Zanubrutinib Pregnancy and Breastfeeding Warnings

Brand names: Brukinsa

Zanubrutinib 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:
-Patients of childbearing potential should avoid becoming pregnant during therapy and for at least 1 week/up to 1 month after stopping treatment.
-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 testing is recommended for patients of childbearing potential before starting this drug.
-Patients of childbearing potential should be advised to use highly effective contraception during therapy and for at least 1 week/up to 1 month after the last dose; local protocol should be consulted regarding contraception timing.
---According to some authorities: It is unknown if this drug can reduce the efficacy of hormonal contraceptives; women using hormonal contraceptives should add a barrier method.
-Male patients should be advised to avoid fathering a child during therapy and for at least 1 week after the last dose; male patients with partners of childbearing potential should be advised to use effective contraception during therapy and for at least 1 week after the last dose.

Animal studies have revealed evidence of teratogenicity and postimplantation loss. After oral doses (30 to 150 mg/kg/day) were administered to pregnant rats during organogenesis, malformations in the heart (2- or 3-chambered hearts) were observed at all dose levels, without maternal toxicity; 30 mg/kg/day is about 5 times the exposure (AUC) in patients given the recommended dose (160 mg twice a day). After doses (30 to 150 mg/kg/day) were administered to pregnant rabbits during organogenesis, postimplantation loss was observed at the highest dose; 150 mg/kg/day is about 32 times the exposure (AUC) in patients given the recommended dose and was associated with maternal toxicity. 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

Zanubrutinib Breastfeeding Warnings

Breastfeeding is not recommended during use of this drug and for at least 2 weeks 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.

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

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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