Immune globulin subcutaneous (Human): Vivaglobn® - For the treatment of primary immunodeficiency diseases

P and T

Volumn 34, Issue 6 PART 2, 2009, Pages 1-21

[No Author Info available]

Author keywords

[No Author keywords available]

Indexed keywords

DIPHENHYDRAMINE; HYDROCORTISONE; IMMUNOGLOBULIN; IMMUNOGLOBULIN G; MEASLES VACCINE; MUMPS VACCINE; PARACETAMOL; RUBELLA VACCINE;

ACUTE KIDNEY FAILURE; AGAMMAGLOBULINEMIA; ANAPHYLAXIS; ASEPTIC MENINGITIS; ATAXIA TELANGIECTASIA; BACKACHE; BRAZIL; CHEST TIGHTNESS; CHILL; CHRONIC GRANULOMATOUS DISEASE; CLINICAL EVALUATION; CLINICAL FEATURE; CLINICAL TRIAL; COMMON VARIABLE IMMUNODEFICIENCY; DIGEORGE SYNDROME; DIZZINESS; DRUG APPROVAL; DRUG EFFICACY; DRUG HYPERSENSITIVITY; DRUG METABOLISM; DRUG SAFETY; DRUG STORAGE; DRUG TOLERABILITY; DRUG WITHDRAWAL; DYSPNEA; EUROPE; FEVER; FLUSHING; GASTROINTESTINAL DISEASE; GERIATRIC PATIENT; HEADACHE; HOME CARE; HUMAN; HYPOTENSION; IMMUNE DEFICIENCY; IMMUNOGLOBULIN A DEFICIENCY; IMMUNOGLOBULIN DEFICIENCY; IMMUNOGLOBULIN G DEFICIENCY; INCIDENCE; INJECTION SITE PAIN; INJECTION SITE PRURITUS; INJECTION SITE SWELLING; KIDNEY DYSFUNCTION; LABORATORY TEST; MALAISE; MYALGIA; NAUSEA; NIJMEGEN BREAKAGE SYNDROME; NORTH AMERICA; PATHOPHYSIOLOGY; PEDIATRICS; PREGNANCY; PREMEDICATION; PREVALENCE; RASH; RECOMMENDED DRUG DOSE; REVIEW; SEVERE COMBINED IMMUNODEFICIENCY; SIDE EFFECT; SKIN REDNESS; SORE THROAT; TACHYCARDIA; THROMBOEMBOLISM; TRANSFUSION RELATED ACUTE LUNG INJURY; TREATMENT CONTRAINDICATION; TREATMENT INDICATION; VOMITING; WISKOTT ALDRICH SYNDROME; X LINKED AGAMMAGLOBULINEMIA;

EID: 67650869300     PISSN: 10521372     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (48)

