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

Treats Friedreich's ataxia.

Brand Name(s):

Skyclarys

When This Medicine Should Not Be Used:

How to Use This Medicine:

Capsule

• 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.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• 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.

Warnings While 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.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• 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

If you notice these less serious side effects, talk with your doctor:

• Diarrhea
• Headache

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088