Afamelanotide (Topical)

Class: Skin and Mucous Membrane Agents, Miscellaneous
Chemical Name: (4S)-4-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-acetamido-3-hydroxypropanoyl]amino]-3-(4-hydroxyphenyl)propanoyl]amino]-3-hydroxypropanoyl]amino]hexanoyl]amino]-5-[[(2S)-1-[[(2R)-1-[[(2S)-1-[[(2S)-1-[[2-[[(2S)-6-amino-1-[(2S)-2-[[(2S)-1-amino-3-methyl-1-oxobutan-2-yl]carbamoyl]pyrrolidin-1-yl]-1-oxohexan-2-yl]amino]-2-oxoethyl]amino]-3-(1H-indol-3-yl)-1-oxopropan-2-yl]amino]-5-carbamimidamido-1-oxopentan-2-yl]amino]-1-oxo-3-phenylpropan-2-yl]amino]-3-(1H-imidazol-4-yl)-1-oxopropan-2-yl]amino]-5-oxopentanoic acid
Molecular Formula: C₇₈H₁₁₁N₂₁O₁₉
CAS Number: 75921-69-6
Brands: Scenesse

Medically reviewed by Drugs.com on Jan 3, 2022. Written by ASHP.

Introduction

Afamelanotide acetate is a skin or mucous membrane agent.

Uses for Afamelanotide (Topical)

Afamelanotide acetate has the following uses:

Afamelanotide acetate 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).

Afamelanotide (Topical) Dosage and Administration

General

Afamelanotide acetate is available in the following dosage form(s) and strength(s):

Implant: 16 mg of afamelanotide.

Dosage

It isessentialthat the manufacturer's labeling be consulted for more detailed information on dosage and administration of this drug. Dosage summary:

Adults

Dosage and Administration

• Afamelanotide acetate should be administered by a healthcare professional who is proficient in the subcutaneous implantation procedure and has completed training prior to administration.

• Insert a single implant, containing 16 mg of afamelanotide, using an SFM Implantation Cannula or other implantation devices that have been determined by the manufacturer to be suitable for implantation of afamelanotide.

• Administer afamelanotide acetate subcutaneously every 2 months.

Cautions for Afamelanotide (Topical)

Contraindications

None.

Warnings/Precautions

Skin Monitoring

Afamelanotide acetate 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.

Specific Populations

Pregnancy

Risk Summary: There are no data on afamelanotide use in pregnant women t...