Afamelanotide 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?
Scenesse · Read September 15, 2026 · Preserved label summary 1
Which population and use does the label cover?
The cited implant label covers increased pain-free light exposure in adults with erythropoietic protoporphyria and a history of phototoxic reactions. This is not a general tanning or cosmetic indication. Label: indications and usage ↗
Which safety limits matter?
The label contraindicates severe hypersensitivity and reports postmarketing anaphylaxis. It also describes increased pigmentation and darkening of existing skin lesions, with skin monitoring addressed in the warnings. Label: contraindications, warnings and precautions ↗
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.
SCENESSE (afamelanotide) implant · SPL version 11 · published 2026-05-13
Label ZIP SHA-256: 2524c0069e687a8d327718fa17678071dd3c817a42624f569870344888f34e29. Extracted XML SHA-256: d58fc4df343aa1a49a633ed2fbfb46eb5cc94ec6d9e059a4e1d86d4dd1f43397.