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ZypAdhera ® (olanzapine pamoate monohydrate)
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ZypAdhera Summary of Product Characteristics (SmPC)
ZypAdhera® (olanzapine pamoate): Next Injection After Post Injection Syndrome
The majority of patients in clinical trials who experienced a post-injection syndrome event continued olanzapine. A general recommendation for the next injection is not available.
All patients fully recovered from the post-injection syndrome event within 1.5 to 72 hours after onset.1
In 70% of events, patients continued to receive further treatment with olanzapine LAI following the event. At the time of datalock, the median number of additional days of study participation following a post-injection syndrome event was 184 days, and the median number of subsequent injections received following the event was 9. Only 1 patient experienced a second post-injection syndrome event, with the second event occurring approximately 6 months after the first event.1
In an analysis of 338 postmarketing cases from 01 March 2009 through 01 March 2014, among the 210 cases where continuation information was available, 55% (116/210) of patients continued olanzapine LAI treatment.2
If olanzapine LAI therapy is continued, the dose and timing of the next injection may occur as previously scheduled or earlier if clinically indicated for exacerbation of schizophrenia symptoms.3
Alternatively oral olanzapine supplementation may be considered if clinically indicated. Then the combined total dose of olanzapine from both formulations should not exceed the corresponding maximum oral olanzapine dose of 20 mg/day.4
If olanzapine pamoate therapy is discontinued, treatment efficacy and/or treatment-emergent AEs may continue for some time.4
The half-life of olanzapine after olanzapine pamoate is 30 days compared to 30 hours following oral administration.4
1. Detke HC, McDonnell DP, Brunner E, et al. Post-injection delirium/sedation syndrome in patients with schizophrenia treated with olanzapine long acting injection, I: analysis of cases. BMC Psychiatry. 2010;10(1):43. http://dx.doi.org/10.1186/1471-244X-10-43
2. Bushe CJ, Falk D, Anand E, et al. Olanzapine long-acting injection: a review of first experiences of post-injection delirium/sedation syndrome in routine clinical practice. BMC Psychiatry. 2015;15:65. http://dx.doi.org/10.1186/s12888-015-0450-9
3. Data on file, Eli Lilly and Company and/or one of its subsidiaries.
4. ZypAdhera [summary of product characteristics] Eli Lilly Netherland B.V., The Netherlands.
Glossary
AE = Adverse Event
LAI =Long Acting Injection
Date of Last Review: December 12, 2019
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