Safety Information
Indication
DOJOLVI® (triheptanoin) is indicated as a source of calories and fatty acids for the treatment of adult and pediatric patients with long-chain fatty acid oxidation disorders (LC-FAOD).
Clinical Use
The safety and efficacy of DOJOLVI in pediatric patients have been established. Clinical studies of DOJOLVI did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients.
Contraindications
Triheptanoin is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient or component of the container.
Most Serious Warnings and Precautions
- Feeding tube dysfunction: Performance and functionality can degrade over time depending on usage and environmental conditions. Do not administer DOJOLVI in feeding tubes manufactured of polyvinyl chloride (PVC). Regularly monitor the feeding tube to ensure proper functioning and integrity.
- Intestinal malabsorption in patients with pancreatic insufficiency: Low or absent pancreatic enzymes may reduce absorption of heptanoate leading to insufficient supplementation of medium-chain fatty acids. Avoid administration of DOJOLVI in patients with pancreatic insufficiency.
For More Information
Please consult the Product Monograph for important information relating to adverse reactions, drug interactions and dosing instructions, including dosage adjustment, which have not been discussed in this piece.
The Product Monograph is also available by calling 1-833-388-5872.