Aubagio Pregnancy Warnings
Use is contraindicated.
AU TGA pregnancy category: X
US FDA pregnancy category: Not assigned.
Risk Summary: This drug is contraindicated for use in pregnant women and females of reproductive potential not using effective contraception because of the potential for fetal harm based on animal data.
Comments:
-This drug can harm a developing fetus.
-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.
-Females of reproductive potential should use effective contraception while taking this drug and should continue until it is verified that plasma concentrations are less than 0.02 mg/L (0.02 mcg/mL, the level expected to have minimal fetal risk, based on animal data).
-Females of reproductive potential who wish to become pregnant should discontinue this drug and undergo an accelerated elimination procedure; effective contraception should be used until it is verified that plasma concentrations are less than 0.02 mg/L (0.02 mcg/mL).
-This drug is detected in human semen. To minimize any possible risk, men not wishing to father a child and their female partners should use effective contraception. Men wishing to father a child should discontinue use of this drug and either undergo an accelerated elimination procedure or wait until verification that the plasma concentration is less than 0.02 mg/L (0.02 mcg/mL).
Animal studies have revealed evidence of embryotoxicity and teratogenicity at plasma exposures lower than that at the maximum recommended human dose (MRHD). High incidences of fetal malformation (primarily craniofacial, and axial, and appendicular skeletal defects) and fetal death were observed. Available human data are limited. Data have not demonstrated an increased rate of congenital malformations or miscarriage following exposure in the early first trimester when followed by an accelerated elimination procedure. Specific patterns of major congenital malformations in humans have not been observed.
AU TGA pregnancy category X: Drugs which have such a high risk of causing permanent damage to the fetus that they should not be used in pregnancy or when there is a possibility of 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.
See references
