Motegrity Pregnancy Warnings
Animal studies have failed to reveal evidence of developmental effects when this drug was given during organogenesis at doses up to 760 times the recommended human dose of 2 mg/day. There was a slight decrease in overall pup survival rate after 7 days, but this may be due to maternotoxicity. There are no controlled data in human pregnancy.
AU TGA pregnancy category B1: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have not shown evidence of an increased occurrence of fetal damage.
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 is not recommended.
AU TGA pregnancy category: B1
US FDA pregnancy category: Not assigned.
Risk Summary: No data available on use of this drug in pregnant women to inform a drug-related risk.
Comment: Women of childbearing potential should use effective contraception during treatment.
See references
Motegrity Breastfeeding Warnings
Use is not recommended and a decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.
Excreted into human milk: Yes
Comments:
-The effects in the nursing infant are unknown.
-There are no data on the effects on milk production.
-Some experts recommend monitoring breastfed infants for diarrhea.
When measured in 8 lactating women, the milk to plasma AUC ratio was 2.65 to 1, and the average amount of drug that was passed to breastfed infants was 1.74 mcg/kg/day, or approximately 6% of the maternal dose (adjusted for body weight).
See references
