Mitapivat

WHY is this medicine prescribed?

Mitapivat is used to treat hemolytic anemia (a blood disorder that occurs when red blood cells are destroyed faster than they can be made in the body) in people with pyruvate kinase deficiency. Mitapivat is in a class of medications called pyruvate kinase activators. It works by increasing pyruvate kinase activity which increases red blood cells in the body.

Are there OTHER USES for this medicine?

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

HOW should this medicine be used?

Mitapivat comes as a tablet to take by mouth. Take with or without food 2 times a day. Take mitapivat at around the same times every day.

Take mitapivat exactly as directed. Ask your doctor or pharmacist to explain any part you do not understand. Do not take more or less of it or take it more often than prescribed by your doctor.

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

Your doctor will probably start you on a low dose of mitapivat and gradually increase your dose, typically every 4 weeks.

Mitapivat controls your condition but does not cure it. Continue to take mitapivat even if you feel well. Do not stop taking mitapivat without talking to your doctor. If you suddenly stop taking mitapivat, you may experience symptoms of acute hemolysis and anemia (yellowing of the skin or whites of the eyes, dark urine, dizziness, confusion, tiredness, difficulty breathing). Your doctor will probably decrease your dose gradually.

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

What SPECIAL PRECAUTIONS should I follow?

Before taking mitapivat,

• tell your doctor or pharmacist if you are allergic to this drug, any part of this drug, or any other drugs, foods or substances. Tell your doctor or pharmacist about the allergy and what symptoms you had.

• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• You should know that mitapivat may decrease the effectiveness of hormonalcontraceptives (birth control pills, patches, rings, and injections). You will need to useanother method of contraception to prevent pregnancy while taking mitapivat. Talk toyour doctor about other ways to prevent pregnancy while you are taking this medication.

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

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

• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking mitapivat, call your doctor.

What SPECIAL DIETARY instructions should I follow?

Talk to your doctor about eating grapefruit or drinking grapefruit juice while taking this medicine.

What should I do IF I FORGET to take a dose?

Take the missed dose as soon as you remember it if it is within 4 hours of the usual dosing time. If more than 4 hours have passed, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

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

• back pain
• joint pain
• nausea, vomiting, diarrhea or stomach pain
• hot flushes (warmth and redness of face, neck, chest or back)
• sore throat
• breast pain or swelling
• constipation
• dry mouth
• rapid or fast heart beat
• tingling or prickly feeling in hands, arms, feet or legs

Some side effects can be serious. If you experience any of these symptoms or those in the HOW section, call your doctor immediately:

• nausea, vomiting, lack of energy, loss of appetite, dark colored urine, pain in the upper right part of the stomach, or yellowing of the skin or eyes

Mitapivat 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 (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

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). Mitapivat tablets should stay in their original blister packaging until ready to use.

Dispose of unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet. Use a medicine take-back program. Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines website https://goo.gl/c4Rm4p for more information.

What should I do in case of OVERDOSE?

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.

What OTHER INFORMATION should I know?

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to mitapivat.

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

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.