DOJOLVI .96 g/mL
Triheptanoin · LIQUID · Ultragenyx Pharmaceutical Inc.
DOJOLVI is a liquid containing triheptanoin at .96 g/mL, taken oral. Manufactured by Ultragenyx Pharmaceutical Inc..
Key Facts
- Brand Name
- DOJOLVI
- Generic Name
- Triheptanoin
- NDC Code (Product)
69794-050- Manufacturer
- Ultragenyx Pharmaceutical Inc.
- Strength
- .96 g/mL
- Dosage Form
- LIQUID
- Route
- ORAL
- Marketing Status
- Application #
- NDA213687
- Drug Class
- Medium-chain Triglyceride [EPC]
- Marketing Start
- 07/01/2020
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE DOJOLVI is indicated as a source of calories and fatty acids for the treatment of adult and pediatric patients with molecularly confirmed long-chain fatty acid oxidation disorders (LC-FAOD). DOJOLVI is a medium-chain triglyceride indicated as a source of calories and fatty acids for the treatment of adult and pediatric patients with molecularly confirmed long-chain fatty acid oxidation disorders (LC-FAOD).
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Assess metabolic requirements by determining daily caloric intake (DCI) prior to calculating the dose of DOJOLVI. ( 2.1 ) For patients receiving another medium-chain triglyceride product, discontinue prior to the first dose of DOJOLVI. ( 2.3 ) 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 mixed thoroughly into semi-solid food/liquid or medical food/formula at mealtimes or with snacks. ( 2.2 ) See the full prescribing information for instructions on how to calculate the volume per dose; initiate and titrate the dosage to achieve the target; and prepare and administer DOJOLVI. ( 2.2 , 2.3 , 2.4 ) 2.1 Important Recommendations Prior to DOJOLVI Treatment 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. 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…
Contraindications
4 CONTRAINDICATIONS None. None.
Drug Interactions
7 DRUG INTERACTIONS Pancreatic Lipase Inhibitors : Avoid co-administration due to potential for reduced clinical effect of DOJOLVI. ( 7.1 ) 7.1 Pancreatic Lipase Inhibitors Co-administration of triheptanoin with a pancreatic lipase inhibitor (e.g., orlistat) may reduce exposure to the triheptanoin metabolite, heptanoate, and reduce the clinical effect of triheptanoin [see Clinical Pharmacology (12.3) ] . Avoid co-administration of DOJOLVI with pancreatic lipase inhibitors.
Adverse Reactions
6 ADVERSE REACTIONS Most common adverse reactions are (≥10%): abdominal pain, diarrhea, vomiting, and nausea. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Ultragenyx Pharmaceutical Inc. at 1-888-756-8657 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety population included 79 patients with LC-FAOD exposed to DOJOLVI in two studies: one open-label 78-week study of DOJOLVI in 29 patients (Study 1) followed by an open-label extension study (Study 2). Twenty-four patients from Study 1 continued into Study 2. Patients ranged from 4 months to 63 years of age and the population was 52% male. Of the 79 patients, 87% were White, 5% were Black or African-American, 4% were Asian, and 4% other. The daily dosage of DOJOLVI ranged between 12% and 41% DCI (which corresponds to 0.7 g/kg/day to 6.0 g/kg/day for pediatric patients and 0.5 g/kg/day to 1.3 g/kg/day for adult patients) for a m…
Frequently Asked Questions
What is DOJOLVI used for?
DOJOLVI contains Triheptanoin. It is a liquid taken oral. Consult your doctor for specific uses.
Is DOJOLVI a controlled substance?
DOJOLVI is not classified as a controlled substance by the DEA.
What is the generic name for DOJOLVI?
The generic name for DOJOLVI is Triheptanoin. There are no other listed brand versions of Triheptanoin.
What is the NDC code for DOJOLVI .96 g/mL?
The NDC (National Drug Code) for DOJOLVI .96 g/mL is 69794-050, listed by Ultragenyx Pharmaceutical Inc..
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)