For Non-US Residents
TASMAR® (tolcapone) 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.
TASMAR® (tolcaphone) inhibits catechol-O-methyltransferase (COMT), an enzyme
that catalyzes the metabolization of levodopa into 3-O-methyldopa. This provides
a prolonged maintenance of serum levodopa levels, which may provide a longer
clinical response to levodopa treatments.
Therefore, TASMAR is most effectively prescribed to prolong the effectiveness
of levodopa and carbidopa treatments after their clinical effectiveness has been
reduced due to the progression of the disease. It can also be prescribed if a
patient is not responding well to other therapies.
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