Rare cases of anaphylaxis/anaphylactoid reactions, including angioedema, have been reported in the post-marketing experience following the Macugen ( Pegaptanib sodium injection ) intravitreal administration procedure

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 Macugen along with various medications administered as part of the injection preparation procedure.

A direct relationship to Pegaptanib or any of the various medications administered as part of the injection preparation procedure or other factors has not been established in these cases.

The patient’s medical history for hypersensitivity reactions should be evaluated prior to performing the intravitreal injection procedure.

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.

Source: FDA, 2006


XagenaMedicine2006