For Non-US Residents

When TASMAR May Be Right

Parkinson’s treatments tend to lose their effectiveness over time, and the symptoms of the disease become stronger. This is called wearing off. TASMAR® (tolcapone) is usually prescribed to combat wearing off. TASMAR is best used when a Parkinson’s patient is no longer getting an adequate response from the Parkinson’s medicines carbidopa and levodopa. TASMAR has a unique method of action that allows it to block a certain enzyme in the brain, COMT. This allows carbidopa and levodopa treatments to regain some of their effectiveness.

TASMAR has been shown to lengthen the ON time – when there is a reduction of symptoms – and reduce the OFF time. For most patients, TASMAR can make a difference in their daily symptoms.

 

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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