Certolizumab Pegol use while Breastfeeding
Drugs containing Certolizumab Pegol: Cimzia
Medically reviewed by Drugs.com. Last updated on Jul 8, 2021.
Certolizumab Pegol Levels and Effects while Breastfeeding
Summary of Use during Lactation
Certolizumab is excreted into breastmilk in some, but not all, women in small amounts. Absorption is unlikely because it is probably destroyed in the infant's gastrointestinal tract. Most experts and professional guidelines consider certolizumab to be acceptable to use during breastfeeding and some consider it to be a first-line treatment for moderate to severe psoriasis.[1-12]
Maternal Levels. One woman received certolizumab pegol 400 mg by subcutaneous injection every 4 weeks during pregnancy and postpartum. The last dose during pregnancy was 1 week prior to delivery. Breastmilk samples were collected 1 and 2 weeks postpartum and 4 hours, 3 days and 6 days after the first postpartum dose which was given at 3 weeks postpartum. Certolizumab was undetectable (<410 mcg/L) in all 5 samples.
Two women were receiving certolizumab pegol 200 mg every two weeks. Certolizumab was undetectable (<0.6 mg/L) in breastmilk one hour after the dose in both women and 4 hours after the dose in one of them.
Seventeen nursing mothers who were taking certolizumab pegol for an inflammatory condition and were at least 6 weeks postpartum had certolizumab measured in their breastmilk at least 8 times over a dosage interval. The maternal dose was 200 mg every 2 weeks in 16 women and 400 mg every 4 weeks in another. Out of 137 breastmilk samples, 77 had no detectable certolizumab and 4 mothers had no detectable (<0.032 mg/L) certolizumab in milk at any time point, including the mother who received the 400 mg dose. Of the 13 other mothers, the highest concentrations found were 0.076 mg/L, which was found in one woman at 6 and 8 days after the dose, and 0.065 and 0.066 mg/L in another at 4 and 6 days after the dose, respectively. All other mothers with detectable certolizumab had milk levels that were less than 0.064 mg/L. The median time of peak milk levels was 5.05 days (range 2.9 to 11.9 days). The estimated average daily infant dose ranged from 0 to 0.0104 mg/kg daily. No measurable levels of total polyethylene glycol were detected in 134 of 137 breast milk samples; 3 samples had indeterminate results upon retesting.
In a multi-center study of women with inflammatory bowel disease in pregnancy (the PIANO registry), 13 women receiving certolizumab pegol provided milk samples at 1, 12, 24, and 48 hours after drug administration. Some also provided samples at 72, 96, 120, and 168 hours after drug administration. Three of the women had detectable (>0.01 mg/L) certolizumab levels in milk. Peak concentrations in breastmilk ranged from 0.27 to 0.29 mg/L and occurred at 12 to 48 hours after the dose.
A woman in Japan with rheumatoid arthritis was treat with certolizumab pegol (dosage not stated) beginning at 28 weeks of pregnancy and continuing postpartum. Breastmilk samples taken before delivery, at delivery, and 4 and 8 weeks postpartum all contained unmeasurable (<0.1 mg/L) amounts of certolizumab.
Infant Levels. One woman received certolizumab pegol 400 mg by subcutaneous injection every 4 weeks during pregnancy and postpartum. The last dose during pregnancy was 1 week prior to delivery. At birth, her infant had a serum concentration 1.02 mg/L. At one month of age, her breastfed (extent not stated) infant had a serum concentration of 0.84 mg/L seven days after the previous injection.[13,16]
Effects in Breastfed Infants
Eight women who received certolizumab pegol during pregnancy and postpartum breastfed (extent not stated) their infants. No mention was made of side effects in the infants.
Seventeen mothers received certolizumab pegol for an inflammatory condition and breastfed their infants. During a study period starting at least 6 weeks postpartum and after at least 3 doses of certolizumab pegol, 8 of the infants experienced 11 adverse effects. None of the infants had any unusual or serious adverse reactions attributed to the drug and all effects were consistent with events typically experienced by infants of the same age, such as upper respiratory infection, Candida infection, or vomiting.
In a multi-center study of women with inflammatory bowel disease in pregnancy (the PIANO registry), 54 women received certolizumab pegol while breastfeeding their infants. Among those who received certolizumab or another biologic agent while breastfeeding, infant growth, development or infection rate was no different from infants whose mothers received no treatment. An additional 67 women received a biologic agent plus a thiopurine. Infant outcomes were similar in this group.
Six women being treated with certolizumab pegol for uveitis during pregnancy and postpartum breastfed their infants (extent not sated). One of the mothers also took hydroxychloroquine. In 6 months of follow-up, no infants had any infections and all had inactivated vaccines specified in the Spanish national immunization program (hepatitis B, diphtheria, tetanus and acellular pertussis [DTaP], inactivated poliovirus, Haemophilus influenzae type B conjugate, pneumococcal conjugate and meningococcal C conjugate). One of the infants also received rotavirus vaccine. No complications were seen with any of the vaccines.
Effects on Lactation and Breastmilk
Relevant published information was not found as of the revision date.
