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7/15/2019

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
    • 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
    • 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
    • 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 10% Liquid intravenous solution for injection, Octapharma, Immune globulin (human) 10%, 100 mL / 10 gram protein bottle, NDC 68982-0850-03
    • Octagam 10% Liquid intravenous solution for injection, Octapharma, Immune globulin (human) 10%, 20 mL / 2 gram protein bottle, NDC 68982-0850-01
    • Octagam 10% Liquid intravenous solution for injection, Octapharma, Immune globulin (human) 10%, 200 mL / 20 gram protein bottle, NDC 68982-0850-04
    • Octagam 10% Liquid intravenous solution for injection, Octapharma, Immune globulin (human) 10%, 50 mL / 5 gram protein bottle, NDC 68982-0850-02
    • 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
    • Privigen 10% Liquid intravenous solution for injection, CSL Behring, Immune globulin (human) 10%, 100 mL / 10 gram protein bottle, NDC 44206-0437-10
    • Privigen 10% Liquid intravenous solution for injection, CSL Behring, Immune globulin (human) 10%, 200 mL / 20 gram protein bottle, NDC 44206-0438-20
    • Privigen 10% Liquid intravenous solution for injection, CSL Behring, Immune globulin (human) 10%, 400 mL / 40 gram protein bottle, NDC 44206-0439-40
    • Privigen 10% Liquid intravenous solution for injection, CSL Behring, Immune globulin (human) 10%, 50 mL / 5 gram protein bottle, NDC 44206-0436-05

Reason for the Shortage

    • CSL Behring has Hizentra and Privigen on shortage due to increased demand.[2]
    • Grifols has Gamunex-C and Flebogamma on shortage due to increased demand.[3]
    • Kedrion Biopharma has Gammaked available to current customers.[4]
    • Octapharma has Octagam on shortage due to increased demand.[5]
    • Takeda has HyQvia, Cuvitru, and Gammagard on shortage due to increased demand.[6]

Available Products

    • 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

Estimated Resupply Dates

    • ADMA Biologics received approval on April 1, 2019 for Asceniv (immune globulin intravenous, human - slra) 10% liquid. The company also recently received approval for Bivigam intravenous immune globulin.The company cannot estimate a launch date but hope to have both products launched sometime in 2019.[1]
    • CSL Behring is releasing Hizentra and Privigen regularly and wholesalers are allocating product.[2]
    • Grifols has all Gamunex-C and Flebogamma presentations on intermittent back order and the company is releasing product as it becomes available.[3]
    • Grifols received approval on July 3, 2019 for Xembify (immune globulin subcutaneous, human - klhw) 20% solution. The company cannot estimate a launch date.[3]
    • Octapharma has all Octagam presentations on allocation.[5]
    • Takeda has Cuvitru and HyQvia on allocation and the company is reviewing all orders.[6]
    • Takeda has all Gammagard Liquid presentations on intermittent back order and the company is allocating product as it becomes available.[6]
    • ADMA Biologics received approval on April 1, 2019 for Asceniv (immune globulin intravenous, human - slra) 10% liquid. The company cannot estimate a launch date.

Implications for Patient Care

    • Immune globulin products are life-saving and critical products for a number of acute and chronic conditions including, but not limited to: B-cell chronic lymphocytic leukemia, chronic inflammatory demyelinating polyneuropathy, idiopathic thrombocytopenic purpura, Kawasaki disease, and primary immunodeficiency diseases.[7]

Safety

    • Product switches may be inevitable during times of shortage. Make every attempt to maintain consistent therapy when possible.

Alternative Agents & Management

    • Organizations facing a shortage should consider the following actions: * Establish a task force or method to approve new starts and ongoing doses. The American Journal of Health-System Pharmacy supplement on immune globulin may be helpful for clinicians. The supplement can be found at: https://academic.oup.com/ajhp/issue/62/16_Supplement_3. * Ensure immune globulin is appropriate and necessary for the indication. Use alternatives if available. * Ensure the dose and interval are appropriate. Data are available regarding dosing using ideal or adjusted body weight.[8-10]

References

    1. ADMA Biologics (personal communication). July 11, 2019.
    2. CSL Behring (personal communication). November 26, and December 10, 2018.
    3. Grifols (personal communication). May 9, and July 11, 2019.
    4. Kedrion (personal communication). April 30, and July 11, 2019.
    5. Octapharma (personal communication). November 26, 2018.
    6. Takeda (personal communication). October 17, November 28, December 3, 2018; January 9 and 17, April 2, March 20, and April 24, 2019.
    7. Immune Globulin. In: McEvoy GK, Snow EK, eds. AHFS 2019 Drug Information. Bethesda, MD: American Society of Health-Systems Pharmacists; 2019: 3377-3397.
    8. Stump SE, Schepers AJ, Jones AR, et al. Comparison of Weight-Based Dosing Strategies for Intravenous Immunoglobulin in Patients with Hematologic Malignancies. Pharmacotherapy. 2017;12:1530-1536.
    9. Rocchio MA, Hussey AP, Southard RA, Szumita PM. Impact of Ideal Body Weight Dosing for all Inpatient I.V. Immune Globulin Indications. Am J Health Syst Pharm. 2013. 70(9): 751-752.
    10. Anderson CR, Olson JA. Correlation of Weight-Based I.V. Immune Globulin Doses with Changes in Serum Immunoglobulin G levels. Am J Health Syst Pharm. 2015. 72(4):285-289.

Updated

Updated July 15, 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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