Medicinal Products

EFFALA 8 mg

Generic drug of the therapeutic class: Oncology and Hematology
active ingredients: 5-aminolevulinic acid
laboratory: Galderma Internat

Medicated plaster
Box of 1 Sachet of 4
All forms

Indication

Disposable devices for the treatment of mild actinic keratosis (KA) of the face and scalp (bald / bare areas) whose diameter does not exceed 1.8 cm.

Dosage EFFALA 8 mg Medicated plaster Box of 1 Pack of 4

Adults (elderly subjects included):

During a photodynamic therapy session (PDT), for the treatment of AK, it is possible to use in one and the same session up to six Effala plasters per patient (out of six different lesions). If the Effala plaster fails to adhere properly to the lesions, it can be fixed with a bandage.

Four hours after placement, remove plaster (plasters) Effala and expose the lesion (s) to red light via a narrow band red light source 630 ± 3 nm for one dose total luminosity of 37 J / cm² on the surface of the lesion. Only CE marked lamps are allowed. These must also be equipped with the necessary filters and / or reflecting mirrors for the lowest possible exposure to heat, blue light and UV radiation. It is important to verify that the patient is receiving the correct light dose. The light dose is determined by parameters such as the size of the light field, the distance between the lamp and the surface of the skin and the illumination time. Note that these parameters vary with the type of lamp used. It is therefore imperative to follow the user manual for each lamp. The safety principles provided with the light source must be respected by both the patient and the professional in charge of the procedure. Throughout the illumination, both the patient and the professional in charge of the intervention will have to wear the appropriate protective glasses corresponding to the light spectrum of the lamp.

Untreated healthy skin surrounding the lesion does not require special protection during illumination.

The lesion response will be evaluated three months after the illumination session; if lesions remain after 3 months, the use of other treatments may be considered.

Children and adolescents:

There is no experience in children under 18 years old.

Against indications

Hypersensitivity to the active substance or the constituent materials of the plaster.

Lack of response to anterior PDT conjugated to preparations containing 5-aminolevulinic acid.

Porphyria.

Effala side effects

a) Almost all the patients (99%) showed localized adverse effects on the treated area (local reactions), which are attributable to the toxic effects of photodynamic therapy (phototoxicity). During the application of Effala and before light exposure to the treated area, 33% of patients showed local reactions, the most common being pruritus, burns and erythema. During exposure to light, erythema, burns and pain are the most frequently reported local reactions. These symptoms are usually of mild or moderate intensity and required the premature interruption of illumination in 1% of patients. Cooling the treated area can relieve this type of symptoms. After treatment, pruritus, erythema, crusting and exfoliation are the most frequent local reactions, also mild to moderate, that can persist for 1 to 2 weeks, sometimes more.

Headache is also a common side effect (<10%) that does not directly involve the treated area.

b) The incidence of adverse events in dynamic phototherapy patients treated with Effala is shown in the table below.

Side effects involving the treated area (local reactions)

General disorders and application site defects

Very common
≥ 1/10

Erythema, exfoliation, irritation, pain, pruritus, crusts

Frequent
≥ 1/100, <1/10

Bleeding, desquamation, suppuration, discomfort, erosion, hyper / hypopigmentation, edema, reaction, swelling, vesicles

Rare
≥ 1/1000, <1/100

Burns, dyschromia, excoriation, inflammation, ulcer

Infections and infestations

Frequent
≥ 1/100, <1/10

pustules

Rare
≥ 1/1000, <1/100

Infection

Adverse effects not involving the treated area

Nervous system disorders

Frequent
≥ 1/100, <1/10

headaches

Infections and infestations

Rare
≥ 1/1000, <1/100

pyoderma

Psychiatric disorders

Rare
≥ 1/1000, <1/100

Emotional distress

Respiratory, thoracic and mediastinal disorders

Rare
≥ 1/1000, <1/100

Epistaxis

Skin and subcutaneous tissue disorders

Rare
≥ 1/1000, <1/100

Dyschromia of the skin

investigations

Rare
≥ 1/1000, <1/100

Elevation of alanine aminotransferase

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