Generic name: levacetylleucine
Brand name: Aqneursa
Dosage form: oral granule for reconstitution (1 g)
Drug class: Miscellaneous metabolic agents

Medically reviewed by Drugs.com on Dec 17, 2024. Written by Cerner Multum.

What is levacetylleucine?

Levacetylleucine is used to treat neurological problems associated with Niemann-Pick disease type C (NPC) in adults and children weighing at least 15 kg (33 pounds).

Levacetylleucine may also be used for purposes not listed in this medication guide.

Levacetylleucine side effects

Get emergency medical help if you have signs of an allergic reaction: hives, difficult breathing, swelling of your face, lips, tongue, or throat.

Less serious side effects may be more likely, or you may have none at all.

Common side effects of levacetylleucine may include:

• cold symptoms such as stuffy nose, sneezing, sore throat;

• stomach pain;

• vomiting; or

• trouble swallowing.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Related/similar drugs

Warnings

Use only as directed. Tell your doctor if you use other medicines or have other medical conditions or allergies.

Before taking this medicine

Tell your doctor if you have or ever had health problems or use other medications.

You may need to have a negative pregnancy test before starting this treatment.

Levacetylleucine may harm an unborn baby. You should use effective birth control while using levacetylleucine and for at least 7 days after your last dose. Tell your doctor if you become pregnant or think you may be pregnant.

Ask a doctor if it is safe to breastfeed while using levacetylleucine.

How should I take levacetylleucine?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Levacetylleucine is usually taken up to three times per day. You may take levacetylleucine with or without food. Follow your doctor's instructions.

Doses are based on weight. Your dose may change if you gain or lose weight.

Read and carefully follow the Instructions for Use provided with your medicine before preparing and giving your first dose. Ask your doctor or pharmacist if you do not understand these instructions.

Be sure you understand how to properly mix this medicine with a liquid (diluent). You may need more than one levacetylleucine powder packet to receive the full dose.

Mix and stir the levacetylleucine powder with 40 mL of a cold or room temperature beverage such as water, almond milk, or orange juice and drink right away. Do not mix with hot liquid. Levacetylleucine can also be given through a feeding tube. Do not store the mixture for later use.

Store at room temperature away from moisture and heat.

Levacetylleucine dosing information

Usual Adult Dose for Niemann-Pick Disease Type C:

Weight 15 to less than 25 kg:
-Morning dose: 1 gram orally once a day
-Evening dose: 1 gram orally once a day

Weight 25 to less than 35 kg:
-Morning dose: 1 gram orally once a day
-Afternoon dose: 1 gram orally once a day
-Evening dose: 1 gram orally once a day

Weight at least 35 kg:
-Morning dose: 2 grams orally once a day
-Afternoon dose: 1 gram orally once a day
-Evening dose: 1 gram orally once a day

Use: For the treatment of neurological manifestations of Niemann-Pick disease type C in patients weighing at least 15 kg

Usual Pediatric Dose for Niemann-Pick Disease Type C:

Weight 15 to less than 25 kg:
-Morning dose: 1 gram orally once a day
-Evening dose: 1 gram orally once a day

Weight 25 to less than 35 kg:
-Morning dose: 1 gram orally once a day
-Afternoon dose: 1 gram orally once a day
-Evening dose: 1 gram orally once a day

Weight at least 35 kg:
-Morning dose: 2 grams orally once a day
-Afternoon dose: 1 gram orally once a day
-Evening dose: 1 gram orally once a day

Use: For the treatment of neurological manifestations of Niemann-Pick disease type C in patients weighing at least 15 kg

What happens if I miss a dose?

Skip the missed dose and use your next dose at the regular time. Do not use two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking levacetylleucine?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

What other drugs will affect levacetylleucine?

Tell your doctor about all your other medicines, especially:

• N-acetyl-leucine supplements.

This list is not complete. Other drugs may affect levacetylleucine, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Further information

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer

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