Vyleesi Side Effects: Nausea, Hyperpigmentation & More

Hypoactive sexual desire disorder (HSDD) is a condition that can affect women, causing a persistent lack of sexual desire that isn’t due to another medical condition, relationship problems, or medication. It’s different from simply not being interested in sex as often as your partner. With HSDD, the lack of desire causes significant distress and can affect your self-esteem and relationships.

Vyleesi (bremelanotide injection) is a medication approved for treating HSDD in premenopausal women. It’s given as a subcutaneous injection, meaning you inject it just under the skin. It’s not for women who’ve gone through menopause, and it’s not for men. Also, it shouldn’t be used just to enhance sexual performance.

Like all medications, Vyleesi can cause side effects, and it’s important to understand what those potential side effects are before you start taking it. While Vyleesi can be helpful for some women, it’s crucial to be aware of the possible downsides so you can make an informed decision about whether it’s right for you.

This article will give you a comprehensive overview of Vyleesi side effects, warnings, and precautions. We’ll discuss common, less common, and serious side effects. We’ll also touch on drug interactions and situations where Vyleesi isn’t recommended.

Common Side Effects of Vyleesi

Like any medication, Vyleesi can come with side effects. It’s important to be aware of these before starting treatment, so you can manage them effectively and know when to seek medical advice.

Nausea

Nausea is one of the most common side effects reported by Vyleesi users. In clinical trials, a significant 40% of patients treated with Vyleesi experienced nausea, compared to only 1% in the placebo group. So, yeah, it’s pretty common.

The good news is that the nausea is usually mild to moderate. It tends to start soon after the injection and usually clears up within a few hours. Still, feeling queasy isn’t fun, so here’s what you can do:

  • Time your injection wisely: Consider injecting Vyleesi at a time when you’re less likely to be bothered by nausea. Maybe after dinner when you’re relaxing?
  • Try OTC remedies: Over-the-counter options like ginger supplements or anti-nausea medications might help. Check with your doctor or pharmacist before taking anything new, just to be safe.

Flushing

Flushing, that sudden redness and warmth, is another common side effect, affecting about 20% of Vyleesi users in clinical trials (compared to less than 1% in the placebo group). It’s basically like a hot flash, but not necessarily related to menopause!

Flushing involves redness of the face, neck, and upper chest, along with a feeling of warmth or heat. It can be a little uncomfortable, but here are a few tips to minimize it:

  • Avoid triggers: Steer clear of things like alcohol or spicy foods before injecting Vyleesi, as these can make flushing worse.
  • Stay cool and hydrated: Keep cool and drink plenty of water.

Headache

Headaches are another potential side effect, reported by about 11% of Vyleesi users in clinical trials (compared to 2% in the placebo group). They’re typically mild to moderate, tension-type headaches, like the kind you get from stress.

For headache relief, you can try:

  • OTC pain relievers: Over-the-counter pain relievers like acetaminophen (Tylenol) or ibuprofen (Advil) can often do the trick.
  • Rest: Find a quiet, dark room and relax. Sometimes that’s all you need!

Injection Site Reactions

Since Vyleesi is an injection, it’s not uncommon to experience some reactions at the injection site. This can include redness, swelling, pain, itching, or even bruising.

To minimize these reactions:

  • Rotate injection sites: Use a different spot each time you inject Vyleesi. This gives the previous site time to heal.
  • Proper technique: Make sure you’re using the correct injection technique. If you’re unsure, ask your doctor or pharmacist to show you.
  • Cold compress: Applying a cold compress to the injection site after administering the medication can help reduce swelling and discomfort.

Less Common and Serious Side Effects of Vyleesi

While many of Vyleesi’s side effects are mild and temporary, there are some less common but more serious side effects to be aware of.

Transient Increase in Blood Pressure and Decrease in Heart Rate

Vyleesi can potentially affect your blood pressure and heart rate. After each dose, it’s possible to experience brief increases in blood pressure and decreases in heart rate.

Clinical trials showed an average increase of 1.9 mmHg in systolic blood pressure (SBP) and 1.7 mmHg in diastolic blood pressure (DBP) after 8 days of dosing. The peak effect on SBP was an average increase of 2.8 mmHg between 4-8 hours after the dose, while DBP peaked at 2.7 mmHg between 0-4 hours. On average, heart rate decreased by 0.5 beats per minute after 8 days of dosing.

If you have pre-existing cardiovascular conditions, it’s crucial to monitor your blood pressure before and during treatment with Vyleesi. Report any persistent or severe increases in blood pressure to your healthcare provider.

Focal Hyperpigmentation

Focal hyperpigmentation, or the darkening of specific areas of the skin, is another potential side effect, particularly in individuals with darker skin tones. Clinical trials revealed that 1% of Vyleesi-treated patients (using up to 8 doses per month) experienced focal hyperpigmentation.

It’s important to regularly monitor your skin for any new or worsening areas of darkening. In some cases, hyperpigmentation may fade over time after you stop using Vyleesi. If you’re concerned about hyperpigmentation, consult a dermatologist for potential treatment options.

Acute Hepatitis

Although rare, there have been reports of acute hepatitis (inflammation of the liver) in Vyleesi users. One case involved a patient who received 10 doses of Vyleesi over a year. While a definitive link hasn’t been established, it’s essential to be aware of the possibility.

Be vigilant for symptoms of liver dysfunction, such as jaundice (yellowing of the skin and eyes), abdominal pain, and dark urine. Report any signs of liver problems to your healthcare provider immediately.

Serious Adverse Reactions

In clinical trials, 1.1% of Vyleesi-treated patients experienced serious adverse reactions, compared to 0.5% in the placebo group. While the overall incidence is low, it’s a reminder that any medication can have potential risks. It is important to weigh the benefits and risks with your doctor.

