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About TheraSphere®

TheraSphere® is a liver cancer therapy that consists of millions of small glass microspheres (20 to 30 micrometers in diameter) containing radioactive Y-90. The product is injected by physicians into the artery of the patient's liver through a catheter, which allows the treatment to be delivered directly to the tumour via blood flow.

TheraSphere® is used in the European Union and in Canada for the treatment of hepatic neoplasia in patients who have appropriately positioned arterial catheters.

In the US, TheraSphere® is used to treat patients with hepatocellular carcinoma (HCC) who can have appropriately positioned hepatic arterial catheters, and can be used as a bridge to surgery or transplantation in these patients. It is also indicated for the treatment of HCC patients with partial or branch portal vein thrombosis or occlusion when clinical evaluation warrants the treatment. TheraSphere® is approved by the U.S. Food and Drug Administration (FDA) under a Humanitarian Device Exemption (HDE). HDE approvals are based on demonstrated safety and probable clinical benefit. However, effectiveness of the indication for use has not been established.

Common side effects include mild to moderate fatigue, pain and nausea for about a week. Physicians describe these symptoms as similar to those of the flu. Some patients experience some loss of appetite and temporary changes in several blood tests. For details on rare or more severe side effects, please refer to the TheraSphere® package insert/instructions for use: United States / International.