Skytrofa Pregnancy Warnings
The manufacturer makes no recommendation regarding use during pregnancy.
US FDA pregnancy category: Not formally assigned to a pregnancy category
Risk summary: Available published data over several decades for somatropin, the active component of this drug, have not identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. In animal reproduction studies, there was no evidence of embryo-fetal or neonatal harm.
Comments:
-There is no data on use in pregnant women to know this drugs risks, including the risk of fetal harm or reproductive effects.
Animal studies of subcutaneous doses up to 13-fold the clinical dose showed no embryonic or fetal development toxicities. A peri- and post-natal development study showed no adverse effects on the pregnant/nursing dam or on development of the conceptus and the offspring after exposure of the dam from implantation through weaning at up to 13-fold the clinical dose There are no controlled data in human pregnancy.
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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Skytrofa Breastfeeding Warnings
The manufacturer makes no recommendation regarding use during lactation.
Excreted into human milk: Data not available
Excreted into animal milk: Data not available
Comments:
-There is no information regarding this drug on the presence in human milk, the effects on a breastfed infant, or effects on milk production.
-High molecular weight therapeutic proteins like this drug are expected to have low passage into human milk and limited systemic exposure in the breastfed infant.
-Published data indicate that exogenous somatropin does not increase the concentration of growth hormone in normal human milk.
-No adverse effects on the breastfed infant have been reported with use of somatropin.
-Consider the developmental and health benefits of breastfeeding along with the mother's clinical need for this medication as well as any potential adverse effects from this drug or the underlying maternal condition.
See references
