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Adalimumab Pregnancy and Breastfeeding Warnings

Adalimumab is also known as: Amjevita, Humira

Adalimumab Pregnancy Warnings

Animal studies have revealed no teratogenic, embryotoxic or fetotoxic effects. There are no controlled data in human pregnancy. 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 Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D and X are being phased out.

AU, UK: Use is not recommended. US: Benefit should outweigh risk. AU TGA pregnancy category: C US FDA pregnancy category: Not assigned. Risk Summary: This drug is actively transferred across the placenta and may affect immune response in the in utero exposed infant. In animal studies, no fetal harm or malformations were observed with IV administration during organogenesis and later in gestation, at doses that produced exposures up to approximately 373 times the maximum recommended human dose (MRHD). Comments: -The use of effective contraception is advised during treatment and for at least 5 months after discontinuation. -This drug crosses the placenta in pregnant women. -This drug inhibits TNF alpha; therefore, if it is administered during pregnancy it could affect the immune response in the infant. -Administration of live vaccines to infants exposed to this drug in utero is not recommended for 5 months following the mother's last injection during pregnancy.

See references

Adalimumab Breastfeeding Warnings

AU, UK: Use should be avoided. US: Benefit should outweigh risk. Excreted into human milk: Yes Comments: -Human immunoglobulins are excreted in breast milk. -Some manufacturers recommend that a woman receiving this drug not breast-feed for at least 5 months after the last treatment.

Limited information indicates that maternal use of this drug produces low levels in milk that do not adversely affect the nursing infant. Because it is a large protein molecule, the amount in milk is likely to be very low and absorption is unlikely because it is probably destroyed in the infant GI tract. Most experts recommend that the drug is probably safe during nursing but caution should be exercised while nursing a newborn or preterm infant.

See references

References for pregnancy information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. "Product Information. Humira (adalimumab)." Abbott Pharmaceutical, Abbott Park, IL.

References for breastfeeding information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. "Product Information. Humira (adalimumab)." Abbott Pharmaceutical, Abbott Park, IL.
  4. United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL: http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT." ([cited 2013 -]):

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