Afamelanotide
Also known as: [Nle4,D-Phe7]-α-MSH, Afamelanotide, AP-001, BMS‑192,131, CUV1647, MT-II precursor analog, NDP-MSH, Scenesse
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Summary
Afamelanotide is a synthetic 13‑amino‑acid analogue of α‑melanocyte‑stimulating hormone approved for the treatment of erythropoietic protoporphyria to increase melanin‑mediated photoprotection.
Mechanism of Action
Selective agonist of melanocortin‑1 receptor (MC1R) → stimulates eumelanin synthesis and provides photoprotection
Routes of Administration
Goals & Uses
- Vitiligo repigmentationInvestigational UseLow
- Reduction of phototoxic pain episodesSymptom ManagementHigh
- Prevention of phototoxic reactions in erythropoietic protoporphyriaDisease ManagementHigh
- Erythropoietic protoporphyria (EPP)TherapeuticHigh
- Xeroderma pigmentosum (XP) – investigationalTherapeuticModerate
- Solar urticaria managementInvestigational UseLow
- Variegate porphyria photoprotectionInvestigational UseLow
- Increased skin melanin/pigmentationPhotoprotectionHigh
- Photoprotection for other photosensitivity disordersResearchModerate
- Erythropoietic protoporphyria (photosensitivity)IndicationHigh
Contraindications
- Other active malignant melanocytic lesionsOncologicHigh
- Melanoma or history of melanomaOncologicHigh
- PregnancyPopulationModeratePotential fetal risk or insufficient safety data
- Hypersensitivity to afamelanotide or excipientsAllergy/immunologicHigh
- Renal or hepatic impairment (severe)Organ ImpairmentModerate
- BreastfeedingPopulationModeratePotential transfer into breast milk or insufficient safety data
- Active malignant melanomaOncologyHigh
- Active malignant melanoma or other pigmented skin cancersOncologyHigh
- Known hypersensitivity to afamelanotide or any excipientsAllergyHigh
Adverse Effects
- HeadacheNeurologicCommonPain in the head or upper neck
- Hyperpigmentation of skin and mucous membranesDermatologicCommon
- HypotensionCardiovascularUncommonLow blood pressure
- Hyperpigmentation of skinDermatologicCommon
- NauseaGastrointestinalCommonFeeling of sickness or urge to vomit
- Implant site reactions (bruising, pain, scarring)Local/dermatologicCommon
- FatigueGeneralUncommonLow energy or tiredness
- Injection site reactionLocalCommonRedness, swelling, itching, bruising, or pain at the injection site
- HyperpigmentationDermatologicCommon
- Injection‑site pain or erythemaLocalCommon
- New or changed melanocytic neviDermatologicUncommon
Drug Interactions
- Immunosuppressants (e.g., cyclosporine)Low
- Photosensitizing agents (e.g., tetracyclines)Moderate
- Photosensitizing agentsModerate
- ImmunosuppressantsLowPotential interaction with immune pathways or infection risk
Population Constraints
- PregnancyReproductive SafetyRelative
- Pediatric patients (<18 years)AgeRelative
- Breastfeeding womenReproductiveRelative
- Patients <12 yearsAgeAbsolute
- Patients with severe hepatic impairmentHepaticRelative
- Patients with numerous atypical neviDermatologic RiskRelative
- Pregnant womenReproductiveRelative
- Children <12 yearsAgeRelative
- Patients with personal or family history of melanomaOncologic HistoryAbsolute
Regulatory Status
- European UnionApprovedApproved: erythropoietic protoporphyriaAuthorized in multiple EU member states.
- United StatesApprovedApproved: erythropoietic protoporphyriaMarketed as Scenesse; subcutaneous implant.
- United KingdomApprovedApproved: erythropoietic protoporphyriaAvailable via prescription.
Approved in the US (Scenesse) and EU for erythropoietic protoporphyria; administered via subcutaneous implant; not indicated for cosmetic tanning.
Evidence & Sources
No sources recorded yet.
Frequently Asked Questions
What is Afamelanotide?
Afamelanotide is a synthetic 13‑amino‑acid analogue of α‑melanocyte‑stimulating hormone approved for the treatment of erythropoietic protoporphyria to increase melanin‑mediated photoprotection.
What is Afamelanotide used for?
Afamelanotide is educationally associated with: Vitiligo repigmentation, Reduction of phototoxic pain episodes, Prevention of phototoxic reactions in erythropoietic protoporphyria, Erythropoietic protoporphyria (EPP), Xeroderma pigmentosum (XP) – investigational, Solar urticaria management, Variegate porphyria photoprotection, Increased skin melanin/pigmentation, Photoprotection for other photosensitivity disorders, Erythropoietic protoporphyria (photosensitivity). Educational only — not medical advice.
How is Afamelanotide administered?
Recorded routes of administration: Subcutaneous.
What are the potential side effects of Afamelanotide?
Reported adverse effects include: Headache, Hyperpigmentation of skin and mucous membranes, Hypotension, Hyperpigmentation of skin, Nausea, Implant site reactions (bruising, pain, scarring), Fatigue, Injection site reaction, Hyperpigmentation, Injection‑site pain or erythema, New or changed melanocytic nevi. This list is not exhaustive — consult a qualified clinician.
Who should avoid Afamelanotide?
Recorded contraindications: Other active malignant melanocytic lesions, Melanoma or history of melanoma, Pregnancy, Hypersensitivity to afamelanotide or excipients, Renal or hepatic impairment (severe), Breastfeeding, Active malignant melanoma, Active malignant melanoma or other pigmented skin cancers, Known hypersensitivity to afamelanotide or any excipients. Consult a qualified clinician before use.