15 mg powder for infusion, solution.
Verteporfin
What Visudyne is and what it is used for
What Visudyne is
Visudyne contains the active substance verteporfin, which is activated by light from a laser in a treatment called photodynamic therapy. When you receive an infusion of Visudyne, it is distributed throughout your body through the blood vessels, including the blood vessels in the back of the eye. When the laser light hits the eye, Visudyne is activated.
What Visudyne is used for
Visudyne is used to treat the wet form of age-related macular degeneration and morbid myopia.
These diseases lead to vision loss. Vision loss is caused by new blood vessels (choroidal neovascularization) that damage the retina (the light-sensitive membrane that covers the back of the eye). There are two types of choroidal neovascularization; classical and occult.
Visudyne is predominantly used in the treatment of classic choroidal neoplasm in adults with age-related macular degeneration and in the treatment of all types of choroidal neoplasm in adults with morbid myopia.
What you need to know before you receive Visudyne
You must not be treated with Visudyne
- if you are allergic to verteporfin or any of the other ingredients of this medicine (listed in section 6).
- if you suffer from porphyria (a rare disease that can lead to increased sensitivity to light).
- if you have any kind of serious liver problems.
Tell your doctor if any of the above apply to you. You should not then be treated with Visudyne.
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before you are given Visudyne
- If during or after treatment, you experience any problems or symptoms related to the infusion such as chest pain, sweating, dizziness, rash, shortness of breath, flushing, irregular heartbeat, or seizures, you should inform your doctor or nurse immediately as the infusion may need to be stopped and your condition may need immediate treatment. Problems related to the infusion can also include sudden loss of consciousness.
- If you have any kind of liver problem or blockage of the bile ducts, talk to your doctor before starting Visudyne treatment.
- If Visudyne gets outside the blood vessel during infusion, and especially if the affected area is exposed to light, this may cause pain, swelling, blistering, and discoloration of the skin in the area where the leakage occurred. If this should occur, the infusion must be discontinued and the skin treated with cold compresses and carefully protected from light until the skin color returns to normal. If necessary, you can take some pain reliever.
- You will be sensitive to bright light for 48 hours after infusion one. During that time, you must avoid exposure to direct sunlight, bright indoor lights such as tanning beds, bright halogen or high-powered lighting of the type used in surgery and dental care, as well as light from light-emitting medical devices such as pulse oximeters (used to measure oxygen in the blood). If you must be outdoors in daylight during the first 48 hours after treatment, you must protect your skin and eyes by wearing protective clothing and dark sunglasses. Sunscreen does not work as protection. Normal indoor lighting is harmless.
- Do not stay in the dark, as normal indoor lighting helps the body excrete Visudyne faster.
- Talk to your doctor if you experience any eye problems after the treatment, such as loss of vision.
Other medicines and Visudyne
Tell your doctor, pharmacist, or nurse 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 taking these medicines can increase your sensitivity to light:
- tetracyclines or sulfonamides (used to treat bacterial infections ),
- phenothiazine (used to treat mental illness or nausea and vomiting),
- sulfonylureas (used to treat diabetes ),
- medicines that lower blood sugar,
- thiazide diuretics (used to lower high blood pressure ),
- griseofulvin (used to treat fungal infection),
- calcium channel blockers (for the treatment of high blood pressure, angina pectoris, and abnormal heart rhythms),
- antioxidants such as beta-carotene or drugs that can remove or inactivate free radicals (such as dimethyl sulfoxide (DMSO), formate, mannitol, and alcohol),
- vasodilators (used to widen blood vessels due to relaxation of smooth muscle ),
- or if you are undergoing radiation therapy,
Pregnancy and breastfeeding
- There is very little experience with the use of Visudyne in pregnant women. You must tell your doctor if you are pregnant, if you think you may be pregnant or if you are planning to have a baby. You should only be treated with Visudyne if your doctor considers it necessary.
- Verteporfin passes into human breast milk in small amounts. Tell your doctor if you are breastfeeding. He/she can decide whether you should be treated with Visudyne. If you are treated with Visudyne, it is recommended that you do not breastfeed for 48 hours after administration.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving ability and use of machinery
After treatment with Visudyne, you may experience certain vision problems, such as abnormal or impaired vision, which may be temporary. If this should happen, you should refrain from driving and using tools or machines until your vision improves.
Visudyne contains small amounts of butylated hydroxytoluene (E321)
This substance is irritating to the eyes, skin, and mucous membranes.
If you come into direct contact with Visudyne, you must therefore rinse the agent thoroughly with plenty of water.
How to use Visudyne
Treatment with Visudyne is a two-step process.
- First, your doctor or pharmacist will prepare the Visudyne infusion solution. It is then given by your doctor or nurse into a vein as a drip ( intravenous infusion ).
