What to Know About Vyleesi (Bremelanotide Injection)

Vyleesi is an injectable medication used to help women who have low sexual desire before they reach menopause. It is used when hypoactive sexual desire disorder does not have a known cause and is causing significant distress. Vyleesi is injected under the skin of the stomach or the thigh at least 45 minutes before a woman is planning to have sex. The injection activates the melanocortin receptors, but scientists do not know how that leads to improved sexual desire. In clinical trials, Vyleesi was shown to be more effective than a placebo injection at improving sexual desire and reducing distress associated with sex. It did not increase the number of satisfying sexual events or affect sexual performance.

Vyleesi was initially approved by the U.S. Food and Drug Administration (FDA) on June 21, 2019.

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Uses

Vyleesi is approved for the treatment of acquired, generalized hypoactive sexual desire disorder (HSDD) in women who have not yet reached menopause. This means that it is for women who have previously had a more satisfying level of sexual desire in the past but who now experience low sexual desire.

The lack of sexual desire should not be related to the situation, the activity, or the sexual partner. Instead, it is a treatment for women who have experienced an overall decline in their ability to feel sexual desire and who find that distressing.

It is not for women whose low sexual desire is caused by:

• A medical condition, such as high blood pressure
• A psychiatric condition, such as depression or anxiety
• Relationship problems with an intimate partner
• Side effects of medication
• Side effects of alcohol or other substances

This medication should not be used by women who have gone through menopause. It should also not be used by men.

Vyleesi is not a sexual performance-enhancing drug and should not be taken for that purpose. It’s intended use is to enhance desire and/or reduce distress associated with low desire.

Before Taking

If you think that Vyleesi might be helpful for you, it’s important to talk to a qualified medical professional.

Before prescribing Vyleesi, your healthcare provider will need to evaluate you for HSDD. She will also need to determine whether your low sexual desire could be caused by something else going on in your life. For example, you may have been prescribed a medication that affects sexual desire, or be experiencing significant stress at home or at work which could also be affecting your desire for sex.

Finally, your healthcare provider will need to assess your overall health and sexual history. The first is to determine whether you have any contraindications for taking Vyleesi. The second is to make certain you’ve experienced sexual desire in the past. A lifelong lack of sexual desire is not an indication for Vyleesi.

However, if you would feel more comfortable with a friend or partner present, let your healthcare provider know. It’s important to be upfront about your needs.

Precautions and Contraindications

Vyleesi should not be prescribed to anyone who has uncontrolled hypertension (high blood pressure) or any known cardiovascular disease. This is because after Vyleesi is injected, blood pressure increases and heart rate declines for several hours after the dose.

Both blood pressure and heart rate usually return to their usual values within 12 hours. However, this is one reason why the medication should not be used more than once in any 24 hours.

Vyleesi is not recommended for use in pregnant women. Although a few women became pregnant while using Vyleesi in clinical trials, there is not enough information to determine that using the drug during pregnancy is safe. Therefore, women using Vyleesi should plan on using an effective form of contraception if their sexual activity puts them at risk of pregnancy.

Finally, individuals with severe kidney (eGFR <30mL/min/1.73 m^2) and/or liver disease (Child-Pugh C, score 10-15) should be counseled carefully before using Vyleesi. Both groups of people are at increased risk of side effects such as nausea and vomiting. Those side effects may also be more severe.

Other Melanocortin Receptor Agonists

There are very few other drugs in this class. None have been approved by the FDA.

In Europe, a melanocortin receptor agonist marketed as Scenesse (melanotan) is used to prevent skin damage in people with certain types of skin disease (erythropoietic protoporphyria) that increase their risk of sun damage.

Dosage

According to the manufacturer, Vyleesi is prescribed as a pre-filled syringe (needle) with an auto-injector. Each syringe contains a single dose of 1.75 milligrams (mg) of bremelanotide in 0.3 milliliters (ml) of solution. The injection is given under the skin of the thigh or abdomen, and each syringe should only be used once.

