Rituximab


Concise Prescribing Info
Indications/Uses
Listed in Dosage.
Dosage/Direction for Use
Adult : IV Non-Hodgkin's lymphoma; Refractory or relapsed follicular lymphoma As monotherapy: 375 mg/m2 via infusion at 50 mg/hr once wkly for 4 doses. May increase rate slowly. If tolerated, may start subsequent infusions at 100 mg/hr and increase slowly. Max rate: 400 mg/hr. W/ cyclophosphamide, vincristine, and prednisolone for follicular lymphoma (CVP) or w/ cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) for diffuse large B-cell lymphoma: 375 mg/m2 on day 1 of the chemotherapy cycle after corticosteroid regimen for up to 8 cycles. Patients who were treated w/ 6-8 cycles of CVP chemotherapy and have not progressed: May give 375 mg/m2 once wkly for 4 doses, may repeat 6 mthly up to 16 doses. Maintenance: 375 mg/m2 is given once every 3 mth (patients who have responded to induction chemotherapy) and once every 2 mth (previously untreated patients) until disease progression or a max period of 2 yr. Rheumatoid arthritis Two 1 g infusion doses, separated by 2 wk. Chronic lymphocytic leukaemia 375 mg/m2, given on the day prior to chemotherapy in cycle 1, followed by 500 mg/m2 on day 1 (every 28 days) of cycles 2-6.
Dosage Details
Intravenous
Non-Hodgkin's lymphoma, Refractory follicular lymphoma, Relapsed follicular lymphoma
Adult: As a single agent, 375 mg/m2 infusion once wkly, for 4 doses at an initial rate of 50 mg/hr. May increase by 50 mg/hr every 30 min. If tolerated, subsequent infusions can be started at 100 mg/hr and increased by 100 mg/hr every 30 min. Max rate: 400 mg/hr. When used w/ CVP (cyclophosphamide, vincristine and prednisolone) for follicular lymphoma or CHOP (cyclophosphamide, doxorubicin, vincristine and prednisone) for diffuse large B-cell lymphoma, 375 mg/m2 given on day 1 of the chemotherapy cycle after corticosteroid regimen, for up to 8 cycles. For patients who were treated w/ 6-8 cycles of CVP chemotherapy and have not progressed, 375 mg/m2 may be given once wkly for 4 doses, may repeat every 6 mth, for up to 16 doses. Maintenance: 375 mg/m2 given once every 3 mth (those who have responded to induction chemotherapy), once every 2 mth initiated 2 mth after the last dose of induction chemotherapy (previously untreated) for a max period of 2 yr.

Intravenous
Chronic lymphocytic leukaemia
Adult: 375 mg/m2, given on the day prior to chemotherapy in cycle 1, followed by 500 mg/m2 on day 1 (every 28 days) of cycles 2-6.

Intravenous
Rheumatoid arthritis
Adult: In patients with moderate to severe rheumatoid arthritis who have inadequate response to other disease-modifying antirheumatic drugs (DMARDs): Given as two 1 g IV infusion doses, separated by 2 weeks (in combination with methotrexate) every 24 weeks or based on clinical evaluation, but not sooner than every 16 weeks. Premedication with a glucocorticoid is recommended 30 minutes prior to each dose.
Reconstitution
Dilute the appropriate dose w/ sodium chloride 0.9% or glucose 5% to a final concentration of between 1 and 4 mg/mL.
Contraindications
Hypersensitivity to murine proteins. Patients w/ active, severe infections. Severely immunocompromised state. Concomitant use w/ live viral vaccines. Lactation.
Special Precautions
Extensive tumour burden, pulmonary insufficiency or pulmonary tumour infiltration; history of cardiac disease. Pregnancy.
Adverse Reactions
Reactivation of hepatitis B virus. Fever and rigors. Pruritus, skin rashes, dyspnoea, bronchospasm, angioedema, transient hypotension, and flushing, asthenia, headache, rhinitis, thrombocytopenia, neutropenia, anaemia, abdominal pain, bowel obstruction, and perforation. Exacerbation of heart failure and angina pectoris. Reversible interstitial pneumonia and interstitial fibrosis. Depletion of immunoglobulin concentrations.
Potentially Fatal: Toxic epidermal necrolysis and Stevens-Johnsons syndrome. Pulmonary or cardiac toxicity during infusion; severe mucocutaneous reactions; severe cytokine release syndrome associated w/ tumour lysis syndrome. Myocardial infarction, ventricular fibrillation, and cardiogenic shock. Increased risk of progressive multifocal leukoencephalopathy. Paraneoplastic pemphigus.
MonitoringParameters
Monitor CBC and platelet counts regularly and for signs of active infection or hepatitis in hepatitis B carriers. Discontinue therapy if viral hepatitis develops. Cardiac monitoring should be performed during and after all infusions. Preexisting pulmonary conditions should be closely monitored for possible infusion-related toxicity. Monitor renal function.
Drug Interactions
Increased risk of renal toxicity w/ cisplatin.
Potentially Fatal: May decrease the efficacy of vaccines and increase the risk of infections in patients immunised w/ live vaccines.
Food Interaction
Diminished efficacy with echinacea, avoid concurrent use. If use is necessary, monitor patient response.
Action
Description: Rituximab is a chimeric monoclonal antibody to CD20 antigen which regulates cell cycle initiation. It binds to the antigen on the cell surface, activating complement-dependent B-cell cytotoxicity; and to human Fc receptors, mediating cell killing through an antibody-dependent cellular toxicity.
Duration: Detectable in serum 3-6 mth after completion of therapy; B-cell recovery 6-12 mth following completion of therapy.
Pharmacokinetics:
Excretion: Mean terminal half-life: Approx 20 days.
Storage
Store between 2-8°C.
Disclaimer: This information is independently developed by MIMS based on Rituximab from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2020 MIMS. All rights reserved. Powered by MIMS.com
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