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This document outlines essential safety information and warnings about the use of Vyleesi (bremelanotide). Please read these carefully and discuss any concerns with your healthcare provider.

• Blood Pressure and Heart Rate Fluctuations: Vyleesi can temporarily increase blood pressure and decrease heart rate, typically within 2 to 4 hours of administration. These effects usually resolve within 12 hours. Individuals with cardiovascular disease or uncontrolled high blood pressure should exercise caution.

• Skin Darkening: The medication may cause skin darkening, particularly on the face, gums, and breasts, due to its action on melanocortin receptors. This effect is more likely with daily use or in individuals with naturally darker skin tones.

• Nausea: Nausea is a common side effect, often occurring about 30 minutes post-injection and easing after approximately 2 hours. This side effect tends to lessen with subsequent doses.

Contraindications:

• Avoid use if you have uncontrolled high blood pressure.
• Refrain from use if you have a known cardiovascular disease.

Please consult your healthcare provider if you fall under any of these categories to determine the suitability of Vyleesi for your condition.

When taking this medication, you might experience some common side effects such as nausea, which occurs in about 40% of users, as well as skin flushing, headache, and reactions at the injection site like redness or pain. These side effects are generally mild and temporary but should be reported to your healthcare provider if they persist or worsen. Additionally, some people may experience vomiting, tiredness, dizziness, or a "pins and needles" sensation in the arms and legs. Minor symptoms like a stuffy nose, hot flush, or cough might also occur.

More serious side effects are rare but require immediate medical attention. These include severe allergic reactions, characterized by rash, itching, swelling of the face, lips, tongue, or throat, and breathing difficulties. A change in skin color, particularly in those with darker skin tones, and potential darkening of areas like the face, gums, and breasts, may occur, though it is unknown if this is permanent. An increase in blood pressure and a decrease in heart rate are possible, typically subsiding within 12 hours post-injection. If you feel dizzy, lightheaded, or unusually weak, or experience confusion or difficulty breathing, seek urgent care.

Always monitor your condition and consult your healthcare provider with any concerns or if you notice other effects not listed here.