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.

5 comments on “Ig products in short supply”

  1. 1
    Any Potgiesser on July 29, 2019

    I have Dermatomyositis and I feel like we are constantly jumping through hoops. 1) can we get coverage? 2) can they find any if we do get approved? 3) facilities seem to have a higher shortage vs smaller companies that treat in-home but how will I react to a new treatment and is it safe with that unknown? I feel like a guinea pig trying this and that just to live a “normal life.” I used to take for granted not popping a million pills daily or scratching my scalp raw.

  2. 2
    Dino Jacovides on August 5, 2019

    I have been Diagnosed with Polyradiculitis. Can this Diagnosis be misdiagnosed instead of an actual Polymyositis? What makes for a differential Diagnosis between the two?

    1. 3
      Linda Kobert on August 7, 2019

      Hello Dino. I’m very sorry you are dealing with this. Unfortunately, we aren’t doctors, so we aren’t able to offer medical advice. Polyradiculitis is not one of the autoimmune, inflammatory muscle diseases that falls in the category of myositis, so I don’t know much about it. We suggest you discuss this question with your health care professional.

  3. 4
    Vivian Crowe on August 10, 2019

    I have dermatomyositis and have been receiving IVIG infusions for the past 10 years. It has allowed me to get off high doses of prednisone, methotrexate and other potent drugs. Which allows me to lead a somewhat normal life.
    This past year my infusion has on occassion been delayed / received reduced doses due to shortages. Of course, this uncertainty increased my anxiety and flare-ups. But then, the ax fell 2 months ago when my doctor informed me they would not be able to get my ivig product again until November. I would have to find another source; shock and panic set-in.
    Fortunately, I had started with a new Neurologist and Rheumatologist via the Myositis/MDA clinic at University of California Irvine. They stepped up quickly and I added an immunologist to my cadre of doctors. My new immunologist, working with my other doctors, now provides my IVIG infusions in the clinic on UCI campas. I now have a long (1 1/2 hour} drive each direction to get my monthly treatments. But, I’m grateful beyond words.
    The mere thought of going back to high doses of prednisone, methotrexate et.al. was nerve racking. Now that I have overlapping immune diseases that require attention and other medications … it would be devastating to have to manage all of these drugs through the fog that sets in when you are overloading your system with organ damaging chemicals.
    We all do what we have to do to fight our daily battle, but I am extremely grateful that I found an alternative path.
    Fight hard, live strong and celebrate every day!

  4. 5
    AmeriPharma Specialty Care on August 29, 2019

    During these difficult times, we would like to extend our hand and offer access to these hard-to-find IVIg and SCIg medications.

    Even in the midst of Ig shortage, AmeriPharma’s extensive relationships with manufacturers and distributors has allowed us to stay fully stocked, so patients have access to the Ig they need.

    AmeriPharma is licensed in 17 states and territories across the United States. We accept Medicare and most private insurances.

    Learn more at: https://bit.ly/30V1gZm
    For faster service, speak to an IVIg pharmacist directly at 855-918-0815.

    AmeriPharma Specialty Care

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