FAQs About Rituximab for Cold Agglutinin Disease

A leading treatment for cold agglutinin disease (CAD) is rituximab. Following  are answers to some questions you might have before you decide to start treatment.

How does rituximab work?

CAD is caused by immune cells in the body called B-cells producing antibodies that bind to red blood cells (RBCs) in cold temperatures. This binding labels the RBCs for destruction by other cells of the immune system.

Rituximab is a therapy that works to reduce the number of B-cells in your body, consequently reducing the production of antibodies. The result is your immune system destroys fewer RBCs, hopefully reducing your symptoms.

CAD is linked to certain types of cancer. Because rituximab also is a cancer treatment, it can improve symptoms of CAD by treating underlying cancer.

The medication is marketed under the name Rituxan in the U.S. (by Genentech and Biogen), and as MabThera in Europe (by Roche).

Can I take it at home?

No. You receive rituximab through an intravenous (IV) infusion, so you must go to a medical center for treatment. In this way clinical staff can monitor you for adverse reactions (side effects).

How often do I need treatment?

The U.S. Food and Drug Administration (FDA) did not approve rituximab to treat CAD. So, its use is “off-label” and there is no treatment regimen for that condition. Your medical team can decide what dosage to use based on doses that the FDA approved for cancer treatment and those cited in medical articles.

Researchers investigated several different treatment regimens of rituximab for CAD in the literature. For example, some studies showed rituximab to be effective in CAD at a dosage of 375 mg/m² once a week for four weeks. Other studies have used it in combination with chemotherapy agents including fludarabine and bendamustine.

In the study with fludarabine, patients received four doses of 375 mg/m2 (milligrams per square meter) rituximab once every 28 days, while also receiving fludarabine orally on the same day plus the next four days afterward.

In the bendamustine study, rituximab patients also received rituximab at a dose of 375 mg/m2 every 28 days for four cycles. They received bendamustine on the same day and also the day following in each cycle.

What are the side effects?

Rituximab can lead to a number of side effects. There can be infusion reactions such as hives, blisters, sores in the mouth or lips, weakness, dizziness, itching and swelling, and chest pain and heart palpitations.

Since rituximab weakens the immune system, you also may be at greater risk of developing progressive multifocal leukoencephalopathy (PML) or other infections. The treatment also can cause reactivation of the hepatitis B virus if you had a previous infection.

The treatment sometimes leads to heart, kidney, and digestive tract problems.

Are there instances when I should not take rituximab?

Because rituximab weakens the immune system you should not take it if you already have a comprised immune system.

You also should not take rituximab if you recently had, or are planning to have, a live virus vaccine.

Rituximab can cause problems if you have or have had viral infections including hepatitis B and C, cytomegalovirus, herpes simplex, parvovirus B19, chickenpox or shingles, or West Nile Virus.

Side effects of rituximab can be more serious if you have a prior history of heart, lung, and/or kidney problems.

Rituximab can cause harm to a developing fetus. So, you should not use it if you are pregnant or plan to become pregnant for at least 12 months following treatment. You also should not breastfeed during treatment or for at least six months afterward.

Last updated: Oct. 1, 2020

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Cold Agglutinin Disease News is strictly a news and information website about the disease. It does not provide medical advice, diagnosis, or treatment. This content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Never disregard professional medical advice or delay in seeking it because of something you have read on this website.