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Ibrutinib Pregnancy and Breastfeeding Warnings

Ibrutinib is also known as: Imbruvica

Medically reviewed on March 20, 2018

Ibrutinib Pregnancy Warnings

Use of this drug is not recommended during pregnancy; it may cause fetal harm based on findings from animal studies.

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

Comments:
-Apprise patients of the potential hazard to a fetus if this drug is used during pregnancy or if the patient becomes pregnant while taking this drug.
-Advise females of reproductive potential and male patients to use highly effective contraceptive measures during treatment with this drug and for 1 to 3 months after treatment cessation, and also instruct male patients not to donate sperm during this time period.
-Verify the pregnancy status of females of reproductive potential prior to initiating this drug, and if they are using hormonal contraception, advise them to add a barrier contraceptive method as it is currently unknown whether this drug reduces the effectiveness of hormonal contraceptives.
-The time period 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

Breastfeeding is not recommended during treatment with this drug.

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

Comments:
-The effects in the nursing infant and on milk production are unknown.
-The amount of drug in breastmilk is likely to be low due to this drug being more than 97% bound to plasma proteins.

See references

References for pregnancy information

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

References for breastfeeding information

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