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Setmelanotide Pregnancy and Breastfeeding Warnings

Setmelanotide is also known as: Imcivree

Setmelanotide Pregnancy Warnings

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. 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 does contain 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 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.

Not recommended

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 not 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.

See references

Setmelanotide Breastfeeding Warnings

There are no data on the effects of this drug on the breastfed infant or its effects on milk production. This drug was detected in rat milk 2 hours after subcutaneous injection in lactating rats; no quantifiable drug concentrations were detected in nursing pups. Because benzyl alcohol has caused significant adverse reactions in low birth weight infants and premature neonates, this drug is not recommended during breastfeeding. However, 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.

Not recommended

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

Comments:
-Because benzyl alcohol is present as a preservative and adverse reactions to IV benzyl alcohol have been reported in premature infants and low birth weight infants, this drug is not recommended during breastfeeding.

See references

References for pregnancy information

  1. "Product Information. Imcivree (setmelanotide)." Rhythm Pharmaceuticals, Boston, MA.

References for breastfeeding information

  1. "Product Information. Imcivree (setmelanotide)." Rhythm Pharmaceuticals, Boston, MA.

Further information

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