Tetanus Immune Globulin (Human) Solvent/Detergent Treated - HyperTET S/D; BayTet
Status: approved; marketed
Organizations involved:
Talecris Biotherapeutics Inc. – Manuf.; R&D; Tech.; USA mark.
Instituto Grifols, S.A. – Parent
NPS Pharmaceuticals Inc – Former
Bayer Corp. – Former
Bayer Schering Pharma AG – Intl. mark.; Parent
New York Blood Center, Inc. – Tech.
Cross ref: See the entries for Tetanus Immune Globulin Products (#784) and Immune Globulin Products (#743).
Description: HyperTET S/D (formerly BayTet) is an aqueous formulation of Tetanus Immune Globulin (Human) Solvent/Detergent Treated or immune globulin containing high titers of antibodies to tetanus toxin obtained from pooled, fractionated Plasma from persons immunized with Tetanus Toxoid, or vaccine containing inactivated toxin from Clostridium tetani bacteria (see the Tetanus Toxoid Vaccines entry, #543). manufacture includes viral inactivation by solvent detergent treatment (0.3% tri-n-butyl phosphate and 0.2% sodium cholate) and two heat (pasteurization) treatments – 30˚C for over six hours during manufacture and heating of final containers at 20-27˚C for 21-28 days.
HyperTET S/D is packaged in prefilled disposable syringes containing 250 units (packages of 1 and 10), and in single dose vials containing 250 units (packages of 10). The solution is 15-18% protein, of which 90% is IgG. The product contains no preservatives, and is stored at 2-8˚C (refrigerated). The product is standardized against the U.S. Standard Antitoxin and the U.S. Control Tetanus Toxin and contains at least 20 tetanus antitoxin units/container.
Nomenclature: Tetanus Immune Globulin/Talecris [BIO]; HyperTET S/D [TR]; BayTet [TR former]; Tetanus Immune Globulin (Human) Solvent/Detergent Treated [FDA full name on product insert]; Tetanus Immune Globulin (Human) [USAN]; Tetanus Immune Human Globulin [former USAN]; Hyper-Tet [SY]; NDC 0026-0634-01; NDC 0026-0634-70; NDC 0026-0634-86 [NDCs for BayTet]; NDC 13533-634-02 [NDC for HyperTET S/D]
Companies.: BayTet was originally developed, manufactured and marketed in the U.S. by Bayer Corp. (Berkeley, CA; formerly Miles Labs.; originally Cutter Labs.), CBER/FDA est. no. 0008; and marketed internationally by Bayer AG and affiliates. In April 2005, Talecris Biotherapeutics Inc., a subsidiary of NPS Pharmaceuticals Inc., acquired the blood/plasma products business of Bayer AG, including manufacturing and U.S. marketing, with Bayer AG, now Bayer Schering Pharma AG, retaining international marketing.
In Feb. 2011, Grifols S.A./Instituto Grifols acquired Talecris Biotherapeutics.
FDA class: Biologic PLA
CBER class: Blood And Blood Derivatives
Approvals: Date = 19571017; first approval
Indications: [portion of the "INDICATIONS AND USAGE” section of product insert/labeling]:
HyperTET S/D is indicated for prophylaxis against tetanus injury in patients whose immunization is incomplete or uncertain (see below). It is also indicated, although evidence of effectiveness is limited, in the regimen of treatment of active cases of tetanus.
Status: In April 2003, Bayer announced that BayTet manufacturing processes “successfully inactivate vaccinia,” eliminating the risk of vaccinia virus infection from donors having received smallpox virus vaccination.
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 for Pooled Plasma, Solvent Detergent Treated (SD Plasma)(#799) 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 $136.33/250 Unit single-dose syringe (Red Book, 2007).
In its March 22, 2006 price list, FFF Enterprises, a major biologics distributor, reported its price as $95.95/250 unit syringe (same in 2005 and 2004).
Companies involvement:
Full monograph
785 Tetanus Immune Globulin/Talecris
Nomenclature:
NDC 13533-634-02 [NDC for HyperTET S/D]
Tetanus Immune Globulin/Talecris [BIO]
BayTet [TR former]
Tetanus Immune Globulin (Human) Solvent/Detergent Treated [FDA full name on product insert]
Tetanus Immune Globulin (Human) [USAN]
Tetanus Immune Human Globulin [former USAN]
HyperTET S/D [TR]
NDC 0026-0634-01; NDC 0026-0634-70; NDC 0026-0634-86 [NDC for BayTet]
FDA Class: Biologic PLA
Year of approval (FDA) = 1957
Date of 1st FDA approval = 19571017
(in format YYYYMMDD)
Index Terms:
antibodies (see also immune globulins; monoclonal antibodies)
biopharmaceutical products
blood products
human materials used<!-- humansource -->
immune globulins, human <!-- immunoglobulins -->
Cohn Fraction II
ethanol
heat treatment (pasteurization)
Plasma (Human)
sodium cholate
tri-n-butyl phosphate (TNBP)
U.S. Control Tetanus Toxin
U.S. Standard Antitoxin (tetanus)
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
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