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Overview
Pegaptanib is a Ophthalmologic Agent that is FDA approved for the treatment of neovascular (wet) age-related macular degeneration. Common adverse reactions include .
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Indications
Macugen is indicated for the treatment of neovascular (wet) age-related macular degeneration.
Dosage
Single-use glass syringe pre-filled with 0.3 mg of Macugen® in a nominal 90 μL solution for intravitreal injection.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Pegaptanib in adult patients.
There is limited information regarding FDA-Labeled Use of Pegaptanib in pediatric patients.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Pegaptanib in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Pegaptanib in pediatric patients.
Contraindications
Ocular or Periocular Infections
Macugen is contraindicated in patients with ocular or periocular infections.
Hypersensitivity
Macugen is contraindicated in patients with known hypersensitivity to pegaptanib sodium or any other excipient in this product.
Warnings
Endophthalmitis
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 [see Dosage and Administration (2.4)].
5.2 Increases in Intraocular Pressure
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 [see Dosage and Administration (2.4)].
5.3 Anaphylaxis
Rare cases of anaphylaxis/anaphylactoid reactions, including angioedema, have been reported in the post-marketing experience following the Macugen intravitreal administration procedure
Adverse Reactions
Clinical Trials Experience
Injection Procedure
Serious adverse events related to the injection procedure occurring in < 1% of intravitreous injections included endophthalmitis [see Warnings and Precautions (5.1)], retinal detachment, and iatrogenic traumatic cataract.
6.2 Clinical Studies Experience
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 events occurred in approximately 10-40% of patients.
The following events were reported in 6-10% of patients receiving Macugen 0.3 mg therapy:
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 exposure