RITUXAN: A LEGACY OF EXPERIENCE
The safety data in the Prescribing Information reflect the experience of 2578 patients with RA treated with Rituxan + MTX in controlled and long-term studies, with a total exposure of 5014 patient-years.[13,15]
*This patient exposure figure was calculated based on global approved indications and was estimated based on the total milligram volume sales divided by the average dose per patient per year. Exposures do not correspond to unique patients.
CYC, cyclophosphamide; GPA, granulomatosis with
polyangiitis; MPA, microscopic polyangiitis; MTX, methotrexate; RA,
rheumatoid arthritis; TNFi, tumor necrosis factor inhibitor; TNF-IR,
tumor necrosis factor inhibitor–inadequate responder.
- Rituxan + MTX has more than a decade of clinical experience in RA
- Rituxan + GCC is the only FDA-approved induction treatment
for adult patients with GPA and MPA
- Rituxan® (rituximab), in combination with methotrexate, is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response to one or more TNF antagonist therapies
- Rituxan® (rituximab), in combination with glucocorticoids, is indicated for the treatment of adult patients with Granulomatosis with Polyangiitis (GPA) (Wegener’s Granulomatosis) and Microscopic Polyangiitis (MPA)
- Rituxan® (rituximab) is indicated for the treatment of adult patients with moderate to severe pemphigus vulgaris
BOXED WARNINGS and Additional Important Safety Information
Infusion Reactions: Rituxan administration can result in serious, including fatal infusion reactions. Deaths within 24 hours of Rituxan infusion have occurred. Approximately 80% of fatal infusion reactions occurred in association with the first infusion. Monitor patients closely. Discontinue Rituxan infusion for severe reactions and provide medical treatment for Grade 3 or 4 infusion reactions.
Severe Mucocutaneous Reactions: Severe, including fatal, mucocutaneous reactions can occur in patients receiving Rituxan. Discontinue Rituxan in patients who experience a severe mucocutaneous reaction. The safety of readministration of Rituxan to patients with severe mucocutaneous reactions has not been determined.
Hepatitis B Virus (HBV) Reactivation: HBV reactivation can occur in patients treated with Rituxan, in some cases resulting in fulminant hepatitis, hepatic failure, and death. Screen all patients for HBV infection before treatment initiation, and monitor patients during and after treatment with Rituxan. Discontinue Rituxan and concomitant medications in the event of HBV reactivation.
Progressive Multifocal Leukoencephalopathy (PML), including fatal PML, can occur in patients receiving Rituxan. Discontinue Rituxan and consider discontinuation or reduction of any concomitant chemotherapy or immunosuppressive therapy in patients who develop PML.