Tazverik Pregnancy Warnings
Administration of this drug to pregnant rats and rabbits during organogenesis resulted in dose-dependent increases in skeletal developmental abnormalities in both species beginning at maternal exposures approximately 1.5 times the adult human exposure at the 800 mg orally 2 times a day.
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.
US FDA pregnancy category: Not assigned.
Risk Summary: Based on findings from animal studies and its mechanism of action 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.
-This drug can render some hormonal contraceptives ineffective.
-Advise females of reproductive potential to use effective non-hormonal contraception during therapy with this drug and for 6 months after.
-Advise males with female partners of reproductive potential to use effective contraception during therapy with this drug and for at least 3 months after.
See references
Tazverik Breastfeeding Warnings
A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.
Excreted into human milk: Unknown
Excreted into animal milk: Unknown
Comments:
-Because of the potential risk for serious adverse reactions from this drug in the breastfed child, advise women not to breastfeed during therapy and for one week after.
See references