1. Immune Deficiency Foundation. Primary Immune Deficiency Diseases in America: The first national survey of patients and specialists. Available at: www.primaryimmune.org/publications/surveys/First-National-Survey-of-Patients- and-Specialists-(1995).pdf. Accessed March 4, 2009.
2. Primary immunodeficiency. Mayoclinic.com. Available at: http://www.mayoclinic.com/health/primary-immunodeficiency/DS01006/DSECTION= symptoms. Accessed February 11, 2009.
3. Boyle JM, Buckley RH. Population prevalence of diagnosed primary immunodeficiency diseases in the United States. J Clin Immunol 2007:27:497-502. (Pubitemid 47319256)
4. National Institutes of Health, National Institute of Child and Human Development (1999). When the Body's Defenses Are Missing: Primary Immunodeficiency. Available at: www.nichd.nih.gov/publications/pubs/ PrimaryImmunocover.cfm. Accessed March 4, 2009.
5. Fischer A. Primary immunodeficiency diseases: An experimental model for molecular medicine. Lancet 2001;357: 1863-1869. (Pubitemid 32539123)
6. Candotti F, Notarangelo L, Visconti R, O'Shea J. Molecular aspects of primary immunodeficiencies: Lessons from cytokine and other signaling pathways. J Clin Invest 2002; 109:1261-1269. (Pubitemid 34546888)
7. National Institutes of Health. Understanding the Immune System: How it Works. NIH Pub No. 03-5423. Available at: www.niaid.nm.gov/Publications/immune/ the-immune-system.pdf. Accessed March 4, 2009.
8. Immunodeficiency disorders. Merck Manual of Diagnosis and Treatment, 18th ed. Whitehouse Station, NJ: Online Medical Library. Available at: www.merck.com/mmpe/ sec13/ch164/ch164a.html. Accessed February 26, 2009.
9. Primary immunodeficiency disorders. In: Porth C, Gaspard KJ, Matfin G (eds.). Essentials of Pathophysiology. Philadelphia: Lippincott Williams & Wilkins; 2006. Available at: http:/books.google.com/books?id=57RQC- 30PtUC&pg= PT624&dq=primary+immunodeficiency+pathophysiology# PPT624,M1. Accessed February 25, 2009.
10. Riminton DS, Limaye S. Primary immunodeficiency diseases in adulthood. Intern Med J 2004;34:348-354. (Pubitemid 38969162)
11. Cooper MA, Pommeling TL, Korányi K. Primary immunodeficiencies. Am Fam Physician 2003;68:2001-2008, 2011.
12. Bonilla FA, Geha RS. Primary immunodeficiency disease. J Allergy Clin Immunol 2003;111:S571-S581.
13. Lederman HM. The clinical presentation of primary immunodeficiency diseases. In: Clinical Focus on Primary Immune Deficiencies. 2000;2:1-5. Immune Deficiency Foundation Available at: www.primaryimmune.org/publications/clinic- focus/cf-aug00.pdf. Accessed February 18, 2009.
14. Approach to the patient with suspected immunodeficiency. Merck Manual of Diagnosis and Treatment, 18th ed. Whitehouse Station, NJ: Online Medical Library. Available at: www.merck.com/mmpe/sec13/ch164/ch164b.html. Accessed February 18, 2009.
15. Jeffrey Modell Foundation. 10 Warning Signs of Primary Immunodeficiency. Available at: www.info4pi.org. Accessed March 5, 2009.
16. Bonilla FA, Bernstein IL, Khan DA, et al. Practice parameter for the diagnosis and management of primary immunodeficiency. Ann Allergy Asthma Immunol 2005;94(5 Suppl 1):S1-S63. Accessed February 18, 2009. Available at: www.guideline.gov/summary/summary.aspx?ss=15&doc-id=7500&nbr=4445. (Pubitemid 40712788)
17. Primary immunodeficiency diseases: Report of a WHO Scientific Group. Clin Exp Immunol 1997;109(1):1-28.
18. Busse PJ, Razvi S, Cunningham-Rundles C. Efficacy of intravenous immunoglobulin in the prevention of pneumonia in patients with common variable immunodeficiency. J Allergy Clin Immunol 2002;109:1001-1004. (Pubitemid 34634312)
19. Immune Deficiency Foundation. Treatment Experiences and Preferences of Patients with Primary Immune Deficiency Diseases: First National Survey. June 20, 2003. Available at: www.primaryimmune.org/publications/surveys/Treatment- Experiences-and-Preferences-(2003).pdf. Accessed March 6, 2009.
20. Shah S. Pharmacy considerations for the use of IGIV therapy. Am J Health Syst Pharm 2005;62(3):S5-S11. (Pubitemid 41153671)
21. Flebogamma (package insert). Los Angeles, CA: Grifols Biologies, Inc.; 2004.
22. Gammagard S/D (Solvent-Detergent Treated) (package insert). Westlake Village, CA: Baxter Healthcare Corporation; 2004.
23. Gammagard Liquid (package insert). Westlake Village, CA: Baxter Healthcare Corporation; 2005.
