Macugen in an injection containing pegaptanib. Pegaptanib is made from a human antibody fragment. It works by keeping new blood vessels from forming under the retina (a sensory membrane that lines the inside of the eye). In people with a certain type of eye disease, new blood vessels grow under the retina where they leak blood and fluid. This is known as the "wet form" of macular degeneration.

Macugen injection is used to treat wet age-related macular degeneration.

Macugenis supplied in a sterile foil pouch with a single-use glass syringe pre-filled with 0.3 mg of pegaptanib.

You should not receive Macugen if you are allergic to pegaptanib, or if you have cataracts or glaucoma, or any type of bacterial, fungal, or viral infection in or around your eyes.

Call your doctor at once if you have eye pain or redness, swelling or puffiness around your eyes, or sudden vision problems at any time during treatment.

Macugen is given as an injection into your eye. You will receive this injection in your doctor's office or other clinic setting.

For a short time after your injection, your eyes will be checked periodically to make sure the injection has not caused any side effects.

Macugen is usually given once every 6 weeks. Follow your doctor's dosing instructions very carefully.

Usual Adult Dose for Macular Degeneration:

0.3 mg via intravitreal injection into the affected eye once every 6 weeks.

Comments: The procedure should be carried out under controlled aseptic conditions. Anesthesia and a broad-spectrum microbicide should be administered before the injection.
No additional benefit has been demonstrated with dose levels above 0.3 mg.

Use: Treatment of neovascular (wet) age-related macular degeneration (AMD).

You should not use Macugen if you are allergic to pegaptanib, or if you have an infection in or around your eyes.

To make sure Macugen is safe for you, tell your doctor if you have::

• glaucoma; or

• cataract.

Tell your doctor if you are pregnant or breastfeeding.

Call your doctor for instructions if you miss an appointment for your Macugen injection.

An overdose is unlikely to cause serious side effects.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Get emergency medical help if you have signs of an allergic reaction to Macugen: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• eye pain or redness, swelling around your eyes;

• sudden vision problems; or

• increased sensitivity to light, or seeing "floaters" in your vision.

Common Macugen side effects may include:

• vision changes;

• eye pain or discomfort;

• eye redness, irritation, sensitivity to light; or

• watery eyes, crusting or drainage.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Medicine used in the eyes is not likely to be affected by other drugs you use. But many drugs can interact. Tell your doctor about all your current medicines, including prescription and over-the-counter medicines, vitamins, and herbal products.