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Lapatinib Pregnancy and Breastfeeding Warnings

Lapatinib is also known as: Tykerb

Medically reviewed on Apr 17, 2017

Lapatinib Pregnancy Warnings

Avoid use of this drug during pregnancy unless clearly necessary.

AU TGA pregnancy category: C
US FDA pregnancy category: D

-This drug is expected to result in adverse reproductive effects based on findings in animals.
-Advise women of reproductive potential to use adequate contraception and avoid becoming pregnant while receiving this drug.

Animal studies revealed administration of this drug during organogenesis and through lactation led to offspring death within the first 4 days after birth. No treatment-related malformations were observed in animals, but alterations (left-sided umbilical artery, cervical rib) and early post-implantation losses occurred at maternally toxic doses. Precocious ossification was also observed in animals, independent of maternal toxicity or fetal body weight changes. There were no effects on mating or fertility in male and female animals at doses up to 8 times the expected human clinical exposure based on AUC; however, significant decreases in fetal body weights and in the number of live fetuses were observed at doses 3.3- and 6.4-times the expected human clinical exposure based on AUC. There are no controlled data in human pregnancy, and the effect of this drug on human fertility is unknown.

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 D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

See references

Lapatinib Breastfeeding Warnings

Although no data are available on the clinical use of this drug during breastfeeding, the amount of drug in breastmilk is likely to be low because it is more than 99% bound to plasma proteins. However, this drug might accumulate in the infant due to its half-life being about 24 hours. Additionally, the risk to the infant may be increased when this drug is given in combination with capecitabine. In animals, growth retardation was observed in offspring which were exposed to this drug via breastmilk.

Discontinue use of this drug during breastfeeding.

Excreted into human milk: Unknown
Excreted into animal milk: Data not available

Comments: The effects in the nursing infant are unknown.

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. Tykerb (lapatinib)." Novartis Pharmaceuticals, East Hanover, NJ.

References for breastfeeding information

  1. United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL:" ([cited 2013 -]):
  2. "Product Information. Tykerb (lapatinib)." 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.