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WARNING

POST-INJECTION DELIRIUM/SEDATION SYNDROME AND INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS

Post-Injection Delirium/Sedation Syndrome - Adverse events with signs and sy mptoms consistent with olanzapine overdose, in particular, sedation (including coma) and/or delirium, have been reported following injections of ZYPREXA RELPREVV (olanzapine extended release injectable suspension) . ZYPREXA RELPREVV (olanzapine extended release injectable suspension) must be administered in a registered healthcare facility with ready access to emergency response services. After each injection, patients must be observed at the healthcare facility by a healthcare professional for at least 3 hours. Because of this risk, ZYPREXA RELPREVV (olanzapine extended release injectable suspension) is available only through a restricted distribution program called ZYPREXA RELPREVV (olanzapine extended release injectable suspension) Patient Care Program and requires prescriber, healthcare facility, patient, and pharmacy enrollment [see DOSAGE AND ADMINISTRATION, WARNINGS AND PRECAUTIONS, OVERDOSAGE, and PATIENT INFORMATION] .

Increased Mortality in Elderly Patients with Dementia-Related Psychosis - Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of seventeen placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in drug- treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients. Over the course of a typical 10­ week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear. ZYPREXA RELPREVV (olanzapine extended release injectable suspension) is not approved for the treatment of patients with dementia-related psychosis [see WARNINGS AND PRECAUTIONS and PATIENT INFORMATION] .