Stivarga Pregnancy Warnings
Animal studies have revealed evidence of embryotoxicity and teratogenicity at exposures lower than human exposures at the recommended dose, with increased incidences of cardiovascular, genitourinary, and skeletal malformations. Adverse fetal effects included increased drug penetration across the blood-brain barrier, delayed ossification, and dose-dependent increases in the incidence of cleft palate, enlarged fontanelle, diaphragmatic hernia, renal pelvis dilation, missing kidney/ureter, small/deformed/malpositioned kidney, and hydronephrosis. The proportion of viable male fetuses decreased with increasing dose. 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.
Use should be avoided.
AU TGA pregnancy category: D
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. It has been found to be embryolethal and teratogenic in rats and rabbits at exposures lower than human exposures at the recommended dose, with increased incidences of cardiovascular, genitourinary, and skeletal malformations.
Comments:
-Based on animal studies and its mechanism of action, this drug may cause fetal harm.
-This drug and its metabolites have been shown to cross the placenta in animals.
-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.
-Advise females of reproductive potential to use effective contraception during therapy and for 2 months after.
-Advise males with female partners of reproductive potential to use effective contraception during therapy and for 2 months after.
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