Visudyne

Visudyne is used together with a special laser light, to treat abnormal blood vessel formation in a part of the eye which, if left untreated, can lead to a loss of eyesight.

Visudyne may also be used for the following problems:

• Pathologic myopia (changes in the eyeball causing vision problems);
• Ocular histoplasmosis (damage to the eye from a fungus found in the soil)

This medicine is to be administered only by or under the immediate supervision of your doctor. This product is available in the powder for solution dosage form.

Before using Visudyne, you must know all about the risks and complications associated with it. This is a decision you and your doctor will make.

For this medicine, the following should be considered:

Allergies: Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric Population: Studies on this medicine have been done only in adult patients, and there is no specific information comparing the use of verteporfin in children with use in other age groups.

Geriatric Population: Studies show that the effects of verteporfin are less in patients 75 years of age or older.

Pregnancy: All Trimesters: Category C: Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breastfeeding: There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions: Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose or other precautions may be necessary.

Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other Interactions: Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems: The presence of other medical problems may affect the use of this medicine.

Make sure you tell your doctor if you have any other medical problems, especially:

• Liver function impairment
• Porphyria—Sensitivity to light may be increased
• Previous reaction to verteporfin—Reaction is more likely to occur again

Proper usage of Visudyne requires strict adherence to your doctor’s orders. Treatment with Visudyne and laser light occurs in two steps. First, the Visudyne is injected into your body. Second, 15 minutes later, a laser light is directed at the affected eye.

Dosing: The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

Before using Visudyne, there are some precautions you must take. For 5 days after you receive an injection of verteporfin, your eyes will be extra sensitive to light, including sunlight and bright indoor lights.

Certain types of sunglasses can help protect your eyes during this time. Check with your doctor about which sunglasses to use.

For 5 days after you receive an injection of verteporfin, your skin will be extra sensitive to sunlight and to very bright indoor lights, such as tanning lamps, bright halogen lighting and lights in dental offices or operating rooms.

Do not expose your skin to direct sunlight or too bright indoor lights during this time. Sunscreens will not protect your skin from a severe reaction to light (blistering, burning, and swelling of the skin).

However, exposure to normal amounts of indoor light (for example, daylight or light from lamps with shades) will help clear up the verteporfin remaining in your skin.

Therefore, do not protect your skin from normal amounts of indoor light. If you have any questions about whether the light in your home is too bright, check with your doctor or nurse. If you do have a severe reaction to light, call your doctor immediately

As with many medications, there are several potential side effects associated with Visudyne. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common:

• blurred vision or other change in vision

Less common:

• the decrease in vision may be severe
• dizziness
• dull nervousness
• eye pain
• fainting
• fast, slow, or irregular heartbeat
• itching, redness, or other irritation of the eye
• pale skin
• pounding in the ears
• troubled breathing on exertion
• unusual bleeding or bruising
• unusual tiredness or weakness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common:

• bleeding
• blistering
• burning
• coldness
• discoloration of the skin
• the feeling of pressure
• infection
• itching
• numbness
• pain
• rash
• redness
• scarring
• stinging
• swelling
• tenderness
• tingling
• ulceration
• warmth at the injection site
• headache

Less common:

• back pain (during infusion of verteporfin)
• chills
• cloudy urine
• constipation
• cough
• decreased hearing
• decreased sensitivity to touch
• diarrhea
• difficult or painful urination
• difficulty in moving
• double vision
• dry eyes
• the feeling of constant movement of self or surroundings
• fever
• the general feeling of discomfort or illness
• hoarseness
• increased sensitivity of skin to sunlight
• joint pain
• lightheadedness
• loss of appetite
• loss of strength or energy
• muscle pain or stiffness
• nausea
• pain, swelling, or redness in joints
• pelvic discomfort
• redness or other discoloration of the skin
• runny nose
• severe sunburn
• shivering
• skin rash
• sore throat
• sweating
• tearing
• tender, swollen glands in neck
• throat congestion
• trouble in sleeping
• trouble in swallowing
• trouble sleeping
• varicose veins
• voice changes
• vomiting

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.