Rabies Immune Globulin (Human) - Imogam Rabies-HT
Status: approved; marketed
Organizations involved:
Sanofi Pasteur S.A. – Manuf.; R&D; Tech.; Intl. mark.
Sanofi Pasteur Inc. – USA mark.
Biotest AG - Manuf. other
Nabi – Former
Cross ref: See the entries for Rabies Immune Globulin Products (#773) and Immune Globulin Products (#743). See also the entries for Rabies Vaccines (#525-#529), generally used in combination with this product.
Description: Rabies Immune Globulin (Human) or Imogam Rabies–HT is an aqueous formulation of immune globulin containing high titers of rabies virus-neutralizing antibodies obtained from pooled fractionated Plasma from donors vaccinated with a rabies vaccine (a human diploid cell cultured vaccine). The product is heat treated (HT; pasteurized) at 58°-60°C for 10 hours for viral inactivation.
Imogam Rabies–HT is packaged as 2 ml single-dose vials and in 10 ml multi-dose vials. Imogam Rabies - HT contains 10-18% protein as immune globulin (primarily IgG). The potency is 150 International Units per milliliter (IU/mL). The 2 mL vial contains 300 IU which is sufficient for a child weighing 15 kg (33 lb). The 10 mL vial contains 1,500 IU which is sufficient for an adult weighing 75 kg (165 lb). Excipients include 0.3 M glycine, and hydrochloric acid or sodium hydroxide for final pH adjustment. The product contains no preservatives, should be stored at 2-8˚C (refrigerated), and has a shelf life of 12 months.
Nomenclature: Rabies Immune Globulin/Aventis [BIO]; Imogam Rabies – HT [TR]; Rabies Immune Globulin (Human) [FDA]; Rabies Immune Globulin [USAN]; Antirabies Serum [SY]; RIG [SY]; NDC 50361-0180-02; NDC 50361-0180-10 [NDC]
Companies.: Imogam Rabies - HT is manufactured by Sanofi Pasteur S.A., FDA CBER est. 1724 (formerly est. 1279), formerly Aventis Pasteur S.A. It is marketed in the U.S. by Sanofi Pasteur Inc., formerly Aventis Pasteur Inc., and internationally by Sanofi Pasteur S.A. affiliates. Aventis Pasteur merged into Sanofi-Aventis S.A. in late 2004.
In April 2006, Sanofi Pasteur contracted with Nabi for fractionation of Plasma for further manufacture of Imogam Rabies-HT. Nabi fractionates plasma at its Boca Raton, FL, facility and ships the bulk to Sanofi Pasteur for completion in Lyon, France. The majority of human plasma now used for Imogam Rabies-HT is collected by Nabi at its plasmapheresis/antibody collection centers in the U.S.
In Sept. 2007, Biotest AG acquired the plasma products business of Nabi.
Manufacture: Besides cold-ethanol fractionation of selected pooled Plasma, manufacture of Imogam Rabies -– HT includes a viral inactivation heat (pasteurization) treatment step, involving heating the product to 58-60˚C (136.4-140˚F) for ten hours. It has been reported that up to 2,000 units of Plasma are pooled for manufacture of Imogam Rabies – HT.
FDA class: Biologic PLA
CBER class: Blood And Blood Derivatives
Approvals: Date = 19840427; first approval, PLA
Date = 20000202; license revoked from Pasteur Merieux Serum et Vaccins, S.A. and granted (reissued) to new owner, Aventis Pasteur S.A.
Indications: [portion of the "Indications and Use” section from recent product insert/labeling]:
Rabies Immune Globulin (Human) IMOGAM RABIES – HT is indicated for individuals suspected of exposure to rabies, particularly severe exposure, with one exception: persons who have been previously immunized with HDCV Rabies Vaccine in a pre or postexposure treatment series should receive only vaccine. Persons who have received Rabies Vaccines other than HDCV or RVA vaccines should have confirmed adequate rabies antibody titers if they are to receive only vaccine. IMOGAM RABIES – HT should be injected as promptly as possible after exposure along with the first dose of vaccine.
Medical: The recommended dose of Imogam Rabies – HT is 20 IU/kg (0.133 mL/kg) or 9 IU/lb (0.06 mL/lb) of body weight administered at time of the first rabies vaccine dose. As much as possible of the recommended dose should be infiltrated around the wound if anatomically feasible and the remainder should be administered intramuscularly in the gluteal region.
Market: The Aventis Pasteur list price (Jan. 2006) for Imogam Rabies–HT is $135.50/2 mL (150 IU/mL) vial; and $677.47/10 mL (150 IU/mL) vial.
The 2007 Average Wholesale Price (AWP) is $177.67/2 mL, with a Direct Price (Manufacturer’s discount price) of $148.06; and $888.37/10 mL, with Direct Price of $740.31 (Red Book, 2007).
Assuming a 68 kg (150 lb.) patient is treated with 20 IU/kg, a total of 1,360 IU would be used, requiring use of a 10 mL vial, costing about $888 at the current AWP.
Companies involvement:
Full monograph
774 Rabies Immune Globulin/Sanofi
Nomenclature:
Rabies Immune Globulin/Sanofi [BIO]
IMOGAM RABIES - HT [TR]
Rabies Immune Globulin (Human) [FDA]
Rabies Immune Globulin [USAN]
Antirabies Serum [SY]
RIG [SY]
NDC 50361-0180-02; NDC 50361-0180-10 [NDC]
FDA Class: Biologic PLA
Year of approval (FDA) = 1984
Date of 1st FDA approval = 19840427
(in format YYYYMMDD)
Index Terms:
antibodies (see also immune globulins; monoclonal antibodies)
biopharmaceutical products
blood products
human materials used<!-- humansource -->
immune globulins, human <!-- immunoglobulins -->
human diploid cells
rabies vaccine
ethanol
glycine
heat treatment (pasteurization)
hydrochloric acid (HCl)
Plasma (Human)
sodium hydroxide
thimerosal (mercury derivative)
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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