Kesimpta Pregnancy Warnings
Animal studies have not demonstrated maternal toxicity or teratogenicity in the fetus, but did reveal evidence of depletion of peripheral B cells and decreased spleen and placental weights. There are no controlled data in human pregnancy.
AU TGA pregnancy category C: Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible. 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.
Benefit should outweigh risk.
AU TGA pregnancy category: C
US FDA pregnancy category: Not assigned
Comments:
-The manufacturer recommends that breastfeeding should be discontinued for the duration of treatment and for 12 months following treatment discontinuation.
-This drug may cause fetal B-cell depletion based on findings from animal studies and the mechanism of action of the drug. Live vaccines should not be administered to neonates and infants exposed to this drug in utero until B-cell recovery occurs.
See references
Kesimpta Breastfeeding Warnings
Safety has not been established
Excreted into human milk: Unknown
Excreted into animal milk: Unknown
Comments:
-The effects in the nursing infant are unknown.
-The manufacturer recommends that breastfeeding should be discontinued for the duration of treatment and for 12 months following treatment discontinuation.
No information is available on the use of this drug during breastfeeding. Because it is a large protein molecule, the amount in milk is likely to be very low and absorption is unlikely because it is probably destroyed in the infant GI tract.
Human IgG is secreted in human milk. Published data suggest that neonatal and infant consumption of breast milk does not result in substantial absorption of these maternal antibodies into circulation.
See references
