      Document 0106
 DOCN  DRG0106
 UNIQUE IDENTIFIER        DRG-0141
 NAME OF SUBSTANCE        Cytomegalovirus Immune Globulin Intravenous
                          (Human) [PDR 1995]
 SYNONYMS                 CMV IgG [AmFAR Tx Dir 1993;6(4)]
 SYNONYMS                 CMV-IGIV [PDR 1995]
 SYNONYMS                 CytoGam [PDR 1995]
 SYNONYMS                 CMVIG-IV [NIAID 92 I-124]
 PROTOCOL ID NUMBERS      NIAID 92 I-124
 SECONDARY SOURCE ID      DRG
 PHARMACOLOGICAL ACTION   MODE OF ACTION: Cytomegalovirus Immune
                          Globulin Intravenous (Human) contains IgG
                          antibodies representative of the large of
                          normal persons who contributed to the plasma
                          pools from which the product was derived. The
                          globulin contains a relatively high
                          concentration of antibodies directed against
                          Cytomegalovirus (CMV). In the case of persons
                          who may be exposed to CMV, this drug can
                          raise the relevant antibodies to levels
                          sufficient to attenuate or reduce the
                          incidence of serious CMV disease. [PDR 1995]
 DISEASES STUDIED/TREATED Treatment of HIV-infected patients with CMV
                          viruria [NIAID 92 I-124]
 CLASSIFICATION CODE      Immunomodulator [NIAID 92 I-124]
 OTHER MAJOR USES         Attenuation of primary CMV disease associated
                          with kidney transplantation [PDR 1995]
 SUBSTANCE INTERACTIONS   Antibodies present in immune globulin
                          preparations may interfere with the immune
                          response to live virus vaccines, such as
                          measles, mumps and rubella. Vaccination
                          should be deferred until approximately three
                          months after administration of the drug. [PDR
                          1995]
 ADVERSE EFFECTS          May cause minor reactions such as flushing,
                          chills, muscle cramps, back pain, fever,
                          nausea, vomiting, and wheezing. Other
                          possible severe reactions include angioedema
                          and anaphylactic shock. [PDR 1995]
 CONTRAINDICATIONS        Contraindicated in individuals with a history
                          of severe reaction associated with the
                          administration of this or other human
                          immunoglobulin preparations and in
                          individuals with selective IgA deficiency.
                          [PDR 1995]
 CHEMICAL/PHYSICAL DATA   DRUG DESCRIPTION: Purified immunoglobulin
                          derived from pooled plasma selected for high
                          titers of antibody for CMV [PDR 1995]
 CHEMICAL/PHYSICAL DATA   DRUG DESCRIPTION: Pooled plasma is
                          fractionated by ethanol precipitation of
                          proteins according to Cohn Methods 6 and 9,
                          modified to yield a product suitable for
                          intravenous administration [PDR 1995]
 CHEMICAL/PHYSICAL DATA   DRUG DESCRIPTION: Composed primarily of IgG
                          with trace amounts of IgA and IgM [PDR 1995]
 CHEMICAL/PHYSICAL DATA   PHYSICAL DESCRIPTION: Sterile lyophilized
                          powder of immunoglobulin G (IgG) stabilized
                          with 5 percent sucrose and 1 percent albumin
                          (human) [PDR 1995]
 SUBSTANCE DELIVERY DATA  DOSAGE FORM: 2500 (+/- 500) mg vials. [PDR
                          1995]
 SUBSTANCE DELIVERY DATA  MODE OF DELIVERY: Intravenous. [PDR 1995]
 SUBSTANCE DELIVERY DATA  STORAGE: Store lyophilized powder between 2
                          and 8 C. [PDR 1995]
 MANUFACTURERS            Connaught Laboratories Incorporated
 MANUFACTURERS            Med Immune, Incorporated
 REFERENCES               FALLOON J. CLINICAL TRIALS FOR THE PREVENTION
                          AND TREATMENT OF HIV-ASSOCIATED INFECTIONS.
                          Crisp Data Base National Institutes of
                          Health.
 REFERENCES               Stratta RJ, Taylor RJ, Bynon JS, Lowell JA,
                          Cattrall MS, Frisbie K, Miller S, Radio SJ,
                          Brennan DC. Viral prophylaxis in combined
                          pancreas-kidney transplant recipients.
                          Transplantation 1994 Feb 27;57(4):506-12.
 REFERENCES               Levinson ML, Jacobson PA. Treatment and
                          prophylaxis of cytomegalovirus disease [see
                          comments]. Pharmacotherapy.
                          1992;12(4):300-18.
 REFERENCES               ASHP therapeutic guidelines of intravenous
                          immune globulin. ASHP Commission on
                          Therapeutics [see comments]. Clin Pharm. 1992
                          Feb;11(2):117-36.
 REFERENCES               Platt D, Maderazo E, Chime-Udeh E. The use of
                          intravenous immune globulin in organ
                          transplantation. Conn Med 1991
                          Aug;55(8):468-70.
 REFERENCES               Jacobson MA, O'Donnell JJ, Rousell R, Dionan
                          B, Mills J 5th. Failure of adjunctive
                          cytomegalovirus intravenous immune globulin
                          to improve efficacy of ganciclovir in
                          patients with acquired immunodeficiency
                          syndrome and cytomegalovirus retinitis: a
                          phase 1 study. Antimicrob Agents Chemother.
                          1990 Jan;34(1):176-8.
 ENTRY MONTH              9205
 LAST REVISION DATE       951004
 

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