Certolizumab Pegol

DEA Class; Rx

Common Brand Names; Cimzia

• DMARDs, TNF Inhibitors; 
• Immunosuppressants

TNF-alpha blocker (TNF-blocker) conjugated to polyethylene glycol; for subcutaneous use
Used in adults for rheumatoid arthritis, psoriatic arthritis, Crohn’s disease, plaque psoriasis, ankylosing spondylitis, and non-radiographical axial spondyloarthritis
Boxed warning regarding increased risk for serious infection and possible malignancy

Indicated for maintaining clinical response in patients with moderate to severe active disease who had an inadequate response to conventional therapy

Indicated for moderate to severe active rheumatoid arthritis (RA)

Indicated for active psoriatic arthritis (PsA)

Indicated for active ankylosing spondylitis (AS)

Indicated for active nonradiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation

Indicated for moderate-to-severe plaque psoriasis (PsO) in patients who are candidates for systemic therapy or phototherapy

History of hypersensitivity reaction to certolizumab pegol or to any of the excipients; reactions have included angioedema, anaphylactoid reaction, serum sickness, and urticaria

• URI (20%)
• Headache (7-18%)
• Nasopharyngitis (4-13%)
• Nausea (11%)
• UTI (7%)
• Arthralgia (6%)
• Serious infections (3%)

Hypersensitivity including anaphylaxis and serious reactions (see Contraindications)

May interfere with aPPT tests

The needle shield inside the removable cap of prefilled syringe contains a derivative of natural rubber latex which may cause an allergic reaction in individuals sensitive to latex

Therapy has been associated with rare cases of new onset or exacerbation of clinical symptoms and/or radiographic evidence of central nervous system demyelinating disease, including multiple sclerosis, and with peripheral demyelinating disease, including Guillain-Barré syndrome; exercise caution in considering use in patients with preexisting or recent-onset central or peripheral nervous system demyelinating disorders; rare cases of neurological disorders, including seizure disorder, optic neuritis, and peripheral neuropathy have been reported in patients treated with drug

Treatment may result in formation of autoantibodies and rarely, in development of a lupus-like syndrome; if a patient develops symptoms suggestive of a lupus-like syndrome following treatment, discontinue treatment

Cases of worsening congestive heart failure (CHF) and new onset CHF reported; therapy has not been formally studied in patients with CHF; however, in clinical studies in patients with CHF with another TNF blocker, worsening congestive heart failure (CHF) and increased mortality due to CHF were observed; exercise caution in patients with heart failure and monitor them carefully

Pregnancy exposure registry monitors pregnancy outcomes in women exposed to the drug during pregnancy

In a clinical study, minimal transfer of certolizumab pegol from plasma to breast milk was observed

400 mg/dose subcutaneously.

400 mg/dose subcutaneously.

Safety and efficacy have not been established.

Safety and efficacy have not been established.

Certolizumab pegol

injection, lyophilized powder for reconstitution

• 200mg/vial

injectable solution, single-dose prefilled syringe

• 200mg/mL