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USE OF TASMAR REQUIRES WRITTEN
INFORMED CONSENT BY THE PATIENT (SEE PATIENT CONSENT SECTION IN THE COMPLETE PRESCRIBING INFORMATION).
WARNING: Due to the risk of potentially
fatal, acute fulminant liver failure, TASMAR should ordinarily be
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).
should not be initiated in patients with clinical evidence of liver
disease or 2 SGPT/ALT or SGOT/AST values
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).
laboratory monitoring is essential (see PRECAUTIONS:Laboratory Tests for the recommended schedule). Liver monitoring may not prevent liver failure;
however, early detection and immediate drug withdrawal are believed
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.
TASMAR® is a registered trademark of Valeant Pharmaceuticals International