Changes in the TASMAR Labeling

The FDA has approved a labeling change for TASMAR® (tolcapone). This revised labeling provides for an overall reduction in the required frequency of liver monitoring. TASMAR is indicated as an adjunct to levodopa and carbidopa for the treatment of the signs and symptoms of idiopathic Parkinson’s disease. Because of the risk of potentially fatal acute fulminant liver failure, TASMAR should ordinarily be used in patients on levodopa/carbidopa who are experiencing symptom fluctuations and not responding satisfactorily to or are not appropriate candidates for other therapies. Patients determined to be appropriate candidates for treatment with TASMAR will now follow the new liver monitoring schedule.

Patients should be advised to self-monitor for signs of liver disease including:

• Persistent nausea
• Lethargy
• Jaundice
• Pruritius
• Fatigue
• Anorexia
• Dark urine
• Right upper quadrant tenderness

Patients who develop evidence of liver injury while taking TASMAR and are withdrawn from treatment for any reason should not be ordinarily considered for re-treatment.

Periodic laboratory monitoring of liver injury of hepatocellular injury is recommended. It is not clear that baseline and 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 withdraw of the suspect drug enhances the likelihood of recovery.

If the dose is increased to 200 mg tid (see DOSAGE AND ADMINSTRATION section), liver enzyme monitoring should take place before increasing the dose and then be conducted every 2 to 4 weeks for the following 6 months of therapy. After 6 months, periodic monitoring is recommended at intervals deemed clinically relevant.

TASMAR should be discontinued is SGPT/ALT or SGOT/AST levels exceed two times (2x) the upper limit of normal (ULN), or if clinical signs and symptoms suggest the onset of hepatic dysfunction. This is also a change from the previous label that stated discontinuation if levels exceeded 1x the ULN.

TASMAR has demonstrated an increase in “ON” time from 1.7-2.9 hours and a decrease in “OFF” time from 1.6-3.2 hours in a 16-hour waking day. For further information, please see the BOXED warning and the complete prescribing information for TASMAR.

Learn more about the label update for Liver Monitoring.