Krystexxa injection Pregnancy Warnings
This drug was not teratogenic in rats and rabbits at doses of 50 and 75 times the maximum recommended human dose (MRHD), respectively, while statistically significant decreases in pup weight were observed. At dose of 10 and 25 times MRHD, no effects on mean fetal body weights were observed. There are adequate and well-controlled studies in pregnant women.
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
US FDA pregnancy category: Not assigned
Risk Summary: There is not data on human pregnancy; animal reproduction studies have not shown structural abnormalities.
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Krystexxa injection Breastfeeding Warnings
Benefit should outweigh risk
Excreted into human milk: Unknown
Excreted into animal milk: Data not available
Comments:
-There are no data on the effects of this drug on the breastfed infant or its effects on milk production.
-The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for this drug and any potential adverse effects to the breastfed infant from the drug or from the underlying maternal condition.
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