Mitapivat (mye-ta-PIV-at)

Treats hemolytic anemia in patients with pyruvate kinase (PK) deficiency.

Brand Name(s):

Pyrukynd, Pyrukynd Taper Pack

When This Medicine Should Not Be Used:

How to Use This Medicine:

Tablet

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• Swallow the tablets whole. Do not split, crush, chew, or dissolve it.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose: If you miss a dose and it is 4 hours or less, take it as soon as possible, then take your next dose at the normal time. If you miss a dose and it is more than 4 hours, skip the missed dose and take your next dose at the normal time. Do not use extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Store the tablet in its original container.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how mitapivat works. Tell your doctor if you are using efavirenz, fluconazole, itraconazole, ketoconazole, midazolam, rifampin, or birth control pills (including ethinyl estradiol).

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have liver disease.
• Do not stop using this medicine suddenly. Your doctor will need to slowly decrease your dose before you stop it completely. This may help prevent worsening of your condition and reduce the risk of acute hemolysis (rapid breakdown of red blood cells).
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blurred vision, severe headache, slow, fast, or uneven heartbeat, lightheadedness, dizziness
• Confusion, dark urine, trouble breathing, unusual tiredness or weakness, yellow eyes or skin
• Stomach pain, diarrhea, loss of appetite, nausea

If you notice these less serious side effects, talk with your doctor:

• Back or joint pain
• Constipation
• Dry mouth
• Numbness, tingling, or burning pain in your hands, arms, legs, or feet
• Sore throat
• Warmth or redness in your face, neck, arms, or upper chest

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088