Vosoritide Pregnancy Warnings
The manufacturer makes no recommendation regarding use during pregnancy.
-According to some authorities: Use should be avoided.
AU TGA pregnancy category: B2
US FDA pregnancy category: Not assigned
Risk summary: There are no available data on the use of this drug during pregnancy to evaluate the drug-associated risk of birth defects, miscarriage, or adverse maternal or fetal outcomes.
Animal studies have failed to reveal evidence of embryofetal toxicity or congenital malformations. Rats and rabbits received this drug subcutaneously at doses equivalent to 14-times and 200-times, respectively, the exposure at the maximum recommended human dose; no effects on embryofetal development were observed. There are no controlled data in human pregnancy.
AU TGA pregnancy category B2: 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 are inadequate or may be lacking, but available data show no 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.
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Vosoritide Breastfeeding Warnings
Benefit should outweigh risk.
-According to some authorities: Use is not recommended.
Excreted into human milk: Data not available
Excreted into animal milk: Yes
Comments:
-There is no information regarding the presence of this drug in human milk, and the effects on the breastfed infant. However, since it is excreted in animal milk, it is likely that the drug will be present in human milk. -The health benefits of breastfeeding should be considered along with the mother's clinical need for treatment and any potential adverse effects on the breastfed child from this drug or from the underlying maternal condition.
See references
