Afamelanotide is a prescription medicine indicated to increase pain free light exposure in adult patients with a history of phototoxic reactions from erythropoietic protoporphyria (EPP). It is available as implants for subcutaneous use. MedsAcross supplies Afamelanotide for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
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)
Source: US FDA prescribing information
Afamelanotide is a synthetic tridecapeptide and a structural analog of α-melanocyte stimulating hormone (α-MSH). Afamelanotide is a melanocortin receptor agonist and binds predominantly to MC1-R. Pharmacodynamics Afamelanotide increases production of eumelanin in the skin independently of exposure to sunlight or artificial UV light sources. Pharmacokinetics The pharmacokinetics of afamelanotide following administration of a single subcutaneous implant of SCENESSE were evaluated in 12 healthy adults. High variability was observed in the plasma concentrations of afamelanotide and for most subjects (9 out of 12), the last measurable afamelanotide concentration was at 96 hours post-dose. The mean ± SD C max and AUC 0-inf were 3.7 ± 1.3 ng/mL and 138.9 ± 42.6 hr*ng/mL, respectively. Absorption The median T max was 36 hr.
Source: US FDA prescribing information
Important Dosage and Administration Information SCENESSE should be administered by a health care professional. All healthcare professionals should be proficient in the subcutaneous implantation procedure and have completed the training program provided by CLINUVEL prior to administration of the SCENESSE implant. Additional information, including a video, is available at http://www.clinuvel.com/US-HCP. The additional information has not been evaluated or approved by the FDA. Insert a single SCENESSE implant subcutaneously above the anterior supra-iliac crest every 2 months. Use the SFM Implantation Cannula to implant SCENESSE. Maintain sun and light protection measures during treatment with SCENESSE to prevent phototoxic reactions related to EPP.
Source: US FDA prescribing information
SCENESSE is contraindicated in patients with a history of severe hypersensitivity reaction to afamelanotide or to any of the excipients in SCENESSE. Known hypersensitivity to afamelanotide or to any of the excipients in SCENESSE.
Source: US FDA prescribing information
Hypersensitivity Skin Monitoring Serious hypersensitivity reactions, including anaphylaxis, have been reported with postmarket use of SCENESSE. Warn patients of the risk of hypersensitivity reactions, including anaphylaxis. If a serious hypersensitivity reaction occurs, initiate appropriate therapy and remove the SCENESSE implant if needed. The patient should not receive any further treatment with SCENESSE. SCENESSE may lead to generalized increased skin pigmentation and darkening of pre-existing nevi and ephelides because of its pharmacologic effect. A full body skin examination (twice yearly) is recommended to monitor pre-existing and new skin pigmentary lesions. Hypersensitivity: Serious hypersensitivity reactions, including anaphylaxis, have been reported. Skin Monitoring: May induce darkening of pre-existing nevi and ephelides due to its pharmacological effect.
Source: US FDA prescribing information
Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of SCENESSE was evaluated in 3 randomized, multicenter, prospective, vehicle controlled clinical trials (Study CUV029, Study CUV030, and Study CUV039) involving 244 adult subjects with erythropoietic protoporphyria (EPP) without significant liver involvement. Subjects received subcutaneous SCENESSE implants containing 16 mg of afamelanotide every 2 months. A total of 125 subjects received SCENESSE and 119 subjects received vehicle implants. Table 1 summarizes the adverse reactions that occurred in more than 2% of subjects.
Source: US FDA prescribing information
Store in a refrigerator at 2°C – 8°C (36°F-46°F). Protect from light.
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
1 presentations of Afamelanotide, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Scenesse 16 mg/16 mg implantSubcutaneous Cold chain | Clinuvel | US FDA | Available on request |
1 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
Yes, on request. MedsAcross lists 1 presentations of Afamelanotide and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Afamelanotide, including Scenesse.
Yes. The US FDA first approved Afamelanotide on 8 October 2019, according to Drugs@FDA.
Yes. Afamelanotide has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.
At least one listed presentation of Afamelanotide must be kept cold, so it is shipped in temperature-controlled packaging. Check the storage line on each presentation.
Afamelanotide is classified under ATC code D02BB02 (Afamelanotide).
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