Antineoplastic (Kinase Inhibitor)
PREGNANCY RECOMMENDATION:No Human Data—Animal Data Suggest Potential Risk
BREASTFEEDING RECOMMENDATION:Potential Toxicity
No reports describing the use of abemaciclib in human pregnancy have been located. Some amount of the drug will probably cross the placenta, so fetal exposure will likely occur. However, the absence of human pregnancy experience prevents a complete assessment of the embryofetal risk. Animal studies showed embryofetal toxicity and teratogenicity. Based on these animal studies and the drug’s mechanism of action, the manufacturer recommends that women with reproductive potential use effective contraception during treatment and for 3 weeks after the last dose. However, using this drug during pregnancy should be based on the pros and cons of the mother’s clinical need for treatment versus any potential fetal risk that might occur from exposure.
No reports describing the use of abemaciclib during human lactation have been located. Some amount of the drug probably enters breast milk, so infant exposure will likely occur. However, due to the concern for potential serious adverse effects in a breastfed infant, the manufacturer recommends that women not breastfeed while being treated with abemaciclib and for at least 3 weeks after the last dose. Nevertheless, breastfeeding while using this drug should be based on the mother’s clinical need for treatment. If used, the infant should be monitored for the most common reported adult side effects of nausea, headache, and abdominal pain (all leading to irritability), decreased appetite, diarrhea, vomiting, alopecia, lethargy, and infections.