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Patients should be instructed to take TASMAR (tolcapone) only as prescribed.

TASMAR (tolcapone) should not be used by patients until there has been a complete discussion of the risks and the patient has provided written acknowledgement that the risks have been explained (see PATIENT ACKNOWLEDGEMENT OF RISKS section).

Patients should be informed of the clinical signs and symptoms that suggest the onset of hepatic injury (persistent nausea, fatigue, lethargy, anorexia, jaundice, dark urine, pruritus, and right upper quadrant tenderness) (see WARNINGS). If symptoms of hepatic failure occur, patients should be advised to contact their physician immediately.

Patients should be informed that hallucinations can occur.

Patients should be informed of the need to have regular blood tests to monitor liver enzymes.

Patients should be advised that they may develop postural (orthostatic) hypotension with or without symptoms such as dizziness, nausea, syncope, and sometimes sweating. Hypotension may occur more frequently during initial therapy. Accordingly, patients should be cautioned against rising rapidly after sitting or lying down, especially if they have been doing so for prolonged periods, and especially at the initiation of treatment with TASMAR (tolcapone) .

Patients should be advised that they should neither drive a car nor operate other complex machinery until they have gained sufficient experience on TASMAR (tolcapone) to gauge whether or not it affects their mental and/or motor performance adversely. Because of the possible additive sedative effects, caution should be used when patients are taking other CNS depressants in combination with TASMAR (tolcapone) .

Patients should be informed that nausea may occur, especially at the initiation of treatment with TASMAR (tolcapone) .

Patients should be advised of the possibility of an increase in dyskinesia and/or dystonia.

There have been reports of patients experiencing intense urges to gamble, increased sexual urges, other intense urges, and the inability to control these urges while taking one or more of the medications that increase central dopaminergic tone and that are generally used for the treatment of Parkinson's disease, including Tasmar (tolcapone) . Although it is not proven that the medications caused these events, these urges were reported to have stopped in some cases when the dose was reduced or the medication was stopped. Prescribers should ask patients about the development of new or increased gambling urges, sexual urges or other urges while being treated with Tasmar (tolcapone) . Patients should inform their physician if they experience new or increased gambling urges, increased sexual urges or other intense urges while taking Tasmar (tolcapone) . Physicians should consider dose reduction or stopping the medication if a patient develops such urges while taking Tasmar (tolcapone) .

Although TASMAR (tolcapone) has not been shown to be teratogenic in animals, it is always given in conjunction with levodopa/carbidopa, which is known to cause visceral and skeletal malformations in the rabbit. Accordingly, patients should be advised to notify their physicians if they become pregnant or intend to become pregnant during therapy (see PRECAUTIONS: Pregnancy).

Tolcapone is excreted into maternal milk in rats. Because of the possibility that tolcapone may be excreted into human maternal milk, patients should be advised to notify their physicians if they intend to breastfeed or are breastfeeding an infant.

PATIENT ACKNOWLEDGEMENT OF RISKS ASSOCIATED WITH TASMAR (tolcapone) TREATMENT

The following is important information that patients should know about TASMAR (tolcapone) .

• TASMAR (tolcapone) should not be used until you and your doctor (insert physician name here: _________________________) have had a complete discussion about the risks and benefits associated with the use of TASMAR (tolcapone) .
• Reports of potentially life-threatening cases of severe hepatocellular injury, including fulminant liver failure resulting in death, have been reported in association with use of TASMAR (tolcapone) .
• There are no laboratory tests that will predict in advance which patients are at an increased risk for liver failure or death from liver failure.
• Patients should have the recommended liver blood tests before treatment with TASMAR (tolcapone) is begun and periodically for the first 6 months of therapy. After the first six months, periodic liver blood tests should be performed as directed by your physician. If the dose of TASMAR (tolcapone) is to be increased, the liver blood tests should be checked before increasing the dose and repeated periodically as described earlier. Liver blood tests may help detect if liver failure has occurred but they may do so only after significant damage, that may not go away, has already occurred.
• Patients must immediately report any unusual symptoms to their physician and be especially aware of persistent nausea, fatigue, lethargy, decreased appetite, jaundice (yellowing of skin or the whites of the eyes), dark urine, itchiness or right-sided abdominal pain.

The above points of information, possibly along with other information, have been explained to me and I have been able to ask my physician questions and discuss risks and benefits associated with TASMAR (tolcapone) treatment.

Patient or Patient Caregiver Signature: __________________________

Date: _______________

NOTE TO PHYSICIAN: It is strongly recommended that you retain a signed copy of this form with the patient's medical records.

SUPPLY OF PATIENT ACKNOWLEDGEMENT FORMS: A supply of Patient Acknowledgement forms is available, free of charge, from your local Valeant representative, or may be obtained at www.Tasmar (tolcapone) .com or by calling 1-800-556-1937. Permission to use the above Patient Acknowledgement form by photocopy reproduction is also hereby granted by Valeant Pharmaceuticals International.

Last reviewed on RxList: 3/12/2009
This monograph has been modified to include the generic and brand name in many instances.