Afamelanotide

Preview FDA label, CLINUVEL INC., subcutaneous, effective 2026-05-11. Full label on DailyMed

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From MedlinePlus, U.S. National Library of Medicine

Quoted from the FDA label. Product labels differ by manufacturer and change over time; confirm against the label for the product you are using. Not yet reviewed by a ClinDose pharmacist.

Dosing in kidney impairment

This label has no separate kidney-impairment dosing section. Check warnings and clinical pharmacology in the full label.

Contraindications

CONTRAINDICATIONS 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 .

Supply and cost

Drug shortage status

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Source: FDA Drug Shortages Database via openFDA

Recalls (last 24 months)

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Source: FDA Enforcement Reports via openFDAFDA recalls and safety alerts

Therapeutic equivalence (Orange Book)

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Source: FDA Orange Book data filesSearch the Orange Book

Price ladder

Not the price at the counter
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These are not what a patient pays at the pharmacy counter. They are what pharmacies, health plans, and government buyers pay, before manufacturer rebates. A patient's cost depends on their insurance (copay, coinsurance, or deductible) or the pharmacy's cash price.

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