Generic Name and Formulations:
Rituximab 10mg/mL; soln for IV infusion; preservative-free.

Company:
Genentech, Inc.

Indications for RITUXAN:
In combination with methotrexate (MTX): to reduce signs/symptoms and inhibit progression of structural damage in moderately-to-severely active rheumatoid arthritis patients who have had an inadequate response to one or more TNF antagonist therapies. Limitations of use: not recommended for use in patients with severe, active infections.

Adult Dose for RITUXAN:
Give glucocorticoids 30 minutes prior to each infusion. In combination with MTX: give two 1000mg IV infusions separated by 2 weeks. Subsequent courses should be given every 24 weeks or based on response, but not sooner than every 16 weeks.

Children's Dose for RITUXAN:
Not recommended.

Pharmacological Class:
B-lymphocyte-restricted differentiation antigen [CD20] inhibitor.

Warnings/Precautions:
Discontinue if severe infusion or mucocutaneous reactions occur (eg, hypoxia, pulmonary infiltrates, acute respiratory distress syndrome, MI, ventricular fibrillation, cardiogenic shock, paraneoplastic pemphigus, Stevens-Johnson syndrome, toxic epidermal necrolysis). Tumor lysis syndrome (esp. with high tumor burden); monitor for renal toxicity, fluid balance, electrolyte abnormalities (correct if occurs); discontinue if SCr rises or oliguria occurs. Monitor for new-onset neurologic manifestations; discontinue if progressive multifocal leukoencephalopathy (PML) develops. Pre-existing cardiovascular disease; monitor during and after treatment. Hepatitis B reactivation with fulminant hepatitis may occur; monitor for signs of active HBV infection, discontinue if occurs. Monitor CBCs, platelet counts during treatment, then periodically. Elderly. Pregnancy (Cat.C). Nursing mothers: not recommended.

Interactions:
Live virus vaccines: not recommended. Renal toxicity with cisplatin.

Adverse Reactions:
Fever, chills, rigors, nausea, pruritus, angioedema, asthenia, hypotension, headache, bronchospasm, throat irritation, rhinitis, urticaria, rash, vomiting, myalgia, dizziness, hypertension, cough, flushing, chest tightness; myelosuppression (eg, lymphopenia, neutropenia, leukopenia, anemia, thrombocytopenia), infusion reactions (may be fatal), mucocutaneous reactions (may be fatal), PML, viral infections (discontinue if serious), tumor lysis syndrome, renal toxicity, bowel obstruction/perforation, hepatitis B reactivation with fulminant hepatitis, cardiac arrhythmias (discontinue if serious).

How Supplied:
Single-use vial (10mL, 50mL)—1