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FAQ
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