Orap Patient, Information, Instructions - Pimozide

Orap Patient, Information, Instructions - Pimozide

PATIENT INFORMATION

Treatment with ORAP exposes the patient to serious risks. A decision to use ORAP chronically in Tourette's Disorder is one that deserves full consideration by the patient (or patient's family) as well as by the treating physician. Because the goal of treatment is symptomatic improvement, the patient's view of the need for treatment and assessment of response are critical in evaluating the impact of therapy and weighing its benefits against the risks. Since the physician is the primary source of information about the use of a drug in any disease, it is recommended that the following information be discussed with patients and/or their families.

ORAP is intended only for use in patients with Tourette's Disorder whose symptoms are severe and who cannot tolerate, or who do not respond to HALDOL^® (haloperidol).

Given the likelihood that a proportion of patients exposed chronically to antipsychotics will develop tardive dyskinesia, it is advised that all patients in whom chronic use is contemplated be given, if possible, full information about this risk. The decision to inform patients and/or their guardians must obviously take into account the clinical circumstances and the competency of the patient to understand the information provided.

There is limited information available on the use of ORAP in children under 12 years of age.

The information available on ORAP from foreign marketing experience and from U.S. clinical trials indicates that ORAP has a side effect profile similar to that of other antipsychotic drugs. Patients should be informed that all types of side effects associated with the use of antipsychotics may be associated with the use of ORAP.

In addition, sudden, unexpected deaths have occurred in patients taking high doses of ORAP for conditions other than Tourette's Disorder. These deaths may have been the result of an effect of ORAP upon the heart. Therefore, patients should be instructed not to exceed the prescribed dose of ORAP and they should realize the need for the initial ECG and for follow-up ECGs during treatment.

Also, pimozide, at a dose about 15 times that given humans, caused an increase in the number of benign tumors of the pituitary gland in female mice. It is not possible to say how important this is. Similar tumors were not seen in rats given pimozide, nor at lower doses in mice, which is reassuring. However, any such finding must be considered to suggest a possible risk of long term use of the drug.

Because substances in grapefruit juice may inhibit the metabolism of pimozide by CYP 3A, patients should be advised to avoid grapefruit juice.

Please also refer to the WARNINGS and PRECAUTIONS sections.