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D EVELOPMENT OF A P AEDIATRIC S PECIFIC I NFLIXIMAB A DMINISTRATION G UIDELINE

Sumayya Kasuji, Pediatric Pharmacist, outlines the need for a new guideline, national practice review, literature review, management of infusion reactions, and the implementation of a new guideline. Details include titrated infusion schedules and dosing strategies.

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D EVELOPMENT OF A P AEDIATRIC S PECIFIC I NFLIXIMAB A DMINISTRATION G UIDELINE

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  1. DEVELOPMENT OF A PAEDIATRIC SPECIFIC INFLIXIMAB ADMINISTRATION GUIDELINE Sumayya Kasuji Paediatric Pharmacist

  2. Outline • Why did we need a new guideline? • National practice review • Literature review • Management of infusion reaction • New guideline

  3. LOCAL PRACTICE PRIOR TO NEW GUIDLEINE

  4. Why did we need a guideline? Constant infusion (Licensed) Titrated infusion schedule In 250mls over 2 hours In 250mls • 10ml/hr for 15 mins • 20ml/hr for 15 mins • 40ml/hr for 15 mins • 80ml/hr for 15 mins • 150ml/hr for 30 mins • 250ml/hr until end of infusion

  5. What did we need? • Determine the place for using a titrated infusion schedule • Develop an easy to follow infliximab prescribing and administration guideline

  6. NATIONAL PRACTICE REVIEW

  7. Literature review Chimeric human-murine IgG1 monoclonal antibody • Sensitivity reactions and antibody formation: • Human antichimeric antibodies (HACA) • Delayed infusion reactions • Acute infusion related reactions • Autoantibodies and lupus like syndrome

  8. Literature review • Concomitant immunosuppressive therapy reduces likelihood of antibody formation • Dose of 6mg/kg associated with lower antibody titre • Presence of antibodies increases risk of infusion reactions occurring

  9. MANAGEMENT OF INFUSION REACTIONS

  10. Summary of new guideline • Dose administered in 250ml of sodium chloride 0.9% • Administer over 2 hours (approx 2ml/min) • Use titrated infusion schedule in children with previous infusion reactions. • Pre-medication given to all children with previous acute reaction • Check and record temperature, pulse and blood pressure every 30 minutes • Monitor for adverse reactions every 30 minutes. • Monitor for 2 hours after infusion initially.

  11. DRUG CHART

  12. DRUG CHART: BACK PAGE

  13. Reference Sources 1. Hyams et al. 2007. Induction and maintenance infliximab therapy for the treatment of moderate- to-severe crohn’s disease in children. Gastroenterology. 132: 863-873. 2. Miele et al. 2004. Human anti-chimeric antibody in children and young adults with inflammatory bowel disease receiving infliximab. Journal of pediatric gastroenterology and nutrition. 38: 502 - 508 3. Jacobstein et al. 2005. Pre-medication and infusion reactions with infliximab: results from a pediatric inflammatory bowel disease consortium. Inflammatory bowel disease. 11: 442-446 4. Kugathasan et al. 2002. Infliximab retreatment in adults and children with crohn’s disease: risk factors for the development of delayed severe systemic reactions. American journal of gastroenterology. 97: 1408-1414 5. Cezard et al. 2003. A prospective study of the efficacy and tolerance of a chimeric antibody to tumour necrosis factors (Remicade) in severe pediatric crohns disease. Journal of pediatric gastroenterology and nutrition. 36: 632-636. 6. Crandall & Mackner. 2003. Infusion reactions to infliximab in children and adolescents: frequency, outcome and a predictive model. Alimentary pharmacology & therapeutics. 17: 75-84 7. Ruperto et al. 2007. A randomised, placebo controlled trial of infliximab plus methotrexate for the treatment of polyarticular-course juvenile rheumatoid arthritis. Arthritis and rheumatism. 56 (9) 3096-3106. 8. Gerloni et al. 2005. Efficacy of repeated intravenous infusions of an anti-TNF- monoclonal antibody (INFLIXIMAB) in persistently active refractory juvenile idiopathic arthritis. Results of an open label prospective study. Arthritis and rheumatology. 52 (2): 548-553 9. AHFS Drug Information. [Online] American Society of Health System Pharmacists 10. Ruperto et al. 2010. long-term efficacy and safety of infliximab plus methotrexaate for the treatment of polyarticular-course juvenile rheumatoid arthritis: findings from an open-label treatment extension. Annals of the rheumatic disease. 69: 718-722 11. Lecluse et al, 2008. Review and expert opinion on prevention and treatment of infliximab infusion reactions. British journal of dermatology. 159 (3): 527-536 12. Wasserman et al. 2004. Infusion related reactions to infliximab in patients with rheumatoid arthritis in a clinical practice setting: relationship to dose, antihistamine pre-treatment and infusion number. The journal of rheumatology. 31:1912-1917 13. Lequerre et al. 2006. Management of infusion reactions to infliximab in patients with rheumatoid arthritis or spondyloarthritis: experience from an immunotherapy unit of rheumatology. The journal of rheumatology. 33:1307-1314 14. MSD, 2009. Personal communication. 15. Schering-Plough Ltd. 2009. Remicade 100mg powder for concentrate for solution for infusion. [Online] available from the World Wide Web: <http://www.emc.medicines.org.uk>.

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