Memorandum

Memorandum Ongoing Intravenous Immune Globulin (IVIG) shortages

Date: 07/03/2019
Organization: Bureau of Health Care Safety and Quality
Referenced Sources: CBER-Regulated Products: Current Shortages
CBER-Regulated Products: Shortages and Discontinuations

Table of Contents

Memo

TO:        Chief Executive Officers, Acute Care and Non- Acute
              Care Hospitals, Blood Banks

FROM:  Elizabeth Daake Kelley, MBA, MPH
              Director, Bureau of Health Care Safety and Quality

DATE:   July 2019

RE:       Ongoing Intravenous Immune Globulin (IVIG) shortages

The purpose of this memorandum is to communicate the Massachusetts Department of Public Health’s (the Department) awareness of ongoing nationwide Intravenous Immune Globulin (IVIG) shortages. IVIG is an essential therapy for the treatment of many debilitating and/or life-threatening immunodeficiency and immune dysregulatory disorders.

Immune Globulin Intravenous (Human) products are licensed by the United States Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER). 

CBER currently has identified the following three applicants/manufacturers reporting that their Immune Globulin product is in limited supply:

  • GAMMAGARD LIQUID® Immune Globulin Infusion (Human) is currently available, though patient shipping schedules may be impacted as continued high demand exceeds production plans and available inventory (Onset April 2019).
  • Gammaplex® Immune Globulin Intravenous (Human) is currently available but due to continued high demand and manufacturing delay, there is a limited supply of this product, which is presently being allocated to a reduced number of existing customers  (Onset October 2018).
  • Cuvitru® Immune Globulin Subcutaneous (Human), 20% Solution is currently available in limited quantity. Patient shipping schedule may be impacted when demand exceeds production plans and available inventory (Onset December 2018).

There are 11 U.S. licensed sources of Immune Globulin Intravenous (Human) products. CBER recommends hospitals contact manufacturers directly to inquire about product availability.

Immune Globulin Intravenous (Human)

The Department encourages all health care organizations to consider the American Society of Health-System Pharmacists (ASHP) Guidelines on Managing Drug Product Shortages when developing and implementing their continuity of operations management plans. The guidance may be found at the following link: ASHP Guidelines on Managing Drug Product Shortages

CBER’s most recent updates on this situation may be found on their website at the following links. Please note that this list is different from the list that the FDA maintains for drug shortages.

The Department will continue to closely monitor this shortage and provide updated information when available. Questions about this memorandum may be directed to eileen.mchale@state.ma.us.

Downloads for Ongoing Intravenous Immune Globulin (IVIG) shortages

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