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.
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 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.
What special precautions should I follow?
Before taking mitapivat,
- tell your doctor or pharmacist if you are allergic to this medication, any part of this medication, or any other medications, 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 while taking mitapivat. 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 hormonal contraceptives (birth control pills, patches, rings, and injections). You will need to use another method of contraception to prevent pregnancy while taking mitapivat. Talk to your 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 are taking these medications before you start taking mitapivat. Do not start any of these medications while taking mitapivat without discussing with your healthcare provider.
- tell your doctor if you have or have ever had any medical conditions listed in the IMPORTANT WARNING section or any other medical conditions.
- 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 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 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 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:
- headache
- difficulty falling asleep or staying asleep
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 ( 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 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. https://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 https://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.