Vadadustat

Vadadustat is used to treat anemia that results from chronic kidney disease in adults who have been on dialysis for at least 3 months.

Vadadustat 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.

Vadadustat is usually taken once per day with or without food.

Vadadustat may be taken before, during, or after dialysis.

Ask your doctor before changing your dose or stopping vadadustat.

Vadadustat may be taken 1 hour before iron supplements (ferric citrate, ferrous sulfate, sodium ferrous citrate, ferric citrate, sucroferric oxyhydroxide) or 1 hour before or 2 hours after medicines that control the amount of phosphorus in your blood (calcium acetate, sevelamer carbonate).

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

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

Your blood pressure will need to be checked often.

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

Store at room temperature away from moisture and heat.

Call your doctor immediately if you experience sudden numbness or weakness (especially on one side of your body), vision or balance issues, shortness of breath, pain, swelling, or warmth in one leg, or if you cannot feel a vibration in the dialysis access area.

Also call your doctor right away if you have seizures, loss of appetite, nausea, stomach pain (upper right side), trouble swallowing, tiredness, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes), bloody or tarry stools, coughing up blood, or vomit that looks like coffee grounds.

You should not use vadadustat if you are allergic to it, or if you have:

• uncontrolled high blood pressure.

Tell your doctor if you have or have ever had:

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

It is not known if vadadustat will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Do not breastfeed while using vadadustat, and for at least 2 days 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.

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

• cancer;
• new or worsening seizures, headache, irritability, fear, confusion, or unusual feelings;
• liver problems--loss of appetite, nausea, vomiting, stomach pain (upper right side), tiredness, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• 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--swelling or discoloration near the access site, 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 vadadustat may include:

• high blood pressure; or
• diarrhea.

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.

Usual Adult Dose for Anemia Associated with Chronic Renal Failure:

Initial dose: 300 mg orally once a dayMaximum dose: 600 mg orally once a dayComments:-Dose adjustments should be in increments of 150 mg to maintain hemoglobin (Hb) levels of 10 to 11 g/dL. Adjustments should be made according to the titration schedule based on changes in Hb (doses may range from 150 to 600 mg per day).-Dosing should be individualized, using the lowest dose sufficient to reduce the need for red blood cell transfusions. Do not target Hb level higher than 11 g/dL.-Increase the dose no more frequently than once every 4 weeks. Decreases can occur more frequently. -Therapy should not be continued beyond 24 weeks if a clinically meaningful increase in hemoglobin levels is not achieved. An alternative explanation for an inadequate response should be sought and treated before re-starting this drug. Use: For the treatment of anemia due to chronic kidney disease in patients who have been in dialysis for at least 3 months

Take the missed dose on the same day you remember it. Take your next dose at the regular time and continue with your once-daily schedule. Do not take two doses in one day.

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

Follow your doctor's instructions regarding any restrictions on food, drinks, or activities.

Take your vadadustat dose at least 1 hour before taking iron supplements (ferric citrate, ferrous sulfate, sodium ferrous citrate, ferric citrate, sucroferric oxyhydroxide) or at least 1 hour before or 2 hours after taking medicines that control the amount of phosphorus in your blood (calcium acetate, sevelamer carbonate).

Tell your doctor about all the medicines you are currently taking. Many drugs can affect vadadustat, especially:

• probenecid;
• gemfibrozil;
• rifampin; or
• teriflunomide.

This list is not complete. Other drugs may affect vadadustat, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.