Levacetylleucine Pregnancy and Breastfeeding Warnings

Brand names: Aqneursa

Medically reviewed by Drugs.com. Last updated on Dec 17, 2024.

Levacetylleucine Pregnancy Warnings

Safety has not been established; benefit should outweigh risk.

US FDA pregnancy category: Not assigned

Risk summary: Based on animal reproduction studies, this drug may cause embryo-fetal harm when administered during pregnancy. No data are available on the use of this drug in pregnant women to inform a drug-related risk.

Comments:
-A negative pregnancy status should be verified in females of childbearing potential prior to initiating therapy.
-This drug can cause embryo-fetal harm.
-Pregnant females should be apprised of the potential risk to the fetus.
-Females of childbearing potential should use effective methods of contraception during treatment and for 7 days after therapy.
-A decision should be made to continue or discontinue the drug, considering the importance of the drug to the mother, potential drug-related risks to the fetus, and potential adverse outcomes from untreated maternal disease.

Animal studies have revealed evidence of increased embryo-fetal death (post implantation loss/resorption), decreased fetal body weight, and increased external and skeletal malformations. These effects were observed at doses approximately 1.4-fold and 6-fold higher than the maximum recommended human dose of 4 grams per day. There are no controlled data in human pregnancy.

See references

Levacetylleucine Breastfeeding Warnings

Safety has not been established.

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

Comments:
-There are no data on the presence of this drug in human milk or the effects of this drug on milk production.
-Developmental and health benefits of breastfeeding should be considered, as well as the mother's clinical need for this drug.
-The effects in the nursing infant are unknown; potential adverse effects in the breastfed child due to this drug or the mother's underlying condition should be considered.

See references

Further information

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