Elahere Pregnancy Warnings
Animal studies have not been conducted. 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.
Use is not recommended.
US FDA pregnancy category: Not assigned
Risk summary:
-No data available on use of this drug in pregnant women to inform a drug-related risk.
-This drug has a potential to cause embryo-fetal toxicity since it contains a genotoxic compound, DM4, which affects actively dividing cells.
-Human IgG is known to cross the placental barrier; therefore, this drug is likely to be transferred from the mother to the developing fetus.
Comments:
-Females of reproductive potential should be tested for pregnancy before starting treatment with this drug.
-Females of reproductive potential should use effective contraception during treatment with this drug and for seven months after the last dose.
-Females of childbearing potential should be apprised of the potential of this drug to cause fetal toxicity if used during pregnancy.
See references
