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Crizotinib Pregnancy and Breastfeeding Warnings

Brand names: Xalkori

Crizotinib Pregnancy Warnings

Animal studies have revealed evidence of embryofetal toxicity. Pregnant rats and rabbits were administered this drug during organogenesis at exposures similar to those expected with the maximum recommended human dose; embryotoxicity and fetotoxicity were observed. Postimplantation loss was increased at doses about 0.6 times the recommended human dose (RHD) based on AUC in rats. No teratogenic effects were observed at doses up to the maternally toxic dose (about 2.7 times the RHD based on AUC) or in rabbits at doses about 1.6 times the RHD based on AUC, though fetal body weights were reduced at these doses. There are no controlled data in human pregnancy.

Based on findings in animals, this drug may cause reduced fertility in females and males of reproductive potential; it is not known if such effects are reversible.

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.

This drug should not be used during pregnancy unless clearly needed.

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

Risk summary: Based on animal studies and its mechanism of action, this drug can cause fetal harm when administered to a pregnant woman; no data available on use of this drug in pregnant women to inform a drug-related risk.

Comments:
-If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential harm to the fetus.
-Male patients should also be apprised of the potential harm to the fetus if their partner is or becomes pregnant.
-Pregnancy status of patients of childbearing potential should be verified before starting this drug.
-Females of childbearing potential should be advised to avoid becoming pregnant and to use effective contraception during therapy and for at least 45 or 90 days after the last dose; local protocol should be consulted regarding contraception timing.
-Male patients with female partners of childbearing potential should be advised to use effective contraception/condoms during therapy and for at least 90 days after the last dose.

See references

Crizotinib Breastfeeding Warnings

Breastfeeding is not recommended during use of this drug and for 45 days after the last dose.
-According to some authorities: 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: Data not available

Comments:
-No information is available on the clinical use of this drug during breastfeeding.
-The effects in the nursing infant are unknown; there is the potential for adverse reactions in breastfed children.
-Because this drug is highly bound to plasma proteins, the amount in milk is likely to be low; however, it has a half-life of about 42 hours and it might accumulate in the infant.

See references

References for pregnancy information

  1. Product Information. Xalkori (crizotinib). Pfizer U.S. Pharmaceuticals Group. 2022.
  2. Product Information. Xalkori (crizotinib). Pfizer Australia Pty Ltd. 2022.
  3. Product Information. Xalkori (crizotinib). Pfizer Ltd. 2023.

References for breastfeeding information

  1. National Library of Medicine (US), National Center for Biotechnology Information. Crizotinib - Drugs and Lactation Database (LactMed) https://www.ncbi.nlm.nih.gov/books/NBK500840/ 2023.
  2. Product Information. Xalkori (crizotinib). Pfizer U.S. Pharmaceuticals Group. 2022.
  3. Product Information. Xalkori (crizotinib). Pfizer Australia Pty Ltd. 2022.
  4. Product Information. Xalkori (crizotinib). Pfizer Ltd. 2023.

Further information

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