Levacetylleucine

Levacetylleucine is used to treat neurological issues related to Niemann-Pick disease type C (NPC) in adults and children who weigh at least 15 kg (33 pounds).

Levacetylleucine may also be used for reasons not mentioned in this medication guide.

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.

Use only as directed. Inform your doctor if you are taking other medicines or if you have other medical conditions or allergies.

Tell your doctor if you have any health problems or if you are taking any other medications.

You may need to take a pregnancy test that shows a negative result before starting this treatment.

Levacetylleucine can harm an unborn baby. You should use effective birth control while taking 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 your doctor if it is safe to breastfeed while taking levacetylleucine.

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

Less serious side effects may happen more often, or you might not have any at all.

Common side effects of levacetylleucine may include:

• cold symptoms like a 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.

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

Skip the missed dose and take your next dose at the usual time. Do not take two doses at once.

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

Follow your doctor's instructions about any restrictions on food, drinks, or activities.

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.