Alpelisib Pregnancy Warnings
Use is not recommended.
US FDA pregnancy category: Not assigned.
Risk Summary: Based on animal data and mechanism of action, this drug can cause fetal harm when administered to a pregnant woman. Administration to pregnant animals during organogenesis caused adverse developmental outcomes including embryofetal mortality (postimplantation loss), reduced fetal weights, and increased incidences of fetal malformations at maternal exposures 0.8 times or greater the equivalent exposure in humans.
Comments:
-This drug can harm a developing fetus.
-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.
-Verify negative pregnancy status in females of reproductive potential prior to initiating therapy.
-Advise females of reproductive potential to use effective contraception during therapy and for one week after the last dose.
-Advise male patients with female partners of reproductive potential to use condoms and effective contraception during therapy and for one week after the last dose.
-This drug is used in combination with fulvestrant; refer to the prescribing information of fulvestrant for lactation information.
Animal studies have revealed evidence of maternal toxicity and embryotoxicity (bent scapula and thickened or bent long bones) and fetal variations (enlarged brain ventricle, decreased bone ossification). Based on findings from animal studies, this drug may impair fertility in males and females. There are no human data of this drug on the effects on fertility. 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.
See references
Alpelisib Breastfeeding Warnings
Use is not recommended.
Excreted into human milk: Unknown
Excreted into animal milk: Data not available
Comments:
-Because of the potential for serious adverse reactions in the breastfed child, advise lactating women to not breastfeed during therapy and for 1 week after the last dose.
-This drug is used in combination with fulvestrant; refer to the prescribing information of fulvestrant for lactation information.
See references
