Truseltiq Pregnancy Warnings
Use is not recommended unless clearly needed.
US FDA pregnancy category: Not assigned.
Risk Summary: Based on findings in animal studies and its mechanism of action this drug can cause fetal harm or loss of pregnancy when administered to a pregnant woman.
Comments:
-Oral administration to pregnant animals during the period of organogenesis at maternal exposures below the human recommended dose resulted in malformations, fetal growth retardation, and embryo-fetal death.
-This drug can cause fetal harm when administered to a pregnant woman.
-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 and potential loss of pregnancy.
-Verify pregnancy status of females of reproductive potential prior to initiating treatment.
-Advise females of reproductive potential to use effective contraception during treatment with and for at least 1 month after the last dose.
-Advise males that are partnered with females of reproductive potential to use effective contraception during treatment with and for at least 1 month after the last dose.
Animal studies conducted using once a day oral administration of this drug resulted in an increase in embryo-fetal lethality at 10 mg/kg/day and reductions in fetal body weights at 3 mg/kg/day or greater (less than 0.1 times the human exposure at the clinical dose of 125 mg). In embryo-fetal study, this decreased the mean number of embryos and increased nonviable embryos and post-implantation loss in females at 3 mg/kg/day. 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
Truseltiq Breastfeeding Warnings
Use is not recommended.
Excreted into human milk: Data not available
Excreted into animal milk: Data not available
Comment: Because of the potential for serious adverse reactions in a nursing child, advise lactating women not to breastfeed during therapy and for at least 1 month after the last dose.
See references
