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Aqneursa (Levacetylleucine): Uses, Side Effects and Dosage

Updated:
Facts
Status:
Prescription (Rx)
Strength:
1000 mg
Active ingredient:

Patient information: uses, side effects, how to take - Aqneursa

INSTRUCTIONS FOR USE

AQNEURSA® [ak nur' sah]

(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)
Preparing AQNEURSA Oral Suspension
Step 1: Wash and dry your hands.

Step 2: Open and empty the entire contents of 1 AQNEURSA packet into a container with 40 mL of:

  • water, orange juice, almond milk, or yogurt (when taken by mouth), or
  • water only when given through a G-tube.

Do not use hot liquid.

Step 3: Stir to form the suspension.

Note:

  • Go to Step 4 for taking AQNEURSA oral suspension by mouth, or
  • Go to Step 6 for giving AQNEURSA oral suspension through a gastrostomy tube (G-tube).
Taking AQNEURSA Oral Suspension by Mouth

Step 4: Swallow AQNEURSA oral suspension right away (within 30 minutes).

Throw away (dispose of) unused AQNEURSA oral suspension if not taken within 30 minutes.

Step 5: If your prescribed dose requires 2 AQNEURSA packets, repeat Steps 1 through 4.
Giving AQNEURSA Oral Suspension Through a Gastrostomy Tube (G-tube)
  • Give AQNEURSA oral suspension through a G-tube that is a French size of 12 or larger.
  • Follow Steps 1 through 3 to prepare AQNEURSA oral suspension.

Note: Only use 40 mL of water for preparing AQNEURSA oral suspension when given through G-tube.

Step 6: Draw up the prepared AQNEURSA oral suspension into a catheter tip syringe.

Step 7: Inject the AQNEURSA oral suspension through the G-tube right away.

Throw away (dispose of) unused AQNEURSA oral suspension if not given right away.

Step 8: Refill the syringe with an additional 20 mL water.
Step 9: Flush the G-tube with water, until no remaining AQNEURSA oral suspension is seen in the syringe or G-tube.
Step 10: If your prescribed dose requires 2 AQNEURSA packets, follow Steps 1 through 3 to prepare the AQNEURSA oral suspension, then repeat Steps 6 through 9.

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 ® is a registered trademark of IntraBio.

This Instructions for Use has been approved by the U.S. Food and Drug Administration.

Issued: 9/2026

About this document

Source: FDA drug labeling via NLM DailyMed · Application number: NDA 219132 · View the label on DailyMed

Revision date stated in the text: September 2026

Found a mistake? Write to us via the contact page.

The information on this site does not replace the advice of a doctor or pharmacist.

Drug information for Aqneursa

Rx or OTC
Prescription (Rx)?
  • This drug is available only with a prescription from a licensed healthcare provider.
  • Rx
Active ingredient Levacetylleucine 1000 mg
Dosage form Granule, for suspension
Route Oral
Marketing status not in the current FDA NDC Directory
Company (applicant) INTRABIO
FDA approval NDA 219132New Drug Application (NDA) Approved September 24, 2024
Reference listed drug This is the reference listed drug (RLD) that generics are compared with.
Manufacturers 1 labelers list this drug on DailyMed
Packages (NDC)
Package
1000 mg – 1 in 1 packet / 28 in 1 carton NDC 83853-101-01

Source: FDA drug labeling via NLM DailyMed, data as of October 31, 2026. FDA data (DailyMed, Orange Book, Drug Shortages, enforcement reports). Not a substitute for the advice of a doctor or pharmacist.