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Tofacitinib Pregnancy and Breastfeeding Warnings

Tofacitinib is also known as: Xeljanz, Xeljanz XR

Medically reviewed on September 13, 2018

Tofacitinib Pregnancy Warnings

At high doses, this drug has been shown to be fetocidal and teratogenic in animal studies. There are no controlled data in human pregnancy.

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 1-877-311-8972 or https://mothertobaby.org/ongoing-study/xeljanz/.

AU TGA pregnancy category D: Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. 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.

Use is not recommended; some experts consider use to be contraindicated.

AU TGA pregnancy category: D
US FDA pregnancy category: Not assigned.

Risk Summary: This drug was fetocidal and teratogenic in animal studies at exposures higher than the maximum recommended human dose (MRHD). Animal studies have also shown reductions in live litter size, postnatal survival, and pup body weights at exposures higher than the MRHD.

Comments:
-This drug can harm a developing fetus.
-A pregnancy exposure registry is available.
-Women of childbearing potential should be advised to use effective contraception during therapy and for at least 4 weeks after the last dose.
-Based on animal studies, this drug may result in reduced fertility in females of reproductive potential.

See references

Tofacitinib Breastfeeding Warnings

Use is not recommended; some experts consider use to be contraindicated.

Excreted into human milk: Unknown
Excreted into animal milk: Yes

Comments: The effects in the nursing infant are unknown

No information is available on the use of this drug during breastfeeding. Until more data become available, this drug should be used with caution during breastfeeding, especially while nursing a newborn or preterm infant. An alternate drug may be preferred. The manufacturer recommends that breastfeeding be discontinued during therapy.

See references

References for pregnancy information

  1. "Product Information. Xeljanz (tofacitinib)." Pfizer U.S. Pharmaceuticals Group, New York, NY.
  2. Pharmaceutical Society of Australia "APPGuide online. Australian prescription products guide online. Available from: URL: http://www.appco.com.au/appguide/default.asp." ([2006]):

References for breastfeeding information

  1. Pharmaceutical Society of Australia "APPGuide online. Australian prescription products guide online. Available from: URL: http://www.appco.com.au/appguide/default.asp." ([2006]):
  2. "Product Information. Xeljanz (tofacitinib)." Pfizer U.S. Pharmaceuticals Group, New York, NY.
  3. 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 -]):

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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