Ruxience®

What is Ruxience®?

If your insurance switched you from Rituxan to Ruxience, you are probably wondering whether it is the same drug. Here is the short answer: yes, for all practical purposes.

Ruxience® (rituximab-pvvr) is a biosimilar. A biosimilar is a close copy of a biologic medicine that is already approved. Before the FDA approves one, the company has to show there is no meaningful difference in how safe it is or how well it works.

Ruxience is approved to treat non-Hodgkin's lymphoma, chronic lymphocytic leukemia, and two blood vessel conditions called GPA and MPA.

It works the same way as Rituxan and is given the same way.

• Your dose: Set by your doctor, based on your condition

• How often: The same schedule as Rituxan

• Total appointment time: Up to 6 or 7 hours for your first visit. Later visits are usually shorter.

Your nurse starts slowly and speeds up as you do well. You will get medicine beforehand to lower the chance of a reaction, and you will be tested for hepatitis B before you start.

How does Ruxience work?

Ruxience works the same way as Rituxan.

B cells are a kind of immune cell. In some diseases, they make antibodies that attack your own body, or they push other immune cells to cause swelling and damage.

B cells carry a marker on their surface called CD20. That marker is how Ruxience finds them.

Here is what it does:

• Ruxience finds B cells. It attaches to the CD20 marker on their surface.

• It clears those cells out. Your immune system removes them from your blood.

• Fewer harmful antibodies get made. This happens gradually over the months after treatment.

• Swelling and damage go down. In the part of your body the disease was affecting.

Ruxience works on the same timeline as Rituxan. B cells clear from your blood within days, and feeling better usually takes weeks to months.

Common side effects:

• Reactions during treatment — most likely during your first one

• Colds and other infections in your nose, throat, or sinuses

• Headache

• Feeling tired

• Low white blood cell counts

Serious side effects — get medical help right away:

• Severe reactions during treatment (BOXED WARNING). Some have been deadly.

• Severe skin reactions (BOXED WARNING). These involve painful blistering or peeling of the skin and mouth. Call your doctor right away if this happens.

• Hepatitis B coming back (BOXED WARNING). This can cause severe liver damage. You will be tested before you start.

• PML (BOXED WARNING). A rare brain infection that is usually fatal.

• Serious infections and lower antibody levels with repeated treatment.