Alternate Drugs to Consider
Nguyen GC, Seow CH, Maxwell C, et al. The Toronto Consensus Statements for the Management of IBD in Pregnancy. Gastroenterology. 2016;150:734–57.e1. [PubMed: 26688268]
van der Woude CJ, Ardizzone S, Bengtson MB, et al. The second European evidenced-based consensus on reproduction and pregnancy in inflammatory bowel disease. J Crohns Colitis. 2015;9:107–24. [PubMed: 25602023]
Flint J, Panchal S, Hurrell A, et al. BSR and BHPR guideline on prescribing drugs in pregnancy and breastfeeding-Part I: Standard and biologic disease modifying anti-rheumatic drugs and corticosteroids. Rheumatology (Oxford). 2016;55:1693–7. [PubMed: 26750124]
Götestam Skorpen C, Hoeltzenbein M, Tincani A, et al. The EULAR points to consider for use of antirheumatic drugs before pregnancy, and during pregnancy and lactation. Ann Rheum Dis. 2016;75:795–810. [PubMed: 26888948]
Amin M, No DJ, Egeberg A, et al. Choosing first-line biologic treatment for moderate-to-severe psoriasis: What does the evidence say? Am J Clin Dermatol. 2018;19:1–13. [PubMed: 29080066]
Matro R, Martin CF, Wolf D, et al. Exposure concentrations of infants breastfed by women receiving biologic therapies for inflammatory bowel diseases and effects of breastfeeding on infections and development. Gastroenterology. 2018;155:696–704. [PubMed: 29857090]
Mahadevan U, Robinson C, Bernasko N, et al. Inflammatory bowel disease in pregnancy clinical care pathway: A report from the American Gastroenterological Association IBD Parenthood Project Working Group. Gastroenterology. 2019;156:1508–24. [PubMed: 30658060]
Picardo S, Seow CH. A pharmacological approach to managing inflammatory bowel disease during conception, pregnancy and breastfeeding: Biologic and oral small molecule therapy. Drugs. 2019;79:1053–63. [PubMed: 31183768]
Sammaritano LR, Bermas BL, Chakravarty EE, et al. 2020 American College of Rheumatology Guideline for the Management of Reproductive Health in Rheumatic and Musculoskeletal Diseases. Arthritis Rheumatol. 2020;72:529–56. [PubMed: 32090480]
Smith CH, Yiu ZZN, Bale T, et al. British Association of Dermatologists guidelines for biologic therapy for psoriasis 2020: A rapid update. Br J Dermatol. 2020;183:628–37. [PubMed: 32189327]
Thatiparthi A, Martin A, Liu J, et al. Biologic treatment algorithms for moderate-to-severe psoriasis with comorbid conditions and special populations: A review. Am J Clin Dermatol. 2021;22:425–42. [PMC free article: PMC8051287] [PubMed: 33861409]
Yeung J, Gooderham MJ, Grewal P, et al. Management of plaque psoriasis with biologic therapies in women of child-bearing potential consensus paper. J Cutan Med Surg. 2020;24(1) Suppl:3s–14s. [PubMed: 32500730]
Mahadevan U, Wolf DC, Dubinsky M, et al. Placental transfer of anti-tumor necrosis factor agents in pregnant patients with inflammatory bowel disease. Clin Gastroenterol Hepatol. 2013;11:286–92. [PMC free article: PMC3913646] [PubMed: 23200982]
Förger F, Zbinden A, Villiger PM. Certolizumab treatment during late pregnancy in patients with rheumatic diseases: Low drug levels in cord blood but possible risk for maternal infections. A case series of 13 patients. Joint Bone Spine. 2016;83:341–3. [PubMed: 26617214]
Clowse ME, Förger F, Hwang C, et al. Minimal to no transfer of certolizumab pegol into breast milk: Results from CRADLE, a prospective, postmarketing, multicentre, pharmacokinetic study. Ann Rheum Dis. 2017;76:1890–6. [PMC free article: PMC5705850] [PubMed: 28814432]
Mahadevan-Velayos U, Siegel C, Abreu MT. Certolizumab use in pregnancy: Low levels detected in cord blood. Presented at the 22nd Annual Organization of Teratogen Information Services Education Conference June 27 - July 1, 2009.
Prieto-Peña D, Calderón-Goercke M, Adán A, et al. Efficacy and safety of certolizumab pegol in pregnant women with uveitis. Recommendations on the management with immunosuppressive and biologic therapies in uveitis during pregnancy. Clin Exp Rheumatol. 2021;39:105–14. [PubMed: 33124565]
CAS Registry Number
Immunoglobulin Fab Fragments
Disclaimer: Information presented in this database is not meant as a substitute for professional judgment. You should consult your healthcare provider for breastfeeding advice related to your particular situation. The U.S. government does not warrant or assume any liability or responsibility for the accuracy or completeness of the information on this Site.
More about certolizumab
- Side Effects
- During Pregnancy
- Dosage Information
- Drug Interactions
- En Español
- 60 Reviews
- Drug class: TNF alfa inhibitors
- Patient Information
- Certolizumab Subcutaneous (Advanced Reading)
- Certolizumab Prefilled Syringes
- Certolizumab Vials
- Other brands
Related treatment guides
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.