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.

Please see full Prescribing Information including Patient Information for additional important safety information and instructions for use.