Setmelanotide Pregnancy and Breastfeeding Warnings

Brand names: Imcivree

Medically reviewed by Drugs.com. Last updated on Nov 13, 2022.

Setmelanotide Pregnancy Warnings

This drug should not be used during pregnancy unless the benefit outweighs the risk to the fetus.

US FDA pregnancy category: Not assigned

Risk Summary:
There are no available data in pregnant women to inform a drug-associated risk for major birth defects and miscarriage, or adverse maternal or fetal outcomes. Weight loss offers no potential benefit to a pregnant woman and may result in fetal harm.

Comments:
-This drug should be discontinued when pregnancy is detected unless the benefits of therapy outweigh the potential risks to the fetus.
-Maternal obesity may increase the risk for congenital malformations, including neural tube defects, cardiac malformations, oral clefts, and limb reduction defects.
-Weight loss during pregnancy may result in fetal harm including increased risk of small for gestational age.

In animal studies, subcutaneous administration to rats was not teratogenic at doses 11 times the maximum recommended human dose (MRHD). Subcutaneous administration to rabbits was not teratogenic at clinical doses and did not result in adverse developmental effects at doses 7 times the MRHD. However, administration of this drug to pregnant rabbits resulted in decreased maternal food consumption leading to embryo-fetal effects. There are no controlled data in human pregnancy.

Weight loss during pregnancy may result in fetal harm including increased risk of small for gestational age. Appropriate weight gain based on pre-pregnancy weight is currently recommended for all pregnant women, including those who are already overweight or obese, due to the obligatory weight gain that occurs in maternal tissues during pregnancy. This drug contains benzyl alcohol as a preservative. Benzyl alcohol is rapidly metabolized in pregnant women and benzyl alcohol exposure in the fetus is unlikely. But significant adverse reactions to IV benzyl alcohol have been reported in low-birth-weight infants and premature neonates.

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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Setmelanotide Breastfeeding Warnings

Use is not recommended.
According to some authorities, a decision should be made to discontinue breastfeeding or discontinue the drug, considering the importance of the drug to the mother.

Excreted into human milk: Unknown
Excreted into animal milk: Yes

Comments:
-The effects of this drug in the nursing infant or on milk production are unknown.
-This drug was present in animal milk, if a drug is present in animal milk it is likely that the drug will be present in human milk.

In animal studies, this drug was detected in animal milk 2 hours after subcutaneous injection in lactating rats; no quantifiable drug concentrations were detected in nursing pups. It is unlikely that a breastfed infant would be exposed to benzyl alcohol in breastmilk because benzyl alcohol is rapidly metabolized by the lactating woman.

See references

Further information

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