Immune Globulin Intravenous (Human) - Polygam S/D
Status: approved; marketed
Organizations involved:
Baxter Hyland Immuno – Manuf.; R&D; Tech.; USA mark.
American National Red Cross (ARC) – USA Mark.; Former
New York Blood Center, Inc. – Tech.
Cross ref: See the Immune Globulin Products entry (#743). See the entry for Immune Globulin (IGIV) or Gammagard S/D (#761) from Baxter, substantially the same product relabeled as Polygam S/D for the American Red Cross (ARC), now Baxter Hyland Immuno.
Description: Polygam S/D refers to lyophilized (freeze-dried) formulations of Immune Globulin Intravenous (Human) or IVIG manufactured by Baxter Hyland Immuno and marketed by the American National Red Cross (ARC), and marketed by Baxter Hyland Immuno after March 2005. Baxter manufactures and markets its own IVIG product, Gammagard S/D. Polygam S/D is the same as Gammagard S/D, except it is manufactured from Plasma collected by the ARC (from unpaid donors). manufacture of Polygam S/D includes solvent detergent viral inactivation.
Polygam S/D is available as lyophilized (freeze-dried) powder at 5% and 10% concentrations. IgG content is 96%. IgG subclasses include 57% IgG1, 30% IgG2, 8% IgG3 and 5% IgG4.
Nomenclature: Immune Globulin (IGIV)/Polygam [BIO]; Polygam S/D [TR]; Immune Globulin Intravenous (Human) [FDA]; gamma globulin, intravenous [SY]; IGIV [SY]; immune globulin, intravenous [SY]; intravenous immune globulin (IVIG) [SY]
History: Polygam and Gammagard, the comparable product from Baxter, were associated with over 100 cases of infection with hepatitis C virus (non-A, non-B hepatitis) and were recalled in 1994. Their manufacturing process was changed to include a solvent detergent (S/D) virus inactivation step and the products were relaunched as Gammagard S/D and Poly-gam S/D.
Companies.: Polygam S/D is manufactured by Baxter Hyland Immuno (Glendale, CA), FDA CBER est. no. 0140. It was formerly marketed in the U.S. by the American National Red Cross (ARC). Baxter Hyland Immuno assumed the plasma derivatives business of ARC in March 2005.
FDA class: Biologic PLA
CBER class: Blood And Blood Derivatives
Approvals: Date = 19860218; approval of Immune Globulin Intravenous (Human) from Baxter Healthcare Corp.
Indications: See other IGIV products for exemplary "INDICATIONS AND USAGE” information. Polygam is approved for treatment of Primary Immunodeficiency Diseases, B-cell Chronic Lymphocytic Leukemia (CLL), Idiopathic Thrombocytopenic Purpura (ITP), and Kawasaki Syndrome.
Tech. transfer: Solvent detergent viral inactivation technology was developed by and nonexclusively licensed from the New York Blood Center. For example, see U.S. patent 4,820,805. See the entry (#799) for Pooled Plasma, Solvent Detergent Treated (SD Plasma) for further information about solvent detergent viral inactivation, used primarily for inactivation of enveloped viruses (e.g., HIV, hepatitis B and C viruses).
Market: The 2007 Average Wholesale Price (AWP) is $64.80/0.5 g single-dose vial;; $252.33/2.5 g vial; and $1,000.30/10 g (Red Book, 2007).
Companies involvement:
Full monograph
764 Immune Globulin (IGIV)/Polygam
Nomenclature:
Immune Globulin (IGIV)/Polygam [BIO]
Immune Globulin Intravenous (Human) [FDA]
Panglobulin [TR foreign]
Polygam S/D [TR]
gamma globulin, intravenous [SY]
IGIV [SY]
immune globulin, intravenous [SY]
intravenous immune globulin (IVIG) [SY]
FDA Class: Biologic PLA
Year of approval (FDA) = 1986
Date of 1st FDA approval = 19860218
(in format YYYYMMDD)
Index Terms:
antibodies (see also immune globulins; monoclonal antibodies)
biopharmaceutical products
blood products
human materials used<!-- humansource -->
immune globulins, human <!-- immunoglobulins -->
lyophilized (freeze-dried)
Plasma (Human)
viral inactivation, solvent detergent
approval dates uncertain (FDA reports erroneous, conflicting, or simply has lost the original approval dates) (FDAapproved)
EU200 Currently Approved in EU
UM001 Marketed Product in US
US200 Currently Approved in US
EM001 Marketed Product in EU
Copyright© 2020, Biotechnology Information Institute