Daprodustat

IMPORTANT WARNING:

Using daprodustat increases the risk that blood clots will form in or move to the legs, lungs, or brain. Tell your doctor if you have or have ever had heart disease and if you have ever had a stroke. Call your doctor immediately or get emergency medical help if you experience any of the following symptoms: pain, tenderness, redness, warmth, and/or swelling in the legs; coolness or paleness in an arm or leg; shortness of breath; cough that won't go away or that brings up blood; chest pain; sudden trouble speaking or understanding speech; sudden confusion; sudden weakness or numbness of an arm or leg (especially on one side of the body) or of the face; sudden trouble walking, dizziness, or loss of balance or coordination; or fainting. If you are being treated with hemodialysis (treatment to remove waste from the blood when the kidneys are not working), a blood clot may form in your vascular access (place where the hemodialysis tubing connects to your body). Tell your doctor if your vascular access stops working as usual.

Your doctor will adjust your dose of daprodustat so that your hemoglobin level (amount of a protein found in red blood cells) is just high enough that you do not need a red blood cell transfusion (transfer of one person's red blood cells to another person's body to treat severe anemia). If you receive enough daprodustat to increase your hemoglobin to a normal or near normal level, there is a greater risk that you will have a stroke or develop serious or life-threatening heart problems including heart attack, and heart failure. Call your doctor immediately or get emergency medical help if you experience any of the following symptoms: chest pain, squeezing pressure, or tightness; shortness of breath; nausea, lightheadedness, sweating, and other early signs of heart attack; discomfort or pain in the arms, shoulder, neck, jaw, or back; or swelling of the hands, feet, or ankles.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to daprodustat. Your doctor may decrease your dose or tell you to stop using daprodustat for a period of time if the tests show that you are at high risk of experiencing serious side effects. Follow your doctor's directions carefully.

Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with daprodustat and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) to obtain the Medication Guide.

Talk to your doctor about the risks of taking daprodustat.

WHY is this medicine prescribed?

Daprodustat is used to treat anemia (a lower than normal number of red blood cells) in people with chronic kidney failure (condition in which the kidneys slowly and permanently stop working over a period of time) who have been receiving hemodialysis for at least 4 months Daprodustat is in a class of medications called HIF PH inhibitors. It works by increasing the hormone, erythropoietin, needed by the body to produce more red blood cells.

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?

Daprodustat comes as a tablet to take by mouth. It is usually taken with or without food one time a day. Take daprodustat at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take daprodustat 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.

Your doctor will likely have to adjust your dose of daprodustat periodically based on your lab work.

Daprodustat controls anemia but does not cure it. Continue to take daprodustat even if you feel well. Do not stop taking daprodustat without talking to your doctor.

What SPECIAL PRECAUTIONS should I follow?

Before taking daprodustat,

• tell your doctor and pharmacist if you are allergic to daprodustat, any other medications, or any of the ingredients in daprodustat tablets. Ask your pharmacist or check the Medication Guide for a list of the ingredients.

• some medications should not be taken with daprodustat. Make sure you have discussed any medications you are currently taking or plan to take before starting daprodustat with your doctor and pharmacist. Before starting, stopping or changing any medications while taking daprodustat, please get the advice of your doctor or pharmacist as your dose may need to be changed or you may need to be monitored more closely.

• tell your doctor if you have hypertension. Your doctor may tell you not to take daprodustat.

• tell your doctor if you have or have ever had liver disease, damage to the lining of the stomach, esophagus, or intestines, history of stomach ulcers, tobacco use or alcohol use, or cancer.

• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking daprodustat, call your doctor. Daprodustat may harm the fetus. You should refrain from breastfeeding while taking daprodustat and for one week after stopping it.

• ask your doctor about the safe use of alcoholic beverages while you are taking daprodustat. Alcohol can make the side effects from daprodustat worse.

• tell your doctor if you use tobacco products. Cigarette smoking can make the side effects from daprodustat worse.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do IF I FORGET to take a dose?

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, 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?

Daprodustat may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• abdominal pain
• dizziness

Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately or get emergency medical treatment:

• nausea or vomiting
• blood in your vomit or stool
• black, tarry stools
• trouble swallowing
• pain in your throat or chest

Daprodustat 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 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 at room temperature and away from excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

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.

Symptoms of overdose may include:

• headache
• nausea, vomiting, diarrhea, or abdominal pain

What OTHER INFORMATION should I know?

Keep all appointments with your doctor and the laboratory. Your doctor will/may order certain lab tests to check your body's response to daprodustat.

Before having any laboratory test, tell your doctor and the laboratory personnel that you are taking daprodustat.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.