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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

References for pregnancy information

  1. (2024) "Product Information. Aqneursa (levacetylleucine)." IntraBio Inc

References for breastfeeding information

  1. (2024) "Product Information. Aqneursa (levacetylleucine)." IntraBio Inc

Further information

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