Mitapivat

Mitapivat is used to treat low red blood cell counts caused by hemolytic anemia (early breakdown of red blood cells) in adults with pyruvate kinase deficiency.

Mitapivat may also be used for reasons that are not mentioned in this medication guide.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

You may take mitapivat with or without food.

Swallow the tablet whole and do not crush, chew, or break it.

Do not share mitapivat with another person, even if they have the same symptoms you have.

Do not change your dose or stop using mitapivat without talking to your doctor. Your doctor will give you instructions for stopping mitapivat.

Store this medicine in the original container at room temperature.

Call your doctor right away if you have jaundice (yellowing of the skin or eyes), dark urine, dizziness, confusion, tiredness, or shortness of breath.

Tell your doctor if you have ever had:

• liver disease.

Tell your doctor if you are pregnant or breastfeeding.

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Mitapivat may cause serious side effects. Call your doctor right away if you have:

• jaundice (yellowing of the skin or eyes);
• dark urine;
• dizziness;
• confusion;
• tiredness; or
• shortness of breath.

Common side effects of mitapivat may include:

• flushing (sudden warmth, redness, or tingly feeling);
• breast swelling and tenderness;
• changes in sexual function;
• irregular heart rhythm;
• abnormal blood tests; or
• back or joint pain.

This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Use the medicine as soon as you can, but skip the missed dose if you are more than 4 hours late for the dose. Do not use two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Sometimes it is not safe to use certain medicines together. Some drugs can change the levels of other drugs in your blood, which may increase side effects or make the medicines less effective.

Other drugs may affect mitapivat, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you are using.