III. Contraindications

IV. Dosing

  1. See Monoclonal Antibody for preparation for use
  2. Dosing
    1. Start: 400 mg SQ every other week at weeks 0, 2 and 4
    2. Next: 400 mg SQ every 4 weeks
  3. Background
    1. Injection sites include thigh and Abdomen (rotate injection sites)
      1. Divide 400 mg dose into 2 separate injection sites
    2. Available as a Preloaded syringe
    3. Refrigerate and protect from light
    4. Allow to warm to room Temperature for 15 to 30 minutes before injection (decreased pain)

VI. Precautions

  1. See TNF Inhibitor
  2. TNF Inhibitors predispose to serious infections and malignancy
  3. Prepare for TNF Inhibitor use with infection screening (e.g. Tuberculosis) and Immunizations
    1. See Monoclonal Antibody

VII. Adverse Effects

  1. See Tumor Necrosis Factor Inhibitor
  2. Mild to moderate Injection site reactions (<10% of patients)

VIII. Safety

  1. Considered safe in Lactation
  2. Pregnancy
    1. May use in pregnancy (any trimester) if indicated and benefit outweighs risk
    2. Fetal exposure risk does NOT appear to increase after 20 weeks (unlike other TNF Inhibitors)

X. References

  1. Hamilton (2020) Tarascon Pocket Pharmacopoeia
  2. (2023) Biologics for Crohn's Disease, Presc Lett, #390826
  3. (2023) Drugs for Inflammatory Bowel Disease, Med Lett Drug Ther 65: 105-12

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Related Studies

Cost: Medications

cimzia (on 3/23/2022 at Medicaid.Gov Survey of pharmacy drug pricing)
CIMZIA 2X200 MG/ML SYRINGE KIT $4,944.14 each

Ontology: certolizumab pegol (C1872109)

Definition (NCI) A Fab fragment of a recombinant, humanized monoclonal antibody directed against the proinflammatory cytokine tumor necrosis factor-alpha (TNF-alpha) and conjugated to polyethylene glycol (PEG), with anti-inflammatory activity. Upon administration, certolizumab binds to TNF-alpha and prevents the interaction of this cytokine with endogenous cell surface receptors, thereby rendering TNF-alpha inactive and inhibiting TNF-mediated inflammatory responses. TNF-alpha is a protein involved in inflammation, cell survival, and apoptosis. Pegylation of certolizumab allows for an improved pharmacokinetic profile.
Definition (NCI) A Fab fragment of a recombinant, humanized monoclonal antibody directed against the proinflammatory cytokine tumor necrosis factor-alpha (TNF-alpha), with anti-inflammatory activity. Upon administration, certolizumab binds to TNF-alpha, preventing the interaction of this cytokine with endogenous cell surface receptors, thereby rendering TNF-alpha inactive and inhibiting TNF-mediated inflammatory responses. TNF-alpha is a protein involved in inflammation, cell survival, and apoptosis.
Concepts Pharmacologic Substance (T121) , Amino Acid, Peptide, or Protein (T116) , Immunologic Factor (T129)
MSH C468008
SnomedCT 430306004, 430307008
English Certolizumab pegol, Certolizumab pegol (product), Certolizumab pegol (substance), certolizumab, CERTOLIZUMAB, certolizumab pegol (medication), CERTOLIZUMAB PEGOL, Certolizumab Pegol, CZP, Certolizumab, certolizumab pegol
Spanish certolizumab pegol (producto), certolizumab pegol (sustancia), certolizumab pegol

Ontology: Cimzia (C2343521)

Concepts Immunologic Factor (T129) , Pharmacologic Substance (T121)
MSH C468008
English Cimzia, UCB Pharma brand of certolizumab pegol