For Non-US Residents

Changes in the TASMAR Labeling FAQ


On February 17, 2006, the Food & Drug Administration (FDA) approved reduced liver monitoring for TASMAR® (tolcapone).

Why did the FDA allow this change?


In May 2005, Valeant Pharmaceuticals submitted a supplemental new drug application for TASMAR that included updated safety data and proposed language for reduced liver monitoring requirements.

The updated safety data includes:

• Reports as of May 2005 of 3 cases of fatal fulminant hepatic failure from more than 40,000 patient years of worldwide use.

• An analysis of laboratory monitoring data in over 3,400 TASMAR-treated patients participating in clinical trials that indicated increases in SGPT/ALT or SGOT/AST, when present, generally occurred within the first 6 months of treatment with TASMAR.

As a result, the FDA accepted changes to the TASMAR prescribing information that allow a reduced liver monitoring schedule for the first 6 months of treatment and recommend periodic monitoring at intervals deemed clinically relevant thereafter.

What does this mean for patients currently on TASMAR?

With reduced liver monitoring language in the prescribing information for TASMAR, patients currently on TASMAR will find that liver monitoring might be reduced. Periodic liver monitoring (every 2-4 weeks) is recommended for the first 6 months of treatment. After 6 months, liver monitoring is recommended at intervals deemed clinically relevant.

If the dose is increased to 200 mg tid (see DOSAGE AND ADMINISTRATION 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 six months, periodic monitoring is recommended at intervals deemed clinically relevant.

What about patients who have started TASMAR within the past 6 months?

Liver enzyme tests can be reduced to a less frequent schedule for these patients. For the initial 6 months, patients need periodic monitoring (i.e., every 2 to 4 weeks) rather than tests every 2 weeks. After 6 months, liver monitoring is recommended at intervals deemed clinically relevant.

How is starting a patient on TASMAR different?

The same procedures still apply for patients starting TASMAR:

• A baseline liver enzyme test is needed to exclude the presence of liver disease

• A patient consent form needs to be signed

However, when a patient begins TASMAR therapy, liver enzyme tests only need to occur periodically (i.e. every 2 to 4 weeks) rather than every 2 weeks. After the first 6 months, liver enzyme tests are recommended at intervals deemed clinically relevant.

Is the patient consent form still valid?

Yes. Before starting treatment, patients still need to be informed of the risks of using TASMAR and a written consent form must be signed. Part of this consent form includes acknowledgement of the liver monitoring recommendations.

What about the Valeant Liver Monitoring Program?

Due to the reduced liver monitoring recommendations for TASMAR, the Valeant Liver Monitoring Program will be discontinued. For the first 6 months of treatment, patients can schedule their periodic liver test through their healthcare provider. After 6 months, liver tests are recommended at intervals deemed clinically relevant.

Who can I contact with questions?

For more information regarding TASMAR, please contact your Valeant sales representative or access the complete prescribing information for TASMAR.

 

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.