      Document 0225
 DOCN  DRG0225
 UNIQUE IDENTIFIER        DRG-0022
 NAME OF SUBSTANCE        Globulin, Immune [USAN 1995]
 SYNONYMS                 IVIG [USP DI 1995]
 SYNONYMS                 IGIV [USP DI 1995]
 SYNONYMS                 Intravenous Gamma Globulin [NIAID ACTG 045]
 SYNONYMS                 Intravenous Immunoglobulin [NIAID ACTG 045]
 SYNONYMS                 Intravenous immune globulin (human) [USP DI
                          1995]
 SYNONYMS                 Human Immunoglobulin [NIAID ACTG 045]
 SYNONYMS                 Gamastan [USAN 1995]
 SYNONYMS                 Gamimune N [USAN 1995]
 SYNONYMS                 Gammagard [USAN 1995]
 SYNONYMS                 Gammagee [USAN 1995]
 SYNONYMS                 Gammar I.V. [USAN 1995]
 SYNONYMS                 Gamulin [USAN 1995]
 SYNONYMS                 Immu-G [USAN 1995]
 SYNONYMS                 Sandoglobulin [USAN 1995]
 SYNONYMS                 Venoglobulin-I (alpha Therapeutic) [USAN
                          1995]
 SYNONYMS                 Globulin, Immune Human Serum [USAN 1995]
 SYNONYMS                 Gammar I.M. [USAN 1993]
 SYNONYMS                 Iveegam [USP DI 1995]
 SYNONYMS                 Polygam [USP DI 1995]
 SYNONYMS                 Immune Globulin Intravenous (Human) [USP DI
                          1995]
 SYNONYMS                 Gammargard SD [USP DI 1995]
 SYNONYMS                 SD-Polygam [USP DI 1995]
 SYNONYMS                 Venoglobulin-S [PDR 1995]
 PROTOCOL ID NUMBERS      NICHD 045
 PROTOCOL ID NUMBERS      NIAID ACTG 051
 PROTOCOL ID NUMBERS      FDA 079A
 PROTOCOL ID NUMBERS      ACTG 185
 SECONDARY SOURCE ID      DRG
 PHARMACOLOGICAL ACTION   MODE OF ACTION: Following intravenous
                          administration, essentially 100 percent of
                          the infused IgG antibodies are immediately
                          available in the recipient's circulation. A
                          relatively rapid fall in serum IgG (about 40
                          percent of the peak level achieved
                          immediately post-infusion) usually occurs in
                          the first week post-infusion, mainly due to
                          the equilibration of IgG between the plasma
                          and the extravascular space. Approximately 3
                          days after intravenous administration IGIV is
                          evenly distributed in the intra- and
                          extravascular compartments. The in vivo
                          intravascular half-life of Gamimune N equals
                          or exceeds the 3-week half-life reported for
                          IgG, but individual patient variation in
                          half-life has been observed. While the drug
                          has been shown to be effective in treating
                          idiopathic thrombocytopenic purpura and
                          post-transfusion purpura, the mechanism of
                          action has not been elucidated. In Phase I
                          human studies, no change in arterial blood pH
                          was observed following intravenous
                          administration of the drug at a dose of 150
                          mg/kg body weight.  [PDR 1995]
 DISEASES STUDIED/TREATED Primary HIV infection - used for maintenance
                          treatment of patients unable to produce
                          sufficient IgG antibodies and patients with
                          thrombocytopenia [USP DI 1995]
 DISEASES STUDIED/TREATED Can prevent or modify certain infections in
                          adult and pediatric patients [USP DI 1995]
 DISEASES STUDIED/TREATED FDA approved 12/27/93 in HIV-infected
                          children as prophylactic therapy against
                          certain bacterial infections [USP DI 1995]
 CLASSIFICATION CODE      Immunomodulator [USAN 1995]
 OTHER MAJOR USES         Used in primary humoral immune deficiency,
                          idiopathic thrombocytopenic purpura, and bone
                          marrow transplantations. [PDR 1995] Also used
                          in Kawasaki disease; chronic lymphocytic
                          leukemia; chronic inflammatory demyelinating
                          neuropathies and in treating infections in
                          high risk, preterm, low-birth weight
                          neonates. [USP DI 1995]
 SUBSTANCE INTERACTIONS   Antibodies in immune globulin preparations
                          may interfere with the body's immune response
                          to some live virus vaccines. These vaccines,
                          e.g., measles, mumps and rubella vaccine,
                          should be administered at least 14 days prior
                          to, or 3 months after immune globulin. [USP
                          DI 1995]
 ADVERSE EFFECTS          May cause malaise, hypotension, faintness,
                          fever, chills, headache, nausea, vomiting,
                          chest tightness, dyspnea, and chest or back
                          pain. May also cause mild, transient
                          tachycardia and a burning sensation in the
                          head. Other potential reactions include
                          anxiety, flushing, wheezing, abdominal
                          cramps, myalgias, arthralgia, and dizziness.
