Composition
Inj 100 mg/500 mg: Per ml: Rituximab 10 mg; 10 ml (100 mg), 50 ml (500 mg); soln in vial.
Indications & Dosage
Treatment of severe active rheumatoid arthritis in patients who have not responded adequately to other disease-modifying antirheumatic drugs (including one or more tumour necrosis factor inhibitors) or cannot intolerant: BY IV INF: Adult: 1 g, then 1 g after 2 weeks, patients should receive premedication before each INF (consult product literature for details). Treatment of previously untreated stage III-IV follicular lymphoma (in combination): BY IV INF: Adult: 375 mg/m2 by IV INF for 8 cycles on day 1 of each chemotherapy cycle after corticosteroid component of CVP. Treatment of chemotherapy-resistant or relapsed stage III-IV follicular non-Hodgkins lymphoma, Previously untreated or relapsed chronic lymphocytic leukaemia: BY IV INF: Adult: 375 mg/m2 once weekly for 4 week. Treatment of diffuse large B-cell non-Hodgkins lymphoma (in combination): BY IV INF: Adult: 375 mg/m2 on day 1 of each chemotherapy cycle for 8 cycles after corticosteroid component of CHOP. See literature. Induction of remission in patients with severe, active granulomatosis with polyangiitis (Wegeners) andmicroscopic polyangiitis (in combination with glucocorticoids): BY IV INF: Adult: (consult product literature).
Administration
Do not administer as an IV push or bolus, dilute to final conc. of 1-4 mg /ml into an infusion bag containing either NS or D5W. Interrupt rituximab infusion for severe reactions and resume at a 50% reduction in rate (e.g. from 100 to 50 mg/hours) when symptom have completely resolved. In most cases, patients who have experienced nonlife-threatening reactions have been able to complete the full course of therapy.
Stability
Store under refrigeration. Protect vials from direct sunlight. Solution for infusion is stable at 2C-8C for 24 hours and at room temperature for an additional 12 hours.
Contraindications
Severe heart failure, severe infection, severe, uncontrolled heart disease (when used to treat granulomatosis with polyangiitis or microscopic polyangiitis)
Precautions
History of pulmonary insufficiency, pulmonary tumour infiltration. History of cardiovascular disease; in adults exacerbation of angina, arrhythmia, and heart failure have been reported, patients receiving cardiotoxic chemotherapy, Withhold antihypertensive medications 12 hrs prior to and throughout infusion, fewer neutrophil and platelet count, infusion reaction, infection, immunization, Use effective contraception method during and for 12 months after treatment. Patients should be monitored for cognitive, neurological, or psychiatric signs and symptoms. If progressive multifocal leucoencephalopathy is suspected, suspend treatment until it has been excluded.
Pregnancy
Positive evidence of risk: Avoid
Lactation
Contraindicated. Discontinue breast-feeding
Side Effects
Abdominal pain, anaemia, aplastic anaemia, arthralgia, asthenia, blood disorders, depression, dyspepsia, hypertension, hypotension, leucopenia, lupus erythematosus-like syndrome, migraine, muscle spasm, pancytopenia, paraesthesia, progressive multifocal leucoencephalopathy, pruritus, rhinitis, severe fatal skin reactions (discontinue), Stevens-Johnson syndrome (discontinue), thrombocytopenia, toxic epidermal necrolysis (discontinue), urticaria, worsening heart failure, recurrence of tuberculosis, septicaemia, and hepatitis B, progressive multifocal leucoencephalopathy