Certolizumab use while Breastfeeding
Drugs containing Certolizumab: Cimzia
Certolizumab Levels and Effects while Breastfeeding
Summary of Use during Lactation
Preliminary data from one patient indicate that certolizumab is minimally excreted into breastmilk, which would be expected because of its high molecular weight. Because certolizumab is also not orally absorbed it is unlikely to adversely affect the breastfed infant over 1 month of age. European experts consider certolizumab to be probably safe during breastfeeding.[1][2] However, long-term follow-up data on infants breastfed during maternal certolizumab use are not available. Until more data become available, an alternative drug may be preferred, especially while nursing a newborn or preterm infant.
Drug Levels
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.[3][4]
Infant Levels. One woman received certolizumab pegol 400 mg by subcutaneous injection every 4 weeks during pregnancy and postpartum. 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.[3] The relative contribution of transplacental and breastmilk acquisition of the drug was not determined.
Effects in Breastfed Infants
Relevant published information was not found as of the revision date.
Possible Effects on Lactation
Relevant published information was not found as of the revision date.
Alternate Drugs to Consider
(Rheumatoid Arthritis) Auranofin, Etanercept, Gold Sodium Thiomalate, Hydroxychloroquine, Infliximab, Methotrexate, Penicillamine, Sulfasalazine
References
1. van der Woude CJ, Kolacek S, Dotan I et al. European evidenced-based consensus on reproduction in inflammatory bowel disease. J Crohn's Colitis. 2010;4:493-510. PMID: 21122553
2. Mahadevan U, Cucchiara S, Hyams JS et al. The London Position Statement of the World Congress of Gastroenterology on Biological Therapy for IBD With the European Crohn's and Colitis Organisation: Pregnancy and Pediatrics. Am J Gastroenterol. 2010. PMID: 21157441
3. Mahadevan-Velayos U, Siegel C, Abreu MT. Certolizumab use in pregnancy: low levels detected in cord blood. Presented at The Teratology Society 49th Annual Meeting. June 27-July 1, 2009.
4. Wolf D, Mahadevan U. Certolizumab pegol use in pregnancy: low levels detected in cord blood. Arthritis Rheum. 2010;62 (Suppl 10):718. Abstract.
Certolizumab Identification
Substance Name
CAS Registry Number
1132819-27-2
Drug Class
- Antibodies, Monoclonal
- Antirheumatic Agents
- Gastrointestinal Agents
Administrative Information
LactMed Record Number
752
Information from the National Library of Medicine's LactMed Database.
Last Revision Date
2011-05-03
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.
See Also...
- Certolizumab use during Pregnancy
- Certolizumab Consumer Information
- Breastfeeding Support Group
- Safe Medications during Breastfeeding
- Medicine use while Breastfeeding
- Medicine use during Pregnancy
Disclaimer: This information is not intended as a substitute for professional judgment. You should consult your healthcare provider for breastfeeding advice related to your particular situation. Use of this website signifies your agreement to the Terms of Use and Online Privacy Policy.
