Name: Aqneursa (levacetylleucine) in Ataxia-telangiectasia: Dosage
Published: 2026-10-02T18:22:10-04:00

Product information and disease description Product description Product information Dosing and administration

Dosage

6 evidence topics · 2 sources

Recommended dosage by body weight

Body weight	Morning dose	Afternoon dose	Evening dose
15 kg to less than 25 kg	“1 gram”	“No Dose”	“1 gram”
25 kg to less than 35 kg	“1 gram”	“1 gram”	“1 gram”
35 kg or more	“2 grams”	“1 gram”	“1 gram”

Basis of the dosage and packet strength

“The recommended dosage of AQNEURSA to be administered orally, with or without food, is based on the patient’s actual body weight (kg), as shown in Table 1” (opens the prescribing information at this quote)
“One AQNEURSA packet contains 1 gram levacetylleucine.” (opens the prescribing information at this quote)
“For AQNEURSA doses of 2 grams, prepare two packets individually” (opens the prescribing information at this quote)
“The approved dosage regimen is based on body weight and not age.” (opens the prescribing information at this quote)

Pregnancy status before treatment initiation

“For females of reproductive potential, verify that the patient is not pregnant” (opens the prescribing information at this quote)

Missed dose

“If a dose of AQNEURSA is missed, skip the missed dose and take the next dose at the scheduled time. Do not take 2 doses at the same time to make up for a missed dose.” (opens the prescribing information at this quote)

Dosage studied in the A-T trial

“Patients weighing ≥35 kg received 4 gram per day (as 2 gram morning dose, 1 gram afternoon dose, and 1 gram evening dose).” (opens the prescribing information at this quote)

Dose rationale: European assessment

“No dose-finding study has been performed by the Applicant. The selection of the dose was purely based on non-clinical data and experience gained from off-label use of racemate N-acetyl-DL-leucine.” (opens the source at this quote in a new tab)
“The Applicant justified the different morning dose of 2 g by the need for a loading dose after no dose overnight.” (opens the source at this quote in a new tab)
“Based on a simulation exercise for children aged 6-12 years and weighing 20-25 kg or 25 to 35 kg, the total daily dose of 2 g and 3 g respectively can be considered acceptable based on matching exposure (AUC24h).” (opens the source at this quote in a new tab)
“The CHMP agreed that the dose of 4 g/day for adults and children weighing at least 35 kg has been demonstrated in both non-clinical and clinical studies to be safe and well-tolerated.” (opens the source at this quote in a new tab)