                          Anaphylactic reactions to this drug may occur
                          in patients with documented histories of
                          severe allergic reactions to immunoglobulin
                          (especially when administered via
                          intramuscular route). [PDR 1995]
 CONTRAINDICATIONS        Contraindicated in individuals who are known
                          to have had an anaphylactic or severe
                          systemic response to immune globulin (human),
                          or in individuals with selective IgA
                          deficiencies who have known antibody against
                          IgA (anti-IgA antibody), since they may
                          experience severe reactions to the IgA which
                          may be present. As with IgG, IGIV may cross
                          the placenta but only during the final weeks
                          of pregnancy. It should be used during
                          pregnancy only if clearly indicated. [PDR
                          1995]
 CHEMICAL/PHYSICAL DATA   DRUG DESCRIPTION: Intravenous immunoglobulin
                          preparations are either solutions or
                          lyophilized dosage forms. Following cold
                          ethanol fractionation of large pools of human
                          plasma these products are all purified by
                          different processes.
 CHEMICAL/PHYSICAL DATA   DRUG DESCRIPTION: Therefore their
                          compositions differ, although they are
                          currently considered therapeutically
                          equivalent.
 CHEMICAL/PHYSICAL DATA   DRUG DESCRIPTION: Two products, SD-Polygam
                          and Gammagard SD undergo a solvent-detergent
                          purification process to inactivate viral
                          contaminants, e.g., hepatitis C virus. [USP
                          DI 1995]
 CHEMICAL/PHYSICAL DATA   PHYSICAL DESCRIPTION: Each of the many brands
                          have different diluents and physical
                          characteristics [USP DI 1995]
 SUBSTANCE DELIVERY DATA  DOSAGE FORM: Single-dose vials of IVIG
                          solution containing 0.5, 2.55, and 12.5 g;
                          single dose vials for reconstitution
                          containing 0.5, 1, 2.5, 3, 5, 6 and 10 g of
                          IVIG lyophilized powder. [USP DI 1995
 SUBSTANCE DELIVERY DATA  MODE OF DELIVERY: Intravenous infusion. [USP
                          DI 1995]
 SUBSTANCE DELIVERY DATA  STORAGE INSTRUCTIONS: Store IVIG solutions at
                          2 C to 8 C unless otherwise specified by the
                          manufacturer; protect from freezing.
 SUBSTANCE DELIVERY DATA  STORAGE INSTRUCTIONS: Store powders for
                          reconstitution at temperatures not exceeding
                          25C unless otherwise specified by the
                          manufacturer. Protect diluent from freezing.
                          [USP DI 1995]
 MANUFACTURERS            Cutter Biological
 MANUFACTURERS            Hyland
 MANUFACTURERS            Armour
 MANUFACTURERS            Merrell Dow
 MANUFACTURERS            Warner-Lambert Parke-Davis
 MANUFACTURERS            Savage
 MANUFACTURERS            Sandoz
 REFERENCES               Mofenson LM, Korelitz J, Pelton S, Moye J Jr,
                          Nugent R, Bethel J. Sinusitis in children
                          infected with human immunodeficiency virus:
                          clinical characteristics , risk factors, and
                          prophylaxis. National Institute of Child
                          Health and Human Development Intravenous
                          Immunoglobulin Clinical Trial Study Group.
