Certolizumab Pegol Application Scope

Indicated for moderate-to-severe active rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, and Crohn’s disease in adults with inadequate response to conventional therapy.

Certolizumab Pegol Characteristics

Ingredients: Certolizumab Pegol (PEGylated Fc-free anti-TNF-α monoclonal antibody fragment)
Properties: Tumor Necrosis Factor (TNF) inhibitor; recombinant DNA-derived biologic; Fc-free to reduce placental transfer
Packaging Specification: 200 mg pre-filled syringe or auto-injector, supplied in packs of 2
Storage: Store refrigerated at 2°C to 8°C; do not freeze; protect from light
Expiry Date: 24 months from date of manufacture
Executive Standard: In accordance with pharmacopeia standards and biologics regulatory requirements
Approval Number: BLA 125160
Date of Revision: February 2019
Manufacturer: UCB Pharma S.A.

Guidelines for the Use of CIMZIA

Dosage and Administration:
- Administration: Administer via subcutaneous injection in thigh or abdomen; rotate injection sites
- Missed Dose: Administer as soon as possible and resume regular schedule
Adverse Reactions:
- Common Adverse Reactions (≥5% and >3% higher than placebo):
  - - Upper respiratory tract infections
    - Rash
    - Urinary tract infections
    - Arthralgia
    - Hypertension
- Serious Adverse Reactions:
  - - Serious infections (tuberculosis, invasive fungal infections, bacterial sepsis)
    - Malignancies (including lymphoma)
    - Demyelinating disorders
    - Heart failure exacerbation
Contraindications:
- Patients with known hypersensitivity to certolizumab pegol or any excipient
- Patients with active tuberculosis or other severe infections
Precautions:
- Infections: Evaluate for TB before initiation; monitor for signs of infection during treatment
- Malignancies: Risk may be increased; monitor patients with risk factors
- Neurological Disorders: Use caution in patients with pre-existing or new-onset demyelinating disorders
- Pregnancy and Lactation: Due to Fc-free structure, minimal placental transfer; can be considered in pregnancy when benefits outweigh risks; unknown if excreted in human milk

Certolizumab Pegol Interactions

Other biologics (e.g., anakinra, abatacept): Increased risk of serious infections—avoid combination
Live vaccines: Avoid during treatment; patients may receive non-live vaccines
Immunosuppressants (e.g., methotrexate): Can be used in combination, but monitor for infection risk

Note:

If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
This content is for reference only. Prescription drugs must be used under a doctor’s guidance and purchased from authorized sources.