For Non-US Residents

What to Expect

Once started on TASMAR® (tolcapone), most patients can expect the following:

• An increase in ON time and a decrease in OFF time – In a 16-hour day, most patients can expect an increase in ON time (when symptoms are controlled) of anywhere from 1.7 - 2.9 hours, and a decrease in OFF time (when symptoms are present) from between 1.6 - 3.2 hours. Learn more in the About TASMAR section.

• Greater effectiveness of levodopa and carbidopa – TASMAR is thought to work by inhibiting a brain enzyme. Read more in How it Works.

• Once or twice monthly blood tests – To make sure no undue stress is placed on the liver, your physician will conduct one or twice monthly blood tests to monitor certain important liver enzymes. You can learn more about this in the Side Effects section.

TASMAR SHOULD NOT BE USED BY PATIENTS UNTIL THERE HAS BEEN A COMPLETE DISCUSSION OF THE RISKS AND THE PATIENT HAS PROVIDED WRITTEN INFORMED CONSENT (SEE PATIENT ACKNOWLEDGEMENT FORM).

WARNING: Because of the risk of potentially fatal, acute fulminant liver failure, TASMAR (tolcapone) should ordinarily be used in patients with Parkinson's disease on l-dopa/carbidopa who are experiencing symptom fluctuations and are not responding satisfactorily to or are not appropriate candidates for other adjunctive therapies (see INDICATIONS and DOSAGE AND ADMINISTRATION sections).

TASMAR therapy should not be initiated if the patient exhibits clinical evidence of liver disease or two SGPT/ALT or SGOT/AST values greater than the upper limit of normal. Patients with severe dyskinesia or dystonia should be treated with caution (see PRECAUTIONS: Rhabdomyolysis).

Laboratory Tests: Although a program of frequent laboratory monitoring for evidence of hepatocellular injury is deemed essential, it is not clear that periodic monitoring of liver enzymes will prevent the occurrence of fulminant liver failure. However, it is generally believed that early detection of drug-induced hepatic injury along with immediate withdrawal of the suspect drug enhances the likelihood for recovery. Accordingly, the following liver monitoring program is recommended.

Please see accompanying complete prescribing information including BOXED warning.

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