IgG Therapy for the Home-Based Patient: Administration and ... - NHIA

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It’s important that patients are educated about the types of adverse reactions associated with SCIG and how to recognize them. Symptoms, such as warmth, redness, and itching may be associated with a lessserious site reaction and may be resolved by working with their clinical team to strategize a pretreatment plan or reexamine needle length, administration procedure, or other variables. See the “SCIG Administration” section on page 5 for more information. Case Study Converting IVIG patient to SCIG Mr. D was a 46yearold male with CIPD. He was experiencing pain and decreased strength in his lower extremities. For four years, he had been receiving the same IVIG formulation (offlabel) at an infusion center. To be treated, he needed to travel 60 minutes (each way) monthly, in addition to wait and infusion time at the hospitalbased infusion clinic. Following his infusions, he experienced severe chronic reactions, including migraine, vomiting, and flulike symptoms and was bedridden for up to three days postinfusion. Overall, his disease state was poorly controlled and his quality of life was greatly diminished. The specialty infusion team worked with Mr. D’s physician to find an alternative IVIG formulation that might reduce the side effects Actual patient not shown. Photo courtesy of Melvin Berger, M.D. and CSL Behring he was experiencing. The team educated the physician on recognizing patientspecific product intolerances as well as raterelated side effects that can be abated by using a standard IVIG infusion rate (which the center was not doing). Mr. D successfully switched to a different IVIG product without incident and received his infusions at home. His infusion reactions resolved—he was no longer bedbound for three days with flulike symptoms each month—and his trips to the infusion center were also eliminated which conservatively saved his payer $20,000 per year in infusion suite costs. Mr. D also reported decreased pain in his limbs and neck. Mr. D then expressed his desire to move to SCIG in order to become even more autonomous. He converted successfully after three nurseteaching visits, and reports having improved energy levels and quality of life. He has regular monthly assessments with his physician, and the specialty pharmacy infusion team follows his progress. Subcutaneous immune globulin therapy offers a safe, less invasive alternative to intravenous IG therapy to those patients and caregivers willing to selfadminister in the home setting. 8 IgG Therapy for the HomeBased Patient: Administration and Delivery Method Considerations
References 1. Marketing Research Bureau, Inc. The plasma proteins market in the U.S. July 2011; 28(12):168. Available at http://www.marketingresearchbureau.com/IBPN_July2011.pdf (accessed on 10/29/2012). 2. Icore Healthcare. Medical pharmacy and oncology trend report, 2 nd edition. 2011:38. Available at: http://www.icorehealthcare.com/icoreutil/trendreportdownload.aspx/ (accessed 10/29/2012). 3. Orange J, Hossny E, Weiler C, et al. Use of intravenous immunoglobulin in human disease: A review of evidence by members of the Primary Immunodeficiency Committee of the American Academy of Allergy, Asthma, and Immunology. J Allergy Clin Immunol.2006;117(4):S525 553. Available at: www.aaaai.org/Aaaai/media/MediaLibrary/PDF%20Documents/Practice%20Resources/2006_i vig_evidence_review.pdf (accessed 10/29/2012). 4. Bruton OC. Agammaglobulinemia. Pediatrics. 1952.Jun;9(6):7228. 5. Berger M, Cupps TR, Fauci AS. Immunoglobulin replacement therapy by slow subcutaneous infusion.Ann Intern Med.1980;93(1):5556. 6. van der Meer JWN, van Furth R. Rood JJ. Subcutaneous administration of gamaglobulin. In: Nydegger UE, ed. Immunotherapy: a guide to immunoglobulin prophylaxis and therapy. London:Academic Press, 1981:13342. 7. Gardulf A, Hammarstrom L, Smith C.I.E. Home treatment of hypogammaglobulinaemia with subcutaneous gammaglobulin by rapid infusion. Lancet. 1991;338(8760):162166. 8. Gardulf A, Andersen V. Bjorkander J. et al. Subcutaneous immunoglobulin replacement in patients with primary antibody deficiencies: safety and costs. Lancet. 1995;345:3659 9. Welch MJ, Stiehm ER. Slow subcutaneous immunoglobulin therapy in a patient with reactions to intramuscular immunoglobulin. J Clin Immunol. 1983;3(3):285286. 10. FDA. Approval letter for Vivaglobin. January 9, 2006. Available at: http://www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/LicensedProductsBLAs/FractionatedPlasmaProducts/ucm 070367.htm (accessed 10/29/2012). 11. Berger, M. Subcutaneous immunoglobulin replacement in primary immune deficiencies.J Clin Immunol.2004;112:17. 12. Hoffmann F, Grimbacher B, Thiel J, et al. Homebased subcutaneous immunoglobulin G replacement therapy under reallife conditions in children and adults with antibody deficiency.Eur J Med Res.2010 Jun 28; 15(6) :23845. 13. Gasper, Gerritsen, Jones. Immunoglobulin treatment by rapid subcutaneous infusion, Arch Dis Child 79(1998);4851. 14. Chapel HM, Spickett GP, Ericson D, Engl W, Eibl MM, Bjorkander J. The comparison of the efficacy and safety of intravenous versus subcutaneous immunoglobulin replacement therapy. J Clin Immunol.2000;20(2):94100. 15. Ugazio AG, Duse M, Re R, Mangili G, Burgio GR. Subcutaneous infusion of gammaglobulins in management of agammaglobulinaemia. Lancet.1982;1(8265):226. 16. Gardulf A, Bjorvell H, Gustafson R, Hammarstrom L, Smith CI. Safety of rapid subcutaneous gammaglobulin infusions in patients with primary antibody deficiency. Immunodeficiency.1993;4(14):8184. 17. Orange JS, Grossman WJ, Navickis RJ, and Wilkes MM. Impact of trough IgG on pneumonia incidence in primary immunodeficiency: A metaanalysis of clinical studies. Clinical Immunology.2010;137:21–30. 18. Haddad E, Berger M, Wang, E, et. al. Higher doses of subcutaneous IgG reduce resource utilization in patients with primary immunodeficiency. J Clin Immunol. 2012. April;32(2):281289. 19. Speidel K. Subcutaneous administration of immunoglobulin replacement therapy in the home care setting.INFUSION.2006.12(3):S1S8. 20. Yong PL, Boyle J, Ballow M, Boyle M, Berger M, Blessing J, et al. Use of intravenous immunoglobulin and adjunctive therapies in the treatment of primary immunodeficiencies: a working group report of and study by the Primary Immunodeficiency Committee of the American Academy of Allergy Asthma and Immunology.J Clin Immunol. 2010;135:255–263. 21. ZLB Behring. Immune Globulin Subcutaneous (Human) Vivaglobin Prescribing information, January 2006. Supplement to INFUSION, November/December 2012 (Vol. 18, No. 6) IgG Therapy for the HomeBased Patient: Administration and Delivery Method Considerations
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IgG Therapy for the Home-Based Patient: Administration and ... - NHIA

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