Macugen is indicated for the treatment of neovascular (wet) age-related macular degeneration.

Macugen 0.3 mg should be administered once every six weeks by intravitreous injection into the eye to be treated.

Macugen should be inspected visually for particulate matter and discoloration prior to administration. Administration of the syringe contents involves attaching the threaded plastic plunger rod to the rubber stopper inside the barrel of the syringe. Do not pull back on the plunger. Remove the syringe needle cap. Holding the syringe with the needle pointing up, check the syringe for bubbles. If there are bubbles, gently tap the syringe with your finger until the bubbles rise to the top of the syringe. Slowly push the plunger up to force all the bubbles out of the syringe.

The injection procedure should be carried out under controlled aseptic conditions, which includes the use of sterile gloves, a sterile drape, and a sterile eyelid speculum (or equivalent). The patients medical history for hypersensitivity reactions should be evaluated prior to performing the intravitreal procedure (see PRECAUTIONS and ADVERSE EVENTS). Adequate anesthesia and a broad-spectrum microbicide should be given prior to the injection.

Following the injection, patients should be monitored for elevation in intraocular pressure and for endophthalmitis. Monitoring may consist of a check for perfusion of the optic nerve head immediately after the injection, tonometry within 30 minutes following the injection, and biomicroscopy between two and seven days following the injection. Patients should be instructed to report any symptoms suggestive of endophthalmitis without delay.

No special dosage modification is required for any of the populations that have been studied (i.e. gender, elderly).

The safety and efficacy of Macugen therapy administered to both eyes concurrently have not been studied.

Macugen (pegaptanib sodium injection) is supplied in a single use 1 mL glass syringe with a gray rubber plunger containing 0.3 mg in a 90 uL deliverable volume. Each syringe is fitted with a fixed 27 gauge needle covered with a gray rubber needle shield and a rigid plastic outside sheath. All are contained in a foil pouch. The accompanying polystyrene plunger rod and white flange are in a separate foil pouch. The two foil pouches are packaged in a carton.

Store in the refrigerator at 2° to 8°C (36° to 46°F). Do not freeze or shake vigorously.

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