For Non-US Residents

Dosing Recommendations


1. Always initiate TASMAR® (tolcapone) at the recommended dose of 100 mg TID.

• In clinical trials, the first dose of TASMAR was always taken with the first dose of levodopa/carbidopa, and subsequent doses were given approximately 6 and 12 hours later.

• TASMAR 200 mg TID should be used only if the anticipated increase in clinical benefit is justified. In clinical trials, elevations of liver enzymes occurred more frequently at the 200 mg TID dose. At this dose, liver monitoring should take place before increasing the dose and be conducted every 2-4 weeks for the following 6 months of therapy. After 6 months, periodic monitoring is recommended at intervals deemed clinically relevant.

• TASMAR can be taken with or without food. TASMAR can be combined with both immediate- and sustained-release formulations of levodopa/carbidopa

2. Monitor and adjust levodopa/carbidopa dosages as needed.

• Levodopa daily dose reduced by up to 23% in patients taking TASMAR 100 mg TID.

• In pivotal studies of patients with motor fluctuations, levodopa daily dose was reduced by 109 mg to 207 mg.

• More than 70% of patients taking >600 mg levodopa required a reduction in their daily levodopa dose.

• Patients who had moderate to severe dyskinesia before treatment required a reduction in their daily levodopa dose.

3. TASMAR should be discontinued in any patient who fails to show substantial clinical benefit within 3 weeks of treatment initiation.

• Withdrawal or abrupt reduction of the TASMAR dose may lead to the emergence of signs and symptoms of Parkinson’s disease or hyperpyrexia and confusion.

• When discontinuing TASMAR, it is recommended to closely monitor the patients and adjust other dopaminergic treatments as needed.




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).

USE OF TASMAR REQUIRES WRITTEN INFORMED CONSENT BY THE PATIENT (SEE PATIENT CONSENT SECTION IN THE COMPLETE PRESCRIBING INFORMATION in the PI).

WARNING: Due to the risk of potentially fatal, acute fulminant liver failure, TASMAR should ordinarily 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 candidates 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 2 SGPT/ALT or SGOT/AST values greater than
the upper limit of normal (ULN) and 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: Rhabdomyolysis in the PI).

Frequent laboratory monitoring is essential (see PRECAUTIONS:Laboratory Tests for the recommended schedule in the PI). 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 ULN or patient exhibits signs of liver failure. Please see accompanying complete prescribing information including BOXED WARNING.