Is Bremelanotide approved by the FDA?
Yes, bremelanotide, marketed under the brand name Vyleesi, is FDA approved. The FDA granted approval for bremelanotide on June 21, 2019. This medication is specifically indicated for the treatment of acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women.
What is Bremelanotide?
Bremelanotide is a medication used to address low sexual desire in women who have not gone through menopause and do not have low sexual desire due to other causes such as relationship issues, health problems, mental illness, or the use of certain medications. It belongs to the drug class known as melanocortin receptor agonists.
How is Bremelanotide Administered?
Bremelanotide is available as a subcutaneous injection, typically administered at a dosage of 1.75 mg. The injection should be given at least 45 minutes before anticipated sexual activity. The use of bremelanotide should not exceed one dose within a 24-hour period or eight doses within a month.
Common Side Effects
The use of bremelanotide can lead to several side effects. Common ones include:
- Nausea and vomiting
- Flushing
- Headache, tiredness, dizziness
- Cough, stuffy nose
- Reactions at the injection site such as pain, bruising, redness, itching, or bleeding
Serious side effects may also occur, such as severe nausea, slow heartbeats, and high blood pressure. Patients should seek medical attention if these occur.
Precautions and Warnings
Bremelanotide should not be used by individuals with certain medical conditions, including heart disease or uncontrolled high blood pressure. It is also not recommended for use by postmenopausal women or men, and it is not intended to enhance sexual performance.
Women using bremelanotide should use effective birth control to prevent pregnancy, as the medication can harm an unborn baby. Additionally, it is advised to avoid breastfeeding while using this medication.
Drug Interactions
Bremelanotide can interact with other medications, potentially affecting how the body absorbs drugs taken orally. Patients should inform their healthcare providers about all medications they are currently taking, including prescription, over-the-counter, vitamins, and herbal products.
Conclusion
Bremelanotide (Vyleesi) was approved by the FDA on June 21, 2019, for treating acquired, generalized HSDD in premenopausal women. This medication offers a new option for women experiencing distressing low sexual desire, provided it is not related to other medical, psychological, or relational issues. As with any medication, it is crucial to follow the prescribed guidelines and consult healthcare providers for any concerns or adverse effects.
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