(rituximab-pvvr)

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What are the possible side effects of RUXIENCE?

What are the possible side effects of RUXIENCE?

RUXIENCE can cause serious side effects, including:
•
See "What is the most important information I should know about RUXIENCE?"
•
Tumor Lysis Syndrome (TLS). TLS is caused by the fast breakdown of cancer cells. TLS can cause you to have:
o
kidney failure and the need for dialysis treatment
o
abnormal heart rhythm
 
TLS can happen within 12 to 24 hours after an infusion of RUXIENCE. Your healthcare provider may do blood tests to check you for TLS. Your healthcare provider may give you medicine to help prevent TLS.
Tell your healthcare provider right away if you have any of the following signs or symptoms of TLS:
o
nausea
o
vomiting
o
diarrhea
o
lack of energy
•
Serious infections. Serious infections can happen during and after treatment with RUXIENCE, and can lead to death. RUXIENCE can increase your risk of getting infections and can lower the ability of your immune system to fight infections. Types of serious infections that can happen with RUXIENCE include bacterial, fungal, and viral infections. After receiving RUXIENCE, some people have developed low levels of certain antibodies in their blood for a long period of time (longer than 11 months). Some of these people with low antibody levels developed infections. People with serious infections should not receive RUXIENCE. Tell your healthcare provider right away if you have any symptoms of infection:
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fever
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cold symptoms, such as runny nose or sore throat that do not go away
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flu symptoms, such as cough, tiredness, and body aches
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earache or headache
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pain during urination
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cold sores in the mouth or throat
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cuts, scrapes or incisions that are red, warm, swollen or painful
•
Heart problems. RUXIENCE may cause chest pain, irregular heartbeats, and heart attack. Your healthcare provider may monitor your heart during and after treatment with RUXIENCE if you have symptoms or heart problems or have a history of heart problems. Tell your healthcare provider right away if you have chest pain or irregular heartbeats during treatment with RUXIENCE.
•
Kidney problems, especially if you are receiving RUXIENCE for NHL. RUXIENCE can cause severe kidney problems that lead to death. Your healthcare provider should do blood tests to check how well your kidneys are working.
•
Stomach and Serious bowel problems that can sometimes lead to death. Bowel problems, including blockage or tears in the bowel can happen if you receive RUXIENCE with chemotherapy medicines. Tell your healthcare provider right away if you have any severe stomach-area (abdomen) pain or repeated vomiting during treatment with RUXIENCE.

Your healthcare provider will stop treatment with RUXIENCE if you have severe, serious or life-threatening side effects.
The most common side effects of RUXIENCE include:

o
infusion-related reactions (see "What is the most important information I should know about RUXIENCE?")
o
infections (may include fever, chills)
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body aches
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tiredness
o
nausea

In adults with GPA or MPA the most common side effects of RUXIENCE also include:

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low white and red blood cells
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swelling
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diarrhea
o
muscle spasms

Other side effects with RUXIENCE include:

o
aching joints during or within hours of receiving an infusion
o
more frequent upper respiratory tract infection

These are not all of the possible side effects with RUXIENCE.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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