Clozapine Update: Change in Monitoring Schedule

Clozapine (brand name Clozaril) is used “second-line” to treat schizophrenia and requires monitoring of blood cell counts. This is an atypical anti-psychotic drug that is used after a patient failed to respond to standard schizophrenia treatment (the standard treatment is called “first-line” treatment).

If you take clozapine as part of your therapeutic regimen, please ask your doctor about what this labeling change means for you.

Changes to monitoring blood cell counts for Clozapine treatment has been sent to health care providers and is as follows:

Dear Health Care Provider:

Novartis would like to inform you of recent changes to the following sections of the prescribing information (PI) for Clozaril. (clozapine) tablets: BOXED WARNING, WARNINGS, CONTRAINDICATIONS, PRECAUTIONS (Information for Patients and Pharmacokinetic-Related Interactions subsections), and ADVERSE REACTIONS (Postmarketing Clinical Experience subsection)

MONITORING FREQUENCY

After reviewing recommendations provided by the Psychopharmacological Drugs Advisory Committee (PDAC) of June 2003 regarding the white blood cell (WBC) monitoring schedule required for all clozapine users, the Food and Drug Administration (FDA) concluded that the current monitoring schedule should be modified. The changes to the monitoring frequency schedule required revisions to the BOXED WARNING (Attachment 1), WARNINGS, and PRECAUTIONS (Information for Patients) sections of the PI. The major changes regarding the frequency and parameters of the monitoring schedule are summarized below:

- Requirement that the absolute neutrophil count (ANC) be determined and reported along with each WBC count.

- New parameters for initiation of Clozaril treatment: WBC t 3500/mm3 and ANC t 2000/mm3.

- Initiation of monthly monitoring schedule after one year (six months weekly, six months every two weeks) of WBC counts and ANCs in the normal range (WBC t 3500/mm3 and ANC t 2000/mm3).

- Addition of cautionary language to prescribers describing the increased risk of agranulocytosis in patients who are rechallenged with clozapine following recovery from an initial episode of moderate leukopenia(3000/mm3 > WBC t 2000/mm3 and/or 1500/mm3 >ANC t 1000/mm3). After recovering from such an episode, these patients are now required to undergo weekly monitoring for 12 months if they are re-challenged.

Call 1-800-FDA-1088 (1-800-332-1088)

Google Search: clozapine blood monitoring

January 16, 2006 | Filed Under !Alerts, Treatment 

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