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Acalabrutinib Pregnancy and Breastfeeding Warnings

Acalabrutinib is also known as: Calquence

Acalabrutinib Pregnancy Warnings

In one animal study, drug administration at doses approximately 4 times the AUC in patients at the recommended human dose (RHD) produced maternal toxicity and resulted in decreased fetal body weights and delayed skeletal ossification. In another animal study, drug administration at doses approximately 16 times the AUC in patients at the RHD produced no effects on embryo-fetal development and survival. An animal fertility study demonstrated no fertility effects in both females and males at exposures 16 to 18 times the AUC in patients at the RHD. There are no controlled data in human pregnancy. 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.

Safety has not been established. US FDA pregnancy category: Not Assigned Comments: -Based on findings in animals, this drug may cause fetal harm. -The presence of this drug and its active metabolite were confirmed in fetal animal plasma. -Advise pregnant women of the potential risk to a fetus.

See references

Acalabrutinib Breastfeeding Warnings

Due to the potential for adverse reactions in a breastfed child from this drug, breastfeeding is not recommended during treatment and for at least 2 weeks after the final dose. Excreted into human milk: Unknown Excreted into animal milk: Yes Comments: The effects in the nursing infant and on milk production are unknown.

See references

References for pregnancy information

  1. "Product Information. Calquence (acalabrutinib)." Astra-Zeneca Pharmaceuticals, Wilmington, DE.

References for breastfeeding information

  1. "Product Information. Calquence (acalabrutinib)." Astra-Zeneca Pharmaceuticals, Wilmington, DE.

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