Fensolvi Pregnancy Warnings
Use is contraindicated.
AU TGA pregnancy category: D
US FDA pregnancy category: Not assigned.
Risk Summary: Based on findings in animal studies and mechanism of action, this drug may cause fetal harm when administered to a pregnant woman. There are no available data in pregnant women to inform the drug-associated risk. Expected hormonal changes that occur with treatment increase the risk for pregnancy loss. In animal developmental and reproductive studies, major fetal abnormalities were observed after administration acetate throughout gestation in rats.
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.
-Patients should be advised that if they miss any doses, breakthrough bleeding or ovulation may occur with the potential for conception.
-This drug may cause spontaneous abortion.
-Based on mechanism of action, this drug may impair fertility in males.
Animal studies have shown reproductive toxicity. Additionally, there was increased fetal mortality and decreased fetal weights in animals. There are no controlled data in human pregnancy.
AU TGA pregnancy category D: Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. Accompanying texts should be consulted for further details.
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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