Levacetylleucine

Levacetylleucine is a prescription medication indicated for the treatment of neurological manifestations of Niemann-Pick disease type C (NPC) in adults and pediatric patients weighing 15 kg and more.

• Levacetylleucine is available under the following different brand names: Aqneursa, N-acetyl-L-leucine.

Common side effects of Levacetylleucine include:

• abdominal pain
• difficulty swallowing 
• upper respiratory tract infections 
• vomiting

Serious side effects of Levacetylleucine include:

• not available

Rare side effects of Levacetylleucine include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors.
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights.
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult and pediatric dosage

Oral suspension

• 1 gram/unit-dose packet

Niemann-pick disease

Adult dosage

• Use actual body weight to calculate the dose
• Adults weighing 35 kg and more
• Morning: 2 grams orally
• Afternoon: 1 gram orally
• Evening: 1 gram orally

Pediatric dosage

• Use actual body weight to calculate the dose
• Children weighing between 15 kg to less than 25 kg: 1 gram orally two times a day (morning and evening)
• Children weighing between 25 kg to less than 35 kg: 1 gram orally three times a day (morning, afternoon, and evening)
• Children weighing 35 kg and more
• Morning: 2 grams orally
• Afternoon: 1 gram orally
• Evening: 1 gram orally

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Levacetylleucine has severe interactions with no other drugs
• Levacetylleucine has serious interactions with no other drugs
• Levacetylleucine has moderate interactions with no other drugs
• Levacetylleucine has minor interactions with no other drugs

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• None

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Levacetylleucine?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Levacetylleucine?”

Cautions

• May cause embryo-fetal harm when administered during pregnancy; advise pregnant women of potential fetal risk
• Drug interaction overview
  • N-acetyl-DL-leucine and N-acetyl-D-leucine
    • Avoid coadministration
  • The D-enantiomer, N-acetyl-D-leucine, competes with levacetylleucine for monocarboxylate transporter uptake, which may reduce levacetylleucine efficacy
  • P-gp substrates
    • Monitor
    • levacetylleucine inhibits P-gp; however, the clinical significance of this finding has not been fully characterized
    • Monitor P-gp substrate more frequently for adverse effects

Pregnancy and Lactation

• Based on findings from animal reproduction studies, may cause embryofetal harm when administered during pregnancy
• Advise pregnant women of potential fetal risk
• Consider the patient's need for therapy and potential drug-related fetal risks if deciding to continue or discontinue treatment during pregnancy
• Verify females of reproductive potential are not pregnant before initiating treatment
• Contraception
  • Advise females of reproductive potential to use effective contraception during treatment and for 7 days after the last dose
• Lactation
  • There are no data regarding the presence of levacetylleucine in human or animal milk, its effects on breastfed infants, milk production
  • Consider the developmental and health benefits of breastfeeding along with the patient’s clinical need for therapy and any potential adverse effects on breastfed infants or from the underlying maternal condition