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Macugen (pegaptanib sodium injection) Labeling Change

Apr 7, 2006 | www.pharmalive.com

Pfizer Pharmaceuticals notified healthcare professionals of important changes in the approved product labeling for Macugen (pegaptanib sodium injection), including changes to the CONTRAINDICATIONS, PRECAUTIONS, ADVERSE EVENTS Post-Marketing, and DOSAGE and ADMINISTRATION sections. Rare reports of anaphylaxis/anaphylactoid reactions, including angioedema following the administration of Macugen along with various medications administered as part of the injection preparation, were described.

Macugen is indicated for the treatment of neovascular (wet) age-related macular degeneration, and is administered once every six weeks by intravitreous injection. Healthcare professionals should evaluate the patient's medical history for hypersensitivity reactions to Macugen prior to using this product.

The Dear Healthcare Professional Letter is below. The updated Approved Product Labeling is attached.

March 6, 2006

Dear Health Care Professional,

(OSI) Eyetech Inc. and Pfizer Inc. would like to inform you about important changes in the Macugen® (pegaptanib sodium injection) Prescribing Information concerning reports of anaphylaxis/anaphylactoid reactions. The following sections have been amended: CONTRAINDICATIONS, PRECAUTIONS, ADVERSE EVENTS Post-Marketing, and DOSAGE and ADMINISTRATION.

Macugen is indicated for the treatment of neovascular (wet) age-related macular degeneration, and is administered once every six weeks by intravitreous injection. Since market introduction in the United States, there have been rare reports of anaphylaxis/anaphylactoid reactions, including angioedema, following administration of Macugenalong with various medications administered as part of the injection preparationprocedure. A direct relationship to pegaptanib or any of the various medicationsadministered as part of the injection preparation procedure or other factors has not beenestablished in these cases. The patient’s medical history for hypersensitivity reactionsshould be evaluated prior to performing the intravitreal injection procedure.

The revisions to the label are as follows with the new information in italics:

Macugen is contraindicated in patients with ocular or periocular infections.

Macugen is contraindicated in patients with known hypersensitivity to pegaptanib sodium or any other excipient in this product.

General

FOR OPHTHALMIC INTRAVITREAL INJECTION ONLY.

Rare cases of anaphylaxis/anaphylactoid reactions, including angioedema, have been reported in the post-marketing experience following the Macugen intravitreal administration procedure (see ADVERSE EVENTS and DOSAGE AND ADMINISTRATION).

CONTRAINDICATIONS

PRECAUTIONS

Post-Marketing Experience: Anaphylaxis/anaphylactoid reactions, including angioedema, have been identified during postapproval use of Macugen. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug 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 patient’s medical history for hypersensitivity reactions should be evaluated prior to performing the intravitreal procedure (see PRECAUTIONS and given prior to the injection.

Healthcare professionals are encouraged to report any serious adverse event information associated with the use of Macugen to Pfizer Inc. at 1-800-438-1985. You can also report the information directly to the FDA via the MedWatch system at 1-800-FDA-1088, by fax at 1-800-FDA-0178, by mail (using a postage-paid form) or the internet atwww.fda.gov/medwatch.

Attached is the revised prescribing information for Macugen®. If you would like further information, please contact the Pfizer Medical Drug Information Department at 1-800- 438-1985.

Sincerely,

Anthony P. Adamis, MD Michael Widlitz MD

Chief Scientific Officer Vice President, US Medical

(OSI) Eyetech, Inc. Pfizer Inc.


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