Classifications: antineoplastic agent; immunomodulator; disease-modifying antirheumatic drug (dmard); Therapeutic:antineoplastic; monoclonal antibody; antirheumatic agent; dmard
Pregnancy Category: C
10 mg/mL injection
Genetically engineered monoclonal antibody that binds with the CD20 antigen on the surface of normal and malignant B lymphocytes.
B-cells are believed to play a role in the pathogenesis of rheumatoid arthritis and associated chronic synovitis. B-cells
may be acting at multiple sites in the autoimmune/inflammatory process including rheumatoid factor and other autoantibody
production, antigen presentation, T-cell activation, and/or proinflammatory cytokine production.
Results in a rapid and sustained depletion of circulating and tissue-based (e.g., thymus, spleen) B lymphocytes in non-Hodgkin's
lymphoma. Used in combination with methotrexate to reduce signs and symptoms of moderately to severely active rhematoid
arthritis (RA) in adults with an inadequate response to one or more TNF antagonist therapies. Rituximab effectiveness in
treatment for rheumatoid arthritis is measured by induced depletion of peripheral B lymphocytes.
Relapsed or refractory CD20 positive, B-cell non-Hodgkin's lymphoma, treatment of rheumatoid arthritis (with methotrexate).
Hypersensitivity to murine proteins, rituximab, or abciximab; angina, cardiac arrhythmias, cardiac disease; pulmonary disease,
chronic lymphocytic leukemia (CLL), lymphoma, severe hypotension; oliguria, rising serum creatinine; viral hepatitis B (HBV),
vaccination; pregnancy (category C), lactation.
Prior exposure to murine-based monoclonal antibodies; history of allergies; asthma and other pulmonary disease (increased
risk of bronchospasm); respiratory insufficiency; older adults; CAD; thrombocytopenia; history of cardiac arrhythmias; hypertension,
renal impairment. Safety and efficacy in children are not established.
Route & Dosage
Adult: IV 375 mg/m2 infused at 50 mg/h, may increase infusion rate q30min (max: 400 mg/h if tolerated), repeat dose on days 8, 15, and 22 (total
of 4 doses)
Adult: IV 1000 mg on days 1 and 15 (with methotrexate)
PREPARE: IV Infusion: Dilute ordered dose to 14 mg/mL by adding to an infusion bag of NS or D5W. Examples: 500 mg in 400 mL yields 1 mg/mL;
500 mg in 75 mL yields 4 mg/mL. Gently invert bag to mix. Discard unused portion left in vial.
ADMINISTER: IV Infusion: Infuse first dose at a rate of 50 mg/h; may increase rate at 50 mg/h increments q30min to maximum rate of 400 mg/h. For
subsequent doses, infuse at a rate of 100 mg/h and increase by 100 mg/h increments q30min up to maximum rate of 400 mg/h.
- Slow or stop infusion if S&S of hypersensitivity appear (see Appendix F).
- Store unopened vials at 2°8° C (36°46° F) and protect from light.
Adverse Effects (≥1%)Body as a Whole:
asthenia, night sweats, fever, chills,
Headache, dizziness, depression
Hypotension, tachycardia, peripheral edema. GI: Nausea,
vomiting, throat irritation, anorexia, abdominal pain, hepatitis
B reactivation with fulminant hepatitis, hepatic failure,
and death. Hematologic: Leukopenia, thrombocytopenia, anemia, neutropenia. Respiratory:
, rhinitis. Skin:
Pruritus, rash urticaria. Other:
Infusion-related reactions: Fever, chills, rigors, pruritus, urticaria, pain, flushing,
chest pain, hypotension, hypertension, dyspnea
; fatal infusion-related reactions
have been reported.
InteractionsDrug: antihypertensive agents
should be stopped 12 h prior to avoid excessive hypotension; cisplatin
may cause additive nephrotoxicity.
612 mo. Half-Life:
60174 h (increases with multiple infusions).
Assessment & Drug Effects
- Lab tests: CBC with differential, peripheral CD20+ B lymphocytes.
- Monitor carefully BP and ECG status during infusion and immediately report S&S of hypersensitivity (e.g., fever, chills,
urticaria, pruritus, hypotension, bronchospasms; see Appendix F for others).
Patient & Family Education
- Do not take antihypertensive medication within 12 h of rituximab infusions.
- Note: Use effective contraception during and for up to 12 mo following rituximab therapy.
- Report any of the following experienced during infusion: itching, difficulty breathing, tightness in throat, dizziness, headache,