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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: Not assigned. Risk Summary: The data concerning the use of this drug in pregnant women are insufficient to inform on drug-associated risk. In reproductive toxicology studies in animals, no fetal malformations were observed with IV administration during organogenesis at doses that produced exposures approximately 29 times the exposure at the maximum recommended human dose (MRHD) of 10 mg/kg/month on an AUC basis; however, in a pre- and postnatal development study in animals, this drug altered immune function in females at 11 times the MRHD on an AUC basis. Comments: -Women of child-bearing potential should use effective contraception during treatment with this drug and up to 14 weeks after the last dose. -Administration of live vaccines to infants exposed to this drug in utero is not recommended for 5 months following the mother's last dose.

-Animal studies have failed to reveal evidence of teratogenicity or fetotoxicity. 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 crosses the placenta into the serum of infants born to women treated during pregnancy; these infants may be at increased risk for infection. 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.

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. 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: http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT." ([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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