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The medication Imcivree (setmelanotide) has several important safety warnings that users should be aware of. It is crucial to understand these risks and discuss any concerns with your healthcare provider. Below are the key warnings associated with this medication:

• Sexual Function Issues: Some individuals may experience sexual problems, including unexpected penile erections in males and unwanted sexual arousal in females. If these occur, consult your prescriber. Seek immediate medical assistance if an erection lasts longer than four hours, as this could lead to permanent damage.

• Mental Health Concerns: Imcivree (setmelanotide) may cause or exacerbate depression and suicidal thoughts or behaviors. Notify your prescriber promptly if you or those around you observe any mood or behavior changes or if you have thoughts of self-harm. Patients with a history of depression or suicidal thoughts are at a higher risk and may need to discontinue the medication.

• Allergic Reactions: Although uncommon, allergic reactions can occur, usually within minutes to hours after an injection. Symptoms like difficulty breathing, throat tightness, or swelling of the face or tongue require immediate medical attention.

• Skin Darkening (Hyperpigmentation): This medication may cause darkening of the skin or moles, which typically resolves after discontinuation. Regular full-body skin examinations by your healthcare provider are recommended before and during treatment to monitor for new skin spots.

• Serious Risks to Newborns and Low Birth Weight Infants: The preservative benzyl alcohol in Imcivree (setmelanotide) can cause severe, life-threatening reactions in newborns, such as "gasping syndrome," which impacts brain function, blood acidity, and breathing. Therefore, this medication should not be used in newborns or young infants.

Always consult with your healthcare provider for personalized medical advice and before making any changes to your medication regimen.

When taking this medication, some common side effects may include mild reactions at the injection site, such as redness, itching, swelling, or pain. Additionally, you might experience skin discoloration, nausea, headache, diarrhea, stomach pain, back pain, tiredness, vomiting, and unplanned penile erections. Though these effects are generally mild, consult your healthcare provider if they persist or worsen.

Other side effects that have been noted include joint pain, weakness, dizziness, dry mouth, dry skin, trouble sleeping, vertigo, hair loss, chills, constipation, flu-like symptoms, muscle spasms, pain in your arms or legs, and rash. It's advisable to inform your healthcare provider if you encounter any of these symptoms.

Certain side effects are rare but serious and warrant immediate medical attention. These include severe depression, suicidal thoughts, and prolonged erections lasting more than four hours. Additionally, a severe allergic reaction may occur, characterized by trouble breathing, swallowing difficulties, a rapid heartbeat, or swelling of the face, lips, tongue, or throat. If you experience any of these severe symptoms, seek urgent medical care. Always stay informed about potential side effects and communicate any concerns with your healthcare provider.