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Drug Safety Evaluations

Olanzapine pamoate for the treatment of schizophrenia – a safety evaluation

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Pages 403-411 | Received 11 Dec 2015, Accepted 11 Jan 2016, Published online: 19 Feb 2016

References

  • Saha S, Chant D, Welham J, et al. A systematic review of the prevalence of schizophrenia. PLoS Med. 2005;2:e141.
  • Millier A, Schmidt U, Angermeyer MC, et al. Humanistic burden in schizophrenia: a literature review. J Psychiatric Res. 2014;54:85–93.
  • Van Os J, Kapur S. Schizophrenia. Lancet. 2009;374(9690):635–645.
  • Lacro JP, Dunn LB, Dolder CR, et al. Prevalence of and risk factors for medication nonadherence in patients with schizophrenia: a comprehensive review of recent literature. J Clin Psychiatry. 2002;63:892–909.
  • Velligan DI, Weiden PJ, Sajatovic M, et al. The expert consensus guideline series: adherence problems in patients with serious and persistent mental illness. J Clin Psychiatry. 2009;70(Suppl 4):1–8.
  • Adams CE, Fenton MK, Quraishi S, et al. Systematic meta-review of depot antipsychotic drugs for people with schizophrenia. Br J Psychiatry. 2001;179:290–299.
  • Kishimoto T, Robenzadeh A, Leucht C, et al. Long-acting injectable vs oral antipsychotics for relapse prevention in schizophrenia: a meta-analysis of randomized trials. Schizophr Bull. 2013;40(1):192–213.
  • Leucht C, Heres S, Kane JM, et al. Oral versus depot antipsychotic drugs for schizophrenia – a critical systematic review and meta-analysis of randomised long-term trials. Schizophr Res. 2011;127:83–92.
  • Samalin L, Charpeaud T, Blanc O, et al. Clinicians’ attitudes toward the use of long-acting injectable antipsychotics. J Nerv Ment Dis. 2013;201(7):553–559.
  • Rummel-Kluge C, Komossa K, Schwarz S, et al. Second-generation antipsychotic drugs and extrapyramidal side effects: a systematic review and meta-analysis of head-to-head comparisons. Schizophr Bull. 2012;38(1):167–177.
  • Eli Lilly and Compagny. Zypadhera 210 mg, 300 mg and 405 mg, powder and solvent for prolonged release suspension for injection: summary of product characteristics. Basingstone: Eli Lilly and Company; 2010.
  • Eli Lilly and Compagny. Zyprexa Relprevv (olanzapine) for extended release injectable suspension: US prescribing information. Indianapolis (IN): Eli Lilly and Company; 2010.
  • Schöttle D, Kuhnigk O, Naber D. Drug safety evaluation of olanzapine pamoate. Expert Opin Drug Saf. 2013;12(6):897–903.
  • Citrome L. Quantifying risk: the role of absolute and relative measures in interpreting risk of adverse reactions from product labels of antipsychotic medications. Curr Drug Saf. 2009;4(3):229–237.
  • Frampton JE. Olanzapine long-acting injection: a review of its use in the treatment of schizophrenia. Drugs. 2010;70(17):2289–2313.
  • Heres S, Kraemer S, Bergstrom RF, et al. Pharmacokinetics of olanzapine long-acting injection: the clinical perspective. Int Clin Psychopharmacol. 2014;29(6):299–312.
  • Citrome L. Olanzapine pamoate: a stick in time? A review of the efficacy and safety profile of a new depot formulation of a second-generation antipsychotic. Int J Clin Pract. 2009;63(1):140–150.
  • Lindenmayer JP. Long-acting injectable antipsychotics: focus on olanzapine pamoate. Neuropsychiatr Dis Treat. 2010;6:261–267.
  • Lauriello J, Lambert T, Andersen S, et al. An 8-week, double-blind, randomized, placebo-controlled study of olanzapine long-acting injection in acutely ill patients with schizophrenia. J Clin Psychiatry. 2008;69(5):790–799.
  • Kane JM, Detke HC, Naber D, et al. Olanzapine long-acting injection: a 24-week, randomized, double-blind trial of maintenance treatment in patients with schizophrenia. Am J Psychiatry. 2010;167(2):181–189.
