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IMCIVREE

IMCIVREE is indicated for chronic weight management in adult and pediatric patients with syndromic obesity, when other weight loss products have failed you.

How is Imcivree (setmelanotide) taken?

The standard dosage is:[1]
• Starting dose:
◦ For most people 12 years and older: 2 mg per day for 2 weeks.
◦ For people between the ages of 6 and 12: 1 mg per day for 2 weeks.

Limitations of Use

IMCIVREE is not indicated for the treatment of patients with the following conditions as IMCIVREE would not be expected to be effective:
• Other types of deceases not related weight loss or FDA-approved indications for IMCIVREE, including obesity associated with other genetic syndromes and general (polygenic) obesity

WARNINGS AND PRECAUTIONS

Disturbance in Sexual Arousal: Firstly, Spontaneous penile erections in males and sexual adverse reactions in females have occurred.

Depression. Secondly, Consider discontinuing IMCIVREE if patients experience clinically significant or persistent depression symptoms.

Furthermore, Skin Pigmentation and Darkening of Pre-existing Nevi: Generalized increased skin pigmentation and darkening of pre-existing nevi have occurred. Perform a full body skin examination prior to initiation and periodically during treatment to monitor pre-existing and new pigmentary lesions.

ADVERSE REACTIONS

• Most common adverse reactions included skin hyperpigmentation, injection site reactions, nausea, headache, diarrhea, abdominal pain, vomiting, depression, and spontaneous penile erection

USE IN SPECIFIC POPULATIONS

Treatment with IMCIVREE is not recommended when breastfeeding. Discontinue IMCIVREE when pregnancy is recognized unless the benefits of therapy outweigh the potential risks to the fetus.