Indicated for:

Non–Hodgkin’s Lymphoma (NHL):

For the treatment of adult patients with:

• Relapsed or refractory, low-grade or follicular, CD20-positive, B-cell NHL as a single agent
• Previously untreated follicular, CD20-positive, B-cell NHL in combination with first line chemotherapy and, in patients achieving a complete or partial response to RITUXAN in combination with chemotherapy, as single-agent maintenance therapy
• Non-progressing (including stable disease), low-grade, CD20-positive, B-cell NHL as a single agent after first-line cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy
• Previously untreated diffuse large B-cell, CD20-positive NHL in combination with cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP) or other anthracycline-based chemotherapy regimens

RITUXAN is indicated for the treatment of pediatric patients aged 6 months and older with:

• Previously untreated, advanced stage, CD20-positive diffuse large B-cell lymphoma (DLBCL), Burkitt lymphoma (BL), Burkitt-like lymphoma (BLL) or mature B-cell acute leukemia (B-AL) in combination with chemotherapy.

Chronic Lymphocytic Leukemia (CLL):

• RITUXAN, in combination with fludarabine and cyclophosphamide (FC), is indicated for the treatment of adult patients with previously untreated and previously treated CD20-positive CLL.

Rheumatoid Arthritis (RA):

• RITUXAN, in combination with methotrexate, is indicated for the treatment of adult patients with moderately- to severely- active rheumatoid arthritis who have had an inadequate response to one or more TNF antagonist therapies.

Granulomatosis with Polyangiitis (GPA) (Wegener’s Granulomatosis) and Microscopic Polyangiitis (MPA):

• RITUXAN, in combination with glucocorticoids, is indicated for the treatment of adult and pediatric patients 2 years of age and older with Granulomatosis with Polyangiitis (GPA) (Wegener’s Granulomatosis) and Microscopic Polyangiitis (MPA). 

Pemphigus Vulgaris (PV):

• The treatment of adult patients with moderate to severe pemphigus vulgaris.

RITUXAN is not recommended for use in patients with severe, active infections.

Do not administer as an intravenous push or bolus. RITUXAN should only be administered by a healthcare professional with appropriate medical support to manage severe infusion reactions that can be fatal if they occur.

The safety and effectiveness of RITUXAN have not been established in pediatric patients with NHL, CLL, PV, or RA.

Rituxan was not studied in pediatric patients with polyarticular juvenile idiopathic arthritis (PJIA) due to concerns regarding the potential for prolonged immunosuppression as a result of B-cell depletion in the developing juvenile immune system.

The safety of immunization with live viral vaccines following RITUXAN therapy has not been studied and vaccination with live virus vaccines is not recommended before or during treatment. For RA patients, physicians should follow current immunization guidelines and administer non-live vaccines at least 4 weeks prior to a course of RITUXAN.

The use of RITUXAN in patients with RA who have not had prior inadequate response to one or more TNF antagonists is not recommended.

Screen all patients for HBV infection by measuring HBsAg and anti-HBc before initiating treatment with RITUXAN. Obtain complete blood counts including platelets (CBC) prior to the first dose.

The safety and efficacy of retreatment with RITUXAN have not been established.

In patients with lymphoid malignancies, during treatment with RITUXAN monotherapy, obtain complete blood counts (CBC) with differential and platelet counts prior to each RITUXAN course. During treatment with RITUXAN and chemotherapy, obtain CBC with differential and platelet counts at weekly to monthly intervals and more frequently in patients who develop cytopenias. In patients with RA, GPA or MPA, obtain CBC with differential and platelet counts at two to four month intervals during RITUXAN therapy. Continue to monitor for cytopenias after final dose and until resolution.

Pneumocystis jiroveci pneumonia (PCP) and anti-herpetic viral prophylaxis is recommended for patients with CLL during treatment and for up to 12 months following treatment as appropriate. PCP prophylaxis is also recommended for patients with GPA and MPA during treatment and for at least 6 months following the last RITUXAN infusion.

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.

Hepatitis B virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure and death, can occur in patients treated with drugs classified as CD20-directed cytolytic antibodies, including RITUXAN. Cases have been reported in patients who are hepatitis B surface antigen (HBsAg) positive and also in patients who are HBsAg negative but are hepatitis B core antibody (anti-HBc) positive. Reactivation also has occurred in patients who appear to have resolved hepatitis B infection (i.e., HBsAg negative, anti-HBc positive and hepatitis B surface antibody [anti-HBs] positive).

JC virus infection resulting in PML and death can occur in RITUXAN-treated patients with hematologic malignancies or with autoimmune diseases. Most cases of PML were diagnosed within 12 months of their last infusion of RITUXAN.

Mucocutaneous reactions, some with fatal outcome, can occur in patients treated with RITUXAN. These reactions include paraneoplastic pemphigus, Stevens-Johnson syndrome, lichenoid dermatitis, vesiculobullous dermatitis, and toxic epidermal necrolysis.

