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Nilotinib Pregnancy and Breastfeeding Warnings

Nilotinib is also known as: Tasigna

Medically reviewed on March 28, 2018

Nilotinib Pregnancy Warnings

Use is not recommended.

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

Risk Summary: In animal reproduction studies, administration of this drug during organogenesis caused adverse developmental outcomes including embryofetal lethality, fetal effects, and fetal variations at maternal exposures (AUC) approximately 2 and 0.5 times, respectively, the exposures in patients at the recommended dose.

Comments:
-Based on findings from animal studies and the mechanism of action, this drug can cause fetal harm when administered to a pregnant woman.
-Adequate methods of contraception should be encouraged.
-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.

Animal studies have revealed evidence of embryotoxicity. There are no controlled data in human pregnancy. It is not known whether this drug can cause fetal harm or adversely affect reproductive capacity in humans.

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.

See references

Nilotinib Breastfeeding Warnings

Although breastfed infants apparently experienced no adverse effects during maternal use of this drug, no long-term data are available. Because it is 98% bound to plasma proteins, the amount in milk is likely to be low; however, there is little published experience, and an alternate drug may be preferred, especially while nursing a newborn or preterm infant.

Use is not recommended.

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

Comments:
-Because of the potential for serious adverse reactions in a nursing child, advise lactating women not to breastfeed during therapy with this drug and for at least 14 days after the last dose.

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. Tasigna (nilotinib)." Novartis Pharmaceuticals, East Hanover, 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. Tasigna (nilotinib)." Novartis Pharmaceuticals, East Hanover, NJ.
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  4. Cerner Multum, Inc. "Australian Product Information." O 0

Further information

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

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