Certolizumab

Drug Levels and Effects:




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,GoldSodiumThiomalate,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.



Substance Identification:




Substance Name:

Certolizumab

CAS Registry Number:

1132819-27-2

Drug Class:


  • Antibodies, Monoclonal, Humanized

  • Antirheumatic Agents

  • Gastrointestinal Agents


  • Administrative Information:




    LactMed Record Number:


    752


    Last Revision Date:


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