Active Ingredient: Temoporfin
Temoporfin is indicated for the palliative treatment of patients with advanced head and neck squamous cell carcinoma failing prior therapies and unsuitable for radiotherapy, surgery or systemic chemotherapy.
For this indication, competent medicine agencies globally authorize below treatments:
Intravenous
0.15 - 0.15 mg per kg of body weight
From 0.15 To 0.15 mg per kg of body weight once every day
The dose is 0.15 mg/kg body weight.
Temoporfin 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.
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. Temoporfin shall not be diluted nor flushed with sodium chloride or any other aqueous solution.
The required dose of temoporfin is administered by slow intravenous injection, over not less than 6 minutes. 96 hours after the administration of temoporfin, 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 temoporfin 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.
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