Ibrutinib Pregnancy and Breastfeeding Warnings

Brand names: Imbruvica

Ibrutinib Pregnancy Warnings

Use is not recommended.

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

Risk summary: Based on animal studies, this drug can cause fetal harm when administered to a pregnant woman; no data available on use of this drug in pregnant women to inform a drug-related risk.

Comments:
-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.
-Pregnancy status should be verified in patients of childbearing potential before starting this drug.
-Female patients of childbearing potential should be advised to avoid becoming pregnant and to use highly effective contraception during therapy and for 1 or 3 months after the last dose; local protocol should be consulted regarding contraception timing.
---According to some authorities: The time period after treatment with this drug when it is safe to become pregnant is unknown.
-Male patients with female partners of childbearing potential should be advised to use effective contraception during therapy and for 1 or up to 3 months after the last dose; local protocol should be consulted regarding contraception timing.
---According to some authorities: Male patients should be advised not to father a child or donate sperm during therapy and for 3 months after the last dose.

Animal studies have revealed evidence of embryofetal toxicity (including structural abnormalities) at exposures greater than 2 times the clinical dose of 420 mg/day. After oral dosing (10, 40, and 80 mg/kg/day) in pregnant rats during organogenesis, visceral malformations (heart and major vessels), increased resorptions, and increased postimplantation loss were observed at 80 mg/kg/day (about 20 times the exposure in patients administered 420 mg/day); decreased fetal weights were seen at 40 mg/kg/day (about 8 times the exposure [AUC] in patients administered 420 mg/day) or greater. After oral dosing (5, 15, and 45 mg/kg/day) in pregnant rabbits during organogenesis, increased resorptions and postimplantation loss were observed at 45 mg/kg/day; skeletal variations (fused sternebrae) were seen at 15 mg/kg/day (about 2.8 times the exposure in patients administered 420 mg/day) or greater. There are no controlled data in human pregnancy.

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

Because this drug is highly bound to plasma proteins, the amount in milk is likely to be low.

Breastfeeding is not recommended during use of this drug and for 1 week after the last dose.

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

Comments:
-No information is available on the clinical use of this drug during breastfeeding.
-The effects in the nursing infant are unknown; there is the potential for serious adverse reactions. A risk to breastfed children cannot be excluded.

See references

Further information

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

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