Rituxan in combination with glucocorticoids (GCC) is the first FDA-approved medicine for people ages 2 years and above with granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA).
Rituxan only targets a specific type of white blood cell found in the immune system. These cells are known as CD20+ B-cells and are thought to be involved in GPA and MPA. Rituxan targets these cells and is thought to reduce their levels in the body.
Because it is thought to interfere with B-cell function and disrupt ANCA production, Rituxan works differently from other medications used to treat GPA and MPA.
ANCA, antineutrophil cytoplasmic antibody.
Rituxan is a prescription medicine used to treat:
Adults with Rheumatoid arthritis (RA): with another prescription medicine called methotrexate, to reduce the signs and symptoms of moderate to severe active RA, after treatment with at least one other medicine called a tumor necrosis factor (TNF) antagonist has been used and did not work well enough.
People with Granulomatosis with Polyangiitis (GPA) (Wegener’s Granulomatosis) and Microscopic Polyangiitis (MPA) ages 2 years and above: with glucocorticoids.
Adults with Pemphigus Vulgaris (PV): to treat moderate to severe PV.
RITUXAN is not indicated in children less than 2 years of age with GPA or MPA or in children with conditions other than GPA or MPA.
Rituxan can cause serious side effects that can lead to death, including:
Infusion-Related Reactions: Infusion-related reactions are very common side effects of Rituxan treatment. Serious infusion-related reactions can happen during your infusion or within 24 hours after your infusion of Rituxan. Your healthcare provider should give you medicines before your infusion of Rituxan 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 Rituxan:
Hepatitis B Virus (HBV) Reactivation: Before you receive your Rituxan 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 Rituxan could cause the virus to become an active infection again. Hepatitis B reactivation may cause serious liver problems, including liver failure and death. Your healthcare provider will monitor you for hepatitis B infection during and for several months after you stop receiving Rituxan. 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 Rituxan.
Progressive Multifocal Leukoencephalopathy (PML): PML is a rare, serious brain infection caused by a virus that can happen in people who receive Rituxan. 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 new or worsening symptoms or if anyone close to you notices these symptoms:
Before receiving Rituxan, tell your healthcare provider if you:
Rituxan can cause serious side effects, including:
Tumor Lysis Syndrome (TLS): TLS is caused by the fast breakdown of cancer cells. TLS can cause you to have:
TLS can happen within 12 to 24 hours after an infusion of Rituxan. 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:
Your healthcare provider will stop treatment with Rituxan if you have severe, serious, or life-threatening side effects.
In adults with GPA or MPA, the most common side effects of Rituxan also include:
Other side effects include:
These are not all of the possible side effects with Rituxan.
Call your healthcare provider for medical advice about side effects. You may report side effects to the FDA at (800) FDA‐1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at (888) 835‐2555.
Please see the Rituxan Prescribing Information and Medication Guide including Most Serious Side Effects for additional Important Side Effect Information.
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