Drug Interactions and Contraindications

Like many medications, Vyleesi has the potential to interact with other drugs you may be taking. It’s crucial to understand these interactions to avoid potential complications and ensure the medication’s effectiveness.

Drug Interactions

One significant interaction to be aware of is Vyleesi’s effect on the absorption of other oral medications, similar to drug interactions seen with other substances. Specifically, Vyleesi can interfere with how your body absorbs medications taken by mouth, and this is particularly important if you’re taking naltrexone.

Naltrexone, often prescribed for alcohol or opioid dependence, relies on maintaining a certain level in your bloodstream to work effectively. Because Vyleesi can mess with how naltrexone is absorbed, it might not reach the necessary concentration to do its job. For this reason, you should avoid using Vyleesi if you’re taking oral medications that depend on having a precise, threshold concentration in your system.

To ensure your safety and the effectiveness of your medications, it’s essential to keep your healthcare provider informed about everything you’re taking. This includes not only prescription drugs but also over-the-counter medications and any herbal supplements you might be using. This information will allow your doctor to assess potential interactions and adjust your treatment plan accordingly.

Contraindications

In addition to drug interactions, certain medical conditions may make Vyleesi unsafe for you to use. These are known as contraindications, and it’s vital to be aware of them before starting treatment.

Vyleesi is contraindicated, or should not be used, in patients with uncontrolled hypertension (high blood pressure) or known cardiovascular disease. The reason for this is that Vyleesi has the potential to cause transient increases in blood pressure and other cardiovascular effects. For individuals already struggling with high blood pressure or heart problems, these effects could be dangerous and exacerbate their existing conditions.

Warnings and Precautions: A Deeper Dive

Like any medication, Vyleesi comes with warnings and precautions that you should be aware of. Let’s explore some key considerations:

Use in Specific Populations

Pregnancy Considerations

Vyleesi is not recommended for use during pregnancy.

Animal studies have suggested the potential for fetal harm, so women should definitely use effective birth control while taking Vyleesi. If you think you may be pregnant, stop using Vyleesi immediately and let your doctor know.

There’s a pregnancy exposure registry for women who use Vyleesi during pregnancy, so your doctor may want to enroll you.

Lactation Considerations

Researchers haven’t studied Vyleesi’s effects on breastfeeding or lactation in humans, so there’s limited data available. Talk with your doctor about the potential risks and benefits before using Vyleesi while breastfeeding.

Renal Impairment

If you have kidney problems, Vyleesi may not be right for you. Some studies show that bremelanotide exposure (AUC) increased:

  • 1.2-fold in mild renal impairment
  • 1.5-fold in moderate renal impairment
  • 2-fold in severe renal impairment

Your doctor may advise you to use Vyleesi with caution if you have renal impairment.

Hepatic Impairment

Similarly, if you have liver problems, Vyleesi may not be right for you. Studies show that bremelanotide exposure (AUC0-inf) increased:

  • 1.2-fold in mild hepatic impairment
  • 1.7-fold in moderate hepatic impairment

Your doctor may advise you to use Vyleesi with caution if you have hepatic impairment.

Frequently Asked Questions

Is Vyleesi better than Addyi?

That’s a tough question! Vyleesi and Addyi are both used to treat hypoactive sexual desire disorder (HSDD) in premenopausal women, but they work differently and have different side effect profiles. Some women may find Vyleesi more effective because it’s taken as needed, while others may prefer Addyi’s daily dosing. It really depends on the individual.

Is Vyleesi similar to Viagra?

Not really. While both Vyleesi and Viagra address sexual dysfunction, they work in completely different ways. Viagra enhances blood flow to the genitals, while Vyleesi affects brain receptors linked to sexual desire. They also target different populations, with Viagra used by men and Vyleesi specifically for premenopausal women with HSDD.

How long does it take for Vyleesi to start working?

Vyleesi is designed to work relatively quickly. You inject it about 45 minutes before you anticipate sexual activity. However, it might take up to eight weeks of regular use to determine if it’s truly effective for you.

What are 5 drugs to avoid in the elderly?

That’s a great question for your doctor or pharmacist! Drug interactions can be tricky, especially as we age. Some medications that might pose risks for older adults include certain antihistamines, sedatives, and NSAIDs. Always double-check with a healthcare professional about medication safety, especially for seniors.

How does Vyleesi make you feel?

Experiences can vary, but some women report feeling increased sexual desire after taking Vyleesi. Common side effects include nausea, flushing, and headache. It’s important to be aware of potential side effects and discuss any concerns with your doctor.

Wrapping Up

Vyleesi, like any medication, has the potential for side effects. Some, like nausea, flushing, and headache, are more common. Others, like changes in blood pressure and hyperpigmentation, are less frequent but require careful monitoring.

It’s important to be aware of these potential adverse reactions before starting Vyleesi. Keep the lines of communication open with your healthcare provider. If you have any concerns or experience any side effects, don’t hesitate to discuss them with your doctor. They can help you determine if Vyleesi is still the right choice for you and manage any side effects that may arise.

Regular blood pressure checks are crucial while taking Vyleesi. Also, pay close attention to your skin. Note any new or unusual darkening, as hyperpigmentation can occur. Report any significant changes to your doctor.

Vyleesi can be a helpful treatment for HSDD when used responsibly and under the guidance of a healthcare professional. Informed decision-making is key. By understanding the potential benefits and risks, communicating openly with your doctor, and monitoring yourself for side effects, you can make the most of Vyleesi and improve your sexual well-being. If you are experiencing concerning side effects, you should seek medical attention.

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