Pronunciation:

ver-te-PORE-fin

Brand Names:

• Visudyne

Dosage Forms:

• Powder for Solution

Classifications:

Therapeutic—

Photosensitizing Agent

Uses of This Medicine:

Verteporfin 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.

Verteporfin 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.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. 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.

Children—

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

Older adults—

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

Breast-feeding—

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.

Other medicines—

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 Use of This Medicine:

Treatment with verteporfin and laser light occurs in two steps. First, the verteporfin 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.

Precautions While Using This Medicine:

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 to 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.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. 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

Decrease in vision, may be severe

dizziness

dull nervousness

eye pain

fainting

fast, slow, or irregular heartbeat

itching, redness, or other irritation of 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 skin, feeling of pressure, infection, itching, numbness, pain, rash, redness, scarring, stinging, swelling, tenderness, tingling, ulceration, and/or 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

feeling of constant movement of self or surroundings

fever

general feeling of discomfort or illness

hoarseness

increased sensitivity of skin to sunlight

joint pain

light headedness

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 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.