Indication

MACUGEN® (pegaptanib sodium injection) is approved to treat Wet Age-Related Macular Degeneration.

Important Safety Information

You should not receive MACUGEN® if you have an infection in or around your eye or if you are hypersensitive (allergic) to pegaptanib sodium or any of the other ingredients. Tell your ophthalmologist about any known allergies.

In the days following MACUGEN® administration, you may be at risk for the development of endophthalmitis (inflammation of the inner coats of the eye due to an infection). If the eye becomes red, sensitive to light, painful, or develops a change in vision, you should see your ophthalmologist immediately so you can be treated early if an infection occurs.

Eye injections like those with MACUGEN® can increase eye pressure. This is something you would not notice; however, your ophthalmologist may do some extra tests after your injection to make sure there are no complications or problems.

Serious side effects related to the injection procedure have been seen in patients receiving eye injections such as MACUGEN®. These include endophthalmitis, a separation in the retina referred to as retinal detachment, and cataract. Less than 1% of injections have caused a serious side effect.

Other, less serious, side effects include eye swelling, blurred vision, cataract, blood in the eye, eye discharge, eye irritation, eye pain, high blood pressure, increased eye pressure, eye discomfort, visual disturbances, burning sensation, redness, light sensitivity, and vision loss. These are usually caused by the injection procedure.

For a complete list of side effects, please see the MACUGEN® product information. If you have any questions or concerns about your treatment, please see your physician and follow all treatment recommendations.

You are encouraged to report side effects of prescription drugs to the FDA.

Visit www.fda.gov/medwatch or call 1-800-FDA-1088.