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Ibrutinib Pregnancy and Breastfeeding Warnings

Ibrutinib is also known as: Imbruvica

Medically reviewed by Last updated on Dec 3, 2019.

Ibrutinib Pregnancy Warnings

Use is not recommended.

AU TGA pregnancy category: D
US FDA pregnancy category: Not Assigned

Risk Summary: This drug is a kinase inhibitor and can cause fetal harm based on findings from animal studies. Administration to pregnant animals during organogenesis at exposures up to 2 to 20 times the recommended human dose caused embryofetal toxicity including structural abnormalities.

-This drug should not be used during pregnancy unless the benefit outweighs the risk to the fetus.
-Advise females of reproductive potential and male patients to use effective contraceptive measures during therapy and for 1 to 3 months after.
-Females taking hormonal contraception should add a barrier contraceptive method as it is currently unknown whether this drug reduces the effectiveness of hormonal contraceptives.
-Male patients should not donate sperm during therapy and for 1 to 3 months after.
-Verify the pregnancy status of females of reproductive potential prior to initiating therapy.
-The time following treatment with this drug where it is safe to become pregnant is unknown.

Animal studies have shown evidence of embryofetal toxicity including structural and skeletal abnormalities (e.g., visceral malformations in the heart and major vessels; fused and unossified sternebrae), decreased fetal weights, increased resorptions, and post-implantation loss at exposures of 2 to 20 times the recommended human dose (RHD). No effects on fertility or reproductive capacities have been observed in animal studies at exposures of 8 and 14 times the RHD. There are no controlled data in human pregnancy or human fertility.

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

Ibrutinib Breastfeeding Warnings

No information is available on the use of this drug during breastfeeding. Because it is more than 97% bound to plasma proteins, the amount in milk is likely to be low. The manufacturer recommends that breastfeeding be discontinued during therapy.

Use is not recommended.

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

-The effects in the nursing infant and on milk production are unknown.

See references

References for pregnancy information

  1. Cerner Multum, Inc. "Australian Product Information." O 0
  2. "Product Information. Imbruvica (ibrutinib)." Pharmacyclics Inc, Sunnyvale, CA.
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

References for breastfeeding information

  1. United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL:" ([cited 2013 -]):
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. "Product Information. Imbruvica (ibrutinib)." Pharmacyclics Inc, Sunnyvale, CA.
  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.