temoporfin

HOS-084326 · has-adverse-reaction-information · PDF-Seite 7

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. The local adverse reactions are characteristic of an acute tissue inflammatory response induced by photoactivation and commonly include oedema and pain followed by necrosis (see section 4.4). Photosensitivity reactions may occur, however, complying with the light protection guidelines (see above section 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. For treatment of other types of pain listed in this section, please see section 4.4. 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. System Organ Class Undesirable effects Infections and infestations Common: Localised infection in the area of photoactivation, e.g. pharyngitis, stomatitis Unknown: Sepsis1 Blood and lymphatic system disorders Common: Anaemia Nervous system disorders Common: Dizziness, burning sensation Vascular disorders Very common: Haemorrhage

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HOS-084322 · has-contraindication-information · PDF-Seite 3

 Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.  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.

HOS-084321 · has-indication-information · PDF-Seite 2

Foscan 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.

HOS-084324 · has-interaction-information · PDF-Seite 6

There is potential for exacerbation of skin photosensitivity if temoporfin is used with other photosensitising active substances. Such a reaction has been reported with topical 5-fluorouracil. No other interactions have been observed. An in vitro study with human liver tissue has shown no potential for drug interaction through inhibition of cytochrome P-450 enzymes by temoporfin.

HOS-084325 · has-pregnancy-information · PDF-Seite 6

Pregnancy There are no data from the use of temoporfin in pregnant women. Studies in animals have shown reproductive toxicity (see section 5.3). Foscan should not be used during pregnancy unless the clinical condition of the woman requires treatment with temoporfin. Women of childbearing potential have to use effective contraception during and up 3 months after treatment. Breast-feeding It is unknown whether temoporfin/metabolites are excreted in human milk. A risk to the newborns/infants cannot be excluded. Breast-feeding should be discontinued for at least one month following injection of Foscan. Fertility The effects of Foscan on fertility in humans have not been studied.

HOS-084323 · has-warning-information · PDF-Seite 3

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. 3 Unplanned or emergency surgical procedures where Foscan has been administered within the previous 30 days must be undertaken only if absolutely necessary and the potential benefits outweigh the risk to the patient. All precautions must be taken to avoid direct illumination of the patient with surgical lamps during these proced

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