For Non-US Residents

Labeling Update

The U.S. Food and Drug Administration (FDA) has approved less-restrictive labeling for TASMAR® (tolcapone). The new labeling reduced how often a doctor is required to monitor a TASMAR patient’s liver function and allows patients to remain on TASMAR at higher ALT levels (a liver enzyme) than previously required. Here’s a breakdown of what the change means for you.

• Less Testing: Under the new guidelines, your doctor will need to perform a SGPT/ALT & SGOT/AST test every 2-4 weeks (twice monthly) for the first six months. After that, the physician can determine how often they should perform tests.

• Greater Convenience: you will mostly likely only need to arrange for blood work to be done once or twice a month for the first six months.

• Quick Results: if your physician does not see clear signs of improvement in you or your loved one’s Parkinson’s symptoms within 3 weeks, they will discontinue TASMAR treatment.

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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