Zypadhera ® (olanzapin)

För fullständig produktresumé för Zypadhera® se FASS.

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ZypAdhera® (olanzapinpamoat): Postinjektionssyndrom

Efter en injektion av olanzapinpamoat upplevde patienter i sällsynta fall tecken på postinjektionssyndrom. Majoriteten återhämtade sig inom 24–72 timmar utan behandling.

Detailled information

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

Initiation of therapy

Patients should be treated initially with oral olanzapine before administering olanzapine pamoate, to establish tolerability and response.2

In order to identify the first olanzapine pamoate dose for all patients, the scheme in Table 1 should be considered.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

Some specific patient populations may require lower starting doses.1 For full information please refer to summary of product characteristics.

Dose adjustment

Patients should be monitored carefully for signs of relapse during the first one to two months of treatment.2

During antipsychotic treatment, improvement in the patient's clinical condition may take several days to some weeks. Patients should be closely monitored during this period.2

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

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

Supplementation

Supplementation with oral olanzapine was not authorised in double-blind clinical studies.2

Antipsychotic supplementation is not required at the initiation of olanzapine pamoate treatment.2

If oral olanzapine supplementation is 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.2

Pharmacokinetic background information

After a single intramuscular injection with olanzapine pamoate, the slow dissolution of the olanzapine pamoate salt in muscle tissue begins immediately and provides a slow continuous release of olanzapine for more than four weeks.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

Important notes

Olanzapine LAI is intended for deep gluteal intramuscular injection only.1

ZypAdhera 210 mg, 300 mg, and 405 mg, powder and solvent for prolonged release suspension for injection must not be confused with olanzapine 10 mg powder for solution for injection.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.

Glossary

LAI = long-acting injection = olanzapine pamoate

Datum fӧr senaste ӧversyn 2019 M05 01

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