Symptom Control

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.