Vamorolone Pregnancy and Breastfeeding Warnings

Brand names: Agamree

Vamorolone Pregnancy Warnings

Corticosteroids should be used during pregnancy only if the benefit outweighs the risk to the fetus.

US FDA pregnancy category: Not assigned

Risk summary: Based on effects in pregnant patients and animals, corticosteroids can cause adverse developmental outcomes when administered to a pregnant woman.

Comments:
-There are no data available on use of this drug in pregnant women to inform a drug-related risk.
-Infants born to mothers who have received substantial doses of corticosteroids during pregnancy should be carefully observed for signs of hypoadrenalism.

Animal studies have not been reported with this drug; however, animal studies conducted with other corticosteroids at clinically relevant doses have shown an increased incidence of cleft palate. In some animal species, an increase in embryofetal death, intrauterine growth retardation, and constriction of the ductus arteriosus were observed.

In humans, various clinical studies suggest that maternal corticosteroid use during the first trimester increases the rate of cleft lip, with or without cleft palate, from about 1 per 1000 infants to 3 to 5 per 1000 infants. Other studies in humans have shown decreased birth weight and intrauterine growth restriction in infants exposed to maternal corticosteroids in utero, which appeared to be dose-related. However, the underlying maternal condition may also contribute to these risks in infants. 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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Vamorolone Breastfeeding Warnings

Safety has not been established.

Excreted into human milk: Unknown
Excreted into animal milk: Data not available

Comments:
-There are no data on the presence of this drug in human milk or the effects of this drug on milk production.
-Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects.
-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 on the breastfed infant.

See references

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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