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Olanzapine Long-Acting Injection (LAI) Shown to Maintain Treatment Benefit in Schizophrenia for up to Six Months
Date:9/2/2008

LAI Post- Injection Syndrome cases observed in olanzapine LAI clinical trials to determine appropriate recommendations for risk and medical management. Safety data were pooled from all completed and ongoing olanzapine LAI clinical trials through 30 September 2007; adverse event data through 31 May 2008 were also reviewed.

As of 31 May 2008, the incidence of Olanzapine LAI Post-Injection Syndrome following administration of olanzapine LAI was 29 cases (in 28 patients) after more than 40,000 injections, yielding a per-injection rate of 0.07 percent and a per-patient rate of 1.4 per cent - or approximately one event per 1,400 injections. No clinically significant decreases in vital signs were observed and all patients recovered completely from signs and symptoms of Olanzapine LAI Post-Injection Syndrome within 1.5 to 72 hours. Approximately 70 percent of patients continued to receive injections after the event. The cumulative risk of experiencing an Olanzapine LAI Post-Injection Syndrome event after one year of treatment was 0.7 to 1.2 percent. (These data were presented as a range due to variable injection intervals).

Across all clinical trials, as of 31 July, no additional cases of Olanzapine LAI Post-Injection Syndrome were reported.

Based on the extensive review of pooled safety data from all olanzapine LAI clinical trials and given that awareness and recognition of these events are key aspects of identifying them and minimizing associated symptoms, Lilly has proposed a comprehensive plan for managing Olanzapine LAI Post-Injection Syndrome risks that includes a detailed product label including a post- injection observation period and an extensive healthcare provider training and educational program.

About Long-acting Injectable Antipsychotic Medications

The World Federation of Societies of Biological Psychiatry (WFSBP) guidelines state that poor or partial treatment compliance is a major problem in the long-term treatment of schi
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