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    brand:

    MABTHERA®

    manufacturer:

    Roche

    active substances:

    RITUXIMAB

    strength:

    500mg

    pack size:

    1 x 50ml (10 mg/ml) Vial

    INFORMATION

    MABTHERA® Indications for Use

    MABTHERA® (rituximab) is indicated for the treatment of Non-Hodgkin’s Lymphoma (NHL), Chronic Lymphocytic Leukemia (CLL), and certain types of autoimmune diseases like Rheumatoid Arthritis (RA). Rituximab is a monoclonal antibody targeting the CD20 antigen found on B lymphocytes, making it effective for depleting B cells and treating these conditions.

    Key Indications:

    • Follicular NHL (stage III-IV) in combination with chemotherapy for patients previously untreated.
    • Maintenance therapy for patients who respond to induction treatment for follicular lymphoma.
    • Treatment of Diffuse Large B-cell Lymphoma (DLBCL) in combination with CHOP chemotherapy.

    MABTHERA® Dosage Information

    MABTHERA is available in intravenous (IV) and subcutaneous (SC) formulations. The subcutaneous version contains 1400 mg/11.7 ml of rituximab.

    • Subcutaneous Dose: 1400 mg as a fixed dose for NHL.
    • Intravenous Dose: Initial dose of 375 mg/m² for follicular NHL.

    For Diffuse Large B-cell Lymphoma (DLBCL), the initial dose is 375 mg/m² intravenously followed by a fixed 1400 mg subcutaneous dose for subsequent cycles.

    MABTHERA® Side Effects and Precautions

    Patients receiving MABTHERA can experience various side effects, ranging from mild to severe. Common reactions involve infusion-related reactions that may include symptoms such as fever, chills, or rigors.

    Common Side Effects:

    • Redness, swelling, and pain at the injection site
    • Fever and rigors
    • Hypotension and hypertension
    • Infections such as bacterial or viral

    Severe Side Effects (less common but more critical):

    • Cytokine Release Syndrome (CRS): A severe immune response to the drug, often seen within hours of administration.
    • Tumor Lysis Syndrome (TLS): A condition caused by the rapid breakdown of tumor cells, which can result in kidney damage or failure.
    • Progressive Multifocal Leukoencephalopathy (PML): A rare but severe brain infection linked to the John Cunningham (JC) virus.

    Precautions:

    • MABTHERA should be administered only by professionals experienced in cancer treatments, with full resuscitation equipment available.
    • Patients receiving subcutaneous injections must first receive the IV formulation to check for tolerability.

    MABTHERA® Clinical Studies or Real-World Outcomes

    Rituximab has been widely studied and used in various clinical trials. The results demonstrate high efficacy in treating CD20-positive B-cell NHL and CLL, with significant patient response rates. MABTHERA is also effective in Rheumatoid Arthritis when combined with methotrexate.

    Efficacy in Clinical Studies:

    • Patients receiving MABTHERA for follicular lymphoma in combination with chemotherapy showed response rates of up to 84.4%.
    • Complete Remission Rates (CRR) were reported to be around 32.2% in patients treated with the subcutaneous formulation.

    Long-Term Results:

    • 12 to 24 months of maintenance therapy in patients with follicular lymphoma significantly improved progression-free survival (PFS).

    MABTHERA® Drug Interactions

    MABTHERA may interact with other medications, particularly those affecting the immune system or the metabolism of rituximab.

    Important Drug Interactions:

    • Immunosuppressive Agents: Increased risk of infections when combined with other immunosuppressants, such as methotrexate.
    • Chemotherapeutic Agents: MABTHERA can be combined with chemotherapy drugs like CHOP, but patients must be monitored closely for hematologic toxicity (e.g., neutropenia, thrombocytopenia).

    Contraindications:

    • Hypersensitivity to murine proteins or any of the components of MABTHERA.
    • Active severe infections like sepsis or tuberculosis.

    MABTHERA® Aftercare Instructions

    Post-treatment care is essential for monitoring patients and mitigating potential side effects.

    Post-Treatment Care:

    • Patients should be monitored for at least 24 hours post-infusion for signs of infusion-related reactions.
    • Hydration and frequent monitoring of renal function are critical, especially in patients at risk of tumor lysis syndrome.

    What to Expect:

    • Redness, swelling, or mild pain at the injection site can last for a few days after the subcutaneous injection.
    • Fever, chills, or nausea can occur immediately after the infusion but typically resolve within 24–48 hours.

    Follow-Up Treatments

    Maintenance therapy may be recommended, particularly for patients with follicular lymphoma. MABTHERA is typically administered every two to three months for up to two years.

    Long-Term Care:

    • Regular monitoring of blood cell counts and immunoglobulin levels is necessary to detect potential immune suppression.
    • For patients with hepatitis B, periodic screening for hepatitis reactivation is recommended during and after treatment.

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