  • Detke HC, Weiden PJ, Llorca P-M, et al. Comparison of olanzapine long-acting injection and oral olanzapine: a 2-year, randomized, open-label study in outpatients with schizophrenia. J Clin Psychopharmacol. 2014;34(4):426–434.
  • McDonnell DP, Landry J, Detke HC. Long-term safety and efficacy of olanzapine long-acting injection in patients with schizophrenia or schizoaffective disorder: a 6-year, multinational, single-arm, open-label study. Int Clin Psychopharmacol. 2014;29(6):322–331.
  • 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.
  • Mamo D, Kapur S, Keshavan M, et al. D2 receptor occupancy of olanzapine pamoate depot using positron emission tomography: an open-label study in patients with schizophrenia. Neuropsychopharmacology. 2008;33(2):298–304.
  • 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.
  • Mauri MC, Maffini M, Di Pace C, et al. “Long-acting” olanzapine in maintenance therapy of schizophrenia: A study with plasma levels. Int J Psychiatry Clin Pract. 2015;19(2):99–105.
  • Eli Lilly and Company. Clinical Trial Results, Zyprexa long-acting injection; [updated 2015 Dec 7]. Available from: www.lillytrials.com/results/ZyprexaLAI.pdf
  • Eli Lilly and Company. Zyprexa Olanzapine Pamoate (OP) Depot, Psychopharmacological Drugs Advisory Committee Briefing Document. 2008; [updated 2015 Dec 7] Available from: www.fda.gov/ohrms/dockets/ac/08/briefing/2008-4338b1-03-Lilly.pdf
  • Center for Drug Evaluation and Research. Application number: 22-173. Olanzapine pamoate depot Medical review(s). 2008; [updated 2015 December 7] Available from: www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022173s000MedR.pdf
  • European Medicines Agency. Assessment Report for Zypadhera. 2008; [Last accessed 2015 Dec 7]. Available from: www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/000890/WC500054428.pdf
  • Food and Drug Administration. FDA Drug Safety Communication (6-18-2013): FDA is investigating two deaths following injection of long-acting antipsychotic Zyprexa Relprevv (olanzapine pamoate); [updated 2015 Dec 7]. Available from: www.fda.gov/Drugs/DrugSafety/ucm356971.htm
  • Food and Drug Administration. FDA Drug Safety Communication (3-23-2015): FDA review of study sheds light on two deaths associated with the injectable schizophrenia drug Zyprexa Relprevv (olanzapine pamoate); [updated 2015 Dec 7]. Available from: www.fda.gov/Drugs/DrugSafety/ucm439147.htm
  • Hill AL, Sun B, McDonnell DP. Incidences of extrapyramidal symptoms in patients with schizophrenia after treatment with long-acting injection (depot) or oral formulations of olanzapine. Clin Schizophr Relat Psychoses. 2014;7(4):216–222.
  • Hill AL, Sun B, Karagianis JL, et al. Dose-associated changes in safety and efficacy parameters observed in a 24-week maintenance trial of olanzapine long-acting injection in patients with schizophrenia. BMC Psychiatry. 2011;11:28.
  • Atkins S, Detke HC, McDonnell DP, et al. A pooled analysis of injection site-related adverse events in patients with schizophrenia treated with olanzapine long-acting injection. BMC Psychiatry. 2014;14:7.
  • Kurtz D, Bergstrom R, McDonnell D, et al. Pharmacokinetics (PK) of multiple doses of olanzapine long-acting injection (OLAI), an intramuscular (IM) depot formulation of olanzapine (OLZ), in stabilised patients with schizophrenia. Biol Psychiatry. 2008;63(Suppl 1):228–235.
  • 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;10:43.
  • Luedecke D, Schöttle D, Karow A, et al. Post-injection delirium/sedation syndrome in patients treated with olanzapine pamoate: mechanism, incidence, and management. CNS Drugs. 2015;29(1):41–46.
