Afamelanotide Brand Name– SCENESSE
What is Afamelanotide
Afamelanotide is a melanocortin-1 receptor (MC1-R) agonist approved to increase pain-free light exposure in patients with a history of phototoxic reactions from erythropoietic protoporphyria (EPP).
EPP is a rare disorder caused by mutations leading to impaired activity of ferrochelatase, an enzyme involved in heme production.
The decrease in ferrochelatase activity leads to an accumulation of protoporphyrin IX (PPIX).
When light reaches the skin, it can react with PPIX causing intense skin pain and skin changes, such as redness and thickening. Afamelanotide increases the production of eumelanin in the skin independent of exposure to sunlight or artificial light sources.
Afamelanotide was evaluated in 2 parallel group clinical trials involving 167 adult patients with EPP. In the first trial (n = 93), the primary endpoint was the total number of hours over 180 days spent in direct sunlight between 10 a.m. and 6 p.m. on days with no pain.
The median number of hours with no pain was 64 hours for patients receiving afamelanotide and 41 hours for patients taking placebo. The second trial (n = 74 patients) looked at the total number of hours over 270 days spent in direct sunlight between 10 a.m. and 3 p.m. during which patients experienced no pain when “most of the day” was spent outside in direct sunlight.
The median number of hours with no pain was 6 hours for patients receiving afamelanotide and 0.75 hours for patients taking placebo.
Afamelanotide may cause skin darkening; a full body skin examination is recommended for patients twice a year.
Indications
- erythropoietic protoporphyria (EPP)
For use in erythropoietic protoporphyria (EPP) to increase pain free light exposure in patients with a history of phototoxic reactions
Side Effects
- cough
- dizziness
- drowsiness
- erythema
- fatigue
- infection
- nausea
- porphyria
- pruritus
- skin hyperpigmentation
- skin irritation
Monitoring Parameters
- skin cancer screening exam
Contraindications
- breast-feeding
- pregnancy
- requires an experienced clinician
- skin hyperpigmentation
Interactions
There are no drug interactions associated with Afamelanotide products.
