DOJOLVI

Generic Name/API: triheptanoin

Manufacturer: Ultragenyx Pharmaceutical Inc.

Dosage Forms & Strength:
Oral Liquid, 100% w/w of triheptanoin.
Oral liquid: clear, colorless to light yellow liquid supplied in a 500 mL bottle containing 100% w/w of
triheptanoin.

Storage:
Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) (see USP
Controlled Room Temperature). Do not freeze.
DOJOLVI can be used for up to 9 months after opening but not beyond the expiration date on the
bottle.
Do not dose or store using materials made of polystyrene or polyvinyl chloride (PVC) containers [see
Dosage and Administration (2.4)].
Pharmacist: Dispense only in glass or HDPE bottles.

  • INDICATION
  • IMPORTANT SAFETY INFORMATION

INDICATIONS
WHAT IS DOJOLVI?
DOJOLVI is a prescription medicine used to treat long-chain fatty acid oxidation disorders (LC-FAOD) in children and adults.

IMPORTANT SAFETY INFORMATION
Before taking DOJOLVI, tell your healthcare provider about all of your medical conditions, including if you:
are pregnant or plan to become pregnant. It is not known if DOJOLVI will harm your unborn baby. Pregnancy Safety Study: There is a pregnancy safety study for women who take DOJOLVI during pregnancy. The purpose of this study is to collect information about your health and your baby’s health. You can talk to your healthcare provider or contact 1-888-756-8657 to enroll in this study or get more information.
are breastfeeding or plan to breastfeed. It is not known if DOJOLVI passes into breast milk. Talk to your healthcare provider about the best way to feed your baby if you take DOJOLVI.
are taking a pancreatic lipase inhibitor, such as orlistat, as it may affect how well DOJOLVI works.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

What are the possible side effects of DOJOLVI?
Feeding tube problems. Feeding tubes may not work as well or stop working over time when taking DOJOLVI. Do not use DOJOLVI in feeding tubes made of polyvinyl chloride (PVC). Check the feeding tube to make sure it is working properly and not breaking down.
Intestinal absorption problems in patients with pancreatic insufficiency. If you have pancreatic insufficiency, consult with your healthcare provider as it may affect how well DOJOLVI works.
The most common side effects of DOJOLVI include:
stomach (abdominal) pain diarrhea vomiting nausea
These are not all the possible side effects of DOJOLVI. Call your healthcare provider for medical advice about side effects. You may report side effects to Ultragenyx Pharmaceutical Inc. at 1-888-756-8657 or FDA at 1-800-FDA-1088.

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