For Non-US Residents

Safety


Please see accompanying complete prescribing information including BOXED warning.


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 CONSENT FORM IN THE COMPLETE PRESCRIBING INFORMATION).


WARNING: Due to the risk of potentially fatal acute fulminant liver failure, TASMAR should be used in patients with Parkinson’s disease on levodopa/carbidopa who have symptom fluctuations and are not responding satisfactorily to, or who are not appropriate for, other adjunctive therapies (see INDICATIONS and DOSAGE AND ADMINISTRATION IN THE PI).


TASMAR should not be initiated in patients with clinical evidence of liver disease or two SGPT/ALT or SGOT/AST values >ULNand should be discontinued if substantial clinical benefit is not seen within 3 weeks.


Patients with severe dyskinesia or dystonia should be treated with caution (see PRECAUTIONS IN THE COMPLETE PRESCRIBING INFORMATION).


Laboratory monitoring is recommended (see PRECAUTIONS: Laboratory Tests in the complete Prescribing Information for the recommended schedule). Liver monitoring may not prevent liver failure; however, early detection and immediate drug withdrawal are believed to enhance the likelihood for recovery. Patients should be advised to self-monitor for signs of liver disease. Discontinue TASMAR if hepatic enzymes exceed 2 times (2X) ULN or patient exhibits signs of liver failure.

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.