low blood pressure and fainting. Vyleesi doesn't have this risk and alcohol limitation; in fact, the medication might make your blood pressure go up a little for several hours after you take a dose.
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Risks and warnings for Vyleesi (bremelanotide)
Vyleesi (bremelanotide) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Brief changes in blood pressure and heart rate
- Risk factors: Medical conditions affecting the heart or blood vessels (cardiovascular disease) | Uncontrolled high blood pressure
Vyleesi (bremelanotide) can briefly raise your blood pressure and lower your heart rate after each dose. In studies, these changes happened 2 to 4 hours after taking a dose of medication. Your blood pressure and heart rate should go back to usual within 12 hours after the dose.
Your prescriber might check your heart health and blood pressure before you start Vyleesi (bremelanotide). Because of these changes in blood pressure and heart rate, this medication isn't recommended for people at high risk for cardiovascular disease.
Your prescriber might periodically check your vital signs at your follow-up visits while you're taking Vyleesi (bremelanotide). Be sure to avoid taking more than one dose in a 24-hour period or more than eight doses in a month. Taking doses more often or too close together can lead to more notable rises in blood pressure.
Darkening of the skin
- Risk factors: Taking Vyleesi (bremelanotide) every day | People with dark skin
It's possible for Vyleesi (bremelanotide) to darken the color of your skin. Some areas where the skin might darken include the face, gums in your mouth, and breasts. This might happen because the medication can attach to melanocortin receptors on skin cells that produce skin color (melanocytes). This causes the color of the skin to darken.
Skin darkening is more likely to happen if you take Vyleesi (bremelanotide) every day or if you have naturally dark skin. Don't use more than 8 doses of Vyleesi (bremelanotide) per month; this might raise your risk for skin darkening. It's not known whether the color of the skin will go back to normal after you stop taking the medication. Talk to your prescriber if you take Vyleesi (bremelanotide) and notice any areas of darkened skin.
Nausea
Vyleesi (bremelanotide) can cause nausea as a side effect. Some people started feeling nauseous after about 30 minutes after an injection and then felt better about 2 hours later. Nausea most commonly happens when you take your first dose of Vyleesi (bremelanotide), and it should improve with each of your following doses.
Talk to a healthcare professional if your nausea doesn't improve with time or if it's too bothersome. They can discuss with you whether any nausea medications can help or whether you should stop taking Vyleesi (bremelanotide).
Vyleesi (bremelanotide) dosage
Typical dosage for Vyleesi (bremelanotide)
The typical dose is 1.75 mg injected under the skin as needed at least 45 minutes before sex.
Don't take more than one dose per day. And it's not recommended to take more than 8 doses per month.
Vyleesi (bremelanotide) contraindications
Contraindications are specific health conditions or situations in which a person should not take a medication due to safety concerns. If you have any of the following conditions or if any of the following apply to you, let your healthcare provider know because Vyleesi (bremelanotide) will not be safe for you to take.
- Uncontrolled high blood pressure
- Known medical condition that affects the heart or blood vessels (cardiovascular disease)
What are alternatives to Vyleesi (bremelanotide)?
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