Brukinsa Pregnancy Warnings
Animal studies have revealed evidence of malformations in the heart, post-implantation loss, decreased body weights, adverse ocular findings (e.g., cataract, protruding eye) at doses higher than the equivalent recommended human dose. 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.
Use should be avoided.
AU TGA pregnancy category: D
US FDA pregnancy category: Not assigned
Risk Summary: Based on findings in animals, this drug can cause fetal harm when administered to a pregnant woman.
Comments:
-This drug can harm a developing fetus.
-Adequate methods of contraception should be encouraged.
-Verify negative pregnancy status in females of reproductive potential prior to initiating therapy.
-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.
-Advise female patients of reproductive potential to use effective contraception during therapy and for at least 1 week after.
-Advise men to avoid fathering a child while receiving this drug and for at least 1 week after.
See references
Brukinsa Breastfeeding Warnings
Use should be avoided.
Excreted into human milk: Unknown
Excreted into animal milk: Data not available
Comments:
-Because of the potential for serious adverse reactions from this drug in a breastfed child, women should not breastfeed during therapy and for at least 2 weeks after the last dose.
See references
