Visudyne
verteporfin
verteporfin
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor, pharmacist or nurse.
This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
If you get any side effects talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
What Visudyne is and what it is used for
What you need to know before you are given Visudyne
How Visudyne is used
Possible side effects
How to store Visudyne
Contents of the pack and other information
Visudyne contains the active substance verteporfin, which is activated by light from a laser in a treatment called photodynamic therapy. When you are given an infusion of Visudyne, it is distributed within your body through the blood vessels, including the blood vessels at the back of the eye. When the laser light is shone into the eye, Visudyne is activated.
Visudyne is used to treat the wet form of age-related macular degeneration and pathological myopia.
These diseases lead to vision loss. Vision loss is caused by new blood vessels (choroidal neovascularisation) that damage the retina (the light-sensitive membrane that lines the back of the eye). There are two types of choroidal neovascularisation: classic and occult.
Visudyne is used for the treatment of predominantly classic choroidal neovascularisation in adults with age-related macular degeneration, and also for the treatment of all types of choroidal neovascularisation in adults with pathological myopia.
if you are allergic to verteporfin or any of the other ingredients of this medicine (listed in section 6).
if you have porphyria (a rare condition that may increase sensitivity to light).
if you have any severe liver problems.
If any of these apply to you, tell your doctor. You should not be given Visudyne.
beat or seizure, please tell your doctor or nurse immediately, as the infusion may need to be stopped and your condition may need to be treated urgently. Infusion-related problems may also include sudden loss of consciousness.
Tell your doctor, nurse or pharmacist if you are taking, have recently taken or might take any other medicines.
Tell your doctor or pharmacist if you are taking any of the following medicines, as they may increase your sensitivity to light:
tetracyclines or sulphonamides (used to treat bacterial infection),
phenothiazines (used to treat psychiatric disorders, or nausea and vomiting),
sulfonylurea (used to treat diabetes),
medicines used to lower blood sugar,
thiazide diuretics (used to reduce high blood pressure),
griseofulvin (used to treat fungal infection),
calcium channel blockers (used to treat high blood pressure, angina and abnormal heart rhythms),
antioxidants such as beta-carotene or medicines that can remove or inactivate free radicals (such as dimethylsulfoxide (DMSO), formate, mannitol and alcohol),
vasodilators (used to widen blood vessels resulting from smooth muscle relaxation),
or, if you are undergoing radiation therapy,
There is very little experience of using Visudyne in pregnant women. It is important to tell your doctor if you are pregnant, if you think you may be pregnant or if you plan to become pregnant. You should only be given Visudyne if your doctor considers it absolutely essential.
Verteporfin passes into human milk in low amounts. Please tell your doctor if you are breastfeeding. He/she will decide whether you should be given Visudyne. It is recommended that, if you are given Visudyne, you do not breastfeed for 48 hours after administration.
Ask your doctor or pharmacist for advice before taking any medicine.
After Visudyne treatment you may have some vision problems, such as abnormal or decreased vision, which may be temporary. If this happens to you, do not drive or use any tools or machines until your vision improves.
This ingredient is irritant to eyes, skin and mucous membranes. If you come into direct contact with Visudyne, you must therefore wash it off thoroughly with water.
Treatment with Visudyne is a two-step process
First your doctor or the pharmacist will prepare the Visudyne infusion solution. It will be administered by your doctor or nurse into a vein using a drip (intravenous infusion).
The second step is the activation of Visudyne in the eye 15 minutes after the start of the infusion. Your doctor will put a special contact lens onto your eye and treat your eye using a special laser. It takes 83 seconds to deliver the laser dose required to activate Visudyne. During this time, you will have to follow your doctor’s instructions and keep your eyes still.
If necessary, Visudyne therapy can be repeated every 3 months, up to 4 times per year.
Visudyne is a treatment for adults only and not indicated for the use in children.
Overdose of Visudyne may prolong the time during which you are sensitive to light and you may need to follow the protection instructions given in section 2 for longer than 48 hours. Your doctor will advise you.
Overdose of Visudyne and light in the treated eye may result in severe vision decrease.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
visual disturbances such as blurred, hazy or fuzzy vision, flashes of light, decreased vision, and a change in the field of vision in the treated eye such as grey or dark shadows, blind spots or black spots.
in the treated eye.
If you experience any of these, tell your doctor straight away. Other side effects:
If you get any side effects, talk to your doctor, nurse or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the
safety of this medicine.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and vial after “EXP”. The expiry date refers to the last day of that month.
Do not store above 25°C. Keep the vial in the outer carton in order to protect from light.
Chemical and physical in-use stability has been demonstrated for 4 hours at 25°C. From a microbiological point of view, the medicine should be used immediately. If not used immediately, the in-use storage time and conditions prior to use are the responsibility of the user and would normally not last longer than 4 hours below 25°C protected from light.
The active substance is verteporfin. Each vial contains 15 mg of verteporfin. After reconstitution, 1 ml contains 2 mg of verteporfin. 7.5 ml of reconstituted solution contains 15 mg of verteporfin.
The other ingredients are dimyristoyl phosphatidylcholine, egg phosphatidylglycerol, ascorbyl palmitate, butylated hydroxytoluene (E321) and lactose monohydrate.
Visudyne is supplied as a dark green to black powder in a clear glass vial. The powder is reconstituted in water prior to use to form an opaque dark green solution.
Visudyne is available in packs containing 1 vial of powder.
17489 Greifswald Germany
Delpharm Huningue S.A.S. 26 rue de la Chapelle 68330 Huningue
France
CHEPLAPHARM Arzneimittel GmbH Ziegelhof 23-24
17489 Greifswald Germany
Reconstitute Visudyne in 7.0 ml water for injections to produce 7.5 ml of a 2.0 mg/ml solution. Reconstituted Visudyne is an opaque dark green solution. It is recommended that reconstituted Visudyne be inspected visually for particulate matter and discoloration prior to administration. For a dose of 6 mg/m2 body surface (the dose recommended for the treatment) dilute the required amount of Visudyne solution in dextrose 50 mg/ml (5 %) solution for infusion to a final volume of 30 ml. Do not use sodium chloride solution. Use of a standard infusion line filter with hydrophilic membranes (such as polyethersulfone) of a pore size of not less than 1.2 μm is recommended.
For storage conditions, please see section 5 of this leaflet.
The vial and any unused portion of reconstituted solution should be discarded after single use.
If material is spilled, it should be contained and wiped up with a damp cloth. Eye and skin contact should be avoided. Use of rubber gloves and eye protection is recommended. Any unused medicine or waste material should be disposed of in accordance with local requirements.