For Non-US Residents
More ON time now requires less liver monitoring.
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, as detailed on the
following chart and text below:
Patients should be advised to self-monitor for
signs of liver disease including:
• Persistent nausea
• 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and are withdrawn from treatment for any reason should not be ordinarily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
the BOXED warning and the complete prescribing information for TASMAR.
Learn more about the labeling update for LiverMonitoring.
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
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.
TASMAR® is a registered trademark of Valeant Pharmaceuticals International