Chemical formula: C₄₄H₃₂N₄O₄ Molecular mass: 680.764 g/mol
Temoporfin interacts in the following cases:
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.
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.
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.
There are no data from the use of temoporfin in pregnant women. Studies in animals have shown reproductive toxicity. Temoporfin 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.
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 temoporfin.
The effects of temoporfin on fertility in humans have not been studied.
The amount of alcohol in this medicinal product may impair the ability to drive or use machines.
On the basis of the pharmacodynamic profile, temoporfin is presumed to be safe or unlikely to produce an effect. To avoid photosensitivity problems, it is advised not to drive during the first 15 days after injection, and to use machines only if it is practical to do so under subdued lighting conditions according to the recommended lighting precautions. Driving and use of machines may resume under normal lighting or daylight conditions once photosensitivity has been shown to have subsided.
All patients who receive temoporfin 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.
Photosensitivity reactions may occur, however, complying with the light protection guidelines 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.
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.
Common: Localised infection in the area of photoactivation, e.g. pharyngitis, stomatitis
Unknown: Sepsis1
Common: Anaemia
Common: Dizziness, burning sensation
Very common: Haemorrhage
Unknown: Vascular rupture
Unknown: Airway obstruction3
Very common: Constipation, stomatitis necrotising, dysphagia
Common: Vomiting, nausea, mouth ulceration
Common: Blister, erythema, skin hyperpigmentations, photosensitivity reaction, skin necrosis2
Common: Trismus3
Unknown: Fistula
Very common: Pain in the photoactivated area, e.g. facial pain, headache, injection site pain, oedema in the photoactivated area, e.g. face oedema, tongue oedema
Common: Pyrexia, injection site reaction, oedema
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
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