verteporfin

HOS-084224 · has-adverse-reaction-information · PDF-Seite 6

Most adverse reactions were mild to moderate and transient in nature. Undesirable effects reported in patients with pathological myopia were similar to those reported in patients with AMD. The most frequently reported adverse reactions to Visudyne (verteporfin for infusion) are injection site reactions (including pain, oedema, inflammation, extravasation, rashes, haemorrhage, discolouration) and visual impairment (including blurred, fuzzy vision, photopsia, reduced visual acuity and visual field defects, including scotoma and black spots). The following adverse reactions were considered potentially related to Visudyne therapy. The adverse reactions are listed by system organ class and frequency using the following convention: 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, adverse reactions are presented in order of decreasing seriousness. Immune system disorders Common Hypersensitivity1. Not known Anaphylactic reaction. Metabolism and nutrition disorders Common Hypercholesteraemia. Nervous system disorders Common Syncope, headache, dizziness1. Uncommon Hyperesthesia. Not known Vasovagal reactions1. Eye disorders Common Severe reduced visual acuity2, visual impairment such as reduced visual acuity, blurred, fuzzy vision, or photopsia, visual field defect such as scotoma, grey or dark haloes and black spots. Uncommon Retinal detachment, retinal haemorrhage, vitreous haemorrhage, retinal oedema. Rare Retinal ischaemia (retinal or choroidal vessel non-perfusion). Not known Retinal pigment epithelial tear, macular oedema. Cardiac disorders Not known Myocardial infarction3. Vascular disorders Uncommon Hypertension. Respiratory, thoracic and mediastinal disorders Common Dyspnoea1. Gastrointestinal disorders Common Nausea. Skin and subcutaneous tissue disorders Common Photosensitivity reaction4. Uncommon Rash, urticaria, pruritus1.

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HOS-084220 · has-contraindication-information · PDF-Seite 3

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Visudyne is also contraindicated in patients with porphyria and in patients with severe hepatic impairment (see “Hepatic impairment” under section 4.2).

HOS-084219 · has-indication-information · PDF-Seite 2

Visudyne is indicated for the treatment of - adults with exudative (wet) age-related macular degeneration (AMD) with predominantly classic subfoveal choroidal neovascularisation (CNV) or - adults with subfoveal choroidal neovascularisation secondary to pathological myopia.

HOS-084222 · has-interaction-information · PDF-Seite 5

No interaction studies have been performed in humans. Other photosensitising agents It is possible that concomitant use of other photosensitising medicinal products (e.g. tetracyclines, sulphonamides, phenothiazines, sulfonylurea, hypoglycaemic medicinal products, thiazide diuretics, and griseofulvin) could increase the potential for photosensitivity reactions. Caution should therefore be exercised when using Visudyne concomitantly with other photosensitising medicinal products (see “Photosensitivity and exposure to light” under section 4.4). Agents which increase verteporfin uptake in the vascular endothelium Agents such as calcium channel blockers, polymixin B, and radiation therapy are known to alter the vascular endothelium. Based on theoretical data and despite the lack of clinical evidence these agents might result in enhanced verteporfin tissue-uptake when used concurrently. Free radical scavengers Although there is no clinical evidence, theoretical data suggest that antioxidants (e.g. beta-carotene) or medicinal products which scavenge free radicals (e.g. dimethylsulfoxide (DMSO), formate, mannitol or alcohol) might quench the activated oxygen species generated by verteporfin, resulting in decreased verteporfin activity. Medicinal products which antagonise blood vessel occlusion Since blood vessel occlusion is the major mechanism of verteporfin action, there is a theoretical possibility that agents such as vasodilators and those which diminish clotting and platelet aggregation (e.g. thromboxane A2 inhibitors) can antagonise the action of verteporfin.

HOS-084223 · has-pregnancy-information · PDF-Seite 5

Pregnancy No clinical data on exposed pregnancies are available for verteporfin. Studies in animals have shown teratogenic effects in one species (rat) (see section 5.3). The potential risk for humans is unknown. Visudyne should not be used during pregnancy unless clearly necessary (only if the benefit justifies the potential risk to the foetus). Breast-feeding Verteporfin and its diacid metabolic are excreted in human milk in low amounts. It should therefore not be administered to nursing mothers, or breastfeeding should be interrupted for 48 hours after administration. 5 Fertility There are no human fertility data for verteporfin. In non-clinical studies, no impairment of fertility and no genotoxicity have been observed (see section 5.3). The clinical relevance is unknown. Patients of reproductive age should be made aware of the lack of fertility data, and Visudyne should only be given after consideration of individual risks and benefits.

HOS-084221 · has-warning-information · PDF-Seite 3

Photosensitivity and exposure to light Patients who receive Visudyne will become photosensitive for 48 hours after the infusion. During that period, patients should avoid exposure of unprotected skin, eyes or other body organs to direct sunlight or bright indoor light such as tanning salons, bright halogen lighting, or high power lighting in surgery operating rooms or dental surgeries. Prolonged exposure to light from light-emitting medical 3 devices such as pulse oximeters should also be avoided for 48 hours following Visudyne administration. If patients have to go outdoors in daylight during the first 48 hours after treatment, they must protect their skin and eyes by wearing protective clothing and dark sunglasses. UV sunscreens are not effective in protecting against photosensitivity reactions. Ambient indoor light is safe. Patients should not stay in the dark and should be encouraged to expose their skin to ambient indoor light, as it will help eliminate the medicinal product quickly through the skin by a process called photobleaching. Use in patients with moderate hepatic impairment or biliary obstruction Visudyne therapy should be considered carefully in patients with moderate hepatic impairment or biliary obstruction since no experience has been gained in these patients. Since verteporfin is excreted primarily via the biliary (hepatic) route, increased verteporfin exposure is possible. Risk of severe decrease of vision Patients who experience a severe decrease of vision (equivalent to 4 lines or more) within one week after treatment should not be re-treated, at least until their vision has completely recovered to pre- treatment level and the potential benefits and risks of subsequent treatment have been carefully considered by the treating physician. Extravasation of the solution for infusion Extravasation of Visudyne, especially if the affected area is exposed to light, can cause severe pain, inflammation, swelling, blistering or discoloration at the injection site. The relief of pain may require analgesic treatment. Localised (skin) necrosis at the injection site following extravasation has also been reported. If extravasation occurs, infusion should be stopped immediately. Protect the affected area thoroughly from bright direct light until swelling and discoloration have disappeared, and put cold compresses on the injection site. To avoid extravasation, a free-flowing intravenous line

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