Vadadustat

Vadadustat may increase the risk of heart attacks, strokes, and clots. Tell your doctor if you have or have ever had cardiovascular or cerebrovascular events such as heart attacks, strokes, or angina (chest pain). If you experience any of the following symptoms, call your doctor immediately: chest, jaw or left arm pain; feeling like squeezing or pressure in the chest; clammy skin or dizziness; trouble walking or speaking; one-sided weakness, numbness of face, arm or leg; sudden development of warmth or redness in arms or legs or at the site of intravenous access.

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

Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with vadadustat 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 (https://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) to obtain the Medication Guide.

Vadadustat is used for treatment of anemia of chronic disease (low red blood cells caused by inflammation from having a disease for longer than 3 months) due to chronic kidney disease (CKD) in adults who have been on dialysis for at least 3 months. Vadadustat is in a class of medications called hypoxia-inducible factor prolyl hydroxylase (HIF PH) inhibitors. It works by increasing the production of red blood cells.

Vadadustat comes as a tablet to take by mouth. It is usually taken with or without food once a day. Take vadadustat at around the same time every day. It can be taken without regards to dialysis schedule. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take vadadustat 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 may adjust your dose of vadadustat based on your lab results. Your dose will not be increased more frequently than every 4 weeks but may be decreased sooner based on results.

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

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before taking vadadustat,

• tell your doctor and pharmacist if you are allergic to vadadustat, any other medications, or any of the ingredients in vadadustat tablet. Ask your pharmacist or check the Medication Guide for a list of the ingredients.
• 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 vadadustat. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• if you are taking any iron-containing supplements, products or binders (e.g. ferrous sulfate, ferrous fumarate, ferrous gluconate, multivitamin, ferric citrate), take them 1 hour after vadadustat.
• Vadadustat should be taken at least 1 hour before or 2 hours after any non-iron-containing phosphate binders (e.g. calcium acetate, sevelamer, and aluminum- or magnesium-containing products).
• tell your doctor if you have hypertension (high blood pressure). Your doctor may (if blood pressure is not well-controlled) tell you not to take vadadustat. Your doctor will monitor your blood pressure closely during treatment with vadadustat and put you on medication, or adjust medications, to manage blood pressure as needed.
• tell your doctor if you have or have ever had liver disease, cirrhosis, seizures or convulsions, gastrointestinal disease such as history of gastrointestinal erosion or peptic ulcer disease, tobacco use, 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 vadadustat, call your doctor.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking vadadustat.
• ask your doctor about the safe use of alcoholic beverages while you are taking vadadustat. Alcohol can make the side effects from vadadustat worse.

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

Take the missed dose as soon as you remember it. However, if it is the same day as 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.

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

• diarrhea (loose stool)
• headache
• tiredness

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

• rash, difficulty breathing or wheezing
• stomach pain, yellowing of skin or whites of eyes, dark urine
• changes in behavior or personality changes, seizures or convulsions or increased frequency of seizures
• stomach pain, bloating, loss of appetite, bright red blood in stool or dark, tarry stools, difficulty or painful swallowing, chest pain, heartburn

Vadadustat 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).

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. https://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 (https://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

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.

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

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.

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