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5/14/2019

Immune Globulin, Intravenous or Subcutaneous (Human)

Products Affected - Description

    • Cuvitru subcutaneous solution for injection, Takeda, Immune globulin (human) 20%, 1 gram protein/5 mL vial, NDC 00944-2850-01
    • Cuvitru subcutaneous solution for injection, Takeda, Immune globulin (human) 20%, 2 grams protein/10 mL vial, NDC 00944-2850-03
    • Cuvitru subcutaneous solution for injection, Takeda, Immune globulin (human) 20%, 4 grams protein/20 mL vial, NDC 00944-2850-05
    • Cuvitru subcutaneous solution for injection, Takeda, Immune globulin (human) 20%, 8 grams protein/40 mL vial, NDC 00944-2850-07
    • Flebogamma DIF solution for injection, Grifols, Intravenous Immune globulin (human) 10%, 10 grams protein/100 mL vial, NDC 69153-0005-02
    • Flebogamma DIF solution for injection, Grifols, Intravenous Immune globulin (human) 10%, 20 grams protein/200 mL vial, NDC 69153-0005-03
    • Flebogamma DIF solution for injection, Grifols, Intravenous Immune globulin (human) 10%, 5 grams protein/50 mL vial, NDC 69153-0005-01
    • Flebogamma DIF solution for injection, Grifols, Intravenous Immune globulin (human) 5%, 0.5 grams protein/10 mL vial, NDC 69153-0004-01
    • Flebogamma DIF solution for injection, Grifols, Intravenous Immune globulin (human) 5%, 10 grams protein/200 mL vial, NDC 69153-0004-04
    • Flebogamma DIF solution for injection, Grifols, Intravenous Immune globulin (human) 5%, 2.5 grams protein/50 mL vial, NDC 69153-0004-02
    • Flebogamma DIF solution for injection, Grifols, Intravenous Immune globulin (human) 5%, 20 grams protein/400 mL vial, NDC 69153-0004-05
    • Flebogamma DIF solution for injection, Grifols, Intravenous Immune globulin (human) 5%, 5 grams protein/100 mL vial, NDC 69153-0004-03
    • Gammagard Liquid solution for injection, Takeda, Immune globulin (human) 10%, 1 gram protein/10 mL bottle, NDC 00944-2700-02
    • Gammagard Liquid solution for injection, Takeda, Immune globulin (human) 10%, 10 gram protein/100 mL bottle, NDC 00944-2700-05
    • Gammagard Liquid solution for injection, Takeda, Immune globulin (human) 10%, 2.5 gram protein/25 mL bottle, NDC 00944-2700-03
    • Gammagard Liquid solution for injection, Takeda, Immune globulin (human) 10%, 20 gram protein/200 mL bottle, NDC 00944-2700-06
    • Gammagard Liquid solution for injection, Takeda, Immune globulin (human) 10%, 30 gram protein/300 mL bottle, NDC 00944-2700-07
    • Gammagard Liquid solution for injection, Takeda, Immune globulin (human) 10%, 5 gram protein/50 mL bottle, NDC 00944-2700-04
    • Gammaked solution for injection, Kedrion Biopharma, Inc., Intravenous or subcutaneous Immune globulin (human) 10%, 1 gram protein/10 mL vial, NDC 76125-0900-01
    • Gammaked solution for injection, Kedrion Biopharma, Inc., Intravenous or subcutaneous Immune globulin (human) 10%, 10 gram protein/100 mL vial, NDC 76125-0900-10
    • Gammaked solution for injection, Kedrion Biopharma, Inc., Intravenous or subcutaneous Immune globulin (human) 10%, 2.5 gram protein/25 mL vial, NDC 76125-0900-25
    • Gammaked solution for injection, Kedrion Biopharma, Inc., Intravenous or subcutaneous Immune globulin (human) 10%, 20 gram protein/200 mL vial, NDC 76125-0900-20
    • Gammaked solution for injection, Kedrion Biopharma, Inc., Intravenous or subcutaneous Immune globulin (human) 10%, 5 gram protein/50 mL vial, NDC 76125-0900-50
    • Gamunex-C solution for injection, Grifols, Intravenous or subcutaneous Immune globulin (human) 10%, 1 gram protein/10 mL vial, NDC 13533-0800-12
    • Gamunex-C solution for injection, Grifols, Intravenous or subcutaneous Immune globulin (human) 10%, 10 grams protein/100 mL vial, NDC 13533-0800-71
    • Gamunex-C solution for injection, Grifols, Intravenous or subcutaneous Immune globulin (human) 10%, 2.5 grams protein/25 mL vial, NDC 13533-0800-15
    • Gamunex-C solution for injection, Grifols, Intravenous or subcutaneous Immune globulin (human) 10%, 20 grams protein/200 mL vial, NDC 13533-0800-24
    • Gamunex-C solution for injection, Grifols, Intravenous or subcutaneous Immune globulin (human) 10%, 40 grams protein/400 mL vial, NDC 13533-0800-40
    • Gamunex-C solution for injection, Grifols, Intravenous or subcutaneous Immune globulin (human) 10%, 5 grams protein/50 mL vial, NDC 13533-0800-20
    • HyQvia subcutaneous solution for injection, Takeda, Immune globulin (human) 10% / Recombinant Human Hyaluronidase, 10 grams protein / 100 mL - 800 units / 5 mL dual vial, NDC 00944-2512-02
    • HyQvia subcutaneous solution for injection, Takeda, Immune globulin (human) 10% / Recombinant Human Hyaluronidase, 2.5 grams protein / 25 mL - 200 units / 1.25 mL dual vial, NDC 00944-2510-02
    • HyQvia subcutaneous solution for injection, Takeda, Immune globulin (human) 10% / Recombinant Human Hyaluronidase, 20 grams protein / 200 mL - 1600 units / 10 mL dual vial, NDC 00944-2513-02
    • HyQvia subcutaneous solution for injection, Takeda, Immune globulin (human) 10% / Recombinant Human Hyaluronidase, 30 grams protein / 300 mL - 2400 units / 15 mL dual vial, NDC 00944-2514-02
    • HyQvia subcutaneous solution for injection, Takeda, Immune globulin (human) 10% / Recombinant Human Hyaluronidase, 5 grams protein / 50 mL - 400 units / 2.5 mL dual vial, NDC 00944-2511-02
    • Octagam 5% Liquid intravenous solution for injection, Octapharma, Immune globulin (human) 5%, 100 mL / 5 gram protein bottle, NDC 68982-0840-03
    • Octagam 5% Liquid intravenous solution for injection, Octapharma, Immune globulin (human) 5%, 20 mL / 1 gram protein bottle, NDC 68982-0840-01
    • Octagam 5% Liquid intravenous solution for injection, Octapharma, Immune globulin (human) 5%, 200 mL / 10 gram protein bottle, NDC 68982-0840-04
    • Octagam 5% Liquid intravenous solution for injection, Octapharma, Immune globulin (human) 5%, 50 mL / 2.5 gram protein bottle, NDC 68982-0840-02
    • Octagam 5% Liquid intravenous solution for injection, Octapharma, Immune globulin (human) 5%, 500 mL / 25 gram protein bottle, NDC 68982-0840-05

