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ANIMAL TOXICOLOGY In animal studies with olanzapine, the principal hematologic findings were reversible peripheral cytopenias in individual dogs dosed at 10 mg/ kg (17 times the maximum recommended human daily dose on a mg/ m 2 basis), dose-related decreases in lymphocytes and neutrophils in mice, and lymphopenia in rats. A few dogs treated with 10 mg/ kg developed reversible neutropenia and/ or reversible hemolytic anemia between 1 and 10 months of treatment. Dose-related decreases in lymphocytes and neutrophils were seen in mice given doses of 10 mg/ kg (equal to 2 times the maximum recommended human daily dose on a mg/ m 2 basis) in studies of 3 months' duration. Nonspecific lymphopenia, consistent with decreased body weight gain, occurred in rats receiving 22.5 mg/ kg (11 times the maximum recommended human daily dose on a mg/ m 2 basis) for 3 months or 16 mg/ kg (8 times the maximum recommended human daily dose on a mg/ m 2 basis) for 6 or 12 months. No evidence of bone marrow cytotoxicity was found in any of the species examined. Bone marrows were normocellular or hypercellular, indicating that the reductions in circulating blood cells were probably due to peripheral (non-marrow) factors.
Literature revised January 14, 2004
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