Setmelanotide U.S. label context · version 1
This page preserves this version's wording and source pins. Open the current profile →
What does the U.S. product label say?
Imcivree · Read September 15, 2026 · Preserved label summary 1
Which population and use does the label cover?
The label covers acquired hypothalamic obesity from age four, and Bardet-Biedl syndrome or specified genetically confirmed POMC, PCSK1 or LEPR deficiency from age two. It explicitly excludes general polygenic obesity and specified benign genetic variants. Label: 1 ↗
Which safety limits matter?
Warnings address sexual-arousal effects, depression or suicidal ideation, serious hypersensitivity, pigmentary changes and new or darkened nevi. For acquired hypothalamic obesity, the label adds acute adrenal insufficiency and, with central diabetes insipidus, sodium imbalance. Label: 4, 5 ↗
Label edition and source pins
U.S. product labeling hosted by the National Library of Medicine. This account concerns this product and label edition; other formulations and jurisdictions require their own records.
IMCIVREE (setmelanotide) solution · SPL version 14 · published 2026-04-02
Label ZIP SHA-256: 3a9024abc434e828923d30e4f860e834f3887ceece2a7a47cdc1c8828105e6f1. Extracted XML SHA-256: b144f343fa74b6d436776a8f7fcb548db348e1c7ffcc8e567930b96cd3b1b812.