Certolizumab Pegol: uses, dosing, side effects & brands

How certolizumab pegol is dosed

From the FDA label for Cimzia (application BLA125160). Other certolizumab pegol products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.

CIMZIA is administered by subcutaneous injection . Injection sites should be rotated and injections should not be given into areas where the skin is tender, bruised, red or hard. When a 400 mg dose is needed (given as two subcutaneous injections of 200 mg), injections should occur at separate sites in the thigh or abdomen. The solution should be carefully inspected visually for particulate matter and discoloration prior to administration. The solution should be a clear to opalescent, colorless to yellow liquid, essentially free from particulates and should not be used if cloudy or if foreign particulate matter is present. CIMZIA does not contain preservatives; therefore, unused portions of drug remaining in the syringe or vial should be discarded. CIMZIA is administered by subcutaneous injection ( 2 ). Crohn's Disease ( 2.1 ) 400 mg initially and at Weeks 2 and 4. If response occurs, follow with 400 mg every four weeks Rheumatoid Arthritis ( 2.2 ) 400 mg initially and at Weeks 2 and 4, followed by 200 mg every other week; for maintenance dosing, 400 mg every 4 weeks can be considered Polyarticular Juvenile Idiopathic Arthritis ( 2.3 ) 10 kg (22 lbs) to less than 20 kg (44 lbs): 100 mg initially and at Weeks 2 and 4, followed by 50 mg every other week 20 kg (44 lbs) to less than 40 kg (88 lbs): 200 mg initially and at Weeks 2 and 4, followed by 100 mg every other week Greater…

Certolizumab Pegol side effects

Who shouldn’t take certolizumab pegol

Certolizumab Pegol drug interactions

Certolizumab Pegol recalls

From the FDA Enforcement database. A recall covers specific lots — not the drug as a whole.

• cimzia (certolizumab pegol)

  Lack of Assurance of Sterility

  UCB Biosciences Inc. · May 8, 2026

Certolizumab Pegol and breastfeeding

From LactMed, the US National Library of Medicine’s Drugs and Lactation Database — quoted, not rewritten.

Certolizumab is excreted into breastmilk in some, but not all, women in small amounts. It is also likely to be partially destroyed in the infant's gastrointestinal tract and absorption by the infant is probably minimal. Polyethylene glycol is not excreted into breastmilk. Numerous experts and professional guidelines have stated that the drug is a low risk to the nursing infant and acceptable to use during breastfeeding. Anti-TNF agents appear to reduce the levels of tumor necrosis factor and IP-10 in the milk of mothers with inflammatory bowel disease in the early postpartum period. This reduction in TNF might lead to decreased milk production, so extra lactation support might be necessary in women taking certolizumab pegol.

National Institute of Child Health and Human Development, record revised July 15, 2026. LactMed states its information is not a substitute for professional judgement.

What people report to the FDA about certolizumab pegol

The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 34,215 reports naming certolizumab pegol, and the FDA flagged 97% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:

• rheumatoid arthritis5,127 reports
• fatigue3,635 reports
• maternal exposure during pregnancy3,093 reports
• psoriatic arthropathy3,079 reports
• arthralgia2,849 reports
• pneumonia2,653 reports
• headache2,453 reports
• rash2,448 reports

Source: openFDA drug/event (FAERS), retrieved September 25, 2026.

Related calculators