• Severe infusion reactions are common, especially with the first dose → premedication and close monitoring required
• Hepatitis B reactivation risk → must screen for HBV before treatment
• Serious infections including PML (fatal brain infection) reported
• Causes prolonged B-cell depletion and immunosuppression
• Tumour lysis syndrome possible, particularly in high tumour burden
• Live vaccines contraindicated during and after treatment
• Avoid in active, severe infections
• Use caution in patients with cardiac disease (arrhythmias, angina, heart failure)
Generic name: Rituximab
Brand name: Rituximab Cipla
Drug class: Anti-CD20 monoclonal antibody
Formulation: Concentrate for solution for IV infusion
Strengths:
• 100 mg / 10 mL
• 500 mg / 50 mL
Mechanism of Action:
Binds to CD20 antigen on B-lymphocytes → induces B-cell death via immune-mediated mechanisms → tumour cell depletion in B-cell malignancies.
A. Non-Hodgkin’s Lymphoma (NHL)
Rituximab is indicated for the treatment of CD20-positive B-cell Non-Hodgkin’s Lymphoma, including:
• Induction therapy
– Used alone or in combination with chemotherapy to induce remission
• Maintenance therapy
– Used as continuous maintenance treatment for up to 2 years in patients who have responded to induction therapy
• Paediatric use
– Children and adolescents ≥ 6 months of age with:
• CD20-positive diffuse large B-cell lymphoma (DLBCL)
• Burkitt lymphoma (BL)
• Burkitt leukaemia (mature B-cell acute leukaemia)
• Burkitt-like lymphoma (BLL)
– Always used in combination with chemotherapy
B. Chronic Lymphocytic Leukaemia (CLL)
Rituximab is indicated for the treatment of adult patients with Chronic Lymphocytic Leukaemia, where:
• It is used in combination with chemotherapy
• Targets CD20-positive malignant B-cells
• Leads to depletion of abnormal lymphocytes accumulating in bone marrow and blood
• Route: Intravenous infusion only
• Premedication required (e.g. antipyretic, antihistamine ± corticosteroid)
• Infusion rate must be controlled and monitored
NHL (Adults):
• Weekly infusions × 4 doses (monotherapy induction), or
• Given on Day 1 of each chemotherapy cycle (usually every 3 weeks)
• Maintenance: One infusion every 2–3 months for up to 2 years
CLL:
• Given in combination with chemotherapy
• Administered on Day 0 (before chemotherapy) of Cycle 1, then Day 1 of subsequent cycles
• Total of 6 cycles (28-day cycles)
• Hypersensitivity to rituximab or murine proteins
• Active, severe infection
• Severe immunodeficiency
• Pregnancy and breastfeeding
• HBV screening prior to treatment
• Vital signs during infusion (BP, pulse, oxygen saturation)
• FBC: Baseline and regularly (risk of cytopenias)
• Infection surveillance (including delayed infections)
• Neurological monitoring for PML symptoms
• Renal function in high tumour burden (tumour lysis risk)
Very Common / Common:
• Infusion reactions (fever, chills, hypotension, rash, dyspnoea)
• Infections (URTI, pneumonia, sepsis)
• Neutropenia, thrombocytopenia, anaemia
• Fatigue, headache
• Nausea, diarrhoea
Serious / Life-Threatening:
• Severe infusion reactions
• Hepatitis B reactivation
• Progressive multifocal leukoencephalopathy (PML)
• Tumour lysis syndrome
• Severe skin reactions (Stevens-Johnson syndrome)
• Cardiac arrhythmias, myocardial infarction
• Pregnancy: Contraindicated
• Breastfeeding: Contraindicated (avoid for 12 months post-therapy)
• Paediatrics: Approved for specific NHL subtypes (see indications)
• Elderly: No dose adjustment, but higher infection risk
• Renal impairment: No formal adjustment, caution with tumour lysis risk
Continue until:
• Completion of planned induction ± maintenance regimen, or
• Disease progression, or
• Unacceptable toxicity
Discontinue permanently if:
• Life-threatening infusion reaction
• PML
• Severe recurrent infections
• Severe hypersensitivity
| Trade Name | |
|---|---|
| Drug Class | 1 |
| Cost | |
| Company | |
|---|---|
| Drug Rep | Admin |
| Indications | Lymphoma, Leukemia |
| Dosage |