FDA LABEL RECORD
SCENESSE
AFAMELANOTIDE. FDA prescribing information for this product, as published on the retrieval date below.
AS THE LABEL RECORDS IT
Product details
| Brand name | SCENESSE |
|---|---|
| Generic name | AFAMELANOTIDE |
| Labeller | CLINUVEL INC. |
| Route | SUBCUTANEOUS |
| Label version | 11 |
| Effective | 2026-05-11 |
| Retrieved by this site | 2026-10-03 |
| Full label | https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=94f53286-11dd-7fbb-e053-2a95a90a7c48 |
INDICATIONS AND USAGE
Quoted from the FDA label
SCENESSE ® is indicated to increase pain free light exposure in adult patients with a history of phototoxic reactions from erythropoietic protoporphyria (EPP). SCENESSE is a melanocortin 1 receptor (MC1-R) agonist indicated to increase pain free light exposure in adult patients with a history of phototoxic reactions from erythropoietic protoporphyria (EPP)
What this page is
A reproduction of a public FDA label record. Everything quoted above is the labeller's wording as published by the FDA, not this site's. Nothing here is regulatory, legal or medical advice, and a label being reproduced says nothing about whether a product is available in any particular country. Labels are revised often; the retrieval date above says when this copy was taken, and the full current label is at the link.
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