Chemical formula: C₈H₁₅NO₃ Molecular mass: 173.105 g/mol PubChem compound: 70912
Levacetylleucine interacts in the following cases:
The potential inhibitory effect of levacetylleucine on multidrug and toxin extrusion proteins (MATE) transporters is unknown; therefore, caution is advised when co-administering levacetylleucine with substrates of MATE transporters.
Levacetylleucine may be an inhibitor of P-glycoprotein (P-gp), breast cancer resistance protein (BCRP) or bile salt export pump (BSEP). The relevance to humans is uncertain. A potential interaction of levacetylleucine with other medicinal products that are substrates of P-gp (e.g. digoxin, dabigatran, loperamide, irinotecan, doxorubicin, vinblastine, paclitaxel, fexofenadine, seliciclib, quinidine, talinolol), BCRP (e.g. sulfasalazine, rosuvastatin) or BSEP cannot be excluded.
Caution should be exercised when levacetylleucine is co-administered with BSEP substrates.
An interaction of levacetylleucine (N-acetyl-L-leucine) with N-acetyl-DL-leucine and N-acetyl-D-leucine has been identified in pharmacology studies indicating that N-acetyl-D-leucine may compete with levacetylleucine for uptake by the monocarboxylate transporters. Concomitant use of levacetylleucine with N-acetyl-DL-leucine and N-acetyl-D-leucine should be avoided.
There are no data on the use of levacetylleucine in pregnant women. Studies in animals have shown reproductive toxicity.
Levacetylleucine is not recommended during pregnancy and in women of childbearing potential not using contraception.
It is unknown whether levacetylleucine or metabolites of levacetylleucine are excreted in human milk. A risk to the newborns and infants cannot be excluded.
A decision must be made as to whether to discontinue breast-feeding or to discontinue/abstain from levacetylleucine therapy, taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
No human data on the effect of levacetylleucine on fertility is available. Animal studies indicate no effects of levacetylleucine on male or female fertility.
Levacetylleucine has no or negligible influence on the ability to drive and use machines.
The most common adverse reaction, with a frequency of 1.2%, is flatulence.
Adverse reactions observed during the placebo-controlled, randomised, crossover clinical study and the open-label, rater-blinded study, including extension phase, in patients with NPC are based on a total of 84 patients with a median treatment duration of 86 days. Within the system organ classes, adverse reactions are listed according to the following frequency categories: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1 000 to <1/100), rare (≥1/10 000 to <1/1 000), very rare (<1/10 000), not known (cannot be estimated from the available data).
Adverse reactions in patients with Niemann-Pick Type C treated with levacetylleucine:
| System Organ Class | Frequency | Adverse reaction |
| Gastrointestinal disorder | Common | Flatulence |
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