Visudyne

(Verteporfin)

The active ingredient in Visudyne is verteporfin and is used as part of a treatment called photodynamic therapy. It is given as a 10-minute IV infusion. The laser light therapy is then started 15 minutes after the infusion begins. Your provider will focus the light on the treatment area to turn on Visudyne in this specific area.

This treatment helps slow vision loss caused by abnormal blood vessels growing beneath the retina. Visudyne is not a cure, but it may help reduce further damage and preserve visual acuity when used correctly and with proper follow-up.

Follow all directions given to you by your doctor and read all documents provided, including the full Prescribing Information, FDA-Approved Product Labeling, Instructions for Use, and Medication Guide before using Visudyne. However, the following is a synopsis of the general guidelines for the use of Visudyne:

• Visudyne is given as an infusion into a vein, usually in the arm.
• After the infusion, the treated eye is exposed to laser light of a specific wavelength to activate the medicine.
• The laser treatment targets abnormal blood vessels beneath the retina.
• Protective measures are required after treatment to avoid direct light exposure. UV sunscreens are not effective in protecting against photosensitivity reactions.
• Dark sunglasses and protective clothing should be worn when outdoors.
• Bright indoor lights should also be avoided for a period recommended by your healthcare professional.
• Follow-up visits are required to assess response and determine if retreatment is needed.

Some mild or common side effects of Visudyne seen in clinical trials include:

• Blurred vision.
• Visual disturbances such as scotoma (blind spot) or reduced visual field.
• Injection site reactions, including pain or swelling.

Some individuals may experience serious side effects while using Visudyne. These side effects may require immediate medical attention. If you experience any of the following, contact your healthcare provider or seek emergency medical help:

• Severe vision loss or a sudden decrease in visual acuity.
• Hypersensitivity reactions, including rashes or swelling.
• Extravasation at the injection site, which may cause discoloration or tissue injury.
• Severe photosensitivity reactions after exposure to direct sunlight or bright indoor light.

These are not all of the possible side effects of Visudyne. You should always seek medical advice from your healthcare provider for any questions or concerns about your medical condition or treatment. Read all patient information, medication guides, or drug information sheets that come with this medication. You can also report adverse effects to the Food and Drug Administration at www.fda.gov/medwatch or 1-800-FDA-1088.

Before starting Visudyne, it is crucial to discuss any existing health conditions with your healthcare provider. You should be sure that your healthcare provider is aware of all your medical conditions, including:

• Porphyria or other conditions that cause sensitivity to light.
• Liver disease may affect drug clearance.
• A history of hypersensitivity reactions.
• Vision loss not related to choroidal neovascularization.

Visudyne should not be used in patients who:

• Have porphyria (blood enzyme deficiency).
• Have known hypersensitivity to verteporfin or any component of the formulation.
• Your healthcare professional will determine whether Visudyne therapy is appropriate for your condition.

Visudyne works during the treatment session when the drug is activated by laser light. Changes in abnormal blood vessels occur shortly after therapy, but improvements or stabilization of vision are assessed over weeks during follow-up visits.

When Visudyne is taken with other prescription drugs, over-the-counter medications, vitamins, and supplements, it may change how they work or increase the frequency or severity of side effects. Make sure that you tell your healthcare professional about anything that you are taking to avoid any negative drug interactions, including:

Photosensitizing medications may increase the risk of light-activated adverse reactions.

Visudyne is available as an intravenous infusion of Visudyne formulation used for photodynamic therapy.

Visudyne should be stored according to the full prescribing information and handled by healthcare professionals in a clinical setting.

Visudyne is manufactured by Bausch + Lomb.

No. There is no generic version of Visudyne currently available.

Visudyne is administered as a procedure-based treatment. Decisions about discontinuation or retreatment are made by your healthcare professional based on follow-up examinations and clinical studies.

Talk to your doctor if you are already pregnant or if you have any plans to become pregnant. They will know or recommend what is best for you based on potential benefits and risks.

Talk to your doctor if you are already breastfeeding or if you have any plans to breastfeed. They will know or recommend what is best for you.