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Imatinib Pregnancy and Breastfeeding Warnings

Imatinib is also known as: Gleevec

Medically reviewed on Aug 27, 2018

Imatinib Pregnancy Warnings

Animal reproductive studies have shown teratogenicity and increased incidence of congenital abnormalities following prenatal exposure to this drug. There have been postmarketing reports of spontaneous abortions and infant congenital anomalies from women who have taken this drug.

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 be used during pregnancy only if the benefit outweighs the risk.

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

Comments:
-Advise women of childbearing potential to use adequate contraception.
-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 hazard to the fetus.

Risk Summary: Based on human and animal data, this drug can cause fetal harm when administered to a pregnant woman.

See references

Imatinib Breastfeeding Warnings

Use is not recommended.

Excreted into human milk: Yes

Comments:
-Women should not breastfeed during treatment and for one month after the last dose.
-A breastfed infant could receive up to 10% of the maternal therapeutic dose based on body weight.

Although a few breastfed infants apparently experienced no adverse effects during maternal use of this drug, no long-term data are available. Avoiding nursing for 8 to 9 hours after a dose would probably reduce the dosage that the infant receives. Most experts recommend that breastfeeding be discontinued during therapy.

See references

References for pregnancy information

  1. Cerner Multum, Inc. "Australian Product Information." O 0
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. "Product Information. Gleevec (imatinib mesylate)." Novartis Pharmaceuticals, East Hanover, NJ.

References for breastfeeding information

  1. Cerner Multum, Inc. "Australian Product Information." O 0
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  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 -]):
  4. "Product Information. Gleevec (imatinib mesylate)." Novartis Pharmaceuticals, East Hanover, NJ.

Further information

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

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