Zypadhera ® (olanzapin)

För fullständig produktresumé för Zypadhera® se FASS.

Denna information är endast avsedd för sjukvårdspersonal verksam i Sverige och som svar på din fråga. Informationen nedan är på engelska

ZypAdhera® (olanzapinpamoat): Tid till verkan

Hos patienter med akuta psykotiska symtom iakttogs läkemedelseffekt så snart som en vecka efter påbörjad behandling. Klinisk förbättring kan ta flera dagar till några veckor.

Label information

Patients should be monitored carefully for signs of relapse during the first one to two months of treatment.1

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.1

Pharmacokinetic considerations

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.1

Approximately 3 months are needed to re-establish steady state.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.1

Information from clinical studies

An 8-week, placebo controlled trial was conducted in adult patients (n=404) who were experiencing acute psychotic symptoms.1

  • Patients were randomized to receive injections of olanzapine pamoate 405 mg every 4 weeks, 300 mg every 2 weeks, 210 mg every 2 weeks, or placebo every 2 weeks. No oral antipsychotic supplementation was allowed.1

  • Total Positive and Negative Symptom Scores (PANSS) showed significant improvement from baseline (baseline mean Total PANSS Score 101) to endpoint (mean changes -22.57, -26.32, -22.49 respectively) with each dose of olanzapine pamoate (405 mg every 4 weeks, 300 mg every 2 weeks, and 210 mg every 2 weeks) as compared to placebo (mean change -8.51).1

  • Visitwise mean change from baseline to endpoint in PANSS Total score indicated that by Day 3, patients in the 300 mg/2 weeks and 405 mg/4 weeks treatment groups had statistically significantly greater reductions in PANSS Total score compared to placebo (-8.6, -8.2, and -5.2, respectively).1

  • All 3 olanzapine pamoate treatment groups showed statistically significantly greater improvement than placebo beginning by end of Week 1.1

These results support efficacy for olanzapine pamoate over 8 weeks of treatment and a drug effect that was observed as early as 1 week after starting treatment with olanzapine pamoate.1

References

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

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

Datum fӧr senaste ӧversyn 2019 M05 01


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