Visudyne

Visudyne is a prescription medication used in combination with photodynamic therapy treat symptoms associated with certain forms of macular degeneration, myopia, or histoplasmosis.

Visudyne belongs to a group of drugs called photosensitizing agents. When these drugs are activated by light, they help to close up leaking blood vessels in the eye.

This medication is available in an injectable form to be given directly into a vein (IV) by a healthcare professional.

Common side effects of Visudyne include pain, redness, or inflammation at the injection site and visual disturbances.

Visudyne can also cause blurred vision and dizziness. Do not drive or operate heavy machinery until you know how Visudyne affects you.

Visudyne is used in combination with laser light therapy to treat the abnormal growth of leaky blood vessels in the eye caused by wet age-related macular degeneration (a disease of the eye that causes loss of the ability to see straight ahead and may make it more difficult to read, drive, or perform other daily activities), pathologic myopia (a serious form of nearsightedness that worsens with time), or histoplasmosis (a fungal infection) of the eye.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• QLT Ophthalmics, Inc.

• Valeant Pharmaceuticals North America LLC

Serious side effects have been reported with Visudyne. See the “Visudyne Precautions” section.

Common side effects of Visudyne include the following:

• pain, redness, swelling, or discoloration at the site of the injection
• back pain during the infusion
• dry eye
• itchy eye
• dry, itchy skin
• constipation
• nausea
• muscle pain or weakness
• decreased sensitivity to touch
• decreased hearing

This is not a complete list of Visudyne side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• anticoagulants such as warfarin (Coumadin, Jantoven)
• antihistamines such as diphenhydramine (Benadryl, Sominex, in Advil PM, in Tylenol PM), chlorpheniramine (Chlor-Trimeton), or doxylamine (Unisom)
• aspirin or other pain medications
• beta carotene
• calcium channel blockers such as amlodipine (Norvasc), diltiazem (Cardizem, Dilacor, Tiazac, others), felodipine (Plendil), isradipine (DynaCirc), nicardipine (Cardene), nifedipine (Adalat, Procardia), nimodipine (Nimotop), nisoldipine (Sular), and verapamil (Calan, Isoptin, Verelan)
• diuretics ('water pills')
• griseofulvin (Fulvicin-U/F, Grifulvin V, Gris-PEG )
• medications for diabetes, mental illness, and nausea; polymyxin B
• sulfa antibiotics
• tetracycline antibiotics such as demeclocycline (Declomycin), doxycycline (Doryx, Vibramycin), minocycline (Dynacin, Minocin), and tetracycline (Sumycin)

This is not a complete list of Visudyne drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Visudyne including the following:

• decrease or changes in vision
• seeing flashes of light
• black spots in vision
• redness and swelling of the eyelid
• pink eye
• chest pain
• fainting
• sweating
• rash
• shortness of breath
• flushing
• rapid or irregular heartbeat
• headache
• lack of energy
• hives and itching

Visudyne can cause blurred vision and dizziness. Do not drive or operate heavy machinery until you know how Visudyne affects you.

Do not take Visudyne if you:

• are allergic to Visudyne or to any of its ingredients
• have porphyria (a condition that causes sensitivity to light)

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Visudyne, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Visudyne, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Visudyne or to any of its ingredients
• have porphyria (a condition that causes sensitivity to light)
• are being treated with radiation therapy
• have or have had gallbladder disease
• have or have had liver disease
• are pregnant or breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X – are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Visudyne falls into category C. There are no well-controlled studies that have been done in pregnant women. Visudyne should be used during pregnancy only if the possible benefit outweighs the possible risk to the unborn baby.

Tell your doctor if you are breastfeeding or plan to breastfeed.

Visudyne has been detected in human breast milk. Because of the possibility for adverse reactions in nursing infants from Visudyne, a choice should be made whether to stop nursing or to stop use of this medication. The importance of the drug to the mother should be considered.

Take Visudyne exactly as prescribed.

This medication is available in an injectable form to be given directly into a vein (IV) by a healthcare professional. Keep all appointments with your healthcare provider.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• how you respond to this medication
• your height

Visudyne therapy consists of two steps: administration of Visudyne and activation of Visudyne with light from a nonthermal diode laser. The dose of Visudyne is based on body surface area and the light administration is based on the lesion size being treated. Therapy may be repeated after 3 months, if needed.

If you take too much Visudyne, call your healthcare provider or local Poison Control Center or seek emergency medical attention right away.

If Visudyne is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

• Store Visudyne at room temperature.
• Keep this and all medicines out of the reach of children.
• Visudyne will make your skin very sensitive to sunlight and you will be likely to get sunburn. Avoid exposure of the skin and eyes to direct sunlight or bright indoor light (e.g. tanning salons, bright halogen lighting, and high power lighting used in operating rooms or dental offices) for 5 days after the Visudyne infusion. Sunscreen will not protect you during this time.
• Ask your doctor about testing your vision while receiving Visudyne therapy.