Indication

VISUDYNE^® (verteporfin for injection) therapy is a photoenhancer indicated for the treatment of patients with predominantly classic subfoveal choroidal neovascularization (CNV) due to age-related macular degeneration, pathologic myopia or presumed ocular histoplasmosis. There is insufficient evidence to indicate VISUDYNE for the treatment of predominantly occult subfoveal CNV.

Important Safety Information

• VISUDYNE^® (verteporfin for injection) is contraindicated for patients with porphyria or known hypersensitivity to any component of this preparation.
• Standard precautions should be taken during infusion of VISUDYNE to avoid extravasation, including but not limited to:
  • A free-flowing intravenous (IV) line should be established before starting VISUDYNE infusion and the line should be carefully monitored.
  • Due to the possibly fragility of vein walls of some elderly patients, it is strongly recommended that the largest arm vein possible, preferably the antecubital, be used for injection.
  • Small veins in the back of the hand should be avoided.
• Extravasation of VISUDYNE, especially if the affected area is exposed to light, can cause severe pain, inflammation, swelling or discoloration at the injection site. Necrosis at the injection site following extravasation has been reported. If extravasation does occur, the infusion should be stopped immediately. The extravasation area must be thoroughly protected from direct light until swelling and discoloration have faded in order to prevent the occurrence of local burn, which could be severe. Cold compresses should be applied to the injection site. Oral medication for pain relief may be administered.
• Following injection with VISUDYNE, care should be taken to avoid exposure of skin or eyes to direct sunlight or bright indoor light for 5 days. If emergency surgery is necessary within 48 hours after treatment, as much of the internal tissue as possible should be protected from intense light.
• Patients who experience severe decrease of vision of 4 lines or more within 1 week after treatment should not be retreated, at least until their vision completely recovers to pretreatment levels and potential benefits and risks of subsequent treatment are carefully considered by the treating physician.
• Cases of anaphylactic reactions have been reported. Immediately discontinue VISUDYNE and initiate appropriate therapy if anaphylactic or other serious allergic reactions occur during or following therapy.
• The most frequently reported adverse events (occurring in approximately 10%-30% of patients) were injection site reactions (including pain, edema, inflammation, extravasation, rashes, hemorrhage, and discoloration), and visual disturbances (including blurred vision, flashes of light, decreased visual acuity, and visual field defects, including scotoma).

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