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Abatacept Pregnancy and Breastfeeding Warnings

Abatacept is also known as: Orencia

Abatacept Pregnancy Warnings

Use is not recommended unless clearly needed. AU TGA pregnancy category: C US FDA pregnancy category: C Comments: -Women of child-bearing potential should use effective contraception during treatment with this drug and up to 14 weeks after the last dose.

-Animal studies have failed to reveal evidence of teratogenicity or fetotoxicity. This drug crosses the placenta. There are no controlled data in human pregnancy. -Rats treated with this drug every 3 days during early gestation throughout the lactation period showed no adverse effects in the offspring at doses up to 45 mg/kg (3-fold a human 10 mg/kg dose based on AUC). At a dose of 200 mg/kg (11-fold a human 10 mg/kg dose based on AUC) alterations of immune function consisted of a 9-fold increase in the T-cell dependent antibody response in female pups and inflammation of the thyroid in one female pup out of 10 males and 10 females evaluated. It has not been determined if these findings indicate a risk for development of autoimmune diseases in humans exposed in utero. -This drug may cross the placenta into the serum of infants born to women treated during pregnancy. These infants may be at increased risk for infection. -Administration of live vaccines to infants exposed to this drug in utero is not recommended for 5 months following the mother's last exposure. To monitor maternal-fetal outcomes of pregnant women exposed to this drug, a pregnancy registry has been established. Healthcare professionals are encouraged to register patients and pregnant women are encouraged to enroll themselves by calling 1-877-311-8972. 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 C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

See references

Abatacept 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: Unknown Excreted into animal milk: Yes Comment: -This drug is a large protein molecule with a molecular weight of 92,000. Only small amounts at most would be expected to enter breastmilk. No information is available on the use of this drug during breastfeeding, so an alternate drug may be preferred, especially 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. Orencia (abatacept)." Bristol-Myers Squibb, Princeton, NJ.

References for breastfeeding information

  1. United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL:" ([cited 2013 -]):
  2. "Product Information. Orencia (abatacept)." Bristol-Myers Squibb, Princeton, NJ.
  3. Cerner Multum, Inc. "Australian Product Information." O 0
  4. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

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