Rabies Immune Globulin (Human) - HyperRAB S/D; BayRab; RIG
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. – R&D; Tech.; Former
Bayer Schering Pharma AG – Intl. mark.
New York Blood Center, Inc. – Tech.
Cross ref: See the Immune Globulin Products entry (#743). See the entries below for specific products. See also the entries for Rabies Vaccines (#525-#529), often used in combination with this product.
Description: HyperRAB S/D (formely BayRab) is an aqueous formulation of Rabies Immune Globulin (Human) or immune globulin containing high titers of rabies virus-neutralizing antibodies obtained from pooled, fractionated Plasma from donors vaccinated with a rabies vaccine. manufacture includes solvent detergent treatment for viral inactivation and two heat (pasteurization) steps.
HyperRAB S/D is packaged in 2 mL single-dose vials and in 10 mL multi-dose vials. HyperRAB S/D has a potency of 150 IU/mL. HyperRAB S/D is formulated as a 15-18% protein (primarily IgG) solution at pH of 6.4-7.2 in 0.21-0.32 M glycine with sodium carbonate for adjustment of pH. The product contains 0.08 to 0.012% thimerosal (sodium ethylmercurithiosalicylate; mercury derivative; see #939) as an antimicrobial preservative. HyperRAB S/D should be stored at 2-8˚C (refrigerated), and has a shelf life of 12 months.
Nomenclature: Rabies Immune Globulin/Talecris [BIO]; HyperRAB S/D [TR]; BayRab [TR former]; Rabies Immune Globulin (Human) [FDA]; Rabies Immune Globulin [USAN]; RIG [TR]; NDC 00026-0618-02; NDC 00026-0618-10 [NDCs, BayRab]; NDC 13533-618-02, NDC 13533-618-10 [NDCs, HyperRAB S/D]
Companies.: BayRab was originally developed and manufactured by Bayer Corp. (Berkeley, CA; formerly Miles Labs.; before that Cutter Labs.), CBER, FDA biologics est. lic. no. 0008. It was marketed in the U.S. by Bayer Corp. and internationally by the parent company, Bayer AG, and affiliates. In April 2005, Talecris Biotherapeutics Inc., CBER/FDA est. no. 1716, a subsidiary of NPS Pharmaceuticals Inc., acquired the blood/plasma products business of Bayer AG, including manufacturing and U.S marketing, with Bayer AG, lager Bayer Schering Pharma AG, retaining international marketing.
In Feb. 2011, Grifols S.A./Instituto Grifols acquired Talecris Biotherapeutics.
Manufacture: The immune globulin is isolated by conventional Cohn-Oncley cold ethanol fractionation of pooled human plasma having received rabies virus vaccine. The immune globulin is isolated from Cohn Fraction II. The fraction II solution is adjusted to a final concentration of 0.3% tri-n-butyl phosphate (TNBP) and 0.2% sodium cholate (solvent detergent viral inactivation), and is heated (pasteurized) and maintained at 30˚C for at least six hours for further viral inactivation. The reactants are removed by precipitation, filtration, ultrafiltration and diafiltration. BayRab is packaged in final containers and heated and heat treated again (maintained at 20-27˚C for 21-28 days) for further viral inactivation. In April 2003, Bayer announced that BayRab manufacturing processes “successfully inactivate vaccinia,” eliminating the risk of vaccinia virus infection from plasma donors having received smallpox virus vaccination.
FDA class: Biologic PLA
CBER class: Blood And Blood Derivatives
Approvals: Date = 19740612; first approval, PLA
Date = 19960800, supplemental PLA; Indication = addition of solvent detergent viral inactivation processing
Indications: [portion of the "INDICATIONS AND USAGE” section from product insert/labeling]:
Rabies vaccine and HyperRAB S/D should be given to all persons suspected of exposure to rabies with one exception: persons who have been previously immunized with rabies vaccine and have a confirmed adequate rabies antibody titer should receive only vaccine. HyperRAB S/D should be administered as promptly as possible after exposure, but can be administered up to the eighth day after the first dose of vaccine is given.
Medical: The recommended dose for HyperRAB S/D is 20 IU/kg (0.133 mL/kg) of body weight given preferably at the time of the first rabies vaccine dose.
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 $181.44/2 mL (150 IU/mL) single-dose vial and $828.14/10 mL (150 IU/mL) vial (Red Book, 2007).
In its March 22, 2005 price list, FFF Enterprises, a major biologics distributor, reported its prices as $130.50/2 mL vial (no change from 2004 or 2005) and $599.00/10 mL vial (no change from 2004 or 2005).
Assuming a 68 kg (150 lb.) patient is treated with 20 IU/kg, a total of 1,360 IU would be administered, requiring use of a 10 mL vial, costing about $828 at the AWP.
Companies involvement:
Full monograph
775 Rabies Immune Globulin/Talecris
Nomenclature:
Rabies Immune Globulin/Talecris [BIO]
BayRab [TR former]
Rabies Immune Globulin (Human) [FDA]
Rabies Immune Globulin [USAN]
Antirabies Serum [SY]
RIG [TR]
HyperRAB S/D [TR]
NDC 00026-0618-02; NDC 00026-0618-10 [NDC]
FDA Class: Biologic PLA
Year of approval (FDA) = 1974
Date of 1st FDA approval = 19740612
(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
rabies vaccine
ethanol
glycine
heat treatment (pasteurization)
Plasma (Human)
sodium bicarbonate
sodium cholate
thimerosal (mercury derivative)
tri-n-butyl phosphate (TNBP)
U.S. Standard Rabies Immune Globulin
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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