Foscan

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. 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.

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 3 using an approved microlens fibre-optic. 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.

Summary of the safety profile All patients who receive Foscan will become temporarily photosensitive and must be instructed to observe precautions to avoid sunlight and bright indoor light. Regarding the tabulated adverse reactions gastrointestinal disorders, adverse skin reactions and general disorders and administration site conditions are the most frequently observed adverse reactions.

Most of the toxicities associated with photodynamic therapy are local effects seen in the region of illumination and occasionally in surrounding tissues. 4). 4) and avoiding unnecessary indoor light during illumination reduces this risk.

The low number of treated patients did not allow identification of adverse reactions, which may be categorised as uncommon and rare. Injection site pain is transient and can be reduced by slowing the injection rate. 4. Tabulated summary of adverse reactions 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), not known (cannot be estimated from the available data).

Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. g. g. g. face oedema, tongue oedema Common: Pyrexia, injection site reaction, oedema Injury, poisoning and procedural complications Very common: Scar2 Common: Thermal burn, sunburn2 1 As a consequence of local infection 2 In the photoactivated area 3 As a consequence of local oedema Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.

All patients who receive Foscan will become temporarily photosensitive. Precautions must be taken to avoid exposure of skin and eyes to direct sunlight or bright indoor light during the first 15 days after injection. Skin photosensitivity reactions are caused by visible light; therefore ultraviolet sunscreens provide no protection.

It is important that patients are re-introduced to normal light gradually (see the light protection guidelines for patients at the end of this section). For 6 months following Foscan treatment prolonged direct sunlight exposure of the injection site arm shall be avoided.

As a precautionary measure, if prolonged outdoor activity is planned, the injection arm should be protected by wearing a long sleeved, coloured shirt. Clinicians should be aware that most of the toxicities associated with photodynamic therapy are local effects seen as consequence of photoactivation.

Photoactivation induces local tissue damage resulting in acute inflammatory response. This response is commonly associated with oedema and pain, followed by necrosis. The photodynamic effect may also lead to damage of the surrounding tissue that may cause fistula, perforation, or vascular rupture as well as infection and subsequent sepsis.

It is therefore important that during photoactivation by laser illumination care should be taken to protect normal tissue surrounding the tumour from photoactivation by proper illumination and shielding techniques. Proactively managing the local effects and diminishing photoactivation in non-tumour areas is important to manage the risks.

Special care must be taken to prevent extravasation at the injection site. If extravasation occurs, protect the area from light for at least 3 months. There is no known benefit from injecting the extravasation site with another substance.

Adverse reactions, including cholangitis, cholecystitis, liver abscess and oesophageal perforation have been reported after unapproved use in the treatment of malignant biliary strictures and mesothelioma. There is a risk of damage of the surrounding area following photoactivation.

1.  Porphyria or other diseases exacerbated by light.  Hypersensitivity to porphyrins.  Tumours known to be eroding into a major blood vessel in or adjacent to the illumination site.  A planned surgical procedure within the next 30 days.

 Co-existing ophthalmic disease likely to require slit-lamp examination within the next 30 days.  Existing therapy with a photosensitizing agent.