References
- Freeman JA, Crassini KR, Best OG, et al. Immunoglobulin G subclass deficiency and infection risk in 150 patients with chronic lymphocytic leukemia. Leuk Lymphoma. 2013;54(1):99–104.
- Griffiths H, Lea J, Bunch C, et al. Predictors of infection in chronic lymphocytic leukaemia (CLL). Clin Exp Immunol. 1992;89(3):374–377.
- Pratt G, Goodyear O, Moss P. Immunodeficiency and immunotherapy in multiple myeloma. Br J Haematol. 2007;138(5):563–579.
- Hamblin AD, Hamblin TJ. The immunodeficiency of chronic lymphocytic leukaemia. Br Med Bull. 2008;87(1):49–62.
- Dhalla F, Misbah SA. Secondary antibody deficiencies. Curr Opin Allergy Clin Immunol. 2015;15:505–513.
- Kumar SK, Dispenzieri A, Lacy MQ, et al. Continued improvement in survival in multiple myeloma: changes in early mortality and outcomes in older patients. Leukemia. 2014;28(5):1122–1128.
- Kumar SK, Rajkumar SV, Dispenzieri A, et al. Improved survival in multiple myeloma and the impact of novel therapies. Blood. 2008;111(5):2516–2520.
- UK CR. Statistics and outlook for chronic lymphocytic leukaemia (CLL) [Internet]. 2016 [cited 2016 Jan 29]. Available from: http://www.cancerresearchuk.org/about-cancer/type/cll/treatment/statistics-and-outlook-for-chronic-lymphocytic-leukaemia.
- UK CR. Statistics and outlook for myeloma [Internet]. 2016 [cited 2016 Jan 29]. Available from: http://www.cancerresearchuk.org/about-cancer/type/myeloma/treatment/statistics-and-outlook-for-myeloma.
- Chinen J, Shearer WT. Secondary immunodeficiencies, including HIV infection. J Allergy Clin Immunol. 2010;125(2):SS195–S203.
- Lucas M, Lee M, Lortan J, et al. Infection outcomes in patients with common variable immunodeficiency disorders: relationship to immunoglobulin therapy over 22 years. J Allergy Clin Immunol. 2010;125(6):1354–1360.e4.
- Orange JS, Grossman WJ, Navickis RJ, et al. Impact of trough IgG on pneumonia incidence in primary immunodeficiency: A meta-analysis of clinical studies. Clin Immunol. 2010;137(1):21–30.
- Quinti I, Soresina A, Guerra A, et al. Effectiveness of immunoglobulin replacement therapy on clinical outcome in patients with primary antibody deficiencies: results from a multicenter prospective cohort study. J Clin Immunol. 2011;31(3):315–322.
- Compagno N, Cinetto F, Semenzato G, et al. Subcutaneous immunoglobulin in lymphoproliferative disorders and rituximab-related secondary hypogammaglobulinemia: a single-center experience in 61 patients. Haematologica. 2014;99(6):1101–1106.
- Günther G, Dreger B. Post-marketing observational study on 5% intravenous immunoglobulin therapy in patients with secondary immunodeficiency and recurrent serious bacterial infections. Microbiol Immunol. 2013;57(7):527–535.
- Casulo C, Maragulia J, Zelenetz AD. Incidence of hypogammaglobulinemia in patients receiving rituximab and the use of intravenous immunoglobulin for recurrent infections. Clin Lymphoma Myeloma Leuk. 2013;13(2):106–111.
- Raanani P, Gafter-Gvili A, Paul M, et al. Immunoglobulin prophylaxis in hematological malignancies and hematopoietic stem cell transplantation. Cochrane Database Syst Rev. 2008;(4):Cd006501.
- Raanani P, Gafter-Gvili A, Paul M, et al. Immunoglobulin prophylaxis in chronic lymphocytic leukemia and multiple myeloma: systematic review and meta-analysis. Leuk Lymphoma. 2009;50(5):764–772.
- Anderson D, Ali K, Blanchette V, et al. Guidelines on the use of intravenous immune globulin for hematologic conditions. Transfus Med Rev. 2007;21(2Suppl 1):S9–S56.
- Oscier D, Dearden C, Eren E, et al. Guidelines on the diagnosis, investigation and management of chronic lymphocytic leukaemia. Br J Haematol. 2012;159(5):541–564.
- Imbach P. Immunotherapy with intravenous immunoglobulins. London: Academic Press; 1991.
- Australia NBA. Criteria for the clinical use of intravenous immunoglobulin in Australia. 2nd ed. 2012. Available from: http://www.blood.gov.au/pubs/ivig/conditions-for-which-IVIg-has-an-established-therapeutic-role.html-cdn-01
- Björkander J, Nikoskelainen J, Leibl H, et al. Prospective open-label study of pharmacokinetics, efficacy and safety of a new 10% liquid intravenous immunoglobulin in patients with hypo- or agammaglobulinemia. Vox Sang. 2006;90(4):286–293.
- Church JA, Leibl H, Stein MR, et al. Efficacy, safety and tolerability of a new 10% liquid intravenous immune globulin [IGIV 10%] in patients with primary immunodeficiency. J Clin Immunol. 2006;26(4):388–395.
- EMA. Kiovig 100 mg/mL, summary of product characteristics [Internet]. 2015 [cited 2016 Jan 29]. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000628/WC500043416.pdf
- Rojavin MA, Hubsch A, Lawo J-P. Quantitative evidence of wear-off effect at the end of the intravenous IgG (IVIG) dosing cycle in primary immunodeficiency. J Clin Immunol. 2016;36(3):210–219.
