- Drugs List
- Therapeutic Indications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
Implants containing afamelanotide.
The implant is administered prior to expected and during increased sunlight exposure, e.g. from spring to early autumn. The number of implants depends on the length of protection required.
1 implant once every 2 months. Three implants per year are recommended with the maximum being four implants per year.
For subcutaneous injection.
Children under 18 years
Severe hepatic disorder
Precautions and Warnings
Females of childbearing potential
Patients over 70 years
Risk factors for skin cancer
History of skin cancer
Pre-malignant skin lesions
Advise ability to drive/operate machinery may be affected by side effects
Treatment to be prescribed and administered by a specialist
Evaluate benefit/risk in long term use >2 years
Perform skin examination every 6 months during treatment
Advise patient to immediately report new skin lesions
Monitor for hypersensitivity reactions for 30 minutes after administration
Female: Contraception required during and for 3 months after treatment
Advise patient on appropriate sun protection methods
The safety of afamelanotide implant has not been evaluated for a duration of longer than 2 years.
Monitor for vital signs, routine haematology and biochemistry after administration of every implant in patients over 70 years of age and those with clinically significant disorders of the gastrointestinal, cardiovascular, respiratory, endocrine (including diabetes), neurological (including seizures) and haematological systems (especially anaemia). A careful decision must be made whether to treat patients with any of these conditions with afamelanotide.
Afamelanotide may induce darkening of pre-existing pigmentary lesions. Monitor changes in pigmentary lesions and other skin abnormalities during the two full body examinations per year. Dermatology specialist advice should be sought with any skin changes that are consistent with skin cancer or its precursors. Special precaution is required in patients with an individual or family history of melanoma (including in-situ melanoma, e.g. lentigo maligna) or suspected or confirmed susceptibility to cutaneous melanoma and/or an individual history of basal cell carcinoma, squamous cell carcinoma (including carcinoma in situ, e.g. Bowen's disease), Merkel cell carcinoma, or other malignant or premalignant skin lesions.
Pregnancy and Lactation
Afamelanotide is contraindicated during pregnancy.
The use of afamelanotide during pregnancy and in women of childbearing potential not using effective contraception is contraindicated by the manufacturer. At the time of writing, human data is limited and animal studies are insufficient with respect to developmental toxicity. The potential risks in human pregnancy are unknown.
Afamelanotide is contraindicated during breastfeeding.
Use of afamelanotide when breastfeeding is contraindicated by the manufacturer. It is unknown if afamelanotide or any of its metabolites are excreted in human milk. A risk to neonates cannot be excluded.
Alanine aminotransferase increased
Aspartate aminotransferase increased
Creatine phosphokinase increased
Discolouration (injection site)
Discolouration of hair
Disturbances of appetite
Erythema at application site
Extrusion of implant
Gastroesophageal reflux disease
Haematoma (injection site)
Hypertrophy (injection site)
Increase in plasma cholesterol
Increase in serum glucose
Increase of liver transaminases
Irritation (injection site)
Irritation at application site
Liver function disturbances
Oedema (injection site)
Oedema of the lips
Pain at application site
Sensation of heaviness
Serum iron decrease
Skin pigmentation changes
Transferrin saturation decreased
Upper respiratory tract infection
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Last Full Review Date: September 2020
Summary of Product Characteristics: Scenesse 16mg implant. Clinuvel Europe Limited. Revised November 2019.
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Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
FDB Disclaimer : FDB Multilex is intended for the use of healthcare professionals and is provided on the basis that the healthcare professionals will retain FULL and SOLE responsibility for deciding what treatment to prescribe or dispense for any particular patient or circumstance.