Avacincaptad pegol (intraocular route)


    Brand Name

    US Brand Name

    Izervay


    Description

    Avacincaptad pegol injection is used to treat geographic atrophy (GA) secondary to age-related macular degeneration (AMD). AMD is a disorder of the retina in the eye that causes blurred vision or blindness.

    This medicine is to be given only by your doctor.

    This product is available in the following dosage forms:

    • 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

    Appropriate studies have not been performed on the relationship of age to the effects of avacincaptad pegol injection in the pediatric population. Safety and efficacy have not been established.

    Geriatric

    Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of avacincaptad pegol injection in the elderly.

    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:

    • Detached retina (eye disorder) or
    • Endophthalmitis (inflammation of the eye) or
    • Increased pressure in the eye or
    • Neovascular (wet) age-related macular degeneration (AMD)—Use with caution. May make these conditions worse.
    • Eye infection or
    • Eye swelling, active—Should not be used in patients with these conditions.

    Proper Use

    An ophthalmologist (eye doctor) will give you this medicine as a shot into the eye. This medicine is usually given once a month for up to 12 months.


    Precautions

    Your eye doctor will want to check your progress closely and at regular visits, especially during the first few days after you receive this medicine, to make sure this medicine is working properly and to check for unwanted effects.

    Serious eye or vision problems (eg, retinal detachment, endophthalmitis, eye infection, increased pressure inside the eye, or neovascular AMD) may occur with this medicine. Check with your eye doctor right away if your have blurred or other change in vision, eye pain, eye redness, headache, seeing flashes or sparks of light, seeing floating spots before the eyes, or a veil or curtain appearing across part of vision, tearing of the eyes several days after you receive this medicine.

    This medicine may cause temporary blurred vision. Do not drive or do anything else that could be dangerous until you can see clearly.


    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 or nurse immediately if any of the following side effects occur:

    More common

    • Bloody eye
    • blurred vision
    • change in vision
    • loss of vision
    • redness of the eye

    Less common

    • Decrease in vision
    • eye pain
    • redness, swelling, or itching of the eyelid
    • seeing floating dark spots or material before the eyes

    Incidence not known

    • Seeing flashes or sparks of light
    • seeing floating spots before the eyes, or a veil or curtain appearing across part of vision
    • tearing of the eyes

    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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