CIMZIA®: The only Fc-free biologic20-22

3 prospective clinical trials suggest negligible to low placental transfer and minimal breast milk transfer, included in the full Prescribing Information1

Transfer molecule
 
 
 

These pharmacokinetic studies were designed solely to assess transfer of drug from mother to infant; conclusions regarding safety and efficacy, including safety of anti-TNFs in pregnant women, risks of major birth defects or other adverse pregnancy outcomes, should not be made based on these data

Pharmacokinetic studies assessing placental transfer

Study 1: Mahadevan U, et al.34

Assessed the placental transfer of multiple anti-TNFs

Study 2: CRIB35

Measured the level of placental transfer of CIMZIA from mothers to infants

Pharmacokinetic study assessing breast milk transfer

Study 3: CRADLE36

Determined the concentrations of CIMZIA in mature breast milk throughout the dosing interval and calculated the average daily infant dose of maternal CIMZIA

Studies did not include patients with plaque psoriasis or patients receiving the recommended dose of 400 mg Q2W34-36

The long-term effect of in utero and neonate exposure to biologic therapies is unknown

The safety of administering live or live-attenuated vaccines to infants exposed in utero is unknown

Limited data from an ongoing pregnancy registry (n=54) on use of CIMZIA in pregnant women are not sufficient to inform a risk of major birth defects or other adverse pregnancy outcomes

The ongoing CIMZIA pregnancy exposure registry monitors pregnancy outcomes in women exposed to CIMZIA during pregnancy. Contact MotherToBaby Pregnancy Studies by Organization of Teratology Information Specialists (OTIS) at 1-877-311-8972 or visit http://mothertobaby.org/pregnancy-studies/

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