Description
Levacetylleucine is used to treat the neurologic symptoms of Niemann-Pick disease type C (NPC).
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Powder for Suspension
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of levacetylleucine in children weighing less than 15 kilograms (kg). Safety and efficacy have not been established.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of levacetylleucine in the elderly.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Acetylleucine
- N-Acetyl-D-Leucine
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Proper Use
Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.
This medicine comes with a patient instructions. Read and follow these instructions carefully. Ask your doctor if you have any questions.
You may take this medicine with or without food.
To prepare the suspension:
- Wash your hands before and after using this medicine.
- Open and empty the packet into a container with 40 milliliters (mL) of liquid (eg, water, orange juice, or almond milk). Do not use hot liquid.
- Stir the mixture. Swallow the oral liquid right away (within 30 minutes). Throw away any unused mixture if not taken within 30 minutes.
You may also give the medicine through a gastrostomy tube (G-tube):
- Wash your hands before and after using this medicine.
- Open and empty the packet into a container with 40 milliliters (mL) of water. Do not use hot water.
- Stir the mixture. Draw the prepared medicine using a catheter tip syringe. Inject the liquid mixture through the G-tube right away. Throw away any unused mixture if not given right away.
- Add 20 mL of water and flush the tube until no remaining medicine is seen in the syringe or tube.
Dosing
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For oral dosage form (suspension):
- For Niemann-Pick disease type C:
- Adults and children weighing 15 kilograms (kg) or more—Dose is based on body weight and must be determined by your doctor.
- Weighing 35 kilograms (kg) or more—2 grams (g) in the morning, 1 g in the afternoon, and 1 g in the evening.
- Weighing 25 kg to less than 35 kg—1 g in the morning, 1 g in the afternoon, and 1 g in the evening.
- Weighing 15 kg to less than 25 kg—1 g in the morning and 1 g in the evening.
- Children weighing less than 15 kg—Use and dose must be determined by your doctor.
- Adults and children weighing 15 kilograms (kg) or more—Dose is based on body weight and must be determined by your doctor.
- For Niemann-Pick disease type C:
Missed Dose
If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Storage
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Mix the expired packets or unused mixture with dirt, cat litter, or used coffee grounds. Place the mixture in a sealed plastic bag and throw away in your household trash.
Precautions
It is very important that your doctor check your or your child's progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.
Using this medicine while you are pregnant can harm your unborn baby. If you can get pregnant, your doctor may give you a pregnancy test before you start using this medicine to make sure you are not pregnant. Use an effective form of birth control during treatment and for at least 7 days after the last dose. If you think you have become pregnant, tell your doctor right away.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
More common
- Body aches or pain
- chills
- cough
- ear congestion
- fever
- headache
- loss of voice
- sneezing
- sore throat
- stuffy or runny nose
- trouble breathing
- unusual tiredness or weakness
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
- Difficulty swallowing
- stomach pain
- vomiting
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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