Voxelotor

Voxelotor is used to treat sickle cell disease (an inherited blood disease) in adults and children 4 years of age and older. Voxelotor is in a class of medications called hemoglobin S (HbS) polymerization inhibitors. It works by helping hemoglobin (a protein in red blood cells) to hold onto more oxygen and to stop red blood cells from becoming misshapen.

Voxelotor comes as a tablet to take or as tablets for oral suspension to take by mouth. It is usually taken once daily with or without food. Take voxelotor at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take voxelotor exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Swallow the oral tablets whole; do not split, chew, or crush them.

The tablets for oral suspension should be placed in a cup with room temperature, clear liquid (i.e. drinking water or clear soda) immediately before swallowing. Follow the detailed instructions for the right amount of liquid based on your dose. After the tablets start to disperse, swirl the contents of the cup until tablets are dispersed. Then wait 1 to 5 minutes, swirl the contents of the cup again and then swallow the contents of the cup. The tablets will may not disperse completely and so there will be some tablet chunks in the liquid. If residue remains in the cup, add more clear liquid and repeat the procedure above to create a new suspension and take the rest. Do not swallow whole, cut, crush, or chew the tablets for oral suspension.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before taking voxelotor,

• tell your doctor and pharmacist if you are allergic to voxelotor, any other medications, or any of the ingredients in voxelotor tablets or voxelotor tablets for oral suspension. Ask your pharmacist for a list of the ingredients.

• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take while taking voxelotor. Some drugs should not be taken with voxelotor or your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• The following nonprescription or herbal products may interact with voxelotor: St. John's wort. Be sure to let your doctor and pharmacist know that you are taking these medications before you start taking voxelotor. Do not start any of these medications while taking voxelotor without discussing it with your healthcare provider.

• tell your doctor if you have or have ever had liver disease.

• tell your doctor if you are pregnant or plan to become pregnant. If you become pregnant while taking voxelotor, call your doctor.

• tell your doctor if you are breast-feeding. Do not breastfeed while taking voxelotor and for 2 weeks after your final dose.

• if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking voxelotor.

Talk to your doctor about eating grapefruit and drinking grapefruit juice while taking this medication.

Unless your doctor tells you otherwise, continue your normal diet.

Skip the missed dose and continue your regular dosing schedule the next day.

• Voxelotor may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

  • headache

  • diarrhea

  • stomach pain

  • nausea

  • fever

• Some side effects can be serious. If you experience any of these symptoms, stop taking voxelotor and call your doctor immediately or get emergency medical treatment:

  • rash, hives, shortness of breath, or facial swelling

• Voxelotor may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

• If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Keep all appointments with your doctor.

Before having any laboratory test, tell your doctor and the laboratory personnel that you are taking voxelotor.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.