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Omaveloxolone (By mouth)

Omaveloxolone (oh-ma-vel-OX-oh-lone)

There may be other brand names for this medicine.

This medicine is not right for everyone. Do not use it if you had an allergic reaction to omaveloxolone.

Your doctor will tell you how much medicine to use. Do not use more than directed.
Take this medicine on an empty stomach at least 1 hour before meal.
Swallow the capsule whole. Do not crush or chew it.
If you are unable to swallow the capsule whole:
- Open the capsule and sprinkle the entire contents onto 2 tablespoons (30 mL) of applesauce. Stir the mixture.
- Swallow the mixture right away. Do not store it for later use
- Do not mix the contents of the capsule with milk or orange juice.
- Do not give the mixture through enteral feeding tube.
Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
Missed dose: If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Some foods and medicines can affect how omaveloxolone works. Tell your doctor if you are using:
- Itraconazole, midazolam, repaglinide, rosuvastatin, verapamil, St John's wort
- Birth control implants, pills, patch, ring
Do not eat grapefruit or drink grapefruit juice while you are using this medicine.

Tell your doctor if you are pregnant or planning to become pregnant. Ask your doctor which form of birth control is right for you while you are using this medicine and for 28 days after the last dose.
Tell your doctor if you are breastfeeding, or if you have liver disease, high cholesterol, or a history of heart disease (including heart failure).
This medicine may cause the following problems:
- Increase in a blood protein called B-Type Natriuretic Peptide (BNP), which affects the heart
- Changes in cholesterol level
Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
Keep all medicine out of the reach of children. Never share your medicine with anyone.

Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
Fast heartbeat
Muscle or bone pain
Rapid weight gain, swelling in your hands, ankles, or feet
Unusual tiredness or weakness

Last Updated: 4/23/2024