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afamelanotide

Scenesse · ATC code D02BB02

Also known as: Afamelanotid

Key facts
Active substance
afamelanotide
Drug class
Moisturizer
ATC code
D02BB02
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
SCENESSE 16 mg implant
Marketing authorisation holder
Clinuvel Europe Limited
Information as of
2026-10-27

Key facts

Afamelanotide is a melanocortin receptor agonist (oligopeptide) given as an implant to prevent phototoxicity in adults with erythropoietic protoporphyria (EPP).

What it is used for

  • Prevention of phototoxicity in adult patients with erythropoietic protoporphyria (EPP)

Dosing

  • Scenesse 16 mg implant: one implant every 2 months prior to expected and during increased sunlight exposure, inserted subcutaneously above the supra-iliac crest
  • Prescribed only by specialists in recognised porphyria centres; inserted only by physicians trained and accredited by the marketing authorisation holder
  • Overall treatment duration is at the specialist's discretion
  • Elderly: use not recommended due to limited data; safety and efficacy in children and adolescents not established
  • Patients are observed for 30 minutes after insertion for immediate-type hypersensitivity

Contraindications

  • Hypersensitivity to the active substance or any excipient
  • Severe hepatic disease
  • Hepatic impairment
  • Renal impairment

Important warnings

  • Uncommon hypersensitivity reactions including anaphylaxis; medical support must be available, the implant removed if needed and treatment discontinued
  • Patients with unstudied concomitant disorders (e.g. gastrointestinal, cardiovascular, endocrine, neurological, haematological) should be treated only after careful decision and monitored after each implant
  • Usual sun protection measures should be maintained during treatment
  • Regular skin monitoring is required (details in the full text)

Side effects

  • Most common: nausea (approximately 19%), headache (20%) and implant site reactions (21%; mainly discolouration, pain, haematoma, erythema), mostly mild
  • Uncommon hypersensitivity reactions including anaphylaxis
  • Other reported reactions include upper respiratory tract infection, melanocytic naevus and appetite changes

Interactions

  • No specific interaction studies have been performed
  • Substances that reduce coagulation (e.g. vitamin K antagonists such as warfarin, acetylsalicylic acid, NSAIDs) may increase bruising or bleeding at the implantation site

Pregnancy and breastfeeding

  • Should not be used during pregnancy; women of childbearing potential must use effective contraception during treatment and for three months thereafter
  • Unknown whether afamelanotide is excreted in breast milk; no clinical data in breastfeeding women

Summary of the official product information, written with AI (Claude, Anthropic) on 2026-10-28. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

Full official text →

Common questions – ask Medelix

For patients

Package leaflet, verbatim

Package leaflet for patients →

Authorisation and brand names by country

Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.

EU – centrally authorised (all member states)

  • ScenesseClinuvel Europe Limited · EMEA/H/C/002548

Source: European Medicines Agency (EMA), product information

Brand names in 3 more European countries
Iceland
Scenesse
Liechtenstein
Scenesse
Norway
Scenesse

EMA – Article 57 product data (EU/EEA), 2026-10-28

Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.

Another question about this substance?

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Sources

  1. European Medicines Agency. Scenesse – EPAR, Product Information (OF THE TEXT Detailed information on this medicinal product i). 2026-10-27. https://www.ema.europa.eu/en/documents/product-information/scenesse-epar-product-information_en.pdf
  2. Wikidata (CC0): ATC D02BB.

Editorial: Medelix editorial team · last updated 2026-10-27 · How these pages are made · Report an error

Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.