Immune Globulin (Ig) therapy is used to treat numerous autoimmune diseases including polymyositis, dermatomyositis, and immune-mediated necrotizing myopathy. Ig can be delivered intravenously (IVIG) or subcutaneously (SCIG). With a shortage of Ig, patients are being asked to reschedule, or even forgo, their infusions.
Michelle Vogel of CSI Pharmacy, a sponsor of MSU and MyositisLIFE.org, provides information about the national Ig shortage. These details help to clarify a lot of misinformation that has been circulating.
1. Plasma collections (donors) is NOT the major cause of this shortage. Of all of the manufacturers who manufacture raw plasma to make IVIG/ SCIG only 1 manufacturer was slow to increase the number of collection facilities. That manufacturer is rectifying the situation.
2. Production problems at certain manufacturing plants have contributed to this shortage by multiple manufacturers (1 manufacturer had a facility closed for a period and 2 are currently having problems).
3. Brands being removed from the marketplace: Carimune and Flebogamma.
4. New brand coming into marketplace by manufacturer may be diverting plasma from current brand of IVIG to new SCIG that will enter marketplace in November.
5. Hospital pharmacists are using the 2002 shortage guidelines to prioritize patients. These are outdated.
Michelle will continue to keep us updated on the Ig shortage and how to be proactive and asks that you please share your stories. And, most importantly, she says to email her if you need her help.
Michelle shared, “During the last shortage, patients died. We are not going to let patients fall through the cracks. You are not alone. I promise to help find a way to get IVIG to your site of care or help transition you to site of care that has IVIG!”
If you need assistance you can email Michelle at michelle@csipharmacy.com
Report IVIG/SCIG Shortage to FDA
To all patients and providers experiencing Immune Globulin shortages, Michell Vogel of CSI Pharmacy spoke to the FDA this past week and they are aware of these shortages but they need to hear from you. Please report any rationing of product, brand change, forced to switch site of service, and/or not receiving your IVIG/SCIG. The more details you give, the better.
Please remember to include your contact information so they can follow up with you.
Food and Drug Administration (FDA)
Center for Biologics Evaluation and Research (CBER)
To report any potential or actual biological product shortage:
Email: CBERshortage@fda.hhs.gov
Phone: (240) 402-8380
Tags: igtherapy ivig scig
