Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Visudyne

Visudyne 15 mg powder for solution for infusion · Abschnitt 4.8 · PDF-Seite 6–7

HOS-091168 · Präparat HOS-084217

6  General disorders and administration site conditions Common Injection site pain, injection site oedema, injection site inflammation, injection site extravasation, asthenia. Uncommon Injection site hypersensitivity, injection site haemorrhage, injection site discoloration, pyrexia, pain. Rare Malaise1. Not known Injection site vesicles, injection site necrosis. Injury, poisoning and procedural complications Common Infusion-related chest pain5, infusion-related reaction primarily presented as back pain5, 6. 1 Vasovagal reactions and hypersensitivity reactions related to Visudyne infusion have been reported. General symptoms can include headache, malaise, syncope, hyperhydrosis, dizziness, rash, urticaria, pruritus, dyspnoea, flushing, and changes in blood pressure and heart rate. On rare occasions these reactions may be severe and potentially include convulsions. 2 Severely reduced visual acuity, equivalent to 4 lines or more, within seven days after treatment was reported in 2.1 % of the verteporfin-treated patients in the placebo-controlled ocular Phase III clinical studies and in less than 1 % of patients in uncontrolled clinical studies. The reaction occurred mainly in patients with occult only (4.9 %) or minimally classic CNV lesions in patients with AMD and was not reported for placebo-treated patients. Partial recovery of vision was observed in some patients. 3 Myocardial infarction has been reported, particularly in patients with previous cardiovascular history, sometimes within 48 hours after the infusion. 4 Photosensitivity reactions (in 2.2 % of patients and <1 % of Visudyne courses) occurred in the form of sunburn following exposure to sunlight, usually within 24 hours from Visudyne treatment. Such reactions should be avoided by compliance with the photosensitivity protection instructions given in section 4.4. 5 Infusion-related back and chest pain, which may radiate to other areas, including, but not limited to, the pelvis, shoulder girdle or rib cage. 6 The higher incidence of back pain during infusion in the Visudyne group was not associated with any evidence of haemolysis or allergic reaction and usually resolved by the end of the infusion.

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