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

Oral administration: preparation of the suspension

“Obtain the required number of AQNEURSA packets for the prescribed dose (one or two packets).” (opens the prescribing information at this quote)
“Open and empty the entire contents of one AQNEURSA packet into a container with 40 mL of water, orange juice, almond milk, or yogurt. Do not use hot liquid.” (opens the prescribing information at this quote)
“Stir to form a suspension.” (opens the prescribing information at this quote)
“Swallow the suspension immediately (within 30 minutes).” (opens the prescribing information at this quote)
“For doses requiring two AQNEURSA packets, repeat steps 2 to 4.” (opens the prescribing information at this quote)
“Discard unused AQNEURSA suspension if not administered within 30 minutes.” (opens the prescribing information at this quote)

Gastrostomy tube administration

“For patients who have a G-tube (French size 12 or larger) in place, administer AQNEURSA as follows:” (opens the prescribing information at this quote)
“Prepare AQNEURSA suspension immediately before administration via gastrostomy tube.” (opens the prescribing information at this quote)
“Open and empty the entire contents of one AQNEURSA packet into a container with 40 mL of water ONLY. Do not use hot liquid.” (opens the prescribing information at this quote)
“Draw up the suspension into a catheter tip syringe.” (opens the prescribing information at this quote)
“Administer the suspension immediately through the G-tube.” (opens the prescribing information at this quote)
“Flush any residual suspension in the catheter tip syringe with an additional 20 mL of water.” (opens the prescribing information at this quote)
“For doses requiring two AQNEURSA packets, repeat steps 3 to 8.” (opens the prescribing information at this quote)
“Discard unused AQNEURSA suspension if not administered immediately.” (opens the prescribing information at this quote)

Administration with respect to food: European Union labeling and planned food effect study

“Food and drink should be avoided 0.5 hours before and 2 hours after administration (see section 5.2).” (opens the source at this quote in a new tab)

“Although, no formal PK study was performed to investigate the effect of food on levacetylleucine PK, in both studies IB1001-201 and IB1001-301, levacetylleucine was advised to be taken 0.5 h before or 2 h after a meal.” (opens the source at this quote in a new tab)
“The Applicant committed to conduct and submit the results (when available) of a food effect PK study (planned in 2026) (REC) and drug-drug interaction study (REC).” (opens the source at this quote in a new tab)

European Union administration: dispersion in water and gastrostomy tube size

“The content of one sachet should be poured into 40 mL (3 tablespoons) of water and stirred until fully dispersed.” (opens the source at this quote in a new tab)
“Aqneursa may be administered via gastrostomy tube (French size 18 or larger).” (opens the source at this quote in a new tab)
“The enteral feeding should be stopped if the patient is on continuous feeding.” (opens the source at this quote in a new tab)

Dispersion of two packets at once: outstanding quality recommendation

“The applicant is recommended to conduct an experiment of dispersion of two sachets in 80 mL of liquid at the same time by September 2025 (REC2).” (opens the source at this quote in a new tab)