Mabthera 500 - Injection Rituximab - 500mg/10ml 1 Injection(s) / Injection Roche Bangladesh Pharmaceutical Introduction: Mabthera 500 is used in the treatment of non-Hodgkin lymphoma (NHL), rheumatoid arthritis, blood cancer (chronic lymphocytic leukemia), granulomatosis with polyangiitis and microscopic polyangiitis. Mabthera 500 is given as an injection under the supervision of doctor. You must take it in a dose as advised by the doctor. Your doctor will decide what dose is necessary and how often you need to take it. This will depend on what you are being treated for and may change from time to time. You should take it exactly as your doctor has advised. Taking it in the wrong way or taking too... Uses of Mabthera 500: Non-Hodgkin lymphoma (NHL)Rheumatoid arthritisBlood cancer (Chronic lymphocytic leukemia)Granulomatosis with polyangiitisMicroscopic polyangiitis Side effects of Mabthera 500: HeadacheWeaknessEdema (swelling)InfectionHair lossItchingChillsFebrile neutropeniaDecreased white blood cell count (neutrophils)Infusion reactionIncreased risk of infectionDecreased blood cells (red cells, white cells, and platelets) How to use Mabthera 500: Your doctor or nurse will give you this medicine. Kindly do not self administer. How Mabthera 500 works: Mabthera 500 is a monoclonal antibody. It works by targeting the unwanted activity of immune cells (B cells) in rheumatoid arthritis and certain types of cancers. What if you forget to take Mabthera 500?: If you miss a dose of Mabthera 500, please consult your doctor. Indication: Non-Hodgkin's lymphoma; follicular lymphoma Administration: Reconstitution: Dilute the appropriate dose w/ sodium chloride 0.9% or glucose 5% to a final concentration of between 1 and 4 mg/mL. IV Administration Consider premedication (ie, paracetamol and diphenhydramine, or glucocorticoids for RA) before each infusion Administer by slow IV infusion only; do not administer as an IV First IV infusion rate: Start 50 mg/hr; increase by 50 mg/hr q30min, not to exceed 400 mg/hr Subsequent IV infusions (90 minutes) Standard IV infusions: Start 100 mg/hr, increase by 100 mg/hr q30min, not to exceed 400 mg/hr; institutional protocols may allow faster increments Adult Dose: Intravenous Non-Hodgkin Lymphoma Recommended dose for NHL 375 mg/m² IV infusion according to the following schedules Relapsed or refractory low-grade or follicular, CD20-positive, B-cell NHL: Once weekly x4-8 doses Retreatment for relapsed or refractory, low-grade or follicular, CD20-positive, B-cell NHL: Once weekly x4 doses Previously untreated, follicular, CD20-positive, B-cell NHL: Administer on Day 1 of each chemotherapy cycle for up to 8 doses; with complete or partial response, initiate maintenance 8 weeks following completion of combination chemotherapy as a single-agent q8weeks for 12 doses Nonprogressing, low-grade, CD20-positive, B-cell NHL, after first-line CVP chemotherapy: Following completion of 6-8 cycles of CVP... Child Dose: Safety and efficacy not established Contraindication: Lactation. Type I hypersensitivity or anaphylactic reactions to murine proteins or component of the formulation. Mode of Action: Rituximab is a chimeric monoclonal antibody to CD20 antigen which regulates cell cycle initiation. It binds to the antigen on the cell surface, activating complement-dependent B-cell cytotoxicity; and to human Fc receptors, mediating cell killing through an antibody-dependent cellular toxicity. Precaution: Extensive tumor burden, pulmonary tumor infiltration or pulmonary insufficiency; history of cardiac disease; effective contraception during and up to 12 mth after treatment; pregnancy. Monitor CBC and platelet counts regularly. Premedication with analgesics, antihistamines and corticosteroids may be recommended. Monitor for signs of active infection or hepatitis in hepatitis B carriers. Discontinue treatment if viral hepatitis develops. Lactation: not known if excreted in breast milk, do not nurse Side Effect: >10% NHL Angioedema (11%), hypotension (10%), Asthenia (26%), chills (33%), dizziness (10%), fever (53%), headache (19%) Pruritus (14%), rash (15%), Abdominal pain (14%), diarrhea (10%), nausea (23%), vomiting (10%) Leukopenia (14%), lymphopenia (48%), neutropenia (14%), thrombocytopenia (12%), Back pain (10%), myalgia (10%) Cough (13%), rhinitis (12%), Infection (31%), night sweats (15%) 1-10% NHL Edema,Flushing,Hypertension,Anxiety,Anemia,Elevated LDH,Hyperglycemia,Bronchospasm, dyspnea, sinusitis, throat irritation, urticaria,RA (Rituximab+Methotrexate vs Methotrexate Alone) Hypertension,Anxiety, asthenia, chills, migraine, paresthesia, pyrexia,Pruritus, urticaria,Dyspepsia, nausea, upper abd pain,Hypercholesterolemia,Arthralgia,Rhinitis, throat irritation, URI Frequency Not Defined Tumor lysis syndrome,Lymphoid malignancies,Hypogammaglobulinemia Potentially Fatal: Pulmonary or cardiac toxicity during infusion; severe mucocutaneous reactions; severe cytokine release syndrome... Interaction: Increased risk of renal toxicity w/ cisplatin. Potentially Fatal: May decrease the efficacy of vaccines and increase the risk of infections in patients immunised w/ live vaccines.