Full Prescribing Information

Cathflo® Activase® (Alteplase) is indicated in adult and pediatric patients for the restoration of function to central venous access devices that have become occluded due to a blood clot.

Status Cathflo Activase was approved by the FDA in September 2001, and later approved in pediatric patients in January 2005. Cathflo Activase, available in a 2 mg single-patient-use vial, is the only marketed thrombolytic available for this indication and offers medical professionals a viable treatment option for a CVAD complication that can hinder patient care.

Important Safety Information In clinical trials, the most serious adverse events reported after treatment were serious blood infections, consider stomach and intestinal bleeding, and clots that form within veins. Cathflo Activase® (Alteplase) should be used with caution if the catheter is infected or might be infected. Using Cathflo Activase in patients with infected catheters may release an infection within the catheter into their bloodstream.

In the first two studies (which enrolled primarily adult patients) involving over 1100 patients, four catheter-related infections occurred from 15 minutes to 1 day after treatment with Alteplase, and a fifth infection occurred on Day 3 after Alteplase treatment. All five patients tested positive for infection in their catheter or infection in their blood within 24 hours after they had symptoms.

Three patients had major bleeding from a source in the digestive system 2 to 3 days after Alteplase treatment. One case of bleeding at the injection site was observed 4 hours after treatment in a patient that already had a low platelet count (platelets help a person's blood to clot). There were no reports of bleeding in the brain.

There were three cases of blood clots happening in the artery below the collar bone, and in arteries in the arm; and these were reported 3 to 7 days after treatment. There were no reports of clots in the lungs.

In the pediatric trial of 300 patients under age 17, three cases of serious blood infection occurred 2 to 44 hours after treatment with Cathflo Activase. All of these patients had evidence of infection before treatment with Cathflo Activase.

Mechanism of Action Cathflo Activase is a thrombolytic that works by targeting fibrin (the substance that causes blood to clot), dissolving the thrombus (blood clot) and restoring function to the central venous access device (CVAD).

Central Venous Access Device (CVAD) It is estimated that 5 million catheters are placed each year in the U.S., and occlusions are a frequent complication. It is estimated that up to 25 percent of all CVADs become occluded and that 60 percent of those occlusions are caused by thrombosis, the formation of a blood clot.