ZypAdhera® (olanzapine pamoate): Initiation of Therapy

Detailed 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

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