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Afamelanotide

What is afamelanotide?

Afamelanotide (SCENESSE®, Clinuvel Pharmaceuticals) is a potent alpha-melanocytestimulating hormone (αMSH) analog term, which stimulates the production of eumelanin in the skin, a tan. This injectable synthetic melanotropic peptide it was previously known as Melanotan I.

Eumelanin is a form of melanin, the tan pigment on the skin Melanin production is generally stimulated by exposure to ultraviolet light (UV) radiation component of sunlight.

  • Exposure to UV radiation causes cellular damage that increases the risk of skin Cancer.
  • A tan protects the skin from further damage by absorbing UV radiation.
  • Melanin also filters out longer wavelengths, providing protection for people in visible light. photosensitivity.
  • Melanin also has antioxidant effects to protect the skin against free radicals. Free radicals are responsible for the symptoms experienced in erythropoietic protoporphyria.

What skin conditions respond to afamelanotide?

Afamelanotide is registered to treat erythropoietic protoporphyria. It has been reported to be beneficial for patients with:

  • Solar urticaria
  • Vitiligo
  • Hailey-Hailey disease

Erythropoietic protoporphyria

Erythropoietic protoporphyria is a rare inherited disorder of metabolism typically manifests in early childhood as painful photosensitivity. One to 20 minutes after sun exposure, patients experience burning pain in exposed skin, usually hands and face, followed by swelling and redness that lasts for several days. Fear of this pain can have a major effect on quality of life, including job and recreational opportunities.

Afamelanotide has been shown through phase III studies to decrease phototoxic Reactions and recovery time in patients with erythropoietic protoporphyria. Afamelanotide was first used for the treatment of erythropoietic protoporphyria in Italy and Switzerland in 2007. It reduced pain and allowed almost all patients to be outdoors for longer periods than before.

Solar urticaria

Solar urticaria is a rare form of chronic physical or inducible urticaria characterized by itching, bump and explode within minutes of exposure to sunlight. The spectrum of action (the part of the electromagnetic spectrum that causes symptoms) is variable, but most often involves long-wavelength UVA and visible light. The use of afamelanotide has been shown under experimental conditions to reduce the formation of scars secondary to increased melanization.

Vitiligo

Vitiligo is a disorder characterized by white patches on the skin due to the selective loss of epidermal melanocytes. UVB phototherapy is a cornerstone of vitiligo management; However, repigmentation has been shown to be faster and higher when phototherapy is used together with afamelanotide.

Hailey-Hailey disease

Afamelanotide was prescribed to 2 patients with Hailey-Hailey disease (benign family pemphigus) resulting in remission.

Does afamelanotide work as a sunscreen?

The use of afamelanotide has been associated with a decrease in 50% in sunburn epidermal cells, as well as a significant reduction in thymine dimer formation (part of the process by which UVB damage DNA) However, the marketers of afamelanotide do not recommend its use as a sunscreen or sunburn treatment.

Contraindications to afamelanotide

As no data is available, contraindications for afamelanotides include:

  • Liver or kidney failure: The metabolism of this drug is not fully understood.
  • Children: safety and effectiveness of this drug in people 0 to 17 years of age has not yet been established.
  • Elderly: It is also recommended that patients over 70 years of age do not take afamelanotide.
  • Pregnancy: It is recommended that pregnant or lactating women not take it.

How to take afamelanotide

Afamelanotide (Scenesse®) comes as a white stick approximately 1.7 cm in length and 1.5 mm in diameter. It contains 16 mg of afamelanotide and is implanted under the skin, usually around the hip. It must be inserted by a specialist doctor every 2 months, before and during greater exposure to sunlight (for example, in summer). It is recommended to have three implants per year, with a maximum of four per year.

The patient is asked to wait 30 minutes in case of allergic reaction the.

Testing before / after starting afamelanotide

Tests before starting afamelanotide may include:

  • Liver and kidney function
  • Pregnancy test

Additional tests may be needed for people with heart or breathing problems, diabetes, Cushing's disease, Addison's disease, Peutz-Jeghers syndromeepilepsy anemia or skin cancer.

Periodic examinations of the skin of the whole body are recommended before and during treatment to evaluate and monitor pigmented injuries and other skin abnormalities, especially in those with a personal history of skin cancer.

Side effects of afamelanotide

Few major side effects have been reported so far.

  • One third of patients experience hyperpigmentation at the implant site
  • There is a low risk of darkening moles anywhere on the body
  • Mild tiredness, headache, dizziness, and nausea after implant administration generally clear up within 72 hours.

There is no evidence that afamelanotide increases the risk of melanoma. the primary The risk factor for melanoma is UVB irradiation. The production of eumelanin reduces the penetration of UVB into the skin and removes free radicals, thus protecting the skin.

Drug interactions with afamelanotide

Due to the method of administration, patients taking anticoagulant medications may experience bruising or bleeding at the implantation site.

No specific drug interactions have been identified to date (2015).

Security measures

  • Women of childbearing potential must use effective contraception during treatment with afamelanotide and for a period of three months thereafter.
  • Patients are advised not to drive or use heavy machinery within 72 hours of afamelanotide administration due to the risk of tiredness and dizziness.
New Zealand approved data sheets are the official source of information for these prescription drugs, including approved uses and risk information. See the New Zealand individual data sheet on the Medsafe website.