|a) Approximately 60 % of patients experience reactions localised to the treatment site that are attributable to toxic effects of the photodynamic therapy (phototoxicity) or to preparation of the lesion. The most frequent symptoms are painful and burning skin sensation typically beginning during illumination or soon after and lasting for a few hours with resolving on the day of treatment. The symptoms are usually of mild or moderate severity and rarely require early termination of illumination. The most frequent signs of phototoxicity are erythema and scab. The majority are of mild or moderate severity and persist for 1 to 2 weeks or occasionally longer. Local phototoxic reactions may be reduced in frequency and severity with repeated treatment of Metvix.b) The incidence of adverse reactions in a clinical trial population of 932 patients receiving the standard treatment regimen and adverse reactions reported from the post marketing surveillance are shown in the table below.|
A study conducted in immunocompromised organ transplant recipients did not identify any safety concern in this population, adverse events being similar to those reported in trials in immunocompetent patients.
|Body system (MedDRA)||Frequency*||Adverse reaction|
|Nervous system disorders
||Eye swelling, eye pain
|Skin and subcutaneous tissue disorders
||Pain of skin, skin burning sensation, scab, erythema
||Skin infection, skin ulcer, skin oedema, skin swelling, blister, skin hemorrhage, pruritus, skin exfoliation, skin warm
||Urticaria, rash, skin irritation, photosensitivity reaction, skin hypopigmentation, skin hyperpigmentation, heat rash, skin discomfort
||Angioedema, face oedema (swelling face), application site eczema, allergic contact dermatitis, rash pustular (application site pustule)
|General disorders and administration site conditions
||Application site discharge, feeling hot
|* Very common adverse reactions: Adverse reactions occurring in ≥1/10) of patients.
Common adverse reactions: Adverse reactions occurring in ≥1/100, <1/10 of patients.
Uncommon adverse reactions: Adverse reactions occurring in ≥1/1000, ≤1/100 of patients.
Not known: Cannot be estimated from the available data
Adverse reactions reported by more than two patients in the clinical studies are included.
Adverse reactions with not known frequency are reported from the post marketing experience.