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Aqneursa
levacetylleucine
Adult Dosing .
Dosage forms: GRANULE: 1 g per pkt
Niemann-Pick dz, type C
- [25-34 kg]
- Dose: 1 g PO tid
- [>35 kg]
- Dose: 2 g PO qam and 1 g PO every afternoon and 1 g PO qpm
renal dosing
- [not defined]
- renal impairment: not defined
- HD/PD: not defined
hepatic dosing
- [not defined]
Peds Dosing .
- Dosage forms: GRANULE: 1 g per pkt
Niemann-Pick dz, type C
- [15-24 kg]
- Dose: 1 g PO bid
- [25-34 kg]
- Dose: 1 g PO tid
- [>35 kg]
- Dose: 2 g PO qam and 1 g PO every afternoon and 1 g PO qpm
renal dosing
- [not defined]
- renal impairment: not defined
- HD/PD: not defined
hepatic dosing
- [not defined]
Contraindications / Cautions .
- hypersensitivity to drug or ingredient
- caution: pts of childbearing potential
Drug Interactions .
Overview
levacetylleucine
leucine analog
- P-gp inhibitor, weak
- avoid combo w/ N-acetyl-DL-leucine or N-acetyl-D-leucine; competition for transporter uptake may decr. levacetylleucine efficacy
Contraindicated
- colchicine
Avoid/Use Alternative
- apixaban
- dabigatran
- ensartinib
- futibatinib
- neratinib
- pralsetinib
- relugolix
- repotrectinib
- rivaroxaban
- sirolimus albumin-bound
- topotecan
- venetoclax
Monitor/Modify Tx
- afatinib
- atorvastatin
- cyclosporine
- digoxin
- edoxaban
- enfortumab vedotin
- everolimus
- mavorixafor
- morphine
- quinidine (antiarrhythmic)
- ranolazine
- sirolimus
- tacrolimus
- talazoparib
- tenofovir alafenamide
- tenofovir disoproxil
- ubrogepant
Caution Advised
- darolutamide
- glecaprevir
- naldemedine
- pibrentasvir
Adverse Reactions .
Serious Reactions
may occur but none reported
Common Reactions
- URI
- abdominal pain
- dysphagia
- vomiting
Safety/Monitoring .
Monitoring Parameters
pregnancy test at baseline
Pregnancy/Lactation .
Pregnancy
Clinical Summary
weigh risk/benefit during pregnancy; no human data available; risk of fetal harm, incl. teratogenicity and embryo-fetal death, based on animal data at 1.4x and 6x MRHD
Individuals of Reproductive Potential
obtain pregnancy test before tx start; avoid pregnancy by using effective contraception during tx and for 7 days after D/C in pts of childbearing potential
Lactation
Clinical Summary
weigh risk/benefit while breastfeeding; no human data available to assess risk of infant harm or effects on milk production
Pharmacology .
Metabolism: tissues; CYP450: none
Excretion: unknown; Half-life: 1h
Subclass: Inherited Metabolic Disorders
Mechanism of Action
exact mechanism of action unknown
Formulary .
No Formulary Selected
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