Chemical formula: C₇₈H₁₁₁N₂₁O₁₉ Molecular mass: 1,646.845 g/mol PubChem compound: 16197727
Afamelanotide interacts in the following cases:
Special caution is warranted in patients with an:
and/or an
There are no or limited amounts of data from the use of afamelanotide in pregnant women. Animal studies are insufficient with respect to developmental toxicity. A risk to newborns/infants cannot be excluded.
Afamelanotide should not be used during pregnancy and in women of childbearing potential not using effective contraception.
It is unknown whether afamelanotide or any of its metabolites are excreted in breast milk. No clinical data are available on the use of afamelanotide in breastfeeding women. A risk to newborns/infants cannot be excluded. Afamelanotide should not be used during breastfeeding.
Women of childbearing potential have to use effective contraception during treatment with afamelanotide and for a period of three months thereafter.
There are no clinical data on the effects of afamelanotide on fertility. Animal studies have not shown any harmful effect on fertility and reproduction.
Afamelanotide has moderate influence on the ability to drive and use machines, especially within 72 hours of administration. Following administration of this medicinal product, somnolence, fatigue, dizziness, and nausea have been reported. Patients should not drive or use machines in case they are affected by these symptoms.
The safety profile is based on pooled data from clinical studies in 425 patients.
The most commonly reported adverse reactions are nausea, experienced by approximately 19% of subjects who received treatment with this medicinal product, headache (20%), and implant site reactions (21%; mainly discolouration, pain, haematoma, erythema). In most cases these adverse reactions are reported to be mild in severity.
The adverse reactions reported during clinical trials conducted with afamelanotide are listed below by MedDRA system organ class and frequency convention. Frequencies are defined as: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000) and not known (cannot be estimated from the available data).
Common: Upper respiratory tract infection
Uncommon: Influenza, Gastrointestinal infection, Gastroenteritis, Folliculitis, Candidiasis, Nasopharyngitis
Uncommon: Haemangioma
Uncommon: Leukopenia
Common: Decreased appetite
Uncommon: Hypercholesterolaemia, Increased appetite
Uncommon: Depression, Depressed mood, Insomnia
Very common: Headache
Common: Migraine, Dizziness, Lethargy, Somnolence
Uncommon: Syncope,Restless leg syndrome, Hyperaesthesia, Presyncope, Post-traumatic headache, Burning sensation, Poor quality sleep, Dysgeusia
Uncommon: Eyelid oedema, Ocular hyperaemia, Dry eye, Presbyopia
Uncommon: Tinnitus
Uncommon: Palpitations, Tachycardia
Common: Flushing, Hot flush
Uncommon: Haematoma, Diastolic hypertension, Hypertension
Uncommon: Dysphonia, Sinus congestion, Rhinitis, Nasal congestion
Very common: Nausea
Common: Abdominal pain, Abdominal pain upper, Diarrhoea, Vomiting
Uncommon: Lip oedema, Lip swelling, Gastroesophageal reflux disease, Gastritis, Dyspepsia, Cheilitis, Abdominal distension, Gingival pain, Abdominal discomfort, Toothache, Abdominal symptom, Bowel movement irregularity, Flatulence, Gingival discolouration, Hypoaesthesia oral, Lip discolouration, Tongue discoloration
Common: Erythema, Melanocytic naevus, Pigmentation disorder, Skin discolouration, Skin hyperpigmentation, Ephelides, Pruritus
Uncommon: Lichen planus, Rash vesicular, Pruritus generalised, Rash, Rash erythematous, Rash papular, Rash pruritic, Skin irritation, Vitiligo, Acne, Eczema, Pigmentation lip, Post inflammatory pigmentation change Seborrhoea, Skin exfoliation, Skin hypopigmentation, Hair colour changes, Hyperhidrosis
Common: Back pain
Uncommon: Arthralgia, Myalgia, Pain in extremity, Muscle spasm, Musculoskeletal pain, Musculoskeletal stiffness, Joint stiffness, Groin pain, Sensation of heaviness
Uncommon: Cystitis
Uncommon: Menorrhagia, Dysmenorrhoea, Breast tenderness, Menstruation irregular, Vaginal discharge, Libido decreased
Common: Implant site, hypersensitivity, Implant site reaction, Implant site pain, Implant site, haematoma, Implant site erythema, Implant site irritation, Asthenia, Fatigue, Implant site discolouration, Feeling hot
Uncommon: Oedema peripheral, Oedema mucosal, Pain, Implant site oedema, Pyrexia, Chills, Injection site haematoma, Injection site irritation, Implant site hypertrophy, Implant site pruritus, Device expulsion, Application site discolouration, Hangover, Influenza like illness
Common: Blood creatine phosphokinase increased
Uncommon: Alanine aminotransferase increased, Aspartate aminotransferase increased, Liver function test abnormal, Transaminases increased, Transferrin saturation decreased, Blood cholesterol increased, Blood glucose increased, Blood iron decreased, Blood pressure diastolic increased, Blood urine present, Biopsy skin
Uncommon: Wound complication, Open wound, Fall, Procedural nausea
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