Dosing Recommendations
1. Always initiate TASMAR® (tolcapone) at the
recommended dose of 100 mg TID.
• In clinical trials, the first dose of
TASMAR was always taken with the first dose of levodopa/carbidopa,
and subsequent doses were given
approximately 6 and 12 hours later.
• TASMAR 200 mg TID should be used only if the anticipated increase
in clinical benefit is justified. In clinical trials, elevations
of liver enzymes occurred more frequently at the 200 mg TID
dose. At this dose, liver monitoring should take place before increasing
the dose and be conducted every 2-4 weeks for the following
6 months of therapy. After 6 months, periodic monitoring is recommended at
intervals deemed clinically relevant.
• TASMAR can be taken with or without food. TASMAR can be combined
with both immediate- and sustained-release formulations of
levodopa/carbidopa
2. Monitor and adjust levodopa/carbidopa dosages as needed.
• Levodopa daily dose reduced by up to
23% in patients taking TASMAR 100 mg TID.
• In pivotal studies of patients with motor fluctuations, levodopa
daily dose was reduced by 109 mg to 207 mg.
•
More than 70% of patients taking >600 mg levodopa required
a reduction in their daily levodopa dose.
• Patients who had moderate to severe dyskinesia before treatment required
a reduction in their daily levodopa dose.
3. TASMAR should be discontinued in any patient who fails to show
substantial clinical benefit within 3 weeks of treatment initiation.
•
Withdrawal or abrupt reduction of the TASMAR dose may lead to the
emergence of signs and symptoms of Parkinson’s disease or hyperpyrexia
and confusion.
• When discontinuing TASMAR, it is recommended to closely monitor the
patients and adjust other dopaminergic treatments as needed.
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