The first and only FDA-approved treatment for patients with long-chain fatty acid oxidation disorders (LC-FAOD).
More information available at www.dojolvi.com
Dojolvi is indicated as a source of calories and fatty acids for the treatment of pediatric and adult patients with molecularly confirmed long-chain fatty acid oxidation disorders (LC-FAOD).
IMPORTANT SAFETY INFORMATION
WARNINGS AND PRECAUTIONS
Feeding Tube Dysfunction
- Feeding tube dysfunction was reported in patients receiving triheptanoin. The contribution of DOJOLVI cannot be ruled out. DOJOLVI should not be administered in feeding tubes manufactured of polyvinyl chloride (PVC). The feeding tube should be monitored regularly to ensure proper functioning and integrity.
Intestinal Malabsorption in Patients with Pancreatic Insufficiency
- Low or absent pancreatic enzymes may result in reduced absorption of heptanoate subsequently leading to insufficient supplementation of medium-chain fatty acids. Administration of Dojolvi should be avoided in patients with pancreatic insufficiency.
- The most common GI-related adverse reactions reported in the pooled safety population of Studies 1 and 2 were abdominal pain (abdominal discomfort, abdominal pain, abdominal distension, abdominal pain upper, GI pain) [60%], diarrhea [44%], vomiting [44%], and nausea [14%].
Pancreatic Lipase Inhibitors
- Co-administration should be avoided due to potential for reduced clinical effect of Dojolvi.
USE IN SPECIFIC POPULATIONS
Pregnancy and Lactation
- There are no available data on triheptanoin use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Women are advised to report pregnancies to Ultragenyx Pharmaceutical Inc. at 1-888-756-8657.
- There are no data on the presence of triheptanoin or its metabolites in human or animal milk, the effects on the breastfed infant, or the effects on milk production.
PATIENT COUNSELING INFORMATION
The patient or caregiver should:
- Read the FDA-approved patient labeling, which includes information on the appropriate oral or feeding tube preparation, administration, and storage.
- Regularly inspect the feeding tube for proper functioning and integrity and report to the healthcare provider if any issues are identified.
- Be informed that pancreatic insufficiency may reduce the clinical effect of Dojolvi and to report any known pancreatic insufficiency to the healthcare provider.
You may report side effects to Ultragenyx Pharmaceutical Inc. at 1-888-756-8657 or FDA at
1-800-FDA-1088 or www.fda.gov/medwatch.
Please see full Prescribing Information, including the Patient Information leaflet, for a complete discussion of the risks associated with Dojolvi.