Tibsovo Pregnancy Warnings
Animal studies have revealed evidence of fetal harm. After oral administration to pregnant rats during organogenesis, adverse embryofetal effects (including lower fetal weights, skeletal variations) were observed; these effects occurred at about 2 times the human exposure (at the recommended dose of 500 mg/day). This drug was maternally toxic at about 3.9 times the human exposure (at the recommended dose of 500 mg/day) in pregnant rabbits treated during organogenesis; spontaneous abortions, decreased fetal weights, skeletal variations, and visceral variations were observed. 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.
The manufacturer makes no recommendation regarding use during pregnancy.
US FDA pregnancy category: Not assigned.
Risk summary: Based on animal data, this drug can cause fetal harm when administered to a pregnant woman; no data available on use of this drug in pregnant women to inform a drug-related risk.
Comments:
-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.
See references
Tibsovo Breastfeeding Warnings
Breastfeeding is not recommended during use of this drug and for 1 month after the last dose.
Excreted into human milk: Unknown
Excreted into animal milk: Data not available
Comments:
-No information is available on the clinical use of this drug during breastfeeding.
-The effects in the nursing infant are unknown; there is the potential for adverse reactions in breastfed children.
This drug is 92% to 96% bound to plasma proteins, thus the amount in milk is likely to be low. However, because its half-life is about 93 hours, this drug may accumulate in the infant.
See references
