Tasmar an Adjunct PD Therapy to Carbidopa/Levodopa

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Tasmar Labeling Changes

Prescribing Information

TASMAR Labeling Change FAQ

Read common physician questions about exactly what the reduced liver monitoring requirements mean for your practice.

New Reduced Liver Monitoring Requirements

The FDA has approved less restrictive labeling for TASMAR. The revised labeling allows for less frequent laboratory monitoring and allows patients to remain on TASMAR at higher ALT levels then previously required. SGPT/ALT & SGOT/AST testing is now recommended periodically (every 2-4 weeks) for the first 6 months. After 6 months, periodic monitoring is recommended at intervals deemed clinically relevant.

If the dose is increased to 200 mg TID, liver 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.

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 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).

Frequent 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 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.

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