Bremelanotide

Bremelanotide is a prescription medication used for treating the symptoms of Hypoactive Sexual Desire Disorder. 

• Bremelanotide is available under the following different brand names: Vyleesi

Adult dosage

Prefilled autoinjector

• 1.75 mg /0.3 mL (single dose)

Hypoactive Sexual Desire Disorder

Adult dosage

• 1.75 mg Subcutaneous as needed, at least 45 minutes before anticipated sexual activity
• Do not administer the above 1 dose per 24 hours
• Above 8 doses/month is not recommended

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

Common side effects of Bremelanotide include:

• nausea,
• vomiting,
• flushing,
• redness, irritation, or pain at the injection site,
• darkening of the skin (face, gums, and breast),
• headache, and
• dizziness

Serious side effects of Bremelanotide include:

• hives,
• difficulty breathing,
• swelling of the face, lips, tongue, or throat,
• temporary increase in blood pressure,
• decrease in heart rate, and
• severe dizziness

Rare side effects of Bremelanotide include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheartedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Bremelanotide has severe interactions with no other drugs.
• Bremelanotide has serious interactions with at least 50 other drugs.
• Bremelanotide has moderate interactions with no other drugs.
• Bremelanotide has minor interactions with no other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• Uncontrolled hypertension
• Known cardiovascular disease

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Bremelanotide?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Bremelanotide?”

Cautions

• Most reported adverse reaction was nausea, which improves for most patients with the second dose; consider discontinuing treatment for persistent or severe nausea or initiating antiemetic therapy in patients who are bothered by nausea but are continuing treatment
• Focal hyperpigmentation
  • Focal hyperpigmentation, including involvement of the face, gingiva, and breasts, was reported
  • Patients with dark skin were more likely to develop focal hyperpigmentation
  • Resolution of focal hyperpigmentation was not confirmed in all patients after discontinuation
  • Consider discontinuing treatment if hyperpigmentation develops
• Increased blood pressure and heart rate reduction
  • Transient increase in blood pressure and reduction in heart rate may occur after each dose
  • Blood pressure and heart rate returned to baseline usually within 12 hours post-dose
  • No additive effects were seen for blood pressure or heart rate the following repeat daily dosing 24 hours apart for up to 16 days
  • Before initiating treatment, and periodically during treatment, consider the patient’s cardiovascular risk and ensure blood pressure is well-controlled
• Drug interactions overview
  • Effect of bremelanotide on other drugs
  • Administration may slow gastric emptying and thus potentially reducing the rate and extent of absorption of concomitantly administered oral medications
  • Avoid use when taking concomitant oral drugs that are dependent on threshold concentrations for efficacy (e.g., antibiotics)
  • Consider discontinuing treatment if there is a delayed drug effect of concomitant oral medications when a quick onset of drug effect is desired (e.g., drugs for pain relief such as indomethacin)
• Naltrexone
  • Avoid use with an orally administered naltrexone-containing product that is intended to treat alcohol and opioid addiction, owing to the severe consequence of naltrexone treatment failure

Pregnancy and Lactation

Few pregnancies in women exposed to bremelanotide in clinical trials are insufficient for determining whether there is a drug-associated risk for major congenital disabilities, miscarriage, or adverse maternal or fetal outcomes

• Pregnancy exposure registry
  • The pregnancy exposure registry monitors pregnancy outcomes in women exposed to bremelanotide during pregnancy
  • Encourage women exposed to drugs to register in the Vyleesi pregnancy exposure registry at (877) 411-2510
• Contraception
  • Not recommended during pregnancy
  • Females of reproductive potential: Use effective contraception during treatment; discontinue treatment if pregnancy is suspected
• Lactation
  • There is no information on the presence of bremelanotide or its metabolites in human milk, the effects on the breastfed infant, or the effects on milk production
  • Consider developmental and health benefits of breastfeeding along with the mother’s clinical need for the drug and any potential adverse effects on the breastfed infant from the drug or the underlying maternal condition