CIMZIA® (Non-English)

CIMZIA® is a tumor necrosis factor-alpha (TNF-α) inhibitor used primarily to treat moderate to severe rheumatoid arthritis in adult patients. It contains certolizumab pegol, a PEGylated, recombinant, humanized Fab’ fragment expressed in Escherichia coli that selectively binds to TNF-α. CIMZIA® is especially suitable for patients who do not respond adequately to conventional disease-modifying antirheumatic drugs (DMARDs), including methotrexate (MTX). It can also be used as monotherapy in MTX-intolerant patients. It has shown efficacy in reducing joint damage and improving physical function when used in combination with MTX.

CIMZIA® is administered subcutaneously and must be started by experienced healthcare providers. The treatment begins with an initial loading dose, followed by maintenance therapy.

• Initial dose: 400 mg at weeks 0, 2, and 4 (2 × 200 mg injections)
  
• Maintenance dose: 200 mg every 2 weeks
  
• Route: Subcutaneous (thigh or abdomen)
  
• Formulation: 1 mL ready-to-use prefilled syringe 

CIMZIA® is indicated for adults with active moderate-to-severe rheumatoid arthritis, particularly in cases with inadequate response to DMARDs. It can be used in combination with MTX or as monotherapy when MTX is not suitable.

Contraindications:

• Hypersensitivity to certolizumab pegol or excipients
  
• Active tuberculosis, sepsis, or other serious infections
  
• Moderate to severe heart failure (NYHA class III/IV)
  

Common Side Effects:

• Infections (e.g., respiratory, urinary tract)
  
• Injection site reactions
  
• Headache
  
• Nausea
  

Serious Side Effects:

• Sepsis, tuberculosis, malignancies
  
• Lupus-like syndrome
  
• Demyelinating disorders
  
• Hematologic abnormalities (e.g., pancytopenia) 

Each prefilled syringe contains:

• Certolizumab pegol 200 mg (active ingredient)
  
• Excipients: Sodium acetate (1.36 mg), Sodium chloride (7.31 mg), Water for injection 

Each box includes:

• 2 prefilled syringes (1 mL each containing 200 mg certolizumab pegol)
  
• 2 alcohol pads
  
• The syringe is latex-free 

CIMZIA® may cause a range of adverse effects, from mild to serious.

Common adverse effects:

• Infections (bacterial, viral, fungal)
  
• Headache, rash, injection site erythema
  
• Elevated liver enzymes, hypertension
  

Uncommon but serious effects:

• Reactivation of hepatitis B
  
• Tuberculosis, opportunistic infections
  
• Heart failure exacerbation
  
• Autoimmune phenomena (e.g., lupus, vasculitis)
  
• Malignancies, including lymphoma and skin cancer 

Proper storage is essential for maintaining product integrity.

• Temperature: Store at 2–8°C (refrigerated)
  
• Do not freeze
  
• Protect from light
  
• Keep in the original packaging
  
• Single-use only; discard after use