Levacetylleucine Dosage

Medically reviewed by Drugs.com. Last updated on Dec 17, 2024.

Applies to the following strengths: 1 g

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

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Precautions

CONTRAINDICATIONS: None

Safety and efficacy have not been established in pediatric patients weighing less than 15 kg.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

Administer with or without food.
Negative pregnancy status should be verified in females of childbearing potential prior to initiating therapy.
Swallow the suspension within 30 minutes of preparation and discard unused suspension if not administered within that time.
If a dose is missed, skip it and take the next dose at the scheduled time. Do not take 2 doses at the same time to make up for a missed dose.
For patients with a G-tube (French size 18 or larger), prepare suspension by mixing the contents of one packet with 40 mL of water only. Do not use hot liquid. Administer immediately via a catheter tip syringe, flush the G-tube with 20 mL of water, and discard any unused suspension if not administered immediately. Repeat the process for doses requiring two packets.

Storage requirements:

At room temperature between 20C to 25C (68F to 77F) with excursion permitted between 15C to 30C (59F to 86F).

Reconstitution/preparation techniques:

For oral use: Use the entire contents of the packet to form a suspension in water, orange juice, or almond milk. Do not use hot liquid.
For G-tube administration: Only use water when preparing packet(s).
For 2 grams doses, prepare two packets of this drug individually.
The manufacturer product information should be consulted.

Patient advice:

Read the US FDA-approved patient labeling (Instructions for Use).
Females of reproductive potential should use effective contraception during treatment and for 7 days after the last dose.
Females of reproductive potential and their caregivers should inform their healthcare provider if they are pregnant or suspect pregnancy during therapy.