Immune Globulin, Intravenous or Subcutaneous (Human) 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]

• • 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.