Visudyne 15 mg powder for solution for infusion

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Visudyne 15 mg powder for solution for infusion

verteporfin

Read the entire leaflet carefully before you are given this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only, and you should not pass it on to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist or nurse, including any adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Visudyne is and what it is used for
2. What you need to know before being given Visudyne
3. How to use Visudyne
4. Possible side effects
5. How to store Visudyne
6. Contents of the pack and other information

1. What Visudyne is and what it is used for

What Visudyne is

Visudyne contains the active substance verteporfin, which is activated by laser light in a treatment known as photodynamic therapy. When you are given a Visudyne infusion, it spreads throughout your body via the blood vessels, including the blood vessels at the back of the eye. When laser light is directed at the eye, Visudyne becomes activated.

What Visudyne is used for

Visudyne is used to treat the wet form of age-related macular degeneration and pathological myopia.

These diseases cause vision loss. The vision loss is due to the growth of new blood vessels (choroidal neovascularization) that damage the retina (the light-sensitive layer lining the back of the eye). There are two types of choroidal neovascularization: classic and occult.

Visudyne is used to treat predominantly classic choroidal neovascularization in adults with age-related macular degeneration, and also to treat all types of choroidal neovascularization in adults with pathological myopia.

2. What you need to know before Visudyne is administered to you

Do not be given Visudyne

• if you are allergic to verteporfin or to any of the other components of this medicine (listed in section 6).
• if you have porphyria (a rare disorder that may increase light sensitivity).
• if you have severe liver problems.

If you are in any of these situations, inform your doctor. You must not be given Visudyne.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before being given Visudyne

• If you experience any infusion-related problems or symptoms during or after treatment such as chest pain, sweating, dizziness, rash, difficulty breathing, flushing, irregular heartbeat, or seizures, inform your doctor or nurse immediately, as the infusion may need to be stopped and you may require urgent treatment. Infusion-related problems may also include sudden loss of consciousness.
• If you have liver problems or a blockage in the bile duct, inform your doctor before starting treatment with Visudyne.
• If Visudyne leaks out of the vein (extravasation) during infusion, and particularly if the affected area is exposed to light, it may cause pain, swelling, blistering, and skin discoloration at the leakage site. If this occurs, the infusion must be stopped, the skin should be treated with cold compresses, and the area must be completely protected from light until the skin color returns to normal. You may need to take a pain reliever.
• You will be sensitive to bright light for 48 hours after the infusion. During this time, avoid direct exposure to sunlight, bright indoor lights such as tanning beds, bright halogen lights, high-intensity surgical or dental lamps, or light from medical light-emitting devices such as pulse oximeters (used to measure blood oxygen levels). If you need to go outdoors during the day within the first 48 hours after treatment, protect your skin and eyes by wearing protective clothing and dark sunglasses. Sunscreens do not provide adequate protection. Dim indoor lighting is safe.
• Do not stay in the dark, as exposure to normal indoor light will help your body eliminate Visudyne more quickly.
• If you notice any eye problems after treatment, such as vision loss, inform your doctor.

Other medicines and Visudyne

Tell your doctor, nurse, or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Inform your doctor or pharmacist if you are taking any of the following medicines, as they may increase your sensitivity to light:

• tetracyclines or sulfonamides (used to treat bacterial infections),
• phenothiazines (used to treat psychiatric disorders, or nausea and vomiting),
• sulfonylureas (used to treat diabetes),
• medications used to lower blood sugar,
• thiazide diuretics (used to reduce high blood pressure),
• griseofulvin (used to treat fungal infections),
• calcium channel blockers (used to treat high blood pressure, angina, and abnormal heart rhythms),
• antioxidants such as beta-carotene or medications that may eliminate or inactivate free radicals (such as dimethyl sulfoxide (DMSO), formate, mannitol, and alcohol),
• vasodilators (used to widen blood vessels by relaxing smooth muscle),
• or if you are undergoing radiation therapy.

Pregnancy and breastfeeding

• There is very limited experience with the use of Visudyne in pregnant women. It is important that you inform your doctor if you are pregnant, think you may be pregnant, or plan to become pregnant. Visudyne will only be given to you if your doctor considers it absolutely essential.
• Verteporfin passes into breast milk in small amounts. Inform your doctor if you are breastfeeding. They 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.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

After treatment with Visudyne, you may experience some vision problems, such as abnormal or decreased vision, which may be temporary. If this occurs, do not drive or operate tools or machinery until your vision improves.

Visudyne contains small amounts of butylated hydroxytoluene (E321)

This component may be irritating to the eyes, skin, and mucous membranes.

Therefore, in case of direct contact with Visudyne, wash the area thoroughly with water.

3. How to use Visudyne

Treatment with Visudyne is a two-step process

• First, your doctor or pharmacist will prepare the Visudyne infusion solution. This will be administered by your doctor or nurse into a vein using an infusion pump (intravenous infusion).

• The second step is the activation of Visudyne in the eye 15 minutes after the start of the infusion. Your doctor will place a special contact lens in your eye and treat it using a special laser. It will take 83 seconds for the laser to deliver the required dose to activate Visudyne. During this time, you must follow your doctor's instructions and keep your eyes still.

If necessary, Visudyne therapy may be repeated every 3 months, up to 4 times per year.

Use in children

Visudyne is a treatment intended only for adults and is not indicated for use in children.

