FDA Approval Letter
Indication
Cathflo Activase (Alteplase) is indicated for the restoration of function to central venous access devices (CVADs) as assessed by the ability to withdraw blood.
Safety Information
Cathflo Activase should not be administered to patients with known hypersensitivity to Alteplase or any component of the formulation.
In clinical trials, the most serious adverse events reported after treatment were sepsis, gastrointestinal bleeding, and venous thrombosis.
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In 2001, Cathflo was approved by the FDA for the restoration of function to central venous access devices, as assessed by the ability to withdraw blood. Cathflo is the only thrombolytic that is FDA-approved for the treatment of occluded catheters.
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