Dojolvi Dosage

Total Daily Dosage Calculation

The target daily dosage from DOJOLVI (%) is converted to a volume of DOJOLVI (mL) to be administered using the following calculation:

• Caloric value of DOJOLVI = 8.3 kcal/mL
• Round the total daily dosage to the nearest whole milliliter.
• Divide the total daily dosage into at least four approximately equal individual doses.

Missed Doses

If a dose is missed, take the next dose as soon as possible with subsequent doses taken at 3 to 4-hour intervals. Skip the missed dose if it will not be possible to take all doses in a day.

For patients not currently taking an MCT product

Initiate DOJOLVI at a total daily dosage of approximately 10% DCI divided into at least four times per day. Increase to the recommended total daily dosage by approximately 5% DCI every 2 to 3 days until the target dosage of up to 35% DCI is achieved.

For patients switching from another MCT product

Discontinue use of MCT products before starting DOJOLVI.

Initiate DOJOLVI at the last tolerated daily dosage (mL) of MCT divided into at least four times per day. Increase the total daily dosage by approximately 5% DCI every 2 to 3 days until the target dosage of up to 35% DCI is achieved.

Tolerability

• Consider more frequent smaller doses if a patient has difficulty tolerating 1/4 of the total daily dosage at one time based on gastrointestinal adverse reactions [see Adverse Reactions (6.1)].
• Monitor the patient's total caloric intake during dosage titration, especially in a patient with gastrointestinal adverse reactions, and adjust all components of the diet as needed.
• If a patient experiences gastrointestinal adverse reaction(s), consider dosage reduction until the gastrointestinal symptoms resolve [see Adverse Reactions (6.1)].
• If a patient is unable to achieve the target daily dosage of up to 35% DCI during dosage titration, maintain the patient at the maximum tolerated dosage.

Oral Preparation and Administration

• Use an oral syringe or measuring cup made of compatible materials as listed above to withdraw the prescribed volume of DOJOLVI from the bottle.
• DOJOLVI can be mixed with soft food or liquid such as:
  • plain or artificially sweetened fat free yogurt
  • fat free milk, formula, or cottage cheese
  • whole grain hot cereal
  • fat free low carbohydrate pudding, smoothies, applesauce, or baby food
• Add the prescribed amount of DOJOLVI to a clean bowl, cup, or container, made of the compatible materials as listed above, which contains an appropriate amount of semi-solid food or liquid that takes into consideration the age, size, and fluid needs of the patient to ensure administration of the full dose.
• Mix DOJOLVI thoroughly into the food or liquid.
• Any unused mixture may be stored for up to 24 hours in refrigerated conditions.
• If not used within 24 hours, discard DOJOLVI mixture in the trash. Do not pour down the sink. Do not save for later.

Feeding Tube Preparation and Administration

​DOJOLVI is administered as an oral or enteral bolus medication. Do not add DOJOLVI to the feeding bag, as the feeding equipment may degrade over time.

DOJOLVI can be administered via oral or enteral feeding tubes manufactured of silicone or polyurethane. Do not use feeding tubes manufactured of polyvinyl chloride (PVC). Feeding device performance and functionality can degrade over time depending on usage and environmental conditions. Regularly monitor the feeding tube to ensure proper functioning and integrity [see Warnings and Precautions (5.1)].

• Use an oral syringe or measuring cup made of compatible materials as listed above to withdraw the prescribed volume of DOJOLVI from the bottle.
• Add the prescribed amount of DOJOLVI to a clean bowl, cup, or container, made of compatible materials as listed above, which contains an amount of medical food or formula that takes into consideration the age, size, and fluid needs of the patient in order to ensure administration of the full dose.
• Mix DOJOLVI thoroughly into the medical food or formula prior to administering via feeding tube, y-connector, or feeding tube extension set made of silicone or polyurethane.
• Draw up the entire amount of the DOJOLVI mixture into a slip tip syringe.
• Remove the residual air from the syringe and connect the syringe directly into the feeding tube port.
• Push the syringe contents into the feeding tube port using steady pressure until empty.
• Flush the feeding tubes with between 5 mL to 30 mL of water. Flush volume should be modified based on specific patient needs and in cases of fluid restriction.
• Discard any unused DOJOLVI mixture in the trash. Do not pour down the sink. Do not save for later use.