Mabthera 1400

• Non-Hodgkin lymphoma (NHL) - relapsed or refractory, low-grade or follicular, CD20-positive, B-cell NHL
• Chronic lymphocytic leukemia (CLL) - previously untreated and treated CD20-positive CLL
• Rheumatoid arthritis (RA) - in combination with methotrexate
• Granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA) - with glucocorticoids
• Pemphigus vulgaris (PV) - moderate to severe

Adult Dose (IV):

• NHL (relapsed/refractory): 375 mg/m² once weekly for 4-8 doses
• NHL (previously untreated follicular): 375 mg/m² on Day 1 of each chemo cycle (up to 8 doses); maintenance every 8 weeks for 12 doses
• DLBCL: 375 mg/m² on Day 1 of each chemo cycle (up to 8 infusions)
• CLL: 375 mg/m² (Cycle 1, day before FC); 500 mg/m² (Cycles 2-6, Day 1); q28 days x6 cycles
• RA: 1000 mg (2 infusions separated by 2 weeks); repeat q24 weeks; with methotrexate
• GPA/MPA: 375 mg/m² once weekly for 4 weeks; with glucocorticoids
• PV: 1000 mg (2 infusions separated by 2 weeks); with glucocorticoids
• Pediatric (NHL/B-AL, ≥6 months): 6 infusions with LMB chemotherapy

Side Effects:

• Infusion-related reactions (fever, chills, rash, dyspnea, hypotension)
• Hepatitis B virus reactivation
• Infections (bacterial, fungal, viral)
• Neutropenia, thrombocytopenia, anemia
• Progressive Multifocal Leukoencephalopathy (PML)
• Tumor Lysis Syndrome (TLS)
• Severe mucocutaneous reactions (SJS, TEN)
• Headache, weakness, edema, hair loss

• Infusion reactions can be fatal; pre-medication and monitoring required
• Hepatitis B testing before treatment; do not use in active HBV
• Discontinue if PML symptoms (new-onset neurologic manifestations) occur
• Discontinue for serious infections
• Embryo-fetal toxicity: Use effective contraception