Inqovi Pregnancy Warnings
Use should be avoided.
US FDA pregnancy category: Not assigned.
Risk Summary: Based on findings from human data, animal studies, and its mechanism of action, this drug can cause fetal harm when administered to a pregnant woman. A case report of IV decitabine use throughout the first trimester during pregnancy revealed adverse developmental outcomes, including major birth defects (structural abnormalities). Animal studies with IV decitabine at 7% of the recommended human dose on a body surface area (mg/m2) basis caused adverse developmental outcomes, including increased embryofetal mortality, alterations to growth, and structural abnormalities. There are no controlled data in human pregnancy.
Comments:
-This drug combination 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.
-Advise females of reproductive potential to use effective contraception during therapy and for 6 months after.
-Based on genotoxicity findings, advise males with female partners of reproductive potential to use effective contraception during therapy and for 3 months after.
-This drug combination may impair male fertility; the reversibility of the effect on fertility is unknown.
Animal studies at 2% to 7% of the equivalent recommended decitabine dose in humans have revealed evidence of growth suppression, exencephaly, defective skull bones, rib/sternebrae defects, phocomelia, digit defects, micrognathia, gastroschisis, and micromelia. Decitabine inhibits proliferation and increases apoptosis of neural progenitor cells of the fetal central nervous system (CNS) and induces palatal clefting in the developing fetus. Studies in mice have also shown that decitabine administration during osteoblastogenesis (Day 10 of gestation) induces bone loss in offspring, embryotoxicity, and teratogenicity. 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.
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