Tasmar®
Indication
TASMAR® (tolcapone) is indicated as an adjunct to levodopa and carbidopa for the treatment of the signs and symptoms of idiopathic Parkinson’s disease.
Product Description
TASMAR® (tolcapone) is an adjunct oral medication that is used in combination with other Parkinson's medicines. It is used in combination with levodopa and carbidopa for patients with severe Parkinson's disease who are not responding satisfactorily to, or are not appropriate candidates for, other adjunct therapies.
TASMAR® is used when other Parkinson's medicines begin to wear off - that is, become less effective over time. When this happens, Parkinson's symptoms may occur or get worse throughout a day, before it is time for the next dose of medicine. TASMAR® helps to counteract this wearing off.
Most patients experience significant results from taking TASMAR®. The average TASMAR® patient has an increase in ON time, otherwise known as the time symptoms are controlled. In a 16-hour waking day, it increases ON time an average of 1.7-2.9 hours, and decreases OFF time anywhere from between 1.6 to 3.2 hours.
Product Availability
- United States
- Australia
- Brazil
- Czech Republic
- Poland
- Slovak Republic
Important Safety Information
TASMAR® SHOULD NOT BE USED BY PATIENTS UNTIL THERE HAS BEEN A COMPLETE DISCUSSION OF THE RISKS AND PATIENT HAS PROVIDED WRITTEN ACKNOWLEDGMENT THAT THE RISKS HAVE BEEN EXPLAINED (SEE PATIENT ACKNOWLEDGMENT OF RISKS SECTION).
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).
TASMAR® should not be initiated in patients with clinical evidence of liver disease or
2 SGPT/ALT or SGOT/AST values >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).
Laboratory monitoring is recommended (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 of recovery. Patients should be advised to self-monitor for signs of liver disease. Discontinue TASMAR® if hepatic enzymes exceed 2 times (2X) ULN or patient exhibits signs of liver failure.
TASMAR® is contraindicated in patients with liver disease and in patients who were withdrawn from TASMAR® because of evidence of TASMAR®-induced hepatocellular injury or who have demonstrated hypersensitivity to the drug or its ingredients. TASMAR® is also contraindicated in patients with a history of non-traumatic rhabdomyolysis or hyperpyrexia and confusion possibly related to medication.
In clinical trials, adverse events reported at a frequency of >10% when TASMAR® was administered in combination with levodopa/carbidopa were dyskinesia, nausea, sleep disorder, dystonia, anorexia, diarrhea, somnolence, excessive dreaming, muscle cramps, orthostatic complaints, dizziness, headache, and confusion.
The majority of these effects are dopaminergic and may be reduced by decreasing the dose of levodopa; however, some may persist despite levodopa dosage adjustment.
Diarrhea was the adverse event that most commonly led to discontinuation.
Patients with severe renal impairment or severe dyskinesia or dystonia should be treated with caution.
The following notable dopaminergic effects occurred but infrequently led to the discontinuation of TASMAR® therapy: symptomatic hypotension (approximately 0.7% of patients withdrew); hallucinations (1.0% to 1.4%); dyskinesia (0.3% to 1.0%).
Cases of severe rhabdomyolysis have been reported; it is impossible to determine what role, if any, TASMAR® played in the pathogenesis. Rare cases of hyperpyrexia and confusion have been reported similar to those reported in association with dose reduction or abrupt withdrawal of other dopaminergic drugs. It is difficult to determine what role TASMAR® may have played. The postmarketing cases involved concomitant administration of several medications affecting brain monoaminergic and anticholinergic systems.
TASMAR® should not be given in conjunction with nonselective MAO inhibitors such as phenelzine and tranylcypromine. TASMAR® can be given concomitantly with a selective MAO-B inhibitor (eg, selegiline).
Patients should be advised not to drive a car or operate complex machinery until they have gained sufficient experience on TASMAR® to know how it affects them.