                          Clin Infect Dis. 1995 Nov;21(5):1175-81.
 REFERENCES               Vittecoq D, Chevret S, Morand-Joubert L,
                          Heshmati F, Audat F, Bary M, Dusautoir R,
                          Bismuth A, Viard JP, Barre-Sinoussi F, et al.
                          Passive immunotherapy in AIDS: a double-blind
                          randomized study based on transfusions of
                          plasma rich in anti-human immunodeficiency
                          virus 1 antibodies vs. transfusions of
                          seronegative plasma. Proc Natl Acad Sci USA.
                          1995 Feb 14;92(4):1195-9.
 REFERENCES               Zuhric SR, Webster AD, Davies R, Fay C,
                          Wallington TB. A prospective controlled
                          crossover trial of a new heat-treated
                          intravenous immunoglobulin. Clin Exp Immunol.
                          1995 Jan;99(1):10-5.
 REFERENCES               Spector SA, Gelber RD, McGrath N, Wara D,
                          Barzilai A, Abrams E, Bryson YJ, Dankner WM,
                          Livingston RA, Connor EM. A controlled trial
                          of intravenous immune globulin for the
                          prevention of serious bacterial infections in
                          children receiving zidovudine for advanced
                          human immunodeficiency virus infection.
                          Pediatric AIDS Clinical Trials Group [see
                          comments]. N Engl J Med. 1994 Nov
                          3;331(18):1181-7.
 REFERENCES               Levy J, Youvan T, Lee ML. Passive hyperimmune
                          plasma therapy in the treatment of acquired
                          immunodeficiency syndrome: results of a
                          12-month multicenter double-blind controlled
                          trial. The Passive Hyperimmune Therapy Study
                          Group [see comments]. Blood. 1994 Oct
                          1;84(7):2130-5.
 REFERENCES               Jahnke L, Applebaum S, Sherman LA,
                          Greenberger PA, Green D. An evaluation of
                          intravenous immunoglobulin in the treatment
                          of human immunodeficiency virus-associated
                          thrombocytopenia. Transfusion. 1994
                          Sep;34(9):759-64.
 REFERENCES               Mofenson LM, Moye J Jr, Korelitz J, Bethel J,
                          Hirschhorn R, Nugent R. Crossover of placebo
                          patients to intravenous immunoglobulin
                          confirms efficacy for prophylaxis of
                          bacterial infections and reduction of
                          hospitalizations in human immunodeficiency
                          virus-infected children. The National
                          Institute of Child Health and Human
                          Development Intravenous Immunoglobulin
                          Clinical Trial Study Group. Pediatr Infect
                          Dis J. 1994 Jun;13(6):477-84.
 REFERENCES               Jablonowski H, Sander O, Willers R, Adams O,
                          Bartmann P, Wahn V. The use of intravenous
                          immunoglobulins in symptomatic HIV infection.
                          Results of a randomized study. Clin Investig.
                          1994 Feb;72(3):220-4.
 REFERENCES               Wintergerst U, Niinivaara-Kreuzer K, Notheis
                          G, Auberger K, Bruckmann C, Gandenberger S,
                          Belohradsky BH. High-dose intravenous
                          immunoglobulins in  the treatment of
                          adolescent and adult HIV-infected
                          hemophiliacs. Clin Investig. 1994
                          Jan;72(2):122-6.
 REFERENCES               Mofenson LM, Moye J Jr. Intravenous immune
                          globulin for the prevention of infections in
                          children with symptomatic human
                          immunodeficiency virus infection. Pediatr
                          Res. 1993 Jan;33(1 Suppl):S80-7;discussion
                          S87-9.
 ENTRY MONTH              8906
 LAST REVISION DATE       960502
 

SOURCE: National Library of Medicine, Bethesda, MD.  Distributed by AEGIS.
