Nulojix Pregnancy Warnings
This drug is only recommended for use during pregnancy when there are no alternatives and the benefit outweighs the risk.
US FDA pregnancy category: Not assigned.
Risk Summary: In animal studies, this drug given during organogenesis was not teratogenic at exposures approximately 16 and 19 times greater than that observed at the maximum recommended human dose (MRHD).
Comments:
-A pregnancy exposure registry is available.
-This drug crossed the placenta in animal studies.
-Adequate methods of contraception should be encouraged.
Animal studies failed to demonstrate teratogenicity at doses approximately 16 to 19 times greater than the exposure associated with the maximum recommended human dose (MRHD). When administered daily during gestation, this drug was associated with maternal toxicity (infections) in a small percentage of study animals at doses approximately 3 times the MRHD exposure and an increased pup mortality (up to 100% pup mortality in some dams). In pups that survived, there were no abnormalities or malformations at doses up to 19 times the MRHD exposure. There are no controlled data in human pregnancy.
To monitor the outcomes of pregnant women exposed to this drug, a pregnancy registry has been established. Physicians are encouraged to register patients and pregnant women are encouraged to register themselves at http://www.transplantpregnancyregistry.org/ or by calling 1-877-955-6877.
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
Nulojix Breastfeeding Warnings
No information is available on the use of this drug during breastfeeding. Because the half-life is 8 to 10 days, it may be more than a month after a dose before the drug is completely cleared from breastmilk.
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: Data not available
Excreted into animal milk: Yes
Comments:
-The effects in the nursing infant are unknown.
See references
