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Levacetylleucine

Also known as: Aqneursa

P-Glycoprotein InhibitorsBreast Cancer Resistance Protein InhibitorsBile Salt Export Pump Inhibitors

Route: Oral

2 interactions on record

Levacetylleucine has 2 known drug interactions based on U.S. FDA drug labeling data. Of these, 1 are contraindicated combinations that should be avoided entirely. Notable interactions include combinations with N-Acetyl-Dl-Leucine, P-Gp Or Bcrp Substrates. Patients taking Levacetylleucine should inform their healthcare provider of all current medications — including over-the-counter drugs and supplements — to avoid potentially harmful combinations. Data sourced from OpenFDA and the NIH National Library of Medicine.

Total: 2
Contraindicated: 1
Moderate: 1

Contraindicated (1)

Levacetylleucine + N-Acetyl-Dl-Leucine— Avoid concomitant use. N-acetyl-DL-leucine competes with levacetylleucine for monocarboxylate transporter uptake, which …

Moderate (1)

Levacetylleucine + P-Gp Or Bcrp Substrates— Monitor more frequently for P-gp substrate related adverse reactions when used concomitantly with levacetylleucine. Leva…

Levacetylleucine + N-Acetyl-Dl-Leucine⛔Contraindicated

Avoid concomitant use. N-acetyl-DL-leucine competes with levacetylleucine for monocarboxylate transporter uptake, which may reduce levacetylleucine efficacy.

Levacetylleucine + P-Gp Or Bcrp Substrates🟡Moderate

Monitor more frequently for P-gp substrate related adverse reactions when used concomitantly with levacetylleucine. Levacetylleucine inhibits P-gp, though clinical significance not fully characterized.

Contraindications

4 CONTRAINDICATIONS None. None. ( 4 )

Pregnancy & Breastfeeding

8.1 Pregnancy Risk Summary Based on findings from animal reproduction studies, AQNEURSA may cause embryo-fetal harm when administered during pregnancy. In animal reproduction studies, an increase in embryo-fetal death (post implantation loss/resorption), decrease in fetal body weight, and increase in external and skeletal malformations were observed in rats and rabbits when levacetylleucine was administered in pregnant rats and rabbits during the period of organogenesis. These effects were observed in rats and rabbits at the doses that were approximately 1.4-fold and 6-fold, respectively, the maximum recommended human dose (MRHD) in patients taking 4 grams of AQNEURSA per day ( see Data ). There are no available data on AQNEURSA use in pregnant females to evaluate a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. Advise a pregnant female of the potential risk to the fetus. The decision to continue or discontinue AQNEURSA treatment during pregnancy should consider the female’s need for AQNEURSA, the potential drug-related risks to the fetus, and the potential adverse outcomes from untreated maternal disease. The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, miscarriage, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Animal Data In a dose-range finding rat embryo-fetal development study, doses of up to 1000 mg/kg/day oral levacetylleucine were administered daily to pregnant females during organogenesis (Gestation Day [GD] 6 through GD 17). Increases in the mean number of resorptions, mean post-implantation losses and skeletal malformations (thoracic arch of the vertebra-fused thoracic arch, misaligned thoracic arch, hemicentric thoracic centrum, and m

Data sourced from U.S. FDA drug labeling via openFDA and the NIH National Library of Medicine. For informational purposes only. Always consult your pharmacist or physician.