  • McDonnell D, Detke HC, Bergstrom RF, et al. Post-injection delirium/sedation syndrome in patients with schizophrenia treated with olanzapine long-acting injection, II: investigations of mechanism. BMC Psychiatry. 2010;10:45.
  • Leucht S, Cipriani A, Spineli L, et al. Comparative efficacy and tolerability of 15 antipsychotic drugs in schizophrenia: a multiple-treatments meta-analysis. Lancet. 2013;382:951–962.
  • Citrome L. New second-generation long-acting injectable antipsychotics for the treatment of schizophrenia. Expert Rev Neurother. 2013;13(7):767–783.
  • Novakovic V, Adel T, Peselow E, et al. Long-acting injectable antipsychotics and the development of postinjection delirium/sedation syndrome (PDSS). Clin Neuropharm. 2013;36(2):59–62.
  • Brissos S, Veguilla MR, Taylor D, et al. The role of long-acting injectable antipsychotics in schizophrenia: a critical appraisal. Ther Adv Psychopharmacol. 2014;4(5):198–219.
  • Weiden PJ, Kozma C, Grogg A, et al. Partial compliance and risk of rehospitalization among California Medicaid patients with schizophrenia. Psychiatr Serv. 2004;55:886–891.
  • Kane JM, Aguglia E, Altamura AC, et al. Guidelines for depot antipsychotic treatment in schizophrenia. European Neuropsychopharmacology Consensus Conference in Siena, Italy. Eur Neuropsychopharmacol. 1998;8:55–66.
  • Keith SJ, Kane JM, Turner M, et al. Academic highlights: guidelines for the use of long-acting injectable atypical antipsychotics. J Clin Psychiatry. 2004;65:120–131.
  • Stip E, Abdel-Baki A, Bloom D, et al. Long-acting injectable antipsychotics: an expert opinion from the Association des Médecins Psychiatres du Quebec. Can J Psychiatry. 2011;56:367–376.
  • Llorca PM, Abbar M, Courtet P, et al. Guidelines for the use and management of long-acting injectable antipsychotics in serious mental illness. BMC Psychiatry. 2013;13:340.
  • Barnes TR. Evidence-based guidelines for the pharmacological treatment of schizophrenia: recommendations from the British Association for Psychopharmacology. J Psychopharmacol. 2011;25:567–620.
  • Hasan A, Falkai P, Wobrock T, et al. World Federation of Societies of Biological Psychiatry (WFSBP) guidelines for biological treatment of schizophrenia, part 2: update 2012 on the long-term treatment of schizophrenia and management of antipsychotic-induced side effects. World J Biol Psychiatry. 2013;14:2–44.
  • Moore TA, Buchanan RW, Buckley PF, et al. The Texas Medication Algorithm Project antipsychotic algorithm for schizophrenia: 2006 update. J Clin Psychiatry. 2007;68:1751–1762.
  • Mauri MC, Volonteri LS, Colasanti A, et al. Clinical pharmacokinetics of atypical antipsychotics: a critical review of the relationship between plasma concentrations and clinical response. Clin Pharmacokinet. 2007;46(5):359–388.
  • Patel MX, Bowskill S, Couchman L, et al. Plasma olanzapine in relation to prescribed dose and other factors: data from a therapeutic drug monitoring service, 1999-2009. J Clin Psychopharmacol. 2011;31(4):411–417.
  • Ascher-Svanum H, Montgomery WS, McDonnell DP, et al. Treatment-completion rates with olanzapine long-acting injection versus risperidone long-acting injection in a 12-month, open-label treatment of schizophrenia: indirect, exploratory comparisons. Int J Gen Med. 2012;5:391–398.
  • Berwaerts J, Liu Y, Gopal S, et al. Efficacy and safety of the 3-month formulation of paliperidone palmitate vs placebo for relapse prevention of schizophrenia: a randomized clinical trial. JAMA Psychiatry. 2015;72(8):830–839.
  • TEVA Pharmaceutical Industries Ltd. Improving access, choice and treatments; [updated 2015 Dec 7]. Available from:www.tevapharm.com/corporate_responsibility/choice_treatments/

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