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Mitapivat may cause liver damage. Tell your doctor if you have or have ever had cirrhosis (scarring) of the liver or other liver disease. If you experience any of the following symptoms, 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.
Because of the risk of liver damage, mitapivat is available only through a special restricted distribution program. You can get mitapivat only if you are registered with this program. Your doctor must enroll you in this program. You can only receive the medication from a pharmacy that participates in the program. Ask your doctor if you have any questions about participating in the program or how to get your medication.
Keep all appointments with your doctor and the laboratory. Your doctor will order certain tests to check your body's response to mitapivat.
You will be given the Medication Guide. Read the information carefully and ask your doctor or pharmacist if you have any questions.
WHY is this medicine prescribed?
Mitapivat is used to treat thalassemia (an inherited condition that causes a low number of red blood cells). 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.
HOW should this medicine be used?
Mitapivat comes as a tablet to take by mouth. Take with for without food twice a day. Take mitapivat at around the same times every day.
Take mitapivat exactly as directed. 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, or crush them.
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.
Are there OTHER USES for this medication?
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
What SPECIAL PRECAUTIONS should I follow?
Before taking mitapivat,
What SPECIAL DIETARY instructions should I follow?
Talk to your doctor about eating grapefruit and drinking grapefruit juice while taking this medication.
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:
Some side effects can be serious. If you experience any of those listed in the IMPORTANT WARNING section, call your doctor immediately.
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 (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).
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 http://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 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 in the refrigerator. Mitapivat may be stored at room temperature for up to 3 months. Record the discard date on the blister wallet or carton when you remove the tablets from the refrigerator. Properly dispose of the tablets by the written discard date or expiration date, whichever occurs first.
Keep all medication out of sight and reach of children as many containers are not child-resistant. Always lock safety caps. Place the medication in a safe location - one that is up and away and out of their sight and reach. http://www.upandaway.org
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 http://goo.gl/c4Rm4p for more information.
What OTHER INFORMATION should I know?
Before having any laboratory test, tell your doctor and the laboratory personnel that you are taking 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.
This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.
The American Society of Health-System Pharmacists, Inc. represents that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. makes no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information is not a substitute for medical care.
AHFS® Patient Medication Information™ Copyright, 2026. The American Society of Health-System Pharmacists®, 4500 East-West Highway, Suite 900, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.
Selected Revisions: April 15, 2026.