- The second step is the activation of Visudyne in the eye 15 minutes after the infusion is started. Your doctor will place a special type of contact lens on your eye and treat the eye with a special laser. It takes 83 seconds to deliver the laser dose required to activate the Visudyne. While this is happening, you must follow the doctor’s instructions and keep your eyes still.
If necessary, the Visudyne therapy can be repeated every three months, up to 4 times a year.
Use for children
Visudyne is a treatment for adults only and is not intended for children.
If you have been given too much Visudyne
If you have received too much Visudyne, you may become sensitive to light for a longer period and you may need to follow the protection instructions in section 2 for longer than 48 hours. Your doctor will then provide you with further information.
Overdosage of Visudyne and light in the treated eye may result in severe visual impairment.
If you have any further questions about this medicine, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some side effects can be serious:
Common (may affect up to 1 in 10 people)
- Eyes: Severe deterioration of visual acuity (loss of 4 lines or more within 7 days of treatment), visual disturbances such as cloudy, blurred, or foggy vision, flashes of light, reduced vision, and changes in the field of vision in the treated eye such as gray or dark shadows, blind spots or black spots.
- General symptoms: Hypersensitivity (allergic reactions), syncope (fainting), headache, dizziness, and shortness of breath.
Uncommon (may affect up to 1 in 100 people)
- Eyes: Bleeding into the retina or into the vitreous (the clear, jelly-like substance that fills the eyeball behind the lens), swelling or fluid accumulation in the retina, and retinal detachment in the treated eye.
- Infusion site reactions: As with other types of injection, some patients experienced bleeding at the infusion site, skin discoloration, and hypersensitivity. If this were to happen to you, it would cause increased photosensitivity in the affected skin area until the green discoloration disappears.
- General symptoms: rash, hives, itching
Rare (may affect up to 1 in 1,000 people)
- Eyes: No blood circulation in the retina or the choroid (the blood-vessel-rich lining of the eye) in the treated eye.
- General symptoms: Feeling of discomfort.
Frequency not known (cannot be estimated from available data)
- Eyes: Damage to the colored layer of the retina, swelling, or fluid accumulation in the macula.
- General symptoms: Vasovagal reactions (dizziness and fainting), sweating, flushing, or changes in blood pressure. In rare cases, these vasovagal reactions and hypersensitivity may be severe and may include seizures.
- Myocardial infarction has been reported, particularly in patients with pre-existing cardiovascular disease, in some cases within 48 hours of treatment with Visudyne. In the event of a suspected heart attack, medical attention must be sought immediately.
- Local skin tissue death ( necrosis ).
If you feel any of these symptoms, talk to your doctor immediately.
Other side effects are :
Common (may affect up to 1 in 10 people)
- Infusion site reactions: as with other types of injection, some patients may experience pain, swelling, inflammation, and fluid leakage at the infusion site.
- General symptoms: nausea, reactions similar to sun damage on the skin, fatigue, infusion-related reactions mainly manifesting as chest pain or back pain, and increased cholesterol.
Uncommon (may affect up to 1 in 100 people)
- General symptoms: pain, increased blood pressure, increased sensitivity, and fever.
Frequency not known (cannot be estimated from available data)
- Infusion site reactions: as with other types of injection, some patients may experience blisters.
- General symptoms: changes in heart rate, infusion-related pain that may present as chest pain and may involve other areas, including hips, shoulders, or chest.
How to store Visudyne
Keep this medicine out of the sight and reach of children.
Use before the expiry date which is stated on the carton and bottle after “EXP”. The expiration date is the last day of the specified month.
Store at a maximum of 25 ºC. Store the vial in the outer carton. Light sensitive.
The chemical and physical stability of the premixed preparation has been demonstrated for 4 hours at 25 °C. From a microbiological point of view, the drug should be used immediately. If not used immediately, the user is responsible for the storage time in the ready-mixed state and its condition before use. Normally, the finished preparation cannot be stored for longer than 4 hours at a maximum of 25 °C, protected from light.
Contents of the packaging and other information
Contents declaration
- The active substance is verteporfin. Each vial contains 15 mg of verteporfin. After preparation , 1 ml contains 2 mg of verteporfin. 7.5 ml of ready-made solution contains 15 mg of verteporfin.
- Other ingredients are dimyristoyl phosphatidylcholine, egg phosphatidylglycerol, ascorbyl palmitate, butylated hydroxytoluene (E321), and lactose monohydrate.
Appearance and package sizes of the medicine
Visudyne is supplied as a dark green to black powder in a clear glass vial. The powder is reconstituted with water before use, forming an opaque dark green solution.
Visudyne is available in packs containing 1 vial of powder.
Marketing Authorisation Holder
CHEPLAPHARM Arzneimittel GmbH
Ziegelhof 24
17489 Greifswald
Germany
Manufacturer
Novartis Pharma GmbH
Roonstrasse 25
90429 Nuremberg
Germany