INFORMATION
MABTHERA® 500mg Key Features and Benefits
MABTHERA® (rituximab) is a monoclonal antibody used in the treatment of non-Hodgkin’s lymphoma (NHL) and chronic lymphocytic leukemia (CLL). It works by targeting the CD20 antigen on B-cells, leading to their destruction.
- Targeted Mechanism: Specifically binds to CD20 on B-lymphocytes to induce immune-mediated cell death.
- Effective in Clinical Trials: Demonstrated high remission rates in NHL and CLL patients.
- Intravenous and Subcutaneous Formulations: IV administration in hospitals, SC injection for maintenance therapy.
- Long-Term Disease Control: Used as monotherapy or with chemotherapy to improve survival rates.
MABTHERA® 500mg Indications
MABTHERA® 500mg is a widely used treatment for various B-cell malignancies and autoimmune disorders. Whether for previously untreated patients or those requiring ongoing care, this monoclonal antibody therapy provides effective solutions for different conditions. With evolving research, updated clinical guidelines continue to refine its role in treating cancers such as B-cell lymphoma and chronic lymphocytic leukemia (CLL). While highly effective, it is essential to consider potential side effects before initiating therapy.
- Non-Hodgkin’s Lymphoma (NHL): Used in treating CD20-positive diffuse large B-cell lymphoma and follicular lymphoma.
- Chronic Lymphocytic Leukemia (CLL): A first-line treatment for CD20-positive CLL in combination with chemotherapy.
- Rheumatoid Arthritis (RA): Recommended for patients who have shown an inadequate response to TNF inhibitors.
- Granulomatosis with Polyangiitis (GPA) & Microscopic Polyangiitis (MPA): Approved for treating vasculitis-related disorders.
MABTHERA® continues to be a cornerstone therapy in hematology and immunology, offering updated and effective solutions for both cancer and autoimmune disease management.
MABTHERA® 500mg Ingredients
Understanding the composition of MabThera® 500mg is essential for both healthcare providers and patients, as its active and inactive ingredients play a crucial role in its effectiveness and safety. While this cancer therapy has been extensively studied, certain reactions have been reported, particularly in individuals with immune sensitivities. Clinical studies continue to assess its safety profile, monitoring any adverse effects that may arise during treatment. Recognizing potential symptoms of allergic or infusion-related reactions can help ensure prompt medical intervention when necessary.
Each vial of MabThera® 500mg contains:
- Active Ingredient: Rituximab 500 mg
- Excipients:
- Sodium citrate
- Polysorbate 80
- Sodium chloride
- Water for injection
These components help stabilize and deliver rituximab effectively, ensuring optimal treatment outcomes for patients undergoing therapy for cancer or autoimmune conditions.
MABTHERA® 500mg How To Use
MABTHERA® is administered intravenously (IV) or subcutaneously (SC) under medical supervision.
Intravenous (IV) Administration
- NHL: 375 mg/m² IV infusion on Day 1 of each chemotherapy cycle for up to 8 cycles.
- CLL: 500 mg/m² IV infusion on Day 1 of each chemotherapy cycle for 6 cycles.
- RA: 1000 mg IV infusion at Weeks 0 and 2, repeated every 24 weeks.
Subcutaneous (SC) Administration
- NHL Maintenance Therapy: 1400 mg SC injection every 2 or 3 months for up to 2 years.
- RA and Vasculitis: Not approved for SC use.
MABTHERA® 500mg Side Effects
Common and serious side effects may occur, including infusion-related reactions and immune suppression.
- Common Side Effects (≥1%):
- Infusion reactions: Fever, chills, nausea, headache, rash.
- Infections: Upper respiratory infections, bronchitis.
- Hematologic effects: Neutropenia, anemia, thrombocytopenia.
- Skin reactions: Rash, itching, and injection site reactions (SC only).
- Serious Risks:
- Progressive Multifocal Leukoencephalopathy (PML): A rare brain infection, monitor for neurological symptoms.
- Severe Infusion Reactions: May be fatal, requires immediate medical intervention.
- Hepatitis B Virus (HBV) Reactivation: Liver function monitoring is essential.
- Cardiac Disorders: Risk of arrhythmias, myocardial infarction in high-risk patients.
Updated MABTHERA® 500mg Clinical Studies
MABTHERA® has been extensively tested in Phase 3 trials, demonstrating its effectiveness in treating B-cell malignancies and rheumatoid arthritis.
Non-Hodgkin’s Lymphoma (NHL) Trials
- PRIMA Study (Follicular Lymphoma):
- 70% of patients remained progression-free at 3 years.
- Significant improvement in overall survival.
- CHOP Combination (Diffuse Large B-Cell Lymphoma):
- Improved 5-year survival rates from 50% to 75%.
Chronic Lymphocytic Leukemia (CLL) Trials
- CLL8 Trial:
- Rituximab + Fludarabine + Cyclophosphamide improved progression-free survival.
- 85% response rate compared to 72% with chemotherapy alone.
Rheumatoid Arthritis (RA) Trials
- REFLEX Study:
- Significant reduction in joint swelling and pain.
- Long-term disease control when combined with methotrexate.
MABTHERA® 500mg Manufacturer Information
- Manufacturer: Roche Pharmaceuticals
- Contact: Local Roche offices or medical representatives.
- Regulatory Approval: Approved by EMA, FDA, and other global health authorities.
Updated MABTHERA® 500mg FAQ
1. How long does it take for MABTHERA® to work?
- Initial improvement in 4-6 weeks, full benefit may take several months.
2. Can MABTHERA® be self-administered?
- IV infusions must be given in a hospital. SC injections may be administered by a healthcare professional.
3. What should I do if I miss a dose?
- Contact your doctor immediately for rescheduling.
4. Can MABTHERA® be used during pregnancy?
- Not recommended. Use effective contraception during and 12 months after treatment.
5. What precautions should be taken with MABTHERA®?
- Monitor for infections, cardiac risks, and infusion reactions.
- Hepatitis B screening before starting therapy.
