Zypadhera ® (olanzapin)

För fullständig produktresumé för Zypadhera® se FASS.

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ZypAdhera® (olanzapinpamoat): Underhållsdos

Underhållsdosen följer efter den inledande dosperioden på 2 månader enligt det rekommenderade dosschemat inom intervallet 150 mg till 300 mg varannan vecka eller 300 till 405 mg var fjärde vecka.

Further information on maintenance dose

Olanzapine LAI provides therapeutic levels of systemic olanzapine from the very first injection. However, approximately 3 months are needed to re-establish steady state.1

During treatment, dose may subsequently be adjusted on the basis of individual clinical status. After clinical reassessment, dose may be adjusted within the range 150 mg to 300 mg every 2 weeks or 300 to 405 mg every 4 weeks (Table 1).2

Table 1. Recommended dose scheme between oral olanzapine and olanzapine pamoate2

Target oral olanzapine dose

Recommended starting dose of olanzapine pamoate

Maintenance dose after 2 month of olanzapine pamoate treatment

10 mg/day

210 mg/2 weeks
or 405 mg/4 weeks

150 mg/2 weeks
or 300 mg/4 weeks

15 mg/day

300 mg/2 weeks

210 mg/2 weeks
or 405 mg/4 weeks

20 mg/day

300 mg/2 weeks

300 mg/2 weeks

These doses of olanzapine LAI have been shown to sustain steady-state olanzapine concentrations over 2 to 4 weeks that correspond to those maintained by an oral dose of 10 to 20 mg olanzapine administered once daily.3

Some specific patient populations may require cautious dose escalation.1 For full information please refer to the summary of product characteristics.

Pharmacokinetic background information

The half-life of olanzapine after olanzapine pamoate is 30 days compared to 30 hours following oral administration.2

During the initial three months of treatment with olanzapine pamoate, accumulation of olanzapine was observed but there was no additional accumulation during long-term use (12 months) in patients who were injected with up to 300 mg every two weeks.2

References

1. Data on file, Eli Lilly and Company and/or one of its subsidiaries.

2. ZypAdhera [summary of product characteristics] Eli Lilly Netherland B.V., The Netherlands.

3. Mitchell M, Kothare P, Bergstrom R, et al. Single- and multiple-dose pharmacokinetic, safety, and tolerability profiles of olanzapine long-acting injection: an open-label, multicenter, nonrandomized study in patients with schizophrenia. Clin Ther. 2013;35(12):1890-1908. http://dx.doi.org/10.1016/j.clinthera.2013.09.023

Glossary

LAI = long-acting injection = olanzapine-pamoate

Datum fӧr senaste ӧversyn 2019 M05 01

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