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PATIENT SERVICES FOR DOJOLVI

Ultragenyx is committed to patients with rare diseases, which is why we created UltraCare Patient Services for DOJOLVI—your patients’ guide throughout their treatment journeys.

Our UltraCare Guides have varied backgrounds, including social workers, healthcare professionals, and patient advocates, and are ready to help patients gain and maintain access to DOJOLVI.

UltraCare Guides help patients and their caregivers:

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Understand their
insurance coverage

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Utilize patient support program resources, including help with billing and coding

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Find and navigate available financial assistance and patient assistance programs that can help to cover co-pay and other out-of-pocket expenses

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Start and stay on DOJOLVI treatment through personalized counseling and education based on the recommendations, advice, and prescription of the patient’s healthcare team

HELP YOUR PATIENTS ENROLL IN ULTRACARE

Step 1: Complete the
Start Form with your patient.

Step 2: Fax the completed*
Start Form to 1-415-723-7474.

Contact our UltraCare Guides for additional support at 1-888-756-8657.

Visit UltraCare

*Please note that a completed form is required for patient enrollment.

Download DOJOLVI materials

DOJOLVI Start Form


Complete the Start Form to prescribe DOJOLVI

DOJOLVI™ (triheptanoin) Start Form

Download >

DOJOLVI Dosing Guide


Step-by-step instructions for storing, administering, and keeping track of DOJOLVI doses

DOJOLVI™ (triheptanoin) Dosing Guide

Download >

Daily Dosing Tracker


A tool your patients can use to keep track of DOJOLVI doses

DOJOLVI™ (triheptanoin) Daily Dosing Tracker

Download >

UltraCare Patient Resource Guide


An overview of resources offered by UltraCare Patient Services

UltraCare Patient Resource Guide

Download >

DOJOLVI Prescribing Information (PI) Booklet


An easy-to-read, large-format version of the full DOJOLVI Prescribing Information

DOJOLVI Prescribing Information (PI) Booklet

Download >

Stay Informed

Sign up to receive more information and updates about DOJOLVI.

FOR US HEALTHCARE PROFESSIONALS

INDICATION

DOJOLVI is a medium-chain triglyceride 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 performance and functionality can degrade over time depending on usage and environmental conditions. In clinical trials, feeding tube feeding dysfunction was reported in patients receiving triheptanoin. The contribution of DOJOLVI cannot be ruled out. 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

  • Pancreatic enzymes hydrolyze triheptanoin and release heptanoate as medium-chain fatty acids in the small intestine. Low or absent pancreatic enzymes may result in reduced absorption of heptanoate subsequently leading to insufficient supplementation of medium-chain fatty acids. Avoid administration of DOJOLVI in patients with pancreatic insufficiency.

ADVERSE REACTIONS

Gastrointestinal (GI)

  • 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%].

DRUG INTERACTIONS

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. Avoid co-administration of DOJOLVI with pancreatic lipase inhibitors.

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. Advise women 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. 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.

PATIENT COUNSELING INFORMATION

  • Advise the patient or caregiver to read the FDA-approved patient labeling, which includes information on the appropriate oral or feeding tube preparation, administration, and storage.
  • Advise the patient or caregiver to regularly inspect the feeding tube for proper functioning and integrity and report to the healthcare provider if any issues are identified.
  • Inform the patient or caregiver that pancreatic insufficiency may reduce clinical effect of DOJOLVI. Any known pancreatic insufficiency should be reported 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.

INDICATION

DOJOLVI is a medium-chain triglyceride 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 performance and functionality can degrade over time depending on usage and environmental conditions. In clinical trials, feeding tube feeding dysfunction was reported in patients receiving triheptanoin. The contribution of DOJOLVI cannot be ruled out. 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

  • Pancreatic enzymes hydrolyze triheptanoin and release heptanoate as medium-chain fatty acids in the small intestine. Low or absent pancreatic enzymes may result in reduced absorption of heptanoate subsequently leading to insufficient supplementation of medium-chain fatty acids. Avoid administration of DOJOLVI in patients with pancreatic insufficiency.

ADVERSE REACTIONS

Gastrointestinal (GI)

  • 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%].

DRUG INTERACTIONS

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. Avoid co-administration of DOJOLVI with pancreatic lipase inhibitors.

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. Advise women 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. 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.

PATIENT COUNSELING INFORMATION

  • Advise the patient or caregiver to read the FDA-approved patient labeling, which includes information on the appropriate oral or feeding tube preparation, administration, and storage.
  • Advise the patient or caregiver to regularly inspect the feeding tube for proper functioning and integrity and report to the healthcare provider if any issues are identified.
  • Inform the patient or caregiver that pancreatic insufficiency may reduce clinical effect of DOJOLVI. Any known pancreatic insufficiency should be reported 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.