For Non-US Residents
Most patients on TASMAR® (tolcapone) will experience
an increase in ON time and a decrease in OFF time. When a new patient
begins TASMAR treatment, results can usually be expected within 3
weeks. See What to Expect for more on this.
TASMAR has been proven to be effective with most Parkinson’s patients. Some patients, however, do show signs of liver dysfunction. Because of this, your doctor will monitor liver function with something called ALT/AST level testing, a simple blood test.
In addition, you can monitor any side effects by taking note of, or having your loved one tell you, about any of the following warning signs:
• Persistent nausea
• Jaundice (yellow skin)
• Dark urine
• Pruritus (extreme itching)
• Upper right abdomen tenderness
If you or your loved one experiences any of these symptoms, call a doctor immediately.
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).
WARNING: Because of the risk of potentially fatal, acute fulminant liver failure, TASMAR (tolcapone) should ordinarily be used in patients with Parkinson's disease on l-dopa/carbidopa who are experiencing symptom fluctuations and are not responding satisfactorily to or are not appropriate candidates for other adjunctive therapies (see INDICATIONS and DOSAGE AND ADMINISTRATION sections).
TASMAR therapy should not be initiated if the patient exhibits clinical evidence of liver disease or two SGPT/ALT or SGOT/AST values greater than the upper limit of normal. Patients with severe dyskinesia or dystonia should be treated with caution (see PRECAUTIONS: Rhabdomyolysis).
Laboratory Tests: Although a program of frequent laboratory monitoring for evidence of hepatocellular injury is deemed essential, it is not clear that 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 withdrawal of the suspect drug enhances the likelihood for recovery. Accordingly, the following liver monitoring program is recommended.
Please see accompanying complete prescribing information including BOXED warning.
TASMAR® is a registered trademark of Valeant Pharmaceuticals International