How to Take and Store

The ideal time to administer a Vyleesi injection may vary. It is recommended that the injection take place at least 45 minutes prior to when you expect you’ll be engaging in sexual activity.

You should not inject Vyleesi more than once every 24 hours. In addition, you should not take more than eight doses per month. If after eight weeks of occasional use your symptoms have not improved, you should stop using Vyleesi.

All listed dosages are according to the drug manufacturer. Check your prescription and talk to your healthcare provider to make sure you are taking the right dose for you.

Vyleesi should not be used if there is any cloudiness, discoloration, or particulate matter in the syringe. Vyleesi should be stored below 77 degrees Fahrenheit and protected from light. It should not be frozen.

Side Effects

Vyleesi has the potential to cause a number of side effects, particularly with more frequent use.

Common

Approximately two out of every five women who took Vyleesi reported experiencing nausea. It was not uncommon for women to need an anti-emetic (anti-vomiting) drug when taking Vyleesi. However, nausea was much less common after the second dose.

Other common side effects include:

• Injection site reactions
• Flushing
• Headache
• Vomiting
• Cough
• Fatigue
• Dizziness

Another side effect of Vyleesi is an increase in blood pressure and a decrease in heart rate. This can last for up to twelve hours. Because of this, individuals with high blood pressure or cardiovascular disease should not take Vyleesi.

Finally, a condition known as focal hyperpigmentation can occur. This involves darkening of the face, gums, and breasts.

Hyperpigmentation is more common in individuals who already have dark skin. It may be permanent. Therefore, if you experience hyperpigmentation, you should consider stopping Vyleesi treatment. Hyperpigmentation was also more common in women who used more than eight doses a month, which is why a maximum of eight monthly doses is recommended.

Warnings and Interactions

Vyleesi affects the rate at which the stomach empties. This, in turn, can affect how oral medications are absorbed into the body.

You should avoid taking Vyleesi if you are taking any medications where you need to have a minimum level of absorption for the drug to be effective, such as an antibiotic. Vyleesi should also be stopped if it alters the efficacy of other medications in a noticeable way⁠—such as by delaying pain relief.

Vyleesi should not be taken if you are receiving oral naltrexone. Naltrexone is a treatment for alcohol and opioid dependence. However, taking Vyleesi while using naltrexone can reduce naltrexone’s effectiveness. This may increase the risk of a relapse.

Dealing with Fear of Self-Injection

Many people are nervous about getting injections, let alone giving one to themselves. This nervousness may become worse if they experience side effects from the injection.

With Vyleesi, it’s important to know that the most common side effect⁠—nausea⁠—gets better with time. Therefore, that aspect of giving yourself an injection should also get easier with time.

As for dealing with more general needle nerves, it’s important to relax and give yourself time to do it right. For some people that means taking the time to read the instructions carefully before they give themselves each injection. For others, it means making the decision to inject, cleaning their skin, and giving the injection as soon as their skin is dry.

Other things that will make it easier to inject yourself with Vyleesi include:

• Practice breathing exercises to help you relax.
• Remember to always wait for your skin to air dry after wiping it with alcohol. This can reduce the sting.
• Switch sides each time you give yourself the injection. That way you won't be injecting into a place that already hurts.
• Make certain you’re injecting into skin that is healthy, not sore, bruised, or irritated. 
• Lift the autoinjector straight off your skin after the injection is done, trying not to turn or tilt it.

Just remember, injecting yourself only gets easier with time. And the nice thing about Vyleesi is that it comes in an autoinjector. That takes a lot of the difficulty out of giving yourself a shot.

With an autoinjector, as long as you follow the instructions, you should be able to give yourself the medication correctly. There is no need to worry about pinching up skin to inject in the correct place. If the injector is positioned correctly on your thigh or stomach, the medication will go in where it’s supposed to go.