Triheptanoin (trye-HEP-ta-noyn)

Treats genetic metabolic disorders called long-chain fatty acid oxidation disorders.

Brand Name(s):

Dojolvi

When This Medicine Should Not Be Used:

How to Use This Medicine:

Liquid

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• It is best to take this medicine with food or milk. Mix this medicine with semi-solid food or other liquids (including fat free yogurt, milk, formula, or cottage cheese, whole grain cereal, fat free low carbohydrate pudding, smoothies, applesauce, or baby food) using a silicone or polyurethane feeding tube. Take this mixture within 24 hours.
• Measure the oral liquid medicine with a marked measuring spoon, oral syringe, or medicine cup.
• Mix or give this medicine using certain containers (including stainless steel, glass, polyethylene, polypropylene, polyurethane, silicone). Do not use this medicine with polystyrene or PVC plastic. Do not add this medicine to the feeding bag.
• Feeding tube:
  • Using a slip tip syringe, inject the mixed solution into the feeding tube port.
  • Flush the feeding tube port with about 5 to 30 milliliters (mL) of water to get all of the medicine.
  • Throw away any unused mixed solution. Do not save for later use.
• Carefully follow your doctor's instructions about any special diet.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose. Take the missed doses 3 to 4 hours apart. If it is not possible to take all of the scheduled doses for the day, skip the missed dose and go back to your regular dosing schedule.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Store the opened bottles for up to 9 months after first opening it. Do not freeze.
• You may store the unused mixture for up to 24 hours in the refrigerator. Throw away unused mixture if not used within 24 hours. Do not store for later use.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how triheptanoin works. Tell your doctor if you are using medicine to treat obesity (including orlistat).

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have pancreas problems.
• This medicine may cause the following problems:
  • Feeding tube problems
  • Stomach or bowel problems (including absorption problems)
• Your doctor will check your progress and the effects of this medicine at regular visits. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing

If you notice these less serious side effects, talk with your doctor:

• Stomach pain or discomfort, diarrhea, nausea, vomiting

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088