Polymyositis, dermatomyositis, and necrotizing myopathy are diseases that are often treated with immunoglobulin (Ig) products, either intravenously (IV) or subcutaneously (SC). Many TMA members find IVIg or SCIg to be a very effective treatment. Recently, however, TMA has become aware of shortages of Ig products in some areas of the country.
IVIg and SCIg are products that contain antibodies, which can be helpful in treating the inflammation of myositis. These products are derived from human blood plasma. They are not chemically manufactured like drugs often are. Instead, they depend on plasma donations from thousands of people, which are then purified to create this specialty drug (one that is not available through a local pharmacy).
TMA talked with a representative from the Food and Drug Administration (FDA) who told us shortages come in waves and are entirely related to increasing demand for plasma and plasma-derived products such as Ig. While Ig is approved primarily for primary immune deficiencies, many other disorders, including myositis, are now being treated with Ig products. This, along with the complex manufacturing and distribution process, is why Ig is in short supply.
The Center for Biologics Evaluation and Research (CBER) is the arm of the FDA that regulates biologic products such as vaccines, probiotics, gene therapies, and blood products like Ig. The Center maintains a website that lists all CBER-regulated products currently in shortage.
If you are having trouble obtaining Ig products, the FDA representative we spoke with suggested that you or your doctor may consider contacting the manufacturer of the prescribed product to explain your situation and ask when you can expect to get your product. This “squeaky wheel” approach may help you access the Ig you need. Manufacturers whose products are in shortage and their phone numbers are identified on the CBER shortage website.
The Immune Deficiency Foundation provides a list of companies that provide Ig products along with website and contact information that identifies the products they manufacture. This may be a helpful resource where your doctor can find a different Ig product that may be more available and can be substituted for your current product.
It may also be helpful for you or your doctor to contact the sales representative for the specialty pharmacy that provides you with IVIg services. It may be possible for them to contact the manufacturer and access your product more quickly.
And finally, because Ig is a blood product that depends on blood donations, you may want to encourage friends and family to donate plasma regularly. Anyone who is 18 years of age or older, weighs more than 110 pounds, and is in good health can be a donor. Ig manufacturers often have their own donation programs, so you may want to contact the company that makes your product to see how to donate. The Plasma Protein Therapeutics Association (PPTA) is an industry organization that also provides a searchable database where you can locate a donation center near you.