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3/4/2022

Immune Globulin, Intravenous or Subcutaneous (Human)

Reason for the Shortage

    • Immune globulin products are available and being allocated by distributors.
    • ADMA Biologics has Asceniv 10% and Bivigam 10% available.[1-2]
    • Grifols has Gamunex-C, Flebogamma, and Xembify available.[4]
    • CSL Behring has Hizentra and Privigen available.[3]
    • Kedrion Biopharma has Gammaked available to current customers.[5]
    • Octapharma has Cutaquig and Octagam available.[6]
    • Takeda has Gammagard, Gammagard S/D, HyQvia, and Cuvitru available.[8]

Available Products

    • Asceniv solution for injection, ADMA Biologics, Immune globulin (human) - slra 10%, 5 gram protein/50 mL single dose vial, NDC 69800-0250-02
    • Bivigam solution for injection, ADMA Biologics, Immune globulin (human) 10%, 5 gram protein/50 mL bottle, NDC 59730-6502-01
    • Cutaquig subcutaneous solution for injection, Octapharma, Subcutaneous Immune globulin (human) - hipp 16.5%, 1 gram protein/6 mL single dose vial, NDC 68982-0810-01
    • Cutaquig subcutaneous solution for injection, Octapharma, Subcutaneous Immune globulin (human) - hipp 16.5%, 1.65 gram protein/10 mL single dose vial, NDC 68982-0810-02
    • Cutaquig subcutaneous solution for injection, Octapharma, Subcutaneous Immune globulin (human) - hipp 16.5%, 2 gram protein/12 mL single dose vial, NDC 68982-0810-03
    • Cutaquig subcutaneous solution for injection, Octapharma, Subcutaneous Immune globulin (human) - hipp 16.5%, 3.3 gram protein/20 mL single dose vial, NDC 68982-0810-04
    • Cutaquig subcutaneous solution for injection, Octapharma, Subcutaneous Immune globulin (human) - hipp 16.5%, 4 gram protein/24 mL single dose vial, NDC 68982-0810-05
    • Cutaquig subcutaneous solution for injection, Octapharma, Subcutaneous Immune globulin (human) - hipp 16.5%, 8 gram protein/48 mL single dose vial, NDC 68982-0810-06
    • 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 61953-0005-02
    • Flebogamma DIF solution for injection, Grifols, Intravenous Immune globulin (human) 10%, 20 grams protein/200 mL vial, NDC 61953-0005-03
    • Flebogamma DIF solution for injection, Grifols, Intravenous Immune globulin (human) 10%, 5 grams protein/50 mL vial, NDC 61953-0005-01
    • Flebogamma DIF solution for injection, Grifols, Intravenous Immune globulin (human) 5%, 10 grams protein/200 mL vial, NDC 61953-0004-04
    • Flebogamma DIF solution for injection, Grifols, Intravenous Immune globulin (human) 5%, 20 grams protein/400 mL vial, NDC 61953-0004-05
    • Flebogamma DIF solution for injection, Grifols, Intravenous Immune globulin (human) 5%, 5 grams protein/100 mL vial, NDC 61953-0004-03
    • 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
    • Gammagard S/D (IGA less than 1 mcg/mL) lyophilized powder for injection, Takeda, Immune globulin (human) 5%, 10 gram protein bottle, NDC 00944-2658-04
    • Gammagard S/D (IGA less than 1 mcg/mL) lyophilized powder for injection, Takeda, Immune globulin (human) 5%, 5 gram protein bottle, NDC 00944-2656-03
    • 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
    • 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
    • Panzyga intravenous solution for injection, Pfizer, Immune globulin (human) - ifas -10%, 10 mL / 1 gram protein bottle, NDC 00069-1011-02
    • Panzyga intravenous solution for injection, Pfizer, Immune globulin (human) - ifas -10%, 100 mL / 10 gram protein bottle, NDC 00069-1312-02
    • Panzyga intravenous solution for injection, Pfizer, Immune globulin (human) - ifas -10%, 200 mL / 20 gram protein bottle, NDC 00069-1415-02
    • Panzyga intravenous solution for injection, Pfizer, Immune globulin (human) - ifas -10%, 25 mL / 2.5 gram protein bottle, NDC 00069-1109-02
    • Panzyga intravenous solution for injection, Pfizer, Immune globulin (human) - ifas -10%, 300 mL / 30 gram protein bottle, NDC 00069-1558-02
    • Panzyga intravenous solution for injection, Pfizer, Immune globulin (human) - ifas -10%, 50 mL / 5 gram protein bottle, NDC 00069-1224-02
    • 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
    • Xembify solution for injection, Grifols, Subcutaneous Immune globulin (human) - klhw 20%, 1 gram protein/5 mL single dose vial, NDC 13533-0810-05
    • Xembify solution for injection, Grifols, Subcutaneous Immune globulin (human) - klhw 20%, 10 gram protein/50 mL single dose vial, NDC 13533-0810-50
    • Xembify solution for injection, Grifols, Subcutaneous Immune globulin (human) - klhw 20%, 2 gram protein/10 mL single dose vial, NDC 13533-0810-10
    • Xembify solution for injection, Grifols, Subcutaneous Immune globulin (human) - klhw 20%, 4 gram protein/20 mL single dose vial, NDC 13533-0810-20

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.[9]

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.[10-12]

References

    1. BioCare SD (personal communication). July 11, August 26, and September 24, 2019; April 6 and August 28, 2020.
    2. ADMA Biologics (personal communication). November 5, 2020; February 2, April 23, and July 7, 2021.
    3. CSL Behring (personal communication). November 26, and December 10, 2018; January 17, February 11, March 20, April 24, and November 20, 2019; January 29, April 6, June 26, and November 6, 2020; January 20, April 23, July 7, November 23, 2021; and March 4, 2022.
    4. Grifols (personal communication). May 9, July 11, September 24, November 20, 2019; January 29, April 6, August 28, and November 6, 2020; January 20, April 23, July 7, September 24, November 23, 2021; and March 4, 2022 .
    5. Kedrion (personal communication). April 30, July 11, 2019; January 29, February 3, and April 6, 2020; January 20, April 23, and September 24, 2021.
    6. Octapharma (personal communication). November 26, 2018; March 20 November 20, 2019; January 29, April 20, June 11, August 28, and November 18, 2020; January 20, April 23, July 7, September 24, November 23, 2021; and March 3, 2022.
    7. Pfizer (personal communication). August 28, 2020.
    8. Takeda (personal communication). October 17, November 28, December 3, 2018; January 9 and 17, April 2, March 20, April 24, September 24, November 20, 2019; January 29, June 4 and 26, August 28, and November 18, 2020; January 20, April 23, July 7, September 24, 2021; and March 4, 2022.
    9. Immune Globulin. In: McEvoy GK, Snow EK, eds. AHFS 2019 Drug Information. Bethesda, MD: American Society of Health-Systems Pharmacists; 2019: 3377-3397.
    10. 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.
    11. 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.
    12. 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 March 4, 2022 by Leslie Jensen, PharmD, Drug Information Specialist. Created February 7, 2019 by Leslie Jensen, PharmD, Drug Information Specialist. © 2022, Drug Information Service, University of Utah, Salt Lake City, UT.

Disclaimer

Drug Shortage Bulletins are copyrighted by the Drug Information Service of the University of Utah and provided by ASHP as its exclusive authorized distributor. 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, with 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 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 ASHP nor the University of Utah endorses or recommends the use of any particular drug. Any application of this information for any purpose shall be limited to personal, non-commercial use.

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