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immune globulin (Gamastan, Gamimune N, Gammagard, Gammar, Sandoglobulin, Venoglobulin-I, Venoglobulin-S, ISG, Vivaglobulin, Gamunex, Privigen, Gammaplex, Flebogamma, Gammaked, Bivigam, Carimune, Hizentra)

Indications: - treatment of immunodeficiency (hypogammaglobulinemia) - bone marrow transplantation - X-linked agammaglobuliniemia - chronic lymphocytic leukemia - treatment of some autoimmune diseases - immune thrombocytopenic purpura (ITP) - Guillain-Barre syndrome - multifocal motor neuropathy - inflammatory demyelinating polyneuropathy - stiff man syndrome [5] - alloimmune disorders - hemolytic disease of the newborn - blood transfusion - Rh isoimmunization - neonatal alloimmune thrombocytopenia - post transfusion purpura [5] - renal graft rejection - *allergic reactions - epidermal necrolysis - Stevens-Johnson syndrome - to provide passive immunity in certain infectious disease (see more specific types of immune globulin) - bacterial infection - pseudomembranous enterocolitis - tetanus - viral infections - rabies virus - rubella, measles, varicella zoster - hepatitis A infection - respiratory syncytial virus - inclusion body myositis - empiric treatment for fever of unknown origin - Maroteaux-Lamy syndrome [5] Contraindications: - thrombocytopenia (except ITP) Caution: 1) do NOT perform skin test: local reaction may occur & be misinterpreted 2) screen for IgA deficiency in hypogammaglobulinemic patients pregnancy-category C safety in lactation ? Dosage: 1) intramuscular (IM) a) hepatitis A: 1] post-exposure prophylaxis 0.02 mL/kg 2] pre-exposure prophylaxis a] < 3 months: 0.02 mL/kg b] > 3 months: 0.06 mL/kg; repeat q4-6 months b) IgG: 1.2-1.3 mL/kg, followed by 0.6-0.66 mL/kg q2-4 weeks c) measles (within 6 days of exposure) 1] 0.25 mL/kg 2] immunosuppressed patient: 0.5 mL/kg (max: 15 mL) d) rubella: 0.55 mL/kg e) varicella 0.6-1.2 mL/kg 2) intravenous (IV) a) primary immunodeficiency: 200-400 mg/kg/month b) idiopathic thrombocytopenic purpura (ITP): - 400 mg/kg/day for 5 days c) chronic lymphocytic leukemia - 400 mg/kg every 3 weeks d) Kawasaki disease: single dose of 2000 mg/kg over 10 hours e) IgG subclass deficiencies: 200-300 mg/kg every 3-4 weeks f) pediatric HIV: 200-400 mg/kg every 2-4 weeks g) Guillain-Barre syndrome: 400 mg/kg for 5 days Injection: IM 165 +/- 15 mg (protein)/mL (10 mL) IV: 2.5 g, 3 g, 5 g, 6 g, 10 g. Pharmacokinetics: 1) appears in plasma immediately following IV administration 2) elimination: liver 3) 1/2life is 21-29 days 4) duration of action: 3-4 weeks Adverse effects: 1) common (> 10%) - pain & tenderness site of IM injection) 2) less common (1-10%) - nausea, flushing, chills 3) uncommon (< 1%) - lethargy, fever, urticaria, angioedema, vomiting, erythema, myalgia, hypersensitivity reactions 4) other a) most adverse reactions related to rate of infusion b) mild chest, hip & joint pain c) leg cramps d) fatigue 5) boxed warning for thrombosis [4] Drug interactions: - live virus vaccines (mumps, measles, rubella) Mechanism of action: 1) passive immunity by increasing antibody titers 2) increased potential for antibody-antigen reactions

Related

immunoglobulin toxoid vaccine

Specific

antithymocyte globulin cytomegalovirus immune globulin (Cytogam) galsulfase (Naglazyme) hepatitis A immune globulin hepatitis B immune globulin (H-BIG, Hep-B-Gammagee, HyperHep) human botulism immune globulin (BIG-IV, BabyBIG) intravenous immunoglobulin (Baygam, Octagam) rabies immune globulin (RIG, Hyperab Imogam) respiratory syncytial virus immune globulin Rho(D) immune globulin (Gamulin Rh, HypRho-D MICRhoGAM, MiniGamulin Rh, Rhesonativ, RhoGAM, WinRho) tetanus immune globulin (HyperTet, TIG, tetanus antitoxin) vaccinia immune globulin (DynPort) varicella-zoster immune globulin (VZIG)

General

transfusion component

References

  1. Saunders Manual of Medical Practice, Rakel (ed), WB Saunders, Philadelphia, 1996, pg 613-614
  2. Drug Information & Medication Formulary, Veterans Affairs, Central California Health Care System, 1st ed., Ravnan et al eds, 1998
  3. Kaiser Permanente Northern California Regional Drug Formulary, 1998
  4. FDA Safety Communication: June 10, 2013 New boxed warning for thrombosis related to human immune globulin products. http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/ucm355986.htm
  5. Deprecated Reference
  6. Patwa HS, Chaudhry V, Katzberg H, Rae-Grant AD, So YT Evidence-based guideline: intravenous immunoglobulin in the treatment of neuromuscular disorders: report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology. Neurology. 2012 Mar 27;78(13):1009-15 PMID: 22454268
  7. Medical Knowledge Self Assessment Program (MKSAP) 17, American College of Physicians, Philadelphia 2015