If you have been given more Visudyne than you should

In case of Visudyne overdose, the period during which you experience light sensitivity may be prolonged, and you may need to follow the protection instructions indicated in section 2 for longer than 48 hours. Your doctor will advise you accordingly.

An overdose of Visudyne combined with light exposure in the treated eye may cause severe vision loss.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

Some adverse effects may be serious:

Common (may affect up to 1 in 10 patients)

• Eye disorders: severe decrease in vision (loss of 4 or more lines within 7 days after treatment), visual disturbances such as blurred or cloudy vision, flashes of light, decreased vision, and changes in the visual field of the treated eye such as dark or grey shadows, blind spots, or black spots.
• General disorders: hypersensitivity (allergic reactions), syncope (fainting), headache, dizziness, difficulty breathing.

Uncommon (may affect up to 1 in 100 patients)

• Eye disorders: bleeding in the retina or vitreous humour (the transparent gel-like substance that fills the eye behind the lens), swelling or fluid retention in the retina, and retinal detachment in the treated eye.
• Injection site reactions: as with other types of injections, some patients experienced bleeding at the injection site, skin discoloration, and hypersensitivity. If this occurs, you will have increased light sensitivity in that area of skin until the greenish discoloration disappears.
• General disorders: rash, urticaria, itching.

Rare (may affect up to 1 in 1,000 patients)

• Eye disorders: lack of blood supply to the retina or choroid (the vascular layer of the eye) in the treated eye.
• General disorders: feeling unwell.

Frequency not known (frequency cannot be estimated from available data)

• Eye disorders: tear in the pigmented layer of the retina, swelling or fluid retention in the macula.
• General disorders: vasovagal reactions (fainting), sweating, flushing, or changes in blood pressure have been reported. In rare cases, hypersensitivity and vasovagal reactions may be severe and potentially include seizures.
• Heart attack has been reported, particularly in patients with prior history of heart disease, in some cases within 48 hours following treatment with Visudyne. In case of suspected heart attack, seek immediate medical attention.
• Localized skin tissue death (necrosis).

If you experience any of these adverse effects, inform your doctor immediately.

Other adverse effects:

Common (may affect up to 1 in 10 patients)

• Injection site reactions: as with other types of injections, some patients experienced pain, swelling, inflammation, and exudation at the injection site.
• General disorders: dizziness (nausea), sunburn-like reactions, fatigue, infusion-related reaction, which mainly presents as chest pain or back pain, and increased cholesterol levels.

Uncommon (may affect up to 1 in 100 patients)

• General disorders: pain, increased blood pressure, increased sensitivity, and fever.

Frequency not known (frequency cannot be estimated from available data)

• Injection site reactions: as with other types of injections, some patients experienced blister formation.
• General disorders: changes in heart rate. Infusion-related reaction that may radiate to other areas, including but not limited to the pelvis, shoulders, or chest.

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor, nurse, or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Visudyne

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the carton after “CAD” and on the vial after “EXP”. The expiry date refers to the last day of the month indicated.

Do not store above 25°C. Store the vial in the outer packaging to protect it from light.

Chemical and physical stability during use has been demonstrated for 4 hours at 25°C. From a microbiological standpoint, the medicine should be used immediately. If not used immediately, the conditions and duration of storage prior to use shall be the responsibility of the user and must not exceed 4 hours at less than 25°C, protected from light.

6. Package contents and other information

Composition of Visudyne

• 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 components are dimyristoyl phosphatidylcholine, egg phosphatidylglycerol, ascorbyl palmitate, butylated hydroxytoluene (E321), and monohydrate lactose.

Appearance of the product and contents of the pack

Visudyne is supplied as a dark green to black powder in a clear glass vial. Prior to use, the powder is reconstituted with water to form an opaque, dark green solution.

Visudyne is available in packs containing 1 vial of powder.

Marketing Authorization Holder

CHEPLAPHARM Arzneimittel GmbH

Ziegelhof 24

17489 Greifswald

Germany

Manufacturer

Delpharm Huningue S.A.S.

26 rue de la Chapelle

68330 Huningue

France

CHEPLAPHARM Arzneimittel GmbH

Ziegelhof 23-24

17489 Greifswald

Germany

Date of the most recent revision of this summary:

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu

This information is intended for healthcare professionals only:

Reconstitute Visudyne with 7.0 ml of water for injections to obtain 7.5 ml of a solution with a concentration of 2.0 mg/ml. Reconstituted Visudyne is an opaque, dark green solution. It is recommended that reconstituted Visudyne be inspected visually for the presence of particles and discoloration prior to administration. To achieve a dose of 6 mg/m² of body surface area (the recommended treatment dose), dilute the required amount of Visudyne solution in 50 mg/ml (5%) dextrose solution for infusion to a final volume of 30 ml. Do not use sodium chloride solution. A standard in-line filter with hydrophilic membranes (such as polyethersulfone) and a pore size of not less than 1.2 micrometers is recommended.

For storage conditions, please refer to section 5 of this summary.

The vial and any unused reconstituted solution must be discarded after use (single use only).

If solution is spilled, it should be wiped up with a damp cloth. Contact with eyes and skin should be avoided. Rubber gloves and eye protection are advised. Disposal of unused medicine and all materials that have come into contact with it must be carried out in accordance with local regulations.