Calquence 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 14 to 16 times the AUC in patients at the RHD. There are no controlled data in human pregnancy.
AU TGA pregnancy category C: Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible. 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.
This drug should not be used during pregnancy unless clearly needed.
AU TGA pregnancy category: C
US FDA pregnancy category: Not Assigned
Comments:
-Based on findings in animals, this drug may cause fetal harm and dystocia.
-The presence of this drug and its active metabolite were confirmed in fetal animal plasma.
-Pregnancy testing is recommended before initiating therapy.
-Advise pregnant women of the potential risk to a fetus.
See references
