DOJOLVI Oral liquid Ref.[10250] Active ingredients:

2. 1 Recommended Dosage

Assess the metabolic requirements of the patient by determining their daily caloric intake (DCI) prior to calculating the dose of DOJOLVI.

For patients receiving another medium-chain triglyceride (MCT) product, discontinue prior to the first dose of DOJOLVI.

The recommended target daily dosage of DOJOLVI is up to 35% of the patient’s total prescribed DCI divided into at least four doses and administered at mealtimes or with snacks.

In order to reach a target daily dosage, patients may require an increase in their total fat intake. All patients treated with DOJOLVI should be under the care of a clinical specialist knowledgeable in appropriate disease-related dietary management based upon current nutritional recommendations.

The neonatal population may require higher fat intake and therefore an increased amount of DOJOLVI. Current nutritional recommendations should be considered when dosing the neonatal population.

The total daily dosage is converted to a volume of DOJOLVI to be administered in mL using the following calculation:

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

2.2 Dosage Initiation and Titration

For patients not currently taking a MCT product

Initiate DOJOLVI at a total daily dosage of approximately 10% DCI divided into at least four times per day and increase to the recommended total daily dosage of up to 35% DCI over a period of 2 to 3 weeks.

For patients switching from another MCT product

Discontinue use of MCT products before starting DOJOLVI.

Initiate DOJOLVI at the last tolerated daily dosage 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

If a patient has difficulty tolerating ¼ of the total daily dosage at one time, more frequent smaller doses may be considered [see Adverse Reactions (6.1)].

Monitor patients' total caloric intake during dosage titration, especially in patients 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.

2.3 Preparation and Administration Instructions

Administer DOJOLVI mixed with semi-solid food or liquids orally or enterally via a silicone or polyurethane feeding tube. Do not administer DOJOLVI alone to avoid gastrointestinal upset.

Prepare or administer DOJOLVI using containers, dosing syringes or measuring cups made of compatible materials such as stainless steel, glass, high density polyethylene (HDPE), polypropylene, low density polyethylene, polyurethane and silicone.

DOJOLVI is not compatible with certain plastics. Do not prepare or administer DOJOLVI using containers, dosing syringes or measuring cups made of polystyrene or polyvinyl chloride (PVC) plastics.

Regularly monitor the containers, dosing components or utensils that are in contact with DOJOLVI to ensure proper functioning and integrity.

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 into the following semi-solid foods and liquids:
  • 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, baby food, etc.
• 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 average consumption of the patient in order to ensure administration of the full dose.
• Mix DOJOLVI thoroughly into the food or liquid.
• The mixture may be stored for up to 24 hours in refrigerated conditions.

Feeding Tube Preparation and Administration

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)].

Preparation and Administration Instructions:

• 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 formula that takes into consideration the age, size and average consumption of the patient in order to ensure administration of the full dose.
• Mix DOJOLVI thoroughly into the formula.
• Draw up the entire amount of the DOJOLVI-formula mixture into a slip tip syringe.
• Remove the residual air from the syringe and connect the syringe directly into the feeding tube feeding port.
• Push the syringe contents into the feeding tube feeding 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 portion of the DOJOLVI-formula mixture. Do not save for later use.
• Administer DOJOLVI over 15 to 20 minutes for patients receiving bolus delivery of enteral feeds. For patients receiving continuous feeds, administer DOJOLVI over 30 to 60 minutes alternating with formula alone.

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 four doses in a day.

Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) (see USP Controlled Room Temperature). Do not freeze.

Opened bottles of DOJOLVI can be used for up to 9 months after opening, but not beyond the expiration date on the bottle.

Do not dose or store using materials made of polystyrene or polyvinyl chloride (PVC) containers [see Dosage and Administration (2.3)].

Pharmacist: Dispense only in Glass or HDPE bottles.