Pronunciation:

vox-EL-oh-tor

Brand Names:

• Oxbryta

Dosage Forms:

• Tablet
• Tablet for Suspension

Classifications:

Therapeutic—

Blood Modifier Agent

Uses of This Medicine:

Voxelotor is used to treat patients with sickle cell disease. Sickle cell disease is an inherited blood disorder in which the red blood cells are abnormally shaped (crescent or sickle shape), that resulted from a mutation in the gene for hemoglobin. Voxelotor works by keeping the hemoglobin in an oxygenated state, thus helping the red blood cells maintain a normal shape and preventing them from binding together and blocking the flow in the blood vessels.

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 performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of voxelotor in children 4 years of age and older. However, safety and efficacy have not been established in children younger than 4 years of age.

Older adults—

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

• Abametapir
• Abemaciclib
• Acalabrutinib
• Alfentanil
• Alprazolam
• Amiodarone
• Apalutamide
• Aprepitant
• Bosentan
• Bosutinib
• Buprenorphine
• Capivasertib
• Carbamazepine
• Cenobamate
• Clarithromycin
• Clozapine
• Cobimetinib
• Codeine
• Colchicine
• Conivaptan
• Crizotinib
• Cyclosporine
• Daridorexant
• Dasatinib
• Dronedarone
• Efavirenz
• Elexacaftor
• Entrectinib
• Enzalutamide
• Etravirine
• Everolimus
• Exagamglogene Autotemcel
• Fedratinib
• Fexinidazole
• Finerenone
• Fosaprepitant
• Fosphenytoin
• Gepirone
• Itraconazole
• Ivacaftor
• Levomethadyl
• Lomitapide
• Lorlatinib
• Lumacaftor
• Lurbinectedin
• Mavacamten
• Midostaurin
• Mitotane
• Mobocertinib
• Modafinil
• Nafcillin
• Nirogacestat
• Oliceridine
• Omaveloxolone
• Oxycodone
• Palovarotene
• Phenobarbital
• Phenytoin
• Pralsetinib
• Primidone
• Repotrectinib
• Rifabutin
• Rifampin
• Roflumilast
• Sirolimus
• Sirolimus Protein-Bound
• St John's Wort
• Sufentanil
• Temsirolimus
• Tezacaftor
• Tolvaptan
• Tramadol
• Venlafaxine
• Zanubrutinib
• Zolpidem

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Amlodipine

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:

• Liver problems, severe—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of This Medicine:

Take this medicine exactly as directed by your doctor. Do not take more of it and do not take it more often than your doctor ordered. This medicine is for a long-term treatment.

This medicine usually comes with patient information leaflet and instructions for use. Read and follow the instructions carefully and make sure you understand them before taking this medicine. If you have any questions, ask your doctor.

Swallow the regular tablet whole. Do not crush, break, or chew it.

Take this medicine at the same time each day, with or without food.

To use the tablet for suspension:

• Do not swallow whole, cut, crush, or chew the tablets.
• Mix the tablet in a room temperature clear liquid (eg, drinking water, apple juice, clear electrolyte drinks, clear flavored drinks, clear soda, or clear sports drinks) before swallowing.
• Swirl the oral liquid until the tablets break apart in the drink. The tablet will not completely dissolve. You will still see small tablet clumps in the mixture. Wait for 1 to 5 minutes, then swirl the mixture again and drink until no tablet residue is left in the cup.

Your doctor may want you to take hydroxyurea (Hydrea®) while you are taking 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 (tablets or tablets for suspension):
  • For sickle cell disease:
    • Adults and children 12 years of age and older—1500 milligrams (mg) once a day.
    • Children 4 to younger than 12 years of age—Dose is base on body weight and must be determined by your doctor.
      • Weighing 40 kilograms (kg) or more—1500 milligrams (mg) once a day.
      • Weighing 20 kg to 40 kg—900 mg once a day.
      • Weighing 10 kg to 20 kg—600 mg once a day.
    • Children younger than 4 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 or your child's progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

You should not take this medicine together with St John's wort.

This medicine may cause serious allergic reactions, which can be life-threatening and requires immediate medical attention. Tell your doctor right away if you have a rash or itching skin, chest pain, fever or chills, mild swelling of the face, trouble breathing, or unusual tiredness or weakness while using this medicine.

This medicine may cause serious skin reactions, including drug reaction with eosinophilia and systemic symptoms (DRESS), which can be life-threatening and requires immediate medical attention. Check with your doctor right away if you have black, tarry stools, chest pain, chills, cough, painful or difficult urination, sore throat, sores, ulcers, or white spots on the lips or in the mouth, swollen glands, trouble breathing, unusual bleeding or bruising, or unusual tiredness or weakness.

Do not change your dose or stop taking this medicine without checking first with your doctor.

Before you have any medical tests, tell the medical doctor in charge that you are taking this medicine. The results of some tests may be affected by this medicine.

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 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:

Rare

Black, tarry stools

chest pain

chills

cough

fever

hives or welts, itching or skin rash

painful or difficult urination

redness of the skin

sore throat

sores, ulcers, or white spots on the lips or in the mouth

swelling of the face

swollen glands

trouble breathing

unusual bleeding or bruising

unusual tiredness or weakness

Incidence not known

Large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

swelling around the eyes

swelling of the eyelids

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

Diarrhea

headache

nausea

stomach pain

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.