Tabrecta Pregnancy Warnings
Use is not recommended.
US FDA pregnancy category: Not assigned.
Risk Summary: Based on animal studies and its mechanism of action, this drug can cause fetal harm when administered to a pregnant woman. Oral administration to pregnant rats and rabbits during organogenesis resulted in malformations at maternal exposures less than the human exposure based on AUC at the 400 mg twice daily dose.
Comments:
-A pregnancy exposure registry is available.
-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.
In rats, maternal toxicity (reduced body weight gain and food consumption) occurred at 1.4 times the human exposure. Fetal effects included reduced fetal weights, irregular/incomplete ossification, and increased incidences of fetal malformations (e.g., abnormal flexure/inward malrotation of hindpaws/forepaws, thinness of forelimbs, lack of/reduced flexion at the humerus/ulna joints and narrowed or small tongue) at doses 0.6 times the human exposure. In rabbits, no maternal effects were detected at doses up to 1.5 times the human exposure. Fetal effects included small lung lobe at 0.016 times the human exposure, and reduced fetal weights, irregular/incomplete ossification and increased incidences of fetal malformations (e.g., abnormal flexure/malrotation of hindpaws/forepaws, thinness of forelimbs/hindlimbs, lack of/reduced flexion at the humerus/ulna joints, small lung lobes, narrowed or small tongue) at a dose of 60 mg/kg/day. 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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