Serious, including fatal, bacterial, fungal, and new or reactivated viral infections can occur during and following the completion of RITUXAN-based therapy.

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.

Acute renal failure, hyperkalemia, hypocalcemia, hyperuricemia, or hyperphosphatemia from tumor lysis, sometimes fatal, can occur within 12−24 hours after the first infusion of RITUXAN in patients with NHL.

Severe, including fatal, renal toxicity can occur after RITUXAN administration in patients with NHL. Renal toxicity has occurred in patients who experience tumor lysis syndrome and in patients with NHL administered concomitant cisplatin therapy during clinical trials. The combination of cisplatin and RITUXAN is not an approved treatment regimen.

Abdominal pain, bowel obstruction and perforation, in some cases leading to death, can occur in patients receiving RITUXAN in combination with chemotherapy.

Cardiac adverse reactions, including ventricular fibrillation, myocardial infarction, and cardiogenic shock may occur in patients receiving RITUXAN.

Bronchiolitis obliterans occurred during and up to 6 months after RITUXAN infusion.

Use of concomitant immunosuppressants other than corticosteroids has not been studied in GPA or MPA patients exhibiting peripheral B-cell depletion following treatment with RITUXAN.

Limited data are available on the safety of the use of biologic agents or disease modifying antirheumatic drugs (DMARDs) other than methotrexate in RA patients exhibiting peripheral B-cell depletion following treatment with rituximab.

Rituximab can cause fetal harm. Advise pregnant women of the risk to a fetus. Women of childbearing potential should use effective contraception while receiving  RITUXAN and for 12 months following treatment.

Since many drugs including antibodies are present in human milk, advise a lactating woman not to breastfeed during treatment and for at least 6 months after the last dose of RITUXAN due to the potential for serious adverse reactions in breastfed infants.

GoToSource

• Use in patients under 6 months of age. GoToSource

• Thrombocytopenic purpura, sjögren’s syndrome, inflammatory myopathies, systemic lupus erythematosus and cryoglobulinemia. GoToSource 

• Systemic connective tissue disorders, hematological diseases, kidney diseases, membranous glomerulonephritis and neuromyelitis optica. GoToSource

• Antisynthetase syndrome (dermatomyositis), autoimmune encephalitis, nephrotic syndrome, neoplastic cerebellar syndrome, pemphigus foliaceus, acquired haemophilia A, acute renal rejection and nephrotic syndrome. GoToSource

• Autoimmune hemolytic anemia associated with non-hodgkin lymphomas. GoToSource

• Graft versus host disease. GoToSource

• Relapsed or refractory hairy cell leukemia. GoToSource

• Multicentric castleman disease. GoToSource

• Post-transplant lymphoproliferative disorders. GoToSource

• Grave’s disease, anti-neutrophil cytoplasmic antibody associated vasculitis, cold agglutinin disease, IgM mediated neuropathy, multiple sclerosis, idiopathic membranous nephropathy and opsoclonus myoclonus. GoToSource

• Chronic fatigue syndrome. GoToSource

• Primary vitreoretinal lymphoma. GoToSource

• Myasthenia gravis. GoToSource

• Evans syndrome. GoToSource

Progressive multifocal leukoencephalopathy (viral infection of the white matter of the brain). GoToSource

Atrial fibrillation (irregular rapid heart rate). GoToSource

Myocardial infarction. GoToSource

Hepatitis B reactivation. GoToSource

Stevens-johnson syndrome (life-threatening skin disorder). GoToSource

Fatal infusion reactions, lichenoid dermatitis (non-inflammatory skin disorder), vesiculobullous dermatitis (autoimmune skin disorder) and toxic epidermal necrolysis. GoToSource

Hypogammaglobulinemia (primary immunodeficiency disease). GoToSource

Neutropenia (low level of neutrophils a type of white blood cell). GoToSource

Anemia, severe or fatal systemic inflammatory response syndrome reactions including pruritus (itching), urticaria/rash, angioedema, laryngeal edema, acute respiratory insufficiency, with or without blood pressure changes or arrhythmias, lymphopenia, leukopenia, bacterial, fungal and viral infections, sepsis, pneumonia, colitis, cerebrovascular infarction, convulsion, epilepsy and serotonin syndrome. GoToSource

Bronchospasm and hypersensitivity pneumonitis (lung inflammation due to breathing in a foreign substance). GoToSource

Hypotension (low blood pressure). GoToSource

Hypoxia (low oxygen levels in tissues). GoToSource

Pulmonary infiltrates. GoToSource

Development of skin and solid tumors. GoToSource

Acute respiratory distress syndrome. GoToSource

Gastrointestinal perforation. GoToSource

Tumor lysis syndrome (metabolic disorder). GoToSource

Lawsuits filed for progressive multifocal leukoencephalopathy, gastrointestinal obstruction and perforation.