Panglobulin
Status: approved; marketed
Organizations involved:
CSL BioPlasma Inc. – USA mark.
CSL Behring AG – Parent
CSL Ltd. – Parent
Baxter Hyland Immuno – USA mark.
American National Red Cross (ARC) – Former
Central Lab. Blood Transfusion Service, Swiss Red Cross – Former
Cross ref: See the Immune Globulin Products entry (#743). See the entry (#770) for Carimune (formerly Sandoglobulin), which is substantially identical to this product, except for Plasma sourcing and U.S. marketing.
Description: Panglobulin is a lyophilized (freeze-dried) formulation of highly refined Immune Globulin Intravenous (Human) obtained from cold alcohol fractionation of pooled Plasma obtained from unpaid U.S. voluntary donors (apparently primarily obtained from the American National Red Cross). Part of the fractionation may be performed by another US.-licensed manufacturer (e.g., American Red Cross).
Panglobulin is packaged in 6-gram and 12-gram vials. The shelf life is 2 years from the date of sterile filling.
Nomenclature: Immune Globulin (IGIV)/CSL [BIO]; Immune Globulin Intravenous (Human) [FDA]; Panglobulin [TR]; gamma globulin [SY]; intravenous immune globulin (IVIG) [SY]
Companies.: Panglobulin is manufactured by CSL Behring AG (at CBER/FDA est. no. 1598; Berne, Switzerland), a subsidiary of CSL Ltd., formerly the Central Laboratory Blood Transfusion Service, Swiss Red Cross (est. no. 0647). The product was co-exclusively marketed in the U.S. by the American National Red Cross (ARC; until March 2005) and ZLB Bioplasma, Inc. (now CSL Bioplasma). In March 2005, Baxter Hyland Immuno assumed the plasma derivatives business of ARC, and assumed co-marketing of Panglobulin.
FDA class: Biologic PLA
CBER class: Blood And Blood Derivatives
Approvals: Date = 19840607; first approval, PLA, for IGIV from Central Laboratory Blood Transfusion Service, Swiss Red Cross
Indications: See other IGIV entries for exemplary "INDICATIONS AND USAGE” information. Panglobulin is approved for primary immunodeficiency; immune thrombocytopenic purpura (ITP); and idiopathic thrombocytopenic purpura, acute and chronic.
Trials: FDA approved Privigen based on two pivotal open-label, prospective, multi-center clinical studies. One study was performed in the U.S. and Europe in subjects with primary immunodeficiency (PI), and the other study was performed in Europe in subjects with chronic immune thrombocytopenic purpura (ITP). In the PI study, 80 adult and pediatric subjects received Privigen every three or four weeks at doses ranging from 200-888 mg/kg for a maximum of 12 months. The annual rate of serious bacterial infections (defined as bacterial pneumonia, meningitis, sepsis, osteomyelitis, and visceral abscesses), the primary endpoint, was 0.08 infections/subject/year. Pneumonia was reported in three subjects, and visceral abscess, osteomyelitis, and septic arthritis in one subject each. The annual rate of any infections, a secondary endpoint, was 3.55 infections/subject/year. In the ITP study, 57 subjects with a platelet count of ≤20 x 109/L received 1 g/kg Privigen twice on each of two consecutive days and were observed for 29 days. A total of 46 (80.7%), responded to Privigen therapy with an increase of platelet count to greater than or equal to 50 x 109/L within seven days after the first administration. Hemolysis occurred in eight subjects treated with Privigen in the ITP study. These cases all resolved uneventfully.
Market: The 2007 Average Wholesale Price (AWP) for Panglobulin NF is $606.00/6 g and $1,212.00/12 g (Red Book, 2007). These AWPs are unchanged from 2004.
Companies involvement:
Full monograph
762 Immune Globulin (IGIV)/CSL
Nomenclature:
Immune Globulin (IGIV)/CSL [BIO]
Panglobulin [TR]
Immune Globulin Intravenous (Human) [FDA]
gamma globulin [SY]
immune globulin, intravenous [SY]
intravenous immune globulin (IVIG) [SY]
FDA Class: Biologic PLA
Year of approval (FDA) = 1984
Date of 1st FDA approval = 19840607
(in format YYYYMMDD)
Index Terms:
antibodies (see also immune globulins; monoclonal antibodies)
biopharmaceutical products
blood products
human materials used<!-- humansource -->
immune globulins, human <!-- immunoglobulins -->
Plasma (Human)
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
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