24. Octagam (package insert). Herndon, VA: Octapharma USA, Inc.; 2004; revised 2007.
25. Gamunex (package insert). Research Triangle Park, NC: Talecris Biotherapeutics, Inc.; revised 2005.
26. Immune Deficiency Foundation. The Changing Face of Primary Immunodeficiency Diseases. IDF Advocate. Summer 2003, No.44. Available at: www.primaryimmune.org/publications/newsletter/idf-newsletter44.pdf. Accessed March 17, 2009.
27. Pierce LR, Jain N. Risks associated with the use of intravenous immunoglobulin. Transfusion Med Rev 2003;17: 241-251. (Pubitemid 37310931)
28. Nydegger UE, Sturzenegger M. Adverse effects of intravenous immunoglobulins. Drug Saf 1999;21:171-185. (Pubitemid 29427880)
29. Murphy E, Martin S, Patterson JV. Developing practice guidelines for the administration of intravenous immunoglobulin. J Infus Nurs 2005;28:1-8. (Pubitemid 41076999)
30. Bagdasarian A, Tonetta S, Harel W, et al. IVIG adverse reactions: Potential role of cytokines and vasoactive substances. Vox Sang 1998;74:74-82. (Pubitemid 28052448)
31. Epstein JS, Gaines A, Kapit R, et al. Important Drug Information (Summer 1999). FDA Medical Bulletin. Available at: www.fda.gov/medbull/summer99/ Globulin.html. Accessed March 5, 2009.
32. Dalakas MC. High-dose intravenous immunoglobulin and serum viscosity: Risk of precipitating thromboembolic events. Neurology 1994;44(2):223-226. (Pubitemid 24070955)
33. Berger M. Subcutaneous immunoglobulin replacement in primary immunodeficiencies. Clin Immunol 2004;112:1-7. (Pubitemid 38781052)
34. Roord JJ, van der Meer JWM, Kuis W, et al. Home treatment in patients with antibody deficiency by slow subcutaneous infusion of gammaglobulin. Lancet 1982;1:689-690. (Pubitemid 12179950)
35. van der Meer JWM, de Windt GE, van den Broek PJ, van Furth R. Subcutaneous immunoglobulin substitution in hypogammaglobulinaemia. In: Krijnen HW, Strengers PFW, Aken WG van (eds.). Immunoglobulins. Amsterdam: Central Laboratory of The Netherlands Red Cross; 1988:71-76.
36. Berger M, Cupps TR, Fauci AS. Immunoglobulin replacement therapy by slow subcutaneous infusion. Ann Intern Med 1980;93:55-56. (Pubitemid 10072004)
37. Chapel H, Spickett G, Ericson D, et al. The comparison of the efficacy and safety of intravenous versus subcutaneous immunoglobulin replacement therapy. J Clin Immunol 2000;20:94-100. (Pubitemid 30314313)
38. Gardulf A, Hammerström L, Smith C. Home treatment of hypogammaglobulinaemia with subcutaneous gamma- globulin by rapid infusion. Lancet 1991;338:162-166.
39. Gaspar J, Gerritsen B, Jones A. Immunoglobulin replacement treatment by rapid subcutaneous infusion. Arch Dis Child 1998;79:48-51. (Pubitemid 28331253)
40. Gardulf A, Hammarström L. Subcutaneous administration of immunoglobulins: What are the advantages? Clin Immunother 1996;6:108-116. (Pubitemid 26323387)
41. Eijkhout HW, van den Broek PJ, van der Meer JWM. Substitution therapy in immunodeficient patients with anti-IgA antibodies or severe adverse reactions to previous immunoglobulin therapy. Neth J Med 2003;61:213-217. (Pubitemid 39089400)
42. Gardulf A, Nicolay U, Asensio O, et al. Rapid subcutaneous IgG replacement therapy is effective and safe in children and adults with primary immunodeficiencies: A prospective, multinational study. J Clin Immunol 2006;26:177-185. (Pubitemid 43869918)
43. Ochs HD, Gardulf A, Praus M, Keissling P. Efficacy and safety of subcutaneous immunoglobulin replacement therapy at home in patients with primary immunodeficiency diseases: Combined analysis of two clinical studies, one in North America and one in Europe (Abstract SU2.47), p S251. Federation of Clinical Immunology Societies (FOCIS), annual meeting, Boston, 2005.
44. Ochs HD, Nicolay U, Peters C. Home-based subcutaneous immunoglobulin replacement therapy in North American patients with primary immunodeficiencies. Poster, Federation of Clinical Immunology Societies (FOCIS), annual meeting, Montreal, 2004.
45. Gardulf A, Andersson E, Lindqvist M, et al. Rapid subcutaneous IgG replacement therapy at home for pregnant immunodeficient women. J Clin Immunol 2001;21:150-154. (Pubitemid 32328767)
46. Berger M, Cupps TR, Fauci AS. High-dose immunoglobulin replacement therapy by slow subcutaneous infusion during pregnancy. JAMA 1982;247:2824-2825.
47. Vivaglobin, prescribing information. King of Prussia, PA: CSL Behring LLC, revised April 2007.
48. Data on file, CSL Behring LLC, 2006.