MacugenMacugen (pegaptanib sodium injection) is a sterile, aqueous solution containing pegaptanib sodium for intravitreous injection. Macugen solution is supplied in a single-dose, pre-filled syringe.

Pegaptanib is a selective vascular endothelial growth factor (VEGF) antagonist. VEGF is a secreted protein that selectively binds and activates its receptors located primarily on the surface of vascular endothelial cells. VEGF induces angiogenesis, and increases vascular permeability and inflammation, all of which are thought to contribute to the progression of the neovascular (wet) form of age-related macular degeneration (AMD), a leading cause of blindness.

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Indication

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

Important Safety Information

  • Macugen (pegaptanib sodium injection) 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.
  • Serious adverse events related to the injection procedure occurring in <1% of intravitreous injections included endophthalmitis, retinal detachment, and iatrogenic traumatic cataract.
  • Most common adverse reactions (reported in 10-40% of patients treated with Macugen for up to two years) are 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.

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Macugen (pegaptanib sodium injection) : Additional information



US/MAC/14/0005