FREQUENTLY ASKED QUESTIONS

Is The Mylan Brand of Clozapine interchangeable with Clozaril*?

Yes.  The Mylan Brand of Clozapine is FDA rated “AB” (bioequivalent or therapeutically equivalent) to Clozaril.  The FDA has approved The Mylan Brand of Clozapine tablets in both the 25 mg and 100 mg strengths.

Is The Mylan Brand of Clozapine interchangeable with the clozapine product from Ivax?

Yes.  All clozapine tablets (Clozaril, The Mylan Brand of Clozapine, and Ivax clozapine) contain the same active ingredient, are approved by the Food and Drug Administration (FDA), are available in the same tablet strengths (25 mg and 100 mg), and meet the same manufacturing standards established by the FDA.

Is it easy to transfer my “continuing therapy” patients to The Mylan Brand of Clozapine tablets?

Yes.  Patients who are simply transferring manufacturers are the easiest to switch.  In fact, the FDA has determined that the Novartis National Non-Rechallenge Master File does NOT need to be contacted for these patients.  The pharmacist should simply send the latest White Blood Cell (WBC) Count and Absolute Neutrophil Count (ANC) Reporting Form of the current manufacturer to the Clozapine Prescription Access System (CPAS).  A retroactive registration for the physician and patient will be performed.  CPAS does not need the signatures of physicians with “continuing therapy” patients.  Please call 800-843-9915 or fax 800-843-9916 for more information regarding this matter.

Do patients have to restart weekly WBC count and ANC reporting if switched to The Mylan Brand of Clozapine?

No.  Patients can continue their monitoring as is.

Agranulocytosis, granulocytopenia, seizures, orthostatic hypotension, tachycardia, drowsiness, and dizziness have been reported in patients taking clozapine.  For more information, please review the full Prescribing Information, which includes BOXED WARNINGS.

*  Registered trademark of Novartis Pharmaceuticals Corporation.