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Certolizumab Pregnancy and Breastfeeding Warnings

Certolizumab is also known as: Cimzia

Certolizumab Pregnancy Warnings

Animal studies have failed to reveal evidence of fetal harm. There are no controlled data in human pregnancy. The use of TNF-alpha inhibitors, including this drug, may affect normal immune response in the newborn. A pediatrician should be consulted regarding the risks and benefits of administering live vaccines in the exposed newborn during the first 12 weeks of life. To monitor the outcomes of pregnant women exposed to this drug, a pregnancy registry has been established. Physicians are encouraged to register patients and pregnant women are encouraged to register themselves by calling 1-800-311-8972. AU TGA pregnancy category C: Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible. Accompanying texts should be consulted for further details. US FDA pregnancy category B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.

Use of this drug during pregnancy is not recommended by the manufacturer. It should be used during pregnancy only if the benefit outweighs the risk to the fetus. AU TGA pregnancy category: C US FDA pregnancy category: B

Certolizumab Breastfeeding Warnings

A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother. Excreted into human milk: Yes (minimally)

Absorption of this drug is unlikely because it is probably destroyed in the infant's gastrointestinal tract. Although the manufacturer recommends that breastfeeding be discontinued during therapy, most experts consider this drug to be probably safe during breastfeeding.

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