Pronunciation:

oh-ma-vel-OX-oh-lone

Brand Names:

• Skyclarys

Dosage Forms:

• Capsule

Classifications:

Therapeutic—

Central Nervous System Agent

Uses of This Medicine:

Omaveloxolone is used to treat Friedreich's ataxia. Friedreich's ataxia is a rare genetic disorder that affects the brain, spinal cord, and nerves.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of omaveloxolone in children younger than 16 years of age. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of omaveloxolone in the elderly.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Abemaciclib
• Abiraterone Acetate
• Acalabrutinib
• Alfentanil
• Alfuzosin
• Alprazolam
• Amiodarone
• Amlodipine
• Amprenavir
• Apalutamide
• Apixaban
• Aprepitant
• Aripiprazole
• Atazanavir
• Atorvastatin
• Avacopan
• Avanafil
• Avapritinib
• Avatrombopag
• Axitinib
• Bedaquiline
• Belumosudil
• Benzhydrocodone
• Bictegravir
• Boceprevir
• Bosentan
• Bosutinib
• Brigatinib
• Budesonide
• Buspirone
• Cabozantinib
• Cannabidiol
• Capmatinib
• Carbamazepine
• Cenobamate
• Cilostazol
• Ciprofloxacin
• Cisapride
• Clarithromycin
• Clindamycin
• Cobicistat
• Cobimetinib
• Codeine
• Colchicine
• Conivaptan
• Copanlisib
• Crizotinib
• Cyclosporine
• Dabrafenib
• Daclatasvir
• Daridorexant
• Darifenacin
• Darolutamide
• Darunavir
• Dasabuvir
• Dasatinib
• Dexamethasone
• Diazepam
• Dihydroergotamine
• Diltiazem
• Docetaxel
• Dofetilide
• Dolutegravir
• Domperidone
• Dronedarone
• Duvelisib
• Efavirenz
• Elagolix
• Elbasvir
• Eletriptan
• Elexacaftor
• Encorafenib
• Entrectinib
• Eplerenone
• Eravacycline
• Ergotamine
• Erythromycin
• Eszopiclone
• Etravirine
• Everolimus
• Felodipine
• Fentanyl
• Finerenone
• Flibanserin
• Fluconazole
• Fluticasone
• Fluvoxamine
• Fosamprenavir
• Fosaprepitant
• Fosnetupitant
• Fosphenytoin
• Fostamatinib
• Fostemsavir
• Ganaxolone
• Gilteritinib
• Glasdegib
• Grazoprevir
• Guanfacine
• Haloperidol
• Hydrocodone
• Hydrocortisone
• Ibrexafungerp
• Ibrutinib
• Idelalisib
• Ifosfamide
• Imatinib
• Indinavir
• Irinotecan
• Irinotecan Liposome
• Istradefylline
• Itraconazole
• Ivabradine
• Ivacaftor
• Ivosidenib
• Ixazomib
• Ketoconazole
• Lapatinib
• Larotrectinib
• Lemborexant
• Lercanidipine
• Letermovir
• Levamlodipine
• Lomitapide
• Lopinavir
• Lorlatinib
• Lovastatin
• Lumacaftor
• Lumateperone
• Lurasidone
• Lurbinectedin
• Macimorelin
• Maraviroc
• Methadone
• Midazolam
• Mitotane
• Mobocertinib
• Modafinil
• Montelukast
• Nafcillin
• Naldemedine
• Naloxegol
• Nateglinide
• Nefazodone
• Nelfinavir
• Neratinib
• Netupitant
• Nifedipine
• Nilotinib
• Nintedanib
• Nisoldipine
• Oliceridine
• Omeprazole
• Ondansetron
• Osilodrostat
• Oxycodone
• Ozanimod
• Paclitaxel
• Pacritinib
• Palbociclib
• Paritaprevir
• Pemigatinib
• Perampanel
• Phenobarbital
• Phenytoin
• Pimavanserin
• Pimozide
• Pitolisant
• Posaconazole
• Primidone
• Progesterone
• Quetiapine
• Quinidine
• Ranolazine
• Repaglinide
• Ribociclib
• Rifabutin
• Rifampin
• Rilpivirine
• Rimegepant
• Ripretinib
• Ritonavir
• Rivaroxaban
• Rolapitant
• Rosiglitazone
• Salmeterol
• Samidorphan
• Saquinavir
• Saxagliptin
• Selexipag
• Selpercatinib
• Selumetinib
• Sildenafil
• Simeprevir
• Simvastatin
• Sirolimus
• Sonidegib
• St John's Wort
• Sufentanil
• Sunitinib
• Tacrolimus
• Tamoxifen
• Tamsulosin
• Tazemetostat
• Telaprevir
• Telithromycin
• Temsirolimus
• Tepotinib
• Tezacaftor
• Thiotepa
• Ticagrelor
• Tipranavir
• Tivozanib
• Tolvaptan
• Trabectedin
• Trazodone
• Triazolam
• Tucatinib
• Ubrogepant
• Upadacitinib
• Vardenafil
• Velpatasvir
• Venetoclax
• Verapamil
• Vinblastine
• Vincristine
• Vincristine Sulfate Liposome
• Vinorelbine
• Voclosporin
• Vorapaxar
• Voriconazole
• Voxelotor
• Voxilaprevir
• Zaleplon
• Ziprasidone
• Zolpidem

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Heart failure, history of or
• High cholesterol or
• Liver disease—Use with caution. May make these conditions worse.

Proper Use of This Medicine:

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

This medicine comes with a patient information leaflet. Read and follow these instructions carefully. Ask your doctor if you have any questions.

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.

Do not eat grapefruit or drink grapefruit juice while you are using this medicine.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (capsules):
  • For the treatment of Friedreich's ataxia:
    • Adults and children 16 years of age and older—150 milligrams (mg) - 3 capsules once a day.
    • Children younger than 16 years of age—Use and dose must be determined by your doctor.

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.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.

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.

This medicine may increase a blood protein called B-Type Natriuretic Peptide (BNP), which affects the heart. Check with your doctor right away if you have decrease in amount of urine, noisy, rattling, or trouble breathing, fast heartbeat, swelling of the fingers, hands, feet, or lower legs, or weight gain.

This medicine may cause changes in your cholesterol levels. Talk to your doctor about this.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St John's wort) or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Back pain

bone pain

chills

cough

dark urine

decrease in amount of urine

diarrhea

fast heartbeat

fever

general feeling of discomfort or illness

headache

joint pain

loss of appetite

muscle aches, pains, and spasms

nausea or vomiting

noisy, rattling, or trouble breathing

runny nose

shivering

sore throat

stomach pain, severe

sweating

swelling of the fingers, hands, feet, or lower legs

unusual tiredness or weakness

weight gain

yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Mouth or throat pain

rash

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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