For Non-US Residents

When people start to take medication for their Parkinson’s disease, they usually notice that their symptoms go away for hours at a time (ON times), then return (OFF times.) Symptoms also return during the wearing off period, when Parkinson’s treatments become less effective.


Moving back and forth between ON and OFF times is a reality for Parkinson’s disease patients. ON times can also be accompanied by side effects called dyskinesias — sudden jerky or uncontrolled movements of the limbs and neck.


Adjusting to medication: ON and OFF cycles
Perhaps the biggest adjustment Parkinson’s disease patients will have to make is learning to live with the "ON-OFF” cycle. This is the back and forth between periods of time with symptoms and periods of time without symptoms. It fast becomes the PD patient’s new rhythm of life.


During ON times, patients report they feel relatively fluid, clear, and in control of their movements. Often, symptoms of PD may be invisible to all but professionals.


During OFF periods, patients experience stiffness, lack of muscular coordination, pain, difficult handwriting — the full range of classic PD symptoms. Most patients have visible symptoms. Typically, patients will cycle between ON and OFF periods three to four times every day, although everyone’s experience is unique.


Signals that OFF times are coming
Often there are warning signs that OFF time is approaching. These can include things such as handwriting problems, overall slowness, loss of sense of smell, stiffness in muscles, and other warning signs.


PD patients will find it beneficial to arrange life around ON and OFF rhythms. In consultation with their doctors, patients can learn to adjust their medication so that it becomes effective when they want it to be.

 

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.