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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:

    insurance coverage icon

    Understand their
    insurance coverage

    patient support icon

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

    financial assistance icon

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

    perswonalized counseling icon

    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
    Patient Brochure

    Information for your patients about LC-FAOD, DOJOLVI, and support available to them

    DOJOLVI™ (triheptanoin) Patient Brochure

    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 >

    VISIT LC-FAOD–RELATED WEBSITES

    Professional organizations

    GMDI logo

    A professional organization dedicated to nutrition therapy for genetic metabolic disorders
    SIMD logo

    A professional organization focused on research and advocacy for patients with inherited metabolic disorders

    Metabolic disease information and advocacy

    International Network for Fatty Acid Oxidation Research and Management (INFORM) logo

    A scientific organization specifically dedicated to research and education about fatty acid oxidation disorders
    MitoAction logo

    An advocacy organization working to educate and support patients with mitochondrial disease and their families

    Rare disease information and advocacy

    NIH Genetic and Rare Diseases Information Center (GARD) logo

    A center within the National Institutes of Health (NIH) that maintains a list of rare diseases and related terms to help people find reliable information about their disease
    Global Genes logo

    An advocacy organization that provides support, education, and resources to the rare disease community
    National Organization for Rare Disorders (NORD) logo

    A patient advocacy organization dedicated to individuals with rare diseases and the organizations that serve them
    Patient Advocacy at Ultragenyx Pharmaceutical

    A dedicated Ultragenyx team committed to providing rare disease education, resources, patient stories, and events

    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.

    LESS -

    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.

    MORE +