This medication is used to treat certain inherited disorders (long-chain fatty acid oxidation disorders- LC-FAOD). People with LC-FAOD cannot break down certain nutrients (fatty acids) to use as energy due to the lack of certain enzymes. Triheptanoin is not a cure for LC-FAOD but is a medium-chain triglyceride that works by providing fatty acids and energy to the body.

Read the Patient Information Leaflet and Instructions for Use leaflet if available from your pharmacist before you start taking this medication and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

If you are taking any other medium-chain triglycerides, your doctor will direct you to stop that medication before starting triheptanoin. Consult your doctor or pharmacist for more details.

Take this medication with food by mouth or through a feeding tube as directed by your doctor, usually four times daily. This medication should be taken at 3- or 4-hour intervals, with meals or snacks.

Carefully measure the dose using a special measuring device/spoon. Do not use a household spoon because you may not get the correct dose. Use only cups, containers, spoons, or oral syringes that are safe to use with triheptanoin as described in the Instructions for Use leaflet. Add the measured dose to a container and mix with soft food or liquid (such as whole-grain hot cereal, fat-free yogurt/milk/formula/cottage cheese, or fat-free low-carbohydrate pudding/smoothies/applesauce/baby food) as directed by your doctor. Take all of the mixture right away. If not taken right away, the mixture may be stored in the refrigerator for up to 24 hours.

If you are giving this medication through a feeding tube, ask your health care professional which feeding tubes are safe to use with triheptanoin, and for detailed instructions on how to properly mix and give it.

To reduce your risk of side effects, your doctor may direct you to start this medication at a low dose and gradually increase your dose. Follow your doctor's instructions carefully.

Use this medication regularly to get the most benefit from it. To help you remember, take it at the same times each day. Do not increase your dose or use this drug more often or for longer than prescribed. Your condition will not improve any faster, and your risk of side effects will increase.

It is very important to continue to follow your doctor's advice about diet while using this medication.

Stomach/abdominal pain, diarrhea, nausea, or vomiting may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before taking triheptanoin, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• intestinal disease (such as pancreatic insufficiency)

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this medication passes into breast milk. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

A product that may interact with this drug is:

• orlistat

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

Do not share this medication with others.

If you miss a dose, take it as soon as you remember and take the following doses at 3- or 4-hour intervals. Skip the missed dose if you cannot take all the prescribed doses in the same day. Do not double the dose to catch up.

Store at room temperature. Do not freeze. Keep the bottle upright. Do not store in containers made of polystyrene or polyvinyl chloride (PVC). Ask your doctor or pharmacist for more details. Once the bottle is opened, this medication expires after 9 months. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.