(rituximab-pvvr)

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What is the most important information I should know about RUXIENCE?

What is the most important information I should know about RUXIENCE?

RUXIENCE can cause serious side effects that can lead to death, including:
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Infusion-related reactions. Infusion-related reactions are very common side effects of RUXIENCE treatment. Serious infusion-related reactions can happen during your infusion or within 24 hours after your infusion of RUXIENCE. Your healthcare provider should give you medicines before your infusion of RUXIENCE to decrease your chance of having a severe infusion-related reaction.
Tell your healthcare provider or get medical help right away if you get any of these symptoms during or after an infusion of RUXIENCE:
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hives (red itchy welts) or rash
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itching
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swelling of your lips, tongue, throat or face
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sudden cough
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shortness of breath, difficulty breathing, or wheezing
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weakness
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dizziness or feel faint
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palpitations (feel like your heart is racing or fluttering)
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chest pain
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Severe skin and mouth reactions. Tell your healthcare provider or get medical help right away if you get any of these symptoms at any time during your treatment with RUXIENCE:
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painful sores or ulcers on your skin, lips or in your mouth
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blisters
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peeling skin
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rash
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pustules
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Hepatitis B virus (HBV) reactivation. Before you receive your RUXIENCE treatment, your healthcare provider will do blood tests to check for HBV infection. If you have had hepatitis B or are a carrier of hepatitis B virus, receiving RUXIENCE could cause the virus to become an active infection again. Hepatitis B reactivation may cause serious liver problems including liver failure, and death. You should not receive RUXIENCE if you have active hepatitis B liver disease. Your healthcare provider will monitor you for hepatitis B infection during and for several months after you stop receiving RUXIENCE.
Tell your healthcare provider right away if you get worsening tiredness, or yellowing of your skin or white part of your eyes, during treatment with RUXIENCE.
•
Progressive Multifocal Leukoencephalopathy (PML). PML is a rare, serious brain infection caused by a virus that can happen in people who receive RUXIENCE. People with weakened immune systems can get PML. PML can result in death or severe disability. There is no known treatment, prevention, or cure for PML.
Tell your healthcare provider right away if you have any new or worsening symptoms or if anyone close to you notices these symptoms:
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confusion
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dizziness or loss of balance
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difficulty walking or talking
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decreased strength or weakness on one side of your body
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vision problems

See "What are the possible side effects of RUXIENCE?" for more information about side effects.

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