Indications and Usage
MACUGEN® (pegaptanib sodium
injection) is indicated for the
treatment of neovascular (wet)
age-related macular degeneration.
FOR OPHTHALMIC INTRAVITREAL INJECTION ONLY
MACUGEN® is contraindicated in patients with ocular or periocular infections, and in patients with known hypersensitivity to pegaptanib sodium or any other excipient in this product.
Intravitreous injections including those with MACUGEN® have been associated with endophthalmitis. Proper aseptic injection technique should always be utilized when administering MACUGEN®. In addition, patients should be monitored during the week following the injection to permit early treatment, should an infection occur.
Increases in intraocular pressure have been seen within 30 minutes of injection with MACUGEN®. Therefore, intraocular pressure as well as the perfusion of the optic nerve head should be monitored and managed appropriately.
Rare cases of anaphylaxis/ anaphylactoid reactions, including angioedema, have been reported in post-marketing experience following the MACUGEN® intravitreal administration procedure. Safety and effectiveness of MACUGEN® in pediatric patients have not been established. Serious adverse events related to the injection procedure occurring in <1% of intravitreous injections included endophthalmitis, retinal detachment, and iatrogenic traumatic cataract.
The most frequently reported adverse events in patients treated with MACUGEN® 0.3 mg for up to two years were anterior chamber inflammation, blurred vision, cataract, conjunctival hemorrhage, corneal edema, eye discharge, eye irritation, eye pain, hypertension, increased intraocular pressure (IOP), ocular discomfort, punctate keratitis, reduced visual acuity, visual disturbance, vitreous floaters, and vitreous opacities. These were seen in approximately 10% to 40% of patients.