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).