New Warnings in Labeling for Clozaril

Novartis has notified healthcare professionals about new warnings and drug information in the labeling for the antipsychotic drug Clozaril (clozapine).

Patients taking clozapine are at increased risk of potentially life-threatening agranulocytosis. The labeling has required white blood cell monitoring for these patients. The new labeling provides for a number of changes regarding the WBC monitoring program.

The frequency of monitoring may be reduced to once every four weeks after the first year of clozapine treatment in patients who have maintained satisfactory white blood cell (WBC) counts. Monitoring instructions for the first year of therapy remain the same: weekly for the first six months, and every two weeks for the second six months.

A new requirement to determine and report the absolute neutrophil count has been added. Previously, only the total white blood cell count was required.
There are new WBC requirements for initiating clozapine therapy: the total WBC count must be at least 3500 per mm3 and the absolute neutrophil count must be at least 2000 per mm3.

If a patient experiences a moderate decrease in either total white blood cell count or absolute neutrophil count, evaluate the risks and benefits of continuing clozapine treatment. If clozapine is continued, white blood cell counts must be monitored weekly for the next 12 months.

The new labeling also warns of increased mortality in elderly patients with dementia that have received clozapine to treat behavioral symptoms, and it reminds physicians that this drug is not approved for use in dementia-related psychosis. There is also a new contraindication in patients who have paralytic ileus.

Category:

News & Politics

Tags:

• Clozaril
• Warning
• Labels
• Antipsychotic
• Clozapine
• FDA
• Life-Threatening
• Agranulocytosis
• Patient
• Safety
• White
• Blood
• Cells

[CDMC1st2006]

thanks quite helpful