INDICATION

Cathflo^®Activase^®(alteplase) is indicated for the restoration of function to central venous access devices as assessed by the ability to withdraw blood.

IMPORTANT SAFETY INFORMATION

Contraindications

Cathflo Activase should not be administered to patients with known hypersensitivity to alteplase or any component of the formulation.

PRECAUTIONS

General

Certain causes of catheter dysfunction should be considered before treatment with Cathflo Activase (e.g. catheter malposition, mechanical failure, constriction by a suture and lipid deposits or drug precipitates within the catheter lumen). These types of conditions should be considered before treatment with Cathflo Activase.

Bleeding

The most frequent adverse reaction associated with all thrombolytics in all approved indications is bleeding.

Should serious bleeding in a critical location (e.g., intracranial, gastrointestinal, retroperitoneal, pericardial) occur, treatment with Cathflo Activase should be stopped and the drug should be withdrawn from the catheter.

Infections

Cathflo Activase should be used with caution in the presence of known or suspected infection in the catheter.

Hypersensitivity

Hypersensitivity, including urticaria, angioedema and anaphylaxis, has been reported in association with use of Cathflo Activase. Monitor patients treated with Cathflo Activase for signs of hypersensitivity and treat appropriately if necessary.

Adverse Reactions

In clinical trials, the most serious adverse events reported after treatment were sepsis, gastrointestinal bleeding, and venous thrombosis.

Please see accompanying full Prescribing Information for additional important safety information.