Visudyne Accelerated Access

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Prescribing Information

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Visudyne® is indicated for the treatment of predominantly classic subfoveal choroidal neovascularization due to age-related macular degeneration, pathologic myopia, or presumed ocular histoplasmosis.

Important Safety Information

Visudyne is contraindicated for patients with porphyria or known hypersensitivity to any component of Visudyne.

Infusion-related transient back pain occurred with Visudyne only. Verteporfin infusion induces temporary photosensitivity; patients should avoid exposure of skin and eyes to direct sunlight or bright indoor light for 5 days. To prevent extravasation, avoid fragile hand veins in favor of larger antecubital veins.

Severe vision decrease (≥4 lines) was reported within 7 days in 1% to 5% of patients. Partial recovery occurs in some patients. Do not re-treat these patients until vision completely recovers to pretreatment levels and potential benefits and risks of subsequent treatment are carefully weighed.

The most frequently reported adverse events (10% to 30% incidence) were injection site reactions (including extravasation and rashes), blurred vision, decreased visual acuity, and visual field defects.

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