Dojolvi is a synthetic is a medium chain triglyceride containing three odd-chain fatty acid molecules.

Dojolvi is a prescription medicine used to treat long-chain fatty acid oxidation disorders in adults and children.

Long-chain fatty acid oxidation disorders are rare genetic disorders that affect the body's ability to break down certain fats and convert them into energy. This can lead to low blood sugar, muscle weakness, heart problems, or life-threatening medical problems.

Before taking Dojolvi, tell your healthcare provider if you are taking a pancreatic lipase inhibitor, such as orlistat (Xenical), as it may affect how well Dojolvi works.

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Before taking this medicine

To make sure Dojolvi is safe for you, tell your doctor if you have ever had: problems with your pancreas. Dojolvi may not work as well if your digestion is affected by a pancreas disorder.

Tell your doctor if you are pregnant or breastfeeding.

If you are pregnant, you may be enrolled in a pregnancy safety study to track the effects of triheptanoin on the baby.

Take Dojolvi exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

If you are taking another medium chain triglyceride product, stop taking it before you start taking Dojolvi.

Dojolvi is usually taken at least 4 times per day with meals or snacks. Follow your doctor's dosing instructions very carefully.

Dojolvi should always be mixed well with liquid or soft food. Do not take the medicine alone or it may upset your stomach. Examples of what to mix this medicine with include:

• fat-free yogurt (plain or flavored);

• fat-free pudding or smoothies;

• low-sugar applesauce;

• fat-free cottage cheese;

• skim (fat-free) milk;

• fat-free baby food; or

• whole grain hot cereal.

Read and carefully follow all instructions about mixing Dojolvi with liquid or soft foods, or how to mix and give the medicine through a feeding tube. Ask your doctor or pharmacist if you do not understand these instructions.

Always mix the medicine in a clean container.

Do not mix or store Dojolvi in any syringe, container or cup made of polystyrene plastic or polyvinyl chloride (PVC). Do not give this medicine through a feeding tube made of PVC.

You may have problems with your feeding tube the longer you keep using Dojolvi. Check your feeding tube frequently to make sure it is working properly.

You may need to follow a special diet while using Dojolvi. Follow all instructions of your doctor or dietitian. Learn about the foods to eat or avoid to help control your condition. You may also need to track the number of calories you consume each day while taking Dojolvi.

Store Dojolvi in the original container at room temperature, away from moisture and heat. Do not freeze.

Store mixed medicine in the refrigerator and use it within 24 hours.

Throw away any unused Dojolvi 90 days after you first opened the bottle or on the expiration date (whichever comes first).

Usual Adult Dose of Dojolvi for Functional Gastric Disorder:

Recommended total daily dose (mL) = patients DCI (kcal) x target % dose of DCI / 8.3 kcal/mL
-Round to nearest whole number
-Divide total daily dose into at least 4 approximately equal individual doses


Dose Initiation/Titration:

Patients not currently taking a medium chain triglyceride (MCT) product:
-Initiate at approximately 10% DCI divided into at least 4 individual doses.
-Increase to recommended total daily dose over 2 to 3 weeks.

Patients switching from another MCT product:
-Discontinue previous MCT before therapy initiation.
-Initiate at last tolerated MCT dose divided into at least 4 individual doses.
-Increase total daily dosage by approximately 5% DCI every 2 to 3 days until target dosage is achieved.


Comments:
-Assess metabolic requirements by determining daily caloric intake (DCI) prior to dose calculations.
-Recommended target is 35% of DCI.
-Caloric value of this product is 8.3 kcal/mL.

Usual Pediatric Dose of Dojolvi for Functional Gastric Disorder:

Recommended total daily dose (mL) = patients DCI (kcal) x target % dose of DCI / 8.3 kcal/mL
-Round to nearest whole number
-Divide total daily dose into at least 4 approximately equal individual doses


Dose Initiation/Titration:

Patients not currently taking a medium chain triglyceride (MCT) product:
-Initiate at approximately 10% DCI divided into at least 4 individual doses.
-Increase to recommended total daily dose over 2 to 3 weeks.

Patients switching from another MCT product:
-Discontinue previous MCT before therapy initiation.
-Initiate at last tolerated MCT dose divided into at least 4 individual doses.
-Increase total daily dosage by approximately 5% DCI every 2 to 3 days until target dosage is achieved.


Comments:
-Assess metabolic requirements by determining daily caloric intake (DCI) prior to dose calculations.
-Recommended target is 35% of DCI.
-Caloric value of this product is 8.3 kcal/mL.
-Neonates may require a higher fat intake and thus an increased dose of this product; consider current nutritional recommendations when dosing in this population.

To make sure Dojolvi is safe for you, tell your doctor if you have ever had: problems with your pancreas. Dojolvi may not work as well if your digestion is affected by a pancreas disorder.

Tell your doctor if you are pregnant or breastfeeding.

If you are pregnant, you may be enrolled in a pregnancy safety study to track the effects of triheptanoin on the baby.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Then take the rest of the day's doses every 3 to 4 hours.

Skip the missed dose if you cannot take all 4 doses in one day. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Get emergency medical help if you have signs of an allergic reaction to Dojolvi: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Common Dojolvi side effects may include:

• nausea, vomiting;

• stomach pain; or

• diarrhea.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your doctor about all your other medicines, especially:

• orlistat (alli, Xenical).

This list is not complete. Other drugs may interact with triheptanoin, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.