Product Information
Maball-RA 500 (Rituximab Injection IP) is a chimeric murine/human monoclonal antibody that binds specifically to the CD20 antigen present on normal and malignant B lymphocytes. This binding initiates immune-mediated processes leading to B-cell lysis. By targeting and depleting B-cells, Maball-RA 500 modifies disease activity in conditions like Non-Hodgkin’s Lymphoma (NHL), Chronic Lymphocytic Leukemia (CLL), and Rheumatoid Arthritis (RA).
The injection is supplied as a 500 mg/50 mL concentrate for solution, intended for intravenous infusion after appropriate dilution. Treatment should be administered under the supervision of experienced healthcare professionals.
Indications
Maball-RA 500 is indicated for the treatment of:
- Non-Hodgkin’s Lymphoma (NHL): For patients with relapsed or refractory, low-grade or follicular, CD20-positive B-cell NHL.
- Chronic Lymphocytic Leukemia (CLL): In combination with chemotherapy for previously untreated and treated CD20-positive CLL.
- Rheumatoid Arthritis (RA): In combination with methotrexate for adult patients with moderate to severe active RA who have had an inadequate response to one or more TNF antagonist therapies.
Composition
Each 50 mL vial of Maball-RA 500 contains:
- Active Ingredient: 500 mg of Rituximab.
- Inactive Ingredients: Sodium chloride, sodium citrate, polysorbate 80, and water for injection.
Dosage and Administration
- Non-Hodgkin’s Lymphoma (NHL):
- Monotherapy: 375 mg/m² body surface area, administered as an intravenous infusion once weekly for 4 or 8 doses.
- Combination Therapy: 375 mg/m² on Day 1 of each chemotherapy cycle, for up to 8 cycles.
- Chronic Lymphocytic Leukemia (CLL):
- 375 mg/m² on the day prior to the initiation of chemotherapy in Cycle 1, followed by 500 mg/m² on Day 1 of each subsequent cycle, for 6 cycles in total.
- Rheumatoid Arthritis (RA):
- Two 1,000 mg intravenous infusions separated by two weeks, in combination with methotrexate. Subsequent courses can be administered based on clinical evaluation, typically at intervals of 24 weeks or more.
Note: Premedication with antihistamines and antipyretics is recommended to reduce infusion-related reactions. Dosage adjustments may be necessary based on patient response and tolerability.
Precautions
- Infusion Reactions: Serious, including fatal, infusion reactions can occur. Monitor patients closely during infusions.
- Infections: Increased risk of serious bacterial, fungal, and new or reactivated viral infections, including hepatitis B. Screen for hepatitis B virus before initiation.
- Cardiac Conditions: Caution in patients with a history of cardiac disease; monitor for arrhythmias and angina during and after infusion.
- Vaccinations: Live vaccines should not be administered concurrently with Maball-RA 500.
- Pregnancy and Lactation: Not recommended during pregnancy. Women of childbearing potential should use effective contraception during and for 12 months after treatment. Discontinue breastfeeding during therapy and for 12 months post-treatment.
Storage
- Store refrigerated at 2°C to 8°C (36°F to 46°F).
- Do not freeze.
- Protect from light; keep the vial in the outer carton until use.
- Use prepared infusion solutions promptly; if not used immediately, store under refrigeration and use within 24 hours.
Note
- Monitoring: Regular monitoring of blood counts and immunoglobulin levels is recommended during and after treatment.
- Tumor Lysis Syndrome: Patients with high tumor burden or rapidly proliferative tumors are at increased risk; appropriate prophylaxis and monitoring are advised.
- Progressive Multifocal Leukoencephalopathy (PML): Monitor for neurological symptoms indicative of PML; discontinue therapy if suspected.
- Patient Counseling: Inform patients about the potential risks and benefits of Maball-RA 500, including the importance of reporting any signs of infection or adverse reactions promptly.
