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Brand Name
Aqneursa
Generic Name
Levacetylleucine
View Brand Information FDA approval date: September 24, 2024
Form: Granule
What is Aqneursa (Levacetylleucine)?
AQNEURSA™ is indicated for the treatment of neurological manifestations of Niemann-Pick disease type C in adults and pediatric patients weighing ≥15 kg. AQNEURSA is indicated for the treatment of neurological manifestations of Niemann-Pick disease type C in adults and pediatric patients weighing ≥15 kg.
Approved To Treat
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Brand Information
AQNEURSA (levacetylleucine)
1DOSAGE FORMS AND STRENGTHS
For oral suspension: 1 gram levacetylleucine as white to off-white strawberry flavored granules in a unit-dose packet.
2CONTRAINDICATIONS
None.
3DESCRIPTION
AQNEURSA (levacetylleucine) for oral suspension contains the drug substance levacetylleucine, a modified amino acid. Levacetylleucine is slightly soluble in aqueous solutions. The chemical name is 2-acetamido-4-methylpentanoic acid. The empirical formula is C
Each packet of AQNEURSA granules contains 1 gram levacetylleucine and the inactive ingredients hypromellose, isomalt and strawberry flavor.
4HOW SUPPLIED/STORAGE AND HANDLING
How Supplied
AQNEURSA (levacetylleucine) for oral suspension is supplied as white to off-white granules in a unit-dose multi-layer aluminum/polyethylene packet. Each packet contains 1.7 gram white to off-white granules, equivalent to 1 gram levacetylleucine.
NDC 83853-101-01: Carton containing 28 unit-dose packets
Storage and Handling
Store AQNEURSA at room temperature between 20°C to 25°C (68°F to 77°F); excursion permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].
5PATIENT COUNSELING INFORMATION
Advise the patient and/or caregiver to read the FDA-approved patient labeling (Instructions for Use).
Embryo-Fetal Toxicity
AQNEURSA may cause embryo-fetal harm. Advise a pregnant female of the potential risk to the fetus. Advise a female of reproductive potential and caregiver to inform their healthcare provider of a known or suspected pregnancy
Distributed by: IntraBio Inc., Austin TX 78701
AQNEURSA
© 2026 IntraBio, Inc. All rights reserved.
6INSTRUCTIONS FOR USE
AQNEURSA
(levacetylleucine)
for oral suspension
This Instructions for Use contains information on how to prepare and take or give AQNEURSA oral suspension. Read this Instructions for Use before you prepare and take or give the first dose of AQNEURSA oral suspension and each time you get a refill. There may be new information. This Instructions for Use does not take the place of talking to you or your child’s healthcare provider about your or your child’s medical condition or treatment.
Important Information You Need to Know Before Taking or Giving AQNEURSA Oral Suspension
- Take or give AQNEURSA oral suspension exactly as instructed by your healthcare provider.
- Take or give AQNEURSA oral suspension with or without food.
- AQNEURSA oral suspension can be taken or given by mouth or through a gastrostomy tube (G-tube) feeding tube (French size 12 or larger).
- Do not use hot liquid with AQNEURSA oral suspension.
- For instructions on disposing of expired AQNEURSA packets or unused AQNEURSA oral suspension, see the end of this Instructions for Use.
Supplies Needed to Prepare and Take or Give AQNEURSA Oral Suspension
Gather the following supplies on a clean flat surface:
- the number of AQNEURSA packets needed for your prescribed dose
- a clean spoon
- a container
- a measuring cup from your pharmacist
- 40 mL of water, orange juice, almond milk, or yogurt
- catheter tip syringe (if giving AQNEURSA oral suspension through G-tube)
Storing AQNEURSA
- Store AQNEURSA at room temperature between 68°F to 77°F (20°C to 25°C).
- Keep AQNEURSA oral suspension and all medicines out of reach of children.
Disposing of Expired AQNEURSA Packets or Unused AQNEURSA Oral Suspension
Throw away (dispose of) expired AQNEURSA packets or unused AQNEURSA oral suspension following the steps below:
- Mix medicine with a substance such as dirt, cat litter, or used coffee grounds.
- Place the mixture in a container such as a sealed plastic bag.
- Throw away (dispose of) the container in your household trash.
Distributed by: IntraBio Inc., Austin, TX 78701
AQNEURSA
This Instructions for Use has been approved by the U.S. Food and Drug Administration.
Issued: 9/2026
7PRINCIPAL DISPLAY PANEL
