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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.
Further
Information
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
References
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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