afamelanotide
Regulatory sources consulted
Approved indications
- Prevention of phototoxicity in adults with erythropoietic protoporphyria.
Contraindications
Absolute
- Hypersensitivity, severe liver disease, or hepatic or renal impairment.
Clinical warnings
- Major warning · Continue usual sun-protection measures. Examine the entire skin every 6 months because pigmented lesions may darken and skin cancer may occur; safety data beyond 2 years are limited. — CIMA SCENESSE 16 mg implante, registro 114969001
- Major warning · Severe hypersensitivity, angioedema, and anaphylaxis have been reported postmarketing. Do not re-expose; implant removal may be required. — DailyMed SCENESSE implant, set ID 94f53286-11dd-7fbb-e053-2a95a90a7c48
- Major warning · Closely monitor unstudied comorbidities and use caution in patients with melanoma or a history of skin cancer. — CIMA SCENESSE 16 mg implante, registro 114969001
Drug interactions
- ModerateAnticoagulants, aspirin, or NSAIDs
Mechanism: They may increase bruising or bleeding at the implant site.
Recommendation: Monitor the implantation site and bleeding risk.
https://cima.aemps.es/cima/dochtml/ft/114969001/FT_114969001.html
Adverse events
Common (≥1%)
Headache · Nausea · Discoloration, pain, bruising, or erythema at the implant site
Pregnancy and lactation
Do not use during pregnancy or breastfeeding. Use effective contraception during treatment and for 3 months afterward.
Recent literature (PubMed)
Vitiligo is a complex disease with a multifactorial nature and a high impact on the quality of life of patients. Although there are multiple therapeutic alternatives, there is currently no fully effective treatment for this disease. In the current era, multiple drugs are being developed for the treatment of autoimmune diseases. This review assesses the available evidence on the pathogenesis of vitiligo, and a comprehensive review of treatments available for vitiligo now and in the near future is provided. This qualitative analysis spans 116 articles. We reviewed the mechanism of action, efficacy and safety data of phototherapy, afamelanotide, cyclosporine, phosphodiesterase 4 inhibitors, trichloroacetic acid, basic fibroblast growth factor, tumor necrosis factor (TNF) inhibitors, secukinumab, pseudocatalase and janus kinase (JAK) inhibitors. At the moment, there is no clearly outstanding option or fully satisfactory treatment for vitiligo, so it is necessary to keep up the development of new drugs as well as the publication of long-term effectiveness and safety data for existing treatments. Afamelanotide is a melanocortin-1 receptor agonist that stimulates melanin production in the skin and is used to decrease pain and itching from light exposure in patients with erythropoietic protoporphyria and X-linked protoporphyria. Afamelanotide has not been linked to serum aminotransferase elevations during therapy nor to instances of idiosyncratic acute liver injury with symptoms and jaundice.
Vitiligo is a common disorder of depigmentation caused by the progressive destruction of melanocytes that affects the skin, hair, and mucous membranes, clinically presenting as depigmented macules and leukotrichia. This condition, affecting millions of people worldwide, has a significant psychosocial burden on patients' quality of life, particularly in relation to skin colour. The etiopathogenesis of this disorder is obscure, but multiple factors contribute to the loss of melanocytes in the skin, like oxidative stress, inflammation, genetics, and autoimmunity. The treatment of vitiligo has been challenging over the past years, but recent developments in understanding the etiopathogenesis of the disease have paved the way for the development of more effective and promising therapeutic treatment options. The aim of this review was to provide an overview of the underlying mechanisms and highlight the latest advances in the treatment of vitiligo. This review was performed according to PRISMA (Preferred Reporting Items for Systematic Reviews and Metanalyses) guidelines. A comprehensive search of the literature was carried out through the PubMed electronic database from inception to 31 December 2023 using the following search terms "vitiligo" AND "JAK inhibitors", "vitiligo" AND "prostaglandin", " vitiligo" AND " afamelanotide", "vitiligo" AND "antioxidants", "vitiligo" AND "vitamin D3", "vitiligo" AND "statins", "vitiligo" AND "TNF-alpha", "vitiligo" AND "interleukin", "vitiligo" AND "light therapy". Two independent reviewers screened titles, abstracts, and full texts to select papers dealing with vitiligo and its treatment. The advent of treatment modalities like Janus kinase inhibitors, prostaglandin analogues, antioxidants, TNF-α inhibitors, targeted phototherapy, and excimer lasers has revolutionized the therapeutic possibilities, offering a ray of hope to the individuals suffering from this devastating condition.
Vitiligo is an acquired hypopigmentation of the skin due to a progressive selective loss of melanocytes; it has a prevalence of 1-2% and appears as rounded, well-demarcated white macules. The etiopathology of the disease has not been well defined, but multiple factors contribute to melanocyte loss: metabolic abnormalities, oxidative stress, inflammation, and autoimmunity. Therefore, a convergence theory was proposed that combines all existing theories into a comprehensive one in which several mechanisms contribute to the reduction of melanocyte viability. In addition, increasingly in-depth knowledge about the disease's pathogenetic processes has enabled the development of increasingly targeted therapeutic strategies with high efficacy and fewer side effects. The aim of this paper is, by conducting a narrative review of the literature, to analyze the pathogenesis of vitiligo and the most recent treatments available for this condition.