(rituximab-pvvr)

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Prescribing Information

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What is RUXIENCE?

What is RUXIENCE?

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Adults with Non-Hodgkin's Lymphoma (NHL): alone or with other chemotherapy medicines.
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Adults with Chronic Lymphocytic Leukemia (CLL): with the chemotherapy medicines fludarabine and cyclophosphamide.
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Adults with Rheumatoid Arthritis (RA): with another prescription medicine called methotrexate, to reduce the signs and symptoms of moderate to severe active RA in adults, after treatment with at least one other medicine called a Tumor Necrosis Factor (TNF) antagonist has been used and did not work well.
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Adults with Granulomatosis with Polyangiitis (GPA) (Wegener's Granulomatosis) and Microscopic Polyangiitis (MPA): with glucocorticoids, to treat GPA and MPA.
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Adults with Pemphigus Vulgaris (PV): to treat moderate to severe PV.

RUXIENCE is not indicated for treatment of children.

Before you receive RUXIENCE, tell your healthcare provider about all of your medical conditions, including if you:

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have had a severe reaction to RUXIENCE or another rituximab product
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have a history of heart problems, irregular heart beat or chest pain
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have lung or kidney problems
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have an infection or weakened immune system
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have or have had any severe infections including:
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Hepatitis B virus (HBV)
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Hepatitis C virus (HCV)
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Cytomegalovirus (CMV)
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Herpes simplex virus (HSV)
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Parvovirus B19
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Varicella zoster virus (chickenpox or shingles)
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West Nile Virus
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have had a recent vaccination or are scheduled to receive vaccinations. You should not receive certain vaccines before or during treatment with RUXIENCE.
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are pregnant or plan to become pregnant. Talk to your healthcare provider about the risks to your unborn baby if you receive RUXIENCE during pregnancy.
Females who are able to become pregnant:
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Your healthcare provider should do a pregnancy test to see if you are pregnant before starting RUXIENCE.
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You should use effective birth control (contraception) during treatment with RUXIENCE and for 12 months after your last dose of RUXIENCE. Talk to your healthcare provider about effective birth control.
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Tell your healthcare provider right away if you become pregnant or think that you are pregnant during treatment with RUXIENCE.
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are breastfeeding or plan to breastfeed. RUXIENCE may pass into your breast milk. Do not breastfeed during treatment and for 6 months after your last dose of RUXIENCE.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you take or have taken:

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a Tumor Necrosis Factor (TNF) inhibitor medicine
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a Disease Modifying Anti-Rheumatic Drug (DMARD)

If you are not sure if your medicine is one listed above, ask your healthcare provider.

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