August 12, 2019

Background

FDA monitoring confirms that, despite increased supply of immune globulin (IG) products in recent years, the demand for IG product has also increased over that same time and there is an ongoing shortage of Immune Globulin (Intravenous) (IGIV) and Immune Globulin (Subcutaneous) (IGSC) products in the United States. This shortage could impact patient care.

In the setting of the increased demand for IG, other factors that ordinarily might not impact availability may have a greater effect. These could include uneven product distribution across different localities, logistics of contractual obligations, production delays, and other factors.

FDA Actions to Improve Immune Globulin Product Supply

FDA does not have legal authority to require a manufacturer to begin producing, continue producing, or increase their production of drugs. However, FDA does work with manufacturers whenever possible to help mitigate shortages when we learn of them. The Agency is working very closely with the applicants/manufacturers listed below to help mitigate the supply situation for IG products as best as possible. It is also working with industry in exploring ways to improve the manufacturing yield of IG products, which are derived from donor plasma.

In addition, the FDA has been informed by the Plasma Protein Therapeutics Association (PPTA) that they have been working with some manufacturers of IG products, to assist healthcare providers in obtaining specific products needed by patient(s). Please see the Additional Information and Resources section of this posting to find the weblink to the PPTA Immunoglobulin Access Materials webpage.

Approaches to Distribution and Use of Immune Globulin Products for Consideration

We are aware that some health care providers, hospitals and medical systems, when faced with shortages of IG products, have taken steps to optimize limited supplies of IG for patients. These strategies have included lowering of doses, delay of treatments, prioritization based on medical need, and use of alternative therapies where those exist.

When IG supplies are limited, health care providers, hospitals, and medical systems may be required to decide which patients will receive priority treatment. We encourage such health care providers, hospitals, and medical systems to prospectively devise an evidence‑based approach to such decisions.

Hospitals and other medical systems with only one IG product contract may wish to consider a second IG product contract to improve resilience during and after this time of shortage.

Complete List of U.S. Licensed Sources of Immune Globulin Products (current as of August 2019)

Immune Globulin Intravenous (Human)

Immune Globulin Subcutaneous (Human)

Contact information for Manufacturers of Immune Globulin Products

If you are a patient experiencing IG access challenges, please contact your health care provider, who is in the best position to assess your medical situation and determine the best course of care for you.

Health care providers, please contact the manufacturer(s) of IG products directly to inquire about availability of product(s) needed for the care of your patient(s).

Contact information is listed below.

ADMA Biologics, Inc. Baxalta US Inc., a Takeda Company Bio Products Laboratory CSL Behring AG Grifols Therapeutics LLC Instituto Grifols, SA Kedrion Biopharma Inc OCTAPHARMA Pharmazeutika Produktionsges.m.b.H Asceniv®

Bivigam®

1-800-458-4244 Cuvitru®

Hyqvia®

Gammagard®

1-800-423-2090 Gammaplex®

1-844-427-5872 Carimune®

Hizentra®

Privigen®

1-800-504-5434

(press option #1 for Medical Information) Gamunex-C®

Xembify®

1-800-243-4153 Flebogamma®

1-800-243-4153 Gammaked®

1-855-353-7466 Octagam®

Cutaquig®

Panzyga®

1-866-766-4860

To Report an Immune Globulin Product Shortage, you may contact FDA at:

Additional Information and Resources: