IMOGAM RABIES-HT- human rabies virus immune globulin injection, solution

IMOGAM RABIES-HT by

Drug Labeling and Warnings

IMOGAM RABIES-HT by is a Other medication manufactured, distributed, or labeled by Sanofi Pasteur Inc., Sanofi Pasteur SA. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Data From Post-marketing Experience

The following additional adverse reactions have been identified during postapproval use of Imogam Rabies – HT. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to Imogam Rabies – HT exposure.

Cardiac Disorders

Gastrointestinal Disorders

General Disorders and Administration Site Conditions

Immune System Disorders

Skin and Subcutaneous System Disorders

Data From Literature

Although not reported specifically for Rabies Immune Globulin (Human), angioneurotic edema and nephrotic syndrome have been reported after injection of immune globulin (IG), a product similar in biochemical composition but without antirabies activity. (7)

Reporting of Adverse Reactions

Encourage reporting by patients, parents or guardians of all suspected adverse reactions occurring after Rabies Immune Globulin (Human) administration. Report suspected adverse reactions following treatment with Rabies Immune Globulin (Human) to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Also report these events to the Pharmacovigilance Department, Sanofi Pasteur Inc., Discovery Drive, Swiftwater, PA 18370 or call 1-800-822-2463.

  • DOSAGE AND ADMINISTRATION

    For wound infiltration and intramuscular administration only.

    Inspect parenteral drug products visually for particulate matter and/or discoloration prior to administration, whenever solution and container permit. If either of these conditions exist, do not administer the product.

    Use Imogam Rabies – HT in conjunction with rabies vaccines such as Rabies Vaccine, Imovax Rabies, for intramuscular immunization, a vaccine prepared from human diploid cell cultures. 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 the time of the first vaccine dose. (3) (8) (9)

    If anatomically feasible, use the full dose of Rabies Immune Globulin (Human) to thoroughly infiltrate the area around and into the wounds. Inject any remaining volume intramuscularly, using a separate needle, at a site distant from vaccine administration. (1) (10)

    Never administer Rabies Immune Globulin (Human) in the same syringe or into the same anatomical site as rabies vaccine. Because Rabies Immune Globulin (Human) may partially suppress active production of antibody, do not give more than the recommended dose. (1) (11)

  • HOW SUPPLIED

    Imogam Rabies – HT is supplied in a 2 mL vial with a minimal potency of 150 International Units per milliliter (IU/mL).

    Vial, 2 mL, NDC: 49281-190-58. Packaged as NDC: 49281-190-20.

    Imogam Rabies – HT contains no preservative. Discard unused portion immediately.

  • STORAGE

    Store Imogam Rabies – HT in the refrigerator at 2° to 8°C (35° to 46°F). DO NOT FREEZE.

  • CLINICAL STUDIES

    Controlled human trials of Rabies Immune Globulin (Human) have not been performed; however, extensive field experience from many areas of the world indicates that post-exposure prophylaxis combining local wound treatment, local infiltration of rabies immune globulin (RIG), and vaccination is uniformly effective when appropriately administered. (1)

    Rabies antibody provides passive protection when given immediately to individuals exposed to rabies virus. (12) Studies of Rabies Immune Globulin (Human), (11) Imogam Rabies, given with the first of five doses of Sanofi Pasteur SA HDCV (7) confirmed that passive immunization with 20 IU/kg of Rabies Immune Globulin (Human) provides maximum circulating antibody with minimum interference of active immunization by HDCV.

    A double-blind randomized trial (6) was conducted to compare the safety and antibody levels achieved following intramuscular injection of Imogam Rabies – HT (heat treated) and Rabies Immune Globulin (Human), Imogam Rabies (non-heat treated). Each Rabies Immune Globulin (Human) was administered on day 0, either alone or in combination with the human diploid cell Rabies Vaccine (Imovax Rabies) using the standard post-exposure prophylactic schedule of day 0, 3, 7, 14, and 28.

    Sixty-four healthy veterinary student volunteers were randomized into four parallel groups of 16 each to receive the following Rabies Immune Globulin (Human) and vaccine regimens:

    The treatment of both Rabies Immune Globulin (Human) and vaccine corresponded to the post-exposure recommended dose of 20 IU/kg of Rabies Immune Globulin (Human) and was administered in three equally divided IM injections of under 5 mL in either gluteus. Serum rabies antibody levels were assessed before treatment and on days 3, 7, 14, 28, 35, and 42 by the Rabies Fluorescent Focus Inhibition Test (RFFIT).

    Serum antibody levels were similar in the Imogam Rabies – HT and Imogam Rabies groups. By day three, 60% of each group had detectable antibody titers of ≥0.05 IU/mL. By day 14, the geometric mean titers (with 95% confidence interval) were 19 IU/mL (11-38) in the Imogam Rabies – HT + vaccine group and 31 IU/mL (20 to 48) in the Imogam Rabies + vaccine group. These differences were not statistically significant.

  • REFERENCES

  • SPL UNCLASSIFIED SECTION

    Product Information as of November 2018

    Manufactured by:
    Sanofi Pasteur SA
    Marcy L'Etoile France

    Distributed by:
    Sanofi Pasteur Inc.
    Swiftwater PA 18370 USA
    1-800-VACCINE (1-800-822-2463)

    US Govt License #1724

  • PRINCIPAL DISPLAY PANEL - 2 mL Vial Label

    Rabies Immune
    Globulin (Human)
    USP 150 IU/mL
    RIG
    Imogam® Rabies – HT

    2 mL

    Dosage: see insert. The patient
    and physician should discuss the
    risks and benefits of this product.

    Mfd. by: Sanofi Pasteur SA
    Marcy L'Etoile France US Govt Lic #1724

    Dist. by: Sanofi Pasteur Inc.
    Swiftwater PA 18370 USA
    1-800-VACCINE (1-800-822-2463)

    Rx only

    PRINCIPAL DISPLAY PANEL - 2 mL Vial Label
  • PRINCIPAL DISPLAY PANEL - 2 mL Vial Carton

    NDC: 49281-190-20
    List No. 1802

    RIG

    2 mL

    Rabies Immune Globulin
    (Human) USP 150 IU/mL
    Imogam® Rabies – HT

    Rx only

    SANOFI PASTEUR

    PRINCIPAL DISPLAY PANEL - 2 mL Vial Carton
  • INGREDIENTS AND APPEARANCE
    IMOGAM RABIES-HT 
    human rabies virus immune globulin injection, solution
    Product Information
    Product TypePLASMA DERIVATIVEItem Code (Source)NDC: 49281-190
    Route of AdministrationINTRAMUSCULAR
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HUMAN RABIES VIRUS IMMUNE GLOBULIN (UNII: 95F619ATQ2) (HUMAN RABIES VIRUS IMMUNE GLOBULIN - UNII:95F619ATQ2) HUMAN RABIES VIRUS IMMUNE GLOBULIN150 [iU]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCINE (UNII: TE7660XO1C) 22.5 mg  in 1 mL
    SODIUM CHLORIDE (UNII: 451W47IQ8X) 1 mg  in 1 mL
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 49281-190-201 in 1 CARTON
    1NDC: 49281-190-582 mL in 1 VIAL, SINGLE-DOSE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    BLABLA10393204/27/1984
    Labeler - Sanofi Pasteur Inc. (086723285)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sanofi Pasteur SA578763542MANUFACTURE

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