- EMA. Guideline on core SmPC for human normal immunoglobulin for intravenous administration (IVIg) [Internet]. 2010 [cited 2016 Jan 29]. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2010/12/WC500099542.pdf.
- Bonilla FA. Subcutaneous immunoglobulin replacement. Immune Deficiency Foundation. 2015;16:1–13.
- Ammann EM, Jones MP, Link BK, et al. Intravenous immune globulin and thromboembolic adverse events in patients with hematologic malignancy. Blood. 2016;127(2):200–207.
- Riker MW, Kennedy C, Winfrey BS, et al. Validation and refinement of the difficult intravenous access score: a clinical prediction rule for identifying children with difficult intravenous access. Acad Emerg Med. 2011;18(11):1129–1134.
- Walsh G. Difficult peripheral venous access: recognizing and managing the patient at risk. J Assoc Vasc Access. 2008;13(4):198–203.
- Acton QA. Advances in immune system research and application. Atlanta (GA): Scholarly Editions; 2013.
- Abolhassani H, Sadaghiani MS, Aghamohammadi A, et al. Home-based subcutaneous immunoglobulin versus hospital-based intravenous immunoglobulin in treatment of primary antibody deficiencies: systematic review and meta analysis. J Clin Immunol. 2012;32(6):1180–1192.
- Rachid R, Bonilla FA. The role of anti-IgA antibodies in causing adverse reactions to gamma globulin infusion in immunodeficient patients: a comprehensive review of the literature. J Allergy Clin Immunol. 2012;129(3):628–634.
- Bhole MV, Burton J, Chapel HM. Self-infusion programmes for immunoglobulin replacement at home: feasibility, safety and efficacy. Immunol Allergy Clin North Am. 2008;28(4):821–832.
- Frost GI. Recombinant human hyaluronidase (rHuPH20): an enabling platform for subcutaneous drug and fluid administration. Expert Opin Drug Deliv. 2007;4(4):427–440.
- EMA. Hizentra: EPAR - product information [Internet]. 2015 [cited 2016 Jan 29]. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002127/WC500107057.pdf.
- Soler-Palacín P, Gasó-Gago I, Fernández-Polo A, et al. Intravenous and subcutaneous immunoglobulin replacement: a two-way road. Optimizing healthcare quality in patients with primary immunodeficiencies. J Clin Immunol. 2014;34(8):1015–1017.
- EMA. HyQvia, summary of product characteristics [PDF]. European Medicines Agency; 2015. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002491/WC500143851.pdf.
- Wasserman RL. Overview of recombinant human hyaluronidase-facilitated subcutaneous infusion of IgG in primary immunodeficiencies. Immunotherapy. 2014;6(5):553–567.
- Allen CH, Etzwiler LS, Miller MK, et al. Recombinant human hyaluronidase-enabled subcutaneous pediatric rehydration. Pediatrics. 2009;124(5):e858–e867.
- Bookbinder LH, Hofer A, Haller MF, et al. A recombinant human enzyme for enhanced interstitial transport of therapeutics. J Control Release. 2006;114(2):230–241.
- Thomas JR, Yocum RC, Haller MF, et al. Assessing the role of human recombinant hyaluronidase in gravity-driven subcutaneous hydration: the INFUSE-LR study. J Palliat Med. 2007;10(6):1312–1320.
- Rowlett J. Extravasation of contrast media managed with recombinant human hyaluronidase. Am J Emerg Med. 2012;30(9):2102.e1–2102.e3.
- Therapeutics H. Hyelenex recombinant – prescribing information [PDF] [Internet]. 2016 [cited 2016 Jan 29]. Available from: http://s1.q4cdn.com/809649746/files/doc_downloads/approved-uspi-lbl301feb2016.pdf.
- Shpilberg O, Jackisch C. Subcutaneous administration of rituximab (MabThera) and trastuzumab (Herceptin) using hyaluronidase. Br J Cancer. 2013;109(6):1556–1561.
- EMA. MabThera 100 mg, summary of product characteristics. London: EMA; 2016.
- EMA. Herceptin: EPAR – product information [Internet]. 2011 [cited 2016 Jan 29]. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Summary_for_the_public/human/000278/WC500049819.pdf.
- Wasserman RL, Melamed I, Stein MR, et al. Recombinant human hyaluronidase-facilitated subcutaneous infusion of human immunoglobulins for primary immunodeficiency. J Allergy Clin Immunol. 2012;130(4):951–7e11.
- Administration FaD. Bioequivalence studies with pharmacokinetic endpoints for drugs submitted under ANDA [Internet]. [cited 2016 Jan 29]. Available from: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM377465.pdf.
- Misbah S, Sturzenegger MH, Borte M, et al. Subcutaneous immunoglobulin: opportunities and outlook. Clin Exp Immunol. 2009;158 Suppl 1:51–59.
- Haller MF. Converting intravenous dosing to subcutaneous dosing with recombinant human hyaluronidase. Pharm Tech. 2007;10:861–864.
- Gardulf A. Immunoglobulin treatment for primary antibody deficiencies: advantages of the subcutaneous route. BioDrugs. 2007;21(2):105–116.
- Jolles S. Hyaluronidase facilitated subcutaneous immunoglobulin in primary immunodeficiency. ImmunoTargets Ther. 2013;2:125–133.