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Visudyne is a brand name for Verteporfin. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: 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.
Verbatim from this product's EMA label. Tap a section to expand.
Visudyne should be administered only by ophthalmologists experienced in the management of patients with age-related macular degeneration or with pathological myopia. 6). The second step is the light activation of Visudyne at 15 minutes after the start of the infusion (see “Method of administration”).
Patients should be re-evaluated every 3 months. In the event of recurrent CNV leakage, Visudyne therapy may be given up to 4 times per year. Treatment of the second eye with Visudyne There are no clinical data to support concomitant treatment of the second eye.
However, if treatment of the second eye is deemed necessary, light should be applied to the second eye immediately after light application in the first eye but no later than 20 minutes from the start of the infusion. 3 Special populations Hepatic impairment Visudyne therapy should be considered carefully in patients with moderate hepatic dysfunction or biliary obstruction.
No experience is available in these patients. Since verteporfin is excreted primarily via the biliary (hepatic) route, increased verteporfin exposure is possible. 2) and does not require any dose adjustment. 3). Renal impairment Visudyne has not been studied in patients with renal impairment.
2). Paediatric population The safety and efficacy of Visudyne in the paediatric population have not been established. Visudyne is not indicated in this population. Method of administration This medicinal product is intended for intravenous infusion only.
For the light activation of Visudyne, a diode laser generating non-thermal red light (wavelength 689 nm ± 3 nm) is used via a slit lamp mounted fibre optic device and a suitable contact lens. At the recommended light intensity of 600 mW/cm2, it takes 83 seconds to deliver the required light dose of 50 J/cm2.
The greatest linear dimension of the choroidal neovascular lesion is estimated using fluorescein angiography and fundus photography. 6X are recommended. The treatment spot should cover all neovasculature, blood and/or blocked fluorescence.
To ensure treatment of poorly demarcated lesion borders, an additional margin of 500 μm should be added around the visible lesion. The nasal edge of the treatment spot must be at least 200 μm from the temporal edge of the optic disc.
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.
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 4 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.
1. 2).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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The maximum spot size used for the first treatment in the clinical studies was 6,400 μm. For treatment of lesions that are larger than the maximum treatment spot size, apply the light to the greatest possible area of active lesion. It is important to follow the above recommendations to achieve the optimal treatment effect.
6.
7 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.
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. 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. 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.
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.
Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
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 should be established before starting Visudyne infusion and the line should be monitored. The largest possible arm vein, preferably the antecubital, should be used for the infusion and small veins in the back of the hand should be avoided.
Hypersensitivity reactions Chest pain, vasovagal reactions and hypersensitivity reactions related to Visudyne infusion have been reported. Both vasovagal and hypersensitivity reactions are associated with general symptoms such as syncope, sweating, dizziness, rash, dyspnoea, flushing, and changes in blood pressure and heart rate.
On rare occasions these reactions may be severe and potentially include convulsions. Patients should be under close medical supervision during the Visudyne infusion. Cases of anaphylactic reactions have been observed in patients receiving Visudyne.
If an anaphylactic or other serious allergic reaction occurs during or following infusion, administration of Visudyne should be discontinued immediately and appropriate therapy initiated. Anaesthesia There are no clinical data on the use of Visudyne in anaesthetised patients.
In sedated or anaesthetised pigs, a Visudyne dose significantly higher than the recommended dose in patients given as a bolus injection caused severe haemodynamic effects including death, probably as a result of complement activation.
Pre-dosing with diphenhydramine diminished these effects, suggesting that histamine may play a role in this process. This effect was not observed in conscious non-sedated pigs, or in any other species, including man. Verteporfin at more than 5 times the expected maximum plasma concentration in treated patients, caused a low level of complement activation in human blood in vitro.
No clinically 5 relevant complement activation was reported in clinical trials but anaphylactic reactions have been reported during post-marketing surveillance. Patients should be under close medical supervision during the Visudyne infusion and caution should be exercised when Visudyne treatment under general anaesthesia is considered.
Other Visudyne contains small amounts of butylated hydroxytoluene (E321), which may be irritant to eyes, skin and mucous membranes. Therefore it must be washed off extensively with water in the event of direct contact.