FOSCAN Solution for injection Ref.[9097] Active ingredients: Temoporfin

Foscan photodynamic therapy must only be administered in specialist oncology centres in which a multidisciplinary team assesses patient treatment and under the supervision of physicians experienced in photodynamic therapy.

Posology

The dose is 0.15 mg/kg body weight.

Paediatric population

There is no relevant use of Foscan in the paediatric population.

Method of administration

Foscan is administered via an in-dwelling intravenous cannula in a large proximal limb vein, preferably in the antecubital fossa, as a single slow intravenous injection over not less than 6 minutes. The patency of the in-dwelling cannula should be tested before injection and every precaution taken against extravasation (see section 4.4).

The dark purple colour of the solution, together with the amber vials makes a visual check for particulates impossible. Thus, an in-line filter must be used as a precautionary measure and is provided in the package. Foscan shall not be diluted nor flushed with sodium chloride or any other aqueous solution.

The required dose of Foscan is administered by slow intravenous injection, over not less than 6 minutes. 96 hours after the administration of Foscan, the treatment site is to be illuminated with light at 652 nm from an approved laser source. Light must be delivered to the entire surface of the tumour using an approved microlens fibre-optic. Wherever possible, the illuminated area must extend beyond the tumour margin by a distance of 0.5 cm.

Light must be administered not less than 90 hours and not more than 110 hours after Foscan injection.

The incident light dose is 20 J/cm², delivered at an irradiance of 100 mW/cm² to the tumour surface, implying an illumination time of approximately 200 seconds.

Each field is to be illuminated once only at each treatment. Multiple non-overlapping fields may be illuminated. Care must be taken to ensure that no area of tissue receives more than the specified light dose. Tissue outside the target area must be shielded completely to avoid photoactivation by scattered or reflected light.

A second course of treatment may be given at the discretion of the treating physician in patients where additional tumour necrosis and removal is deemed appropriate, with a recommended minimum interval of 4 weeks between treatments.

In the event of an overdose, laser treatment would result in deeper tumour necrosis than would be expected with the recommended dose. Illumination of the tumour should only be carried out if the potential benefit justifies the potential risk of excessive necrosis. If the tumour is not illuminated, a period of at least 4 weeks between overdose and re-administration of Foscan must be allowed.

The adverse reactions associated with overdose would be expected to be limited to photosensitivity reactions. Exposure to ambient light after overdose carries an increased risk of photosensitivity reactions. Published clinical research has shown that the duration and intensity of photosensitivity at the recommended dose of 0.15 mg/kg were reduced by one third relative to a dose of 0.3 mg/kg. Animal studies have shown some haematological and blood chemistry changes (decreased platelets, erythrocytes and haemoglobin, increased neutrophils, fibrinogen, bilirubin, triglyceride and cholesterol).

Strict observance of the reduced light regime is required. A skin photosensitivity test must be carried out before the patient returns to normal light conditions.

No specific systemic symptoms are known to be associated with overdose. Treatment should be supportive.

Limited information is available on the effects of overexposure to laser light during treatment. Increased damage to tissue was noted.

Shelf life: 5 years.

Once opened, the solution must be used immediately.

Do not store above 25°C.

Store in the original package in order to protect from light.

Type I amber glass vials with a bromobutyl elastomer stopper and aluminium seal containing either 1 ml or 3 ml or 6 ml of solution for injection.

Each pack contains 1 vial and a filter with Luer lock connections for syringe and cannula. Not all pack sizes may be marketed.

Appropriate precaution must be taken when handling this medicinal product. Studies have shown that Foscan is non-irritant. Each vial represents a single dose and any unused solution must be discarded.

Foscan is photosensitive. Once removed from its packaging it must be administered immediately. Where delay is unavoidable, the solution must be protected from light.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements