
Recelbia10 mg/ml
Healthcare Pharmaceuticals Ltd.
Rituximab is a chimeric monoclonal antibody directed against the CD20 antigen on B-lymphocytes.
Rituximab is a chimeric monoclonal antibody directed against the CD20 antigen on B-lymphocytes. It is used, alone or in combination with other agents, for the following conditions:
Guidelines and clinical experience also support use of Rituximab (off-label with respect to the original FDA label) in certain B-cell-mediated or autoantibody-mediated conditions, such as refractory idiopathic thrombocytopenic purpura (ITP), certain forms of vasculitis-associated glomerulonephritis, and select autoimmune cytopenias, generally reserved for cases refractory to first-line therapy and under specialist supervision.
All uses of Rituximab require administration by a healthcare professional in a setting equipped to manage severe infusion reactions.
Rituximab must be administered by, or under the direct supervision of, a qualified healthcare professional, with full resuscitation equipment immediately available, because of the risk of severe infusion reactions. Rituximab is given only as an intravenous infusion — never as an intravenous push or bolus.
| Indication | Typical Adult Dose |
|---|---|
| Non-Hodgkin's Lymphoma | 375 mg/m² IV once weekly for 4 to 8 doses, alone or combined with chemotherapy per regimen; maintenance schedules vary by protocol |
| Chronic Lymphocytic Leukemia | 375 mg/m² on Day 0/1 of cycle 1, then 500 mg/m² on Day 1 of cycles 2–6 (28-day cycles), combined with fludarabine and cyclophosphamide |
| Rheumatoid Arthritis | Two 1,000 mg IV infusions separated by 2 weeks, combined with methotrexate; re-treatment courses no more often than every 24 weeks based on clinical evaluation |
| GPA / MPA | 375 mg/m² IV once weekly for 4 weeks (induction), combined with glucocorticoids, followed by maintenance dosing per protocol |
| Pemphigus Vulgaris | Two 1,000 mg IV infusions separated by 2 weeks, with maintenance infusions at month 12 and thereafter per response |
Premedication with an antipyretic (e.g., paracetamol) and an antihistamine is recommended before every infusion; glucocorticoid premedication is required for the RA, GPA/MPA, and PV indications. The first infusion is started at a slow rate and increased gradually if tolerated; subsequent infusions may be given at a faster initial rate if the prior infusion was well tolerated. See Administration and Precautions and Warnings for full detail.
Adverse effects associated with Rituximab vary by indication but commonly include:
Rituximab is contraindicated in patients with a known history of severe hypersensitivity (e.g., anaphylaxis) to Rituximab or to murine (mouse) proteins, or to any component of the formulation.
Disclaimer
The information provided is accurate to the best of our knowledge, but it does not replace professional medical advice. We cannot guarantee its completeness or accuracy, and the absence of specific information about a drug should not be taken as an endorsement. We are not responsible for any consequences arising from this information, so please consult a healthcare professional for any concerns or questions.