Exkivity Pregnancy Warnings
Animal studies have revealed evidence of embryolethality, fetotoxicity, and maternal toxicity. Oral administration to pregnant rats during organogenesis resulted in embryolethality due to postimplantation loss (embryofetal death), decreased fetal weights, and maternal toxicity (reduced body weight gain and food consumption) at 10 mg/kg/day (about 1.7 times the human exposure based on AUC at 160 mg once daily). There are no controlled data in human pregnancy.
Based on animal studies, this drug may impair fertility in males and females of reproductive potential.
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 is not recommended unless clearly needed.
US FDA pregnancy category: Not assigned.
Risk summary: Based on animal studies and its mechanism of action, this drug can cause fetal harm when administered during pregnancy; no data are available on use of this drug in pregnant women.
Comments:
-Pregnant women should be apprised of the potential harm to the fetus; females of childbearing potential should be advised to avoid becoming pregnant during therapy.
-Pregnancy status should be verified in females of childbearing potential prior to initiating therapy.
-Females of childbearing potential should be advised to use highly effective nonhormonal contraception during therapy and for 1 month after the last dose; this drug may render hormonal contraceptives ineffective.
-Male patients with female partners of childbearing potential should be advised to use effective contraception during therapy and for 1 week after the last dose.
See references
