Ankylosing spondylitis, Crohn disease, Plaque psoriasis, Psoriatic arthritis, Rheumatoid arthritis, Axial spondyloarthritis, nonradiographic

Antirheumatic, Disease Modifying; Gastrointestinal Agent, Miscellaneous; Tumor Necrosis Factor (TNF) Blocking Agent

Onset of action:
Psoriasis: Response best determined after 3 to 4 months.Distribution: Vss: 4.7 to 8 L.
Bioavailability:
SubQ: ~80% (range: 76% to 88%).Half-life elimination:
~14 daysTime to peak, plasma:
54 to 171 hours

Hypersensitivity to certolizumab pegol or any component of the formulation.

Use of immune modulating therapies in pregnancy should be individualized to optimize maternal disease and pregnancy outcomes.

The decision to continue or discontinue breastfeeding during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and benefits of treatment to the mother. However, tumor necrosis factor alpha (TNFα) blocking agents are considered compatible with breastfeeding.

>10%:
Gastrointestinal: Nausea (≤11%)
Immunologic: Antibody development (7% to 23%; neutralizing: 3% to 8%)
Infection: Infection (38%)
Respiratory: Upper respiratory tract infection (18% to 22%)
1% to 10%:Central nervous system: Headache (4%)Dermatologic: Skin rash (9%)Genitourinary: Urinary tract infection (7% to 8%)Hematologic & oncologic: Positive ANA titer (4%)Hepatic: Increased serum transaminases (≤4%)Infection: Herpes virus infections (2%)Local: Injection site reaction (2% to 3%)Neuromuscular & skeletal: Arthralgia (6%)Respiratory: Cough (3%)

Ankylosing spondylitis: SUBQ:
Initial: 400 mg, repeat dose 2 and 4 weeks after initial dose; Maintenance: 200 mg every 2 weeks or 400 mg every 4 weeks.
Crohn disease (alternative agent): SUBQ:
Initial: 400 mg, repeat dose 2 and 4 weeks after initial dose; Maintenance: 400 mg every 4 weeks Plaque psoriasis: SUBQ:
400 mg every other week. Note: For patients ?90 kg, an initial dose of 400 mg at weeks 0, 2, and 4 followed by 200 mg every other week thereafter may be considered.Psoriatic arthritis: SUBQ:
Initial: 400 mg, repeat dose 2 and 4 weeks after initial dose; Maintenance: 200 mg every other week. May consider maintenance dose of 400 mg every 4 weeks.Rheumatoid arthritis:SUBQ
Initial: 400 mg, repeat dose 2 and 4 weeks after initial dose; Maintenance: 200 mg every other week. May consider maintenance dose of 400 mg every 4 weeks.Axial spondyloarthritis, nonradiographic: SUBQ:
Initial: 400 mg, repeat dose 2 and 4 weeks after initial dose; Maintenance: 200 mg every 2 weeks or 400 mg every 4 weeks.

There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied); pharmacokinetics of the pegylated (polyethylene glycol) component of certolizumab is expected to be dependent on renal function.

There are no dosage adjustments provided in the manufacturer’s labeling.