Verteporfin (intravenous route, injection route)


    Brand Name

    US Brand Name

    Visudyne


    Description

    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.

    This product is available in the following dosage forms:

    • Powder for Solution

    Before Using

    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.

    Pediatric

    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.

    Geriatric

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

    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 Use

    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

    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

    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.






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