Scenesse Approval History
Reviewed by J.Stewart BPharm Last updated on Oct 14, 2019.
FDA Approved: Yes (First approved October 8, 2019)
Brand name: Scenesse
Generic name: afamelanotide
Dosage form: Implant
Company: Clinuvel Pharmaceuticals Ltd.
Treatment for: Prevention of Phototoxicity in Erythropoietic Protoporphyria
Scenesse (afamelanotide) is a selective agonist of the melanocortin 1 receptor (MC1R) indicated for the prevention of phototoxicity in adult patients with erythropoietic protoporphyria (EPP).
- Scenesse is a subcutaneous implant administered every two months by a healthcare professional proficient in the subcutaneous implantation procedure.
- Patients should maintain sun protection measures during treatment with Scenesse to prevent phototoxic reactions related to erythropoietic protoporphyria.
- Scenesse may induce skin darkening, and a full body skin examination is recommended twice a year.
- Patients should monitor the implant insertion site and report any reactions to their healthcare provider.
- Common side effects include implant site reaction, nausea, oropharyngeal pain, cough, fatigue, dizziness, skin hyperpigmentation, somnolence, melanocytic nevus, respiratory tract infection, non-acute porphyria, and skin irritation.
Development History and FDA Approval Process for Scenesse
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