MABTHERA® 500mg (Non-English)

MABTHERA® 500mg is a monoclonal antibody formulation containing rituximab, used for the treatment of CD20-positive B-cell non-Hodgkin lymphomas (NHL) and chronic lymphocytic leukemia. Rituximab is a chimeric monoclonal antibody that targets the CD20 antigen, which is present on the surface of B lymphocytes. The product is administered as an intravenous infusion and is indicated in combination with chemotherapy or as maintenance therapy following induction. It works primarily by initiating B-cell lysis through complement-dependent cytotoxicity and antibody-dependent cellular cytotoxicity.

• Concentration: 500 mg rituximab per vial
  
• Form: Sterile concentrate for solution for infusion
  
• Mode of action: Binds to CD20, promoting B-cell depletion
  

MABTHERA® should be administered under the supervision of an experienced healthcare provider in a facility with full resuscitation equipment.

• Route: Intravenous infusion only
  
• Initial dose: 375 mg/m² body surface area
  
• Infusion rate: Start slowly and increase gradually
  
• Premedication: Paracetamol and antihistamines; corticosteroids if required
  
• Frequency: Often once weekly during induction; less frequent during maintenance
  

MABTHERA® is indicated for various forms of non-Hodgkin lymphoma and chronic lymphocytic leukemia.

• Indications:
  
  • CD20-positive follicular lymphoma (first-line and relapsed)
    
  • Diffuse large B-cell lymphoma (in combination with CHOP)
    
  • Maintenance after successful induction
    
• Contraindications:
  
  • Severe active infections
    
  • Hypersensitivity to rituximab or murine proteins
    
  • Severely immunocompromised individuals
    
• Common Side Effects:
  
  • Infusion-related reactions (fever, chills, hypotension)
    
  • Infections (bacterial, viral)
    
  • Neutropenia, nausea, rash
    

MABTHERA® contains the active ingredient rituximab, a genetically engineered chimeric antibody.

• Active ingredient: Rituximab 500 mg per vial
  
• Other excipients may include:
  
  • Sodium citrate
    
  • Polysorbate 80
    
  • Sodium chloride
    
  • Water for injections
    

The packaging includes:

• 1 vial of 500 mg rituximab concentrate (50 mL)
  
• Package leaflet with detailed instructions and safety information
  
• Requires dilution before use in 0.9% NaCl or D5W
  

Yes, MABTHERA® has several potential side effects, with some being serious.

• Very common:
  
  • Infusion reactions (fever, rigors)
    
  • Infections (sinusitis, bronchitis)
    
  • Nausea, fatigue
    
• Serious:
  
  • Tumor lysis syndrome
    
  • Hepatitis B reactivation
    
  • Progressive multifocal leukoencephalopathy (PML)
    
  • Severe mucocutaneous reactions (e.g., Stevens-Johnson syndrome)
    

Proper storage is essential to maintain product integrity.

• Storage temperature: 2°C to 8°C (refrigerated)
  
• Do not freeze
  
• Keep in original packaging to protect from light
  
• Shelf-life: Check product label for expiration