Loading…
DOJOLVI is a brand name for Triheptanoin, supplied as a liquid. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: DOJOLVITM (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). 1.1 Pediatrics (<18 years) Based on the data submitted and reviewed by Health Canada, the safety and efficacy of DOJOLVI in pediatric…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations Assess the metabolic requirements of the patient by determining their daily caloric intake (DCI) prior to calculating the dose of DOJOLVI. The neonatal and infant population may require higher fat intake and therefore an increased amount of DOJOLVI.
Current nutritional recommendations should be considered when dosing the neonatal or infant population. 2 Recommended Dose and Dosage Adjustment The recommended target daily dosage of DOJOLVI is up to 35% of the patient’s total prescribed DCI divided into at least four doses, administered at mealtimes or with snacks, at 3 to 4 hour intervals or as directed by the healthcare provider.
In order to reach a target daily dosage, patients may require an increase in their total fat intake. 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.
3 𝑘𝑐𝑎𝑙 𝑚𝐿 𝑜𝑓 𝐷𝑂𝐽𝑂𝐿𝑉𝐼 Dosage Initiation and Titration For patients not currently taking a medium-chain triglyceride (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 1/4 of the total daily dosage at one time, more frequent smaller doses may be considered. Monitor patients’ DCI 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. Maintain the patient at the maximum tolerated dosage up to 35% DCI. 3 Administration Administer DOJOLVI mixed with semi-solid food or liquids orally or enterally.
Do not administer DOJOLVI alone to avoid gastrointestinal upset. DOJOLVI is not compatible with certain plastics. 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.
1 Adverse Reaction Overview The most common adverse reactions to DOJOLVI reported in the pooled safety population of Study 1 and Study 2 were gastrointestinal (GI)-related, and included abdominal pain (abdominal discomfort, abdominal distension, abdominal pain, abdominal pain upper, GI pain) [60%], diarrhea [44%], vomiting [44%], and nausea [14%].
In the pooled safety population (Study 1 and Study 2) 5 (6%) subjects had TEAEs leading to dose discontinuation including myalgia, gastroesophageal reflux disease, pain, diarrhea, vomiting and rhabdomyolysis, the latter 3 considered related to triheptanoin.
3%) including 12 subjects (41%) in Study 1 and 9 subjects (12%) in Study 2. Of these, GI adverse reactions led to dose reductions in 35% and 12% of patients in Study 1 and Study 2, respectively and included abdominal pain (28%), diarrhea (24%), and nausea (3%) in Study 1 and diarrhea (7%), and abdominal pain (5%) in Study 2.
Dose interruptions were made to triheptanoin in 16 subjects (20%) including 10 subjects (34%) in Study 1 and 8 subjects (11%) in Study 2. Of these, GI adverse reactions led to dose interruptions in 3 subjects (10%) in Study 1 for diarrhea (7%), abdominal pain (7%), nausea (3%) and vomiting (3%) and 5 subjects (7%) in Study 2 for vomiting (5%) and diarrhea (1%).
2 Clinical Trial Adverse Reactions Because clinical trials are conducted under very specific conditions, the adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse reaction information from clinical trials is useful for identifying drug-related adverse events and for approximating rates. The assessment of adverse reactions was based on a safety population that included 79 patients with LC-FAOD exposed to DOJOLVI in two studies: one open-label single arm 78- week study of DOJOLVI in 29 patients (Study 1 [UX007-CL201]) followed by an open-label extension study (Study 2 [UX007-CL202]).
General Feeding Tube Dysfunction Feeding tube performance and functionality can degrade over time depending on usage and environmental conditions. In clinical trials, feeding tube dysfunction was reported in patients receiving DOJOLVI.
The contribution of DOJOLVI to these events cannot be ruled out. Do not administer DOJOLVI in feeding tubes manufactured of PVC. Regularly monitor the feeding tube to ensure proper functioning and integrity. Hepatic/Biliary/Pancreatic Intestinal Malabsorption in Patients with Pancreatic Insufficiency Pancreatic enzymes hydrolyze triheptanoin and release heptanoate as medium-chain fatty acids in the small intestine.
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. 1 Pregnant Women 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.
In animal reproduction studies conducted in pregnant rats and rabbits administered triheptanoin during the period of organogenesis, the primary toxicological effect (reduced body weight gain) was considered to be specific to decreased food consumption related to taste aversion in animals.
2 Breast-feeding 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. Medium-chain triglycerides Route of Administration Dosage Form / Strength/Composition Non-medicinal Ingredients oral Liquid, 100% w/w N/A DOJOLVITM (triheptanoin) Product Monograph Page 8 of 21 and other fatty acids are normal components of breastmilk and the composition of breastmilk varies within feedings, over stages of lactation, and between mothers and populations due to maternal factors including genetics, environment, and diet.
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. For a complete listing, see Dosage Forms, Strengths, Composition and Packaging.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Know a brand we are missing in Canada? Suggest a brand →
Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
DOJOLVITM (triheptanoin) Product Monograph Page 6 of 21 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 syringes or measuring cups 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 semi-solid foods and liquids.
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 PVC. Feeding tube performance and functionality can degrade over time depending on usage and environmental conditions. Regularly monitor the feeding tube to ensure proper functioning and integrity.
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. 4 Missed Dose If a dose (one of the portions taken throughout the day) is missed, take the next dose as soon as possible. Skip the missed dose if it will not be possible to take all doses in a day.
Twenty-four patients from Study 1 continued into Study 2 and the remaining patients were treatment naïve (n=19) or rolled over from investigator sponsored trials (IST)/another trial (n=31). 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. 2 g/kg/day for adult patients for a mean duration of 30 months. The most common adverse reactions from the pooled safety population of Study 1 and Study 2 were gastrointestinal (GI) in nature (Table 2).
Table 2:
Adverse Reactions Reported in Patients with LC-FAOD from Study 1 and Study 2 Adverse Reaction DOJOLVI N=79 (%) Abdominal Paina 60 Diarrhea 44 Vomiting 44 Nausea 14 a Abdominal Pain includes the following grouped terms: Abdominal Discomfort, Abdominal distension, Abdominal pain, Abdominal pain upper, and Gastrointestinal pain Gastrointestinal (GI) Adverse Reactions GI adverse reactions were severe (1%), moderate (22%) and mild (77%) in severity.
In Study 3, a 4-month double-blind randomized controlled study in 32 adult and pediatric patients with a confirmed diagnosis of LC-FAOD, commonly reported adverse reactions with triheptanoin were similar to those reported in Study 1 and Study 2.
3 Less Common Clinical Trial Adverse Reactions Not applicable. 4 Clinical Trial Adverse Reactions (Pediatrics) The safety profile of triheptanoin in the pediatric population appears to be similar to that observed in the adult population.
5 Post-Market Adverse Reactions No post-market data are available.
The developmental and health benefits of breastfeeding should be considered along with the clinical need for DOJOLVI and any potential adverse effect on the breastfed infant from DOJOLVI or from the underlying condition. 3 Pediatrics The safety and efficacy of DOJOLVI in pediatric patients have been established.
4 Geriatrics Clinical studies of DOJOLVI did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients. 5 Hepatic Insufficiency No studies have been conducted to evaluate the PK of triheptanoin and its metabolites in patients with hepatic impairment.
6 Renal Insufficiency No studies have been conducted to evaluate the PK of triheptanoin and its metabolites in patients with renal impairment.