Daprodustat

Daprodustat is used to treat anemia caused by chronic kidney disease in adults who have been on dialysis for at least 4 months.

Daprodustat may also be used for reasons 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.

Ask your doctor before changing your dose or stopping daprodustat.

Take daprodustat once a day with or without food.

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

Using daprodustat may increase your risk of developing cancer. Ask your doctor about your individual risk.

Daprodustat may be taken at the same time as iron supplements or medicines that control the amount of phosphorus in your blood.

Your blood pressure will need to be checked often.

You will need blood tests before and during treatment with daprodustat, and your dose may change based on the results.

Store at room temperature away from moisture and heat.

Call your doctor at once if you have:

• sudden numbness or weakness (especially on one side of the body)
• problems with vision or balance
• shortness of breath
• pain, swelling, or warmth in one leg
• do not feel a vibration in the dialysis access area

Also call your doctor at once if you have:

• stomach pain
• bloody or tarry stools
• nausea
• vomit that looks like coffee grounds
• trouble swallowing
• chest or throat pain

You should not use daprodustat if you have:

• uncontrolled high blood pressure; or
• if you use certain medicines called strong CYP450 2C8 inhibitors, such as gemfibrozil.

Tell your doctor if you have or have ever had:

• high blood pressure, heart disease, or heart failure;
• a stroke;
• damage to the lining of the stomach, esophagus, or intestines;
• stomach ulcers;
• cancer;
• if you smoke tobacco or drink alcohol; or
• liver disease.

May harm an unborn baby. Do not use if you are pregnant. Tell your doctor if you become pregnant.

Do not breastfeed while using daprodustat, and for at least 1 week after your last dose.

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

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

• heart problems--swelling, rapid weight gain, feeling short of breath;
• heart attack symptoms--chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;
• signs of a stroke--sudden numbness or weakness (especially on one side of the body), severe headache, slurred speech, problems with vision or balance;
• signs of a blood clot in the lung--chest pain, sudden cough or shortness of breath, dizziness, coughing up blood;
• signs of a blood clot deep in the body--pain, swelling, or warmth in one leg;
• dialysis access problems--dialysis access is not working, or if you do not feel a vibration in the dialysis access area; or
• stomach pain, bloody or tarry stools, nausea, vomit that looks like coffee grounds, trouble swallowing, chest or throat pain.

Common side effects of daprodustat may include:

• severe headache, blurred vision, pounding in your neck or ears;
• dialysis access problems;
• stomach pain;
• heart attack;
• stroke;
• a blood clot in the lung; or
• a blood clot deep in the body.

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

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

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

Overdose symptoms may include headache and nausea.

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.

Tell your doctor about all your other medicines, especially:

• clopidogrel; or
• rifampin.

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