Reason for the Shortage

    • Baxalta has HyQvia and Cuvitru on shortage due to increased demand.
    • CSL Behring has Hizentra available.
    • Grifols has Gamunex-C and Flebogamma on shortage due to increased demand.
    • Kedrion Biopharma has Gammaked on shortage due to increased demand.
    • Takeda has Gammagard Liquid on shortage due to increased demand.

Available Products

    • Hizentra subcutaneous solution for injection, CSL Behring, Immune globulin (human) 20%, 1 gram protein/5 mL vial, NDC 44206-0451-01
    • Hizentra subcutaneous solution for injection, CSL Behring, Immune globulin (human) 20%, 10 grams protein/50 mL vial, NDC 44206-0455-10
    • Hizentra subcutaneous solution for injection, CSL Behring, Immune globulin (human) 20%, 2 grams protein/10 mL vial, NDC 44206-0452-02
    • Hizentra subcutaneous solution for injection, CSL Behring, Immune globulin (human) 20%, 4 grams protein/20 mL vial, NDC 44206-0454-04

Estimated Resupply Dates

    • Baxalta has Cuvitru and HyQvia on allocation and the company is reviewing all orders.
    • Grifols has all Gamunex-C and Flebogamma presentations on intermittent back order and the company is releasing product as it becomes available.
    • Kedrion Biopharma has all Gammaked presentations on back order and the company estimates a release date of late-May 2019.
    • Octapharma has all Octagam presentations on allocation.
    • Takeda has all Gammagard Liquid presentations on intermittent back order and the company is allocating product as it becomes available.

Updated

Updated May 14, 2019 by Michelle Wheeler, PharmD, Drug Information Specialist. Created February 7, 2019 by Leslie Jensen, PharmD, Drug Information Specialist. © 2019, Drug Information Service, University of Utah, Salt Lake City, UT.

Disclaimer

This information is provided through the support of Vizient to ASHP solely as a service to its members, which shall not use this information for their further commercial use. The content was prepared by the Drug Information Center of University of Utah. Vizient, ASHP, and the University of Utah make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, which respect to such information, and specifically disclaim all such warranties. Users of this information are advised that decisions regarding the use of drugs and drug therapies are complex medical decisions and that in using this information, each user must exercise his or her own independent professional judgment. Neither Vizient, ASHP nor the University of Utah assumes any liability for persons administering or receiving drugs or other medical care in reliance upon this information, or otherwise in connection with this bulletin. Neither Vizient, ASHP nor University of Utah endorses or recommends the use of any drug.

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