Kimyrsa Pregnancy Warnings
Animal studies have failed to reveal evidence of fetal harm; however, the doses studied were equivalent to 25% of the single 1200 mg clinical dose. There are no controlled data in human pregnancy.
US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus.
US FDA pregnancy category: C
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Kimyrsa Breastfeeding Warnings
A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.
Excretion into human milk: Unknown
Excretion into animal milk: Yes
Comments:
-Breastfed infants should be monitored for diarrhea, headache, nausea, subcutaneous/limb abscesses, vomiting, and candidiasis (e.g., diaper rash, thrush).
-Alternative agents (e.g., clindamycin, daptomycin, doxycycline, sulfamethoxazole-trimethoprim, vancomycin) may be preferred when breastfeeding newborn or preterm infants.
See references