Vadadustat (vad-a-DOO-stat)

Treats anemia caused by chronic kidney disease (CKD).

Brand Name(s):

Vafseo

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 tablet whole. Do not cut, crush, or chew it.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take 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.

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 vadadustat works. Tell your doctor if you are using cefaclor, ceftizoxime, famotidine, furosemide, gemfibrozil, oseltamivir carboxylate, penicillin G, probenecid, rifampicin, rosuvastatin, simvastatin, sitagliptin, sulfasalazine, or teriflunomide.
• Take this medicine at least 1 hour before taking iron supplements or medicines that contain iron (including ferric citrate, sucroferric oxyhydroxide).
• Take this medicine at least 1 hour before or 2 hours after taking phosphate binders that do not contain iron (including calcium acetate, sevelamer carbonate).

Warnings While Using This Medicine:

• It is not safe to take this medicine during pregnancy. It could harm an unborn baby. Tell your doctor right away if you become pregnant.
• Do not breastfeed during treatment and for 2 days after the last dose.
• Tell your doctor if you have liver disease, cancer, heart disease, high blood pressure, stroke, or stomach or bowel problems (including gastrointestinal erosion, peptic ulcer). Tell your doctor if you also smoke or drink alcohol.
• This medicine may cause the following problems:
  • Increased risk of heart attack, stroke, or blood clots (may be life-threatening)
  • Liver problem
  • High blood pressure
  • Seizures
  • Increased risk of serious stomach or bowel problems (including damage to the stomach lining, esophagus, and intestines)
  • Cancer
• 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, dizziness, nervousness, slow or fast heartbeat
• Chest pain that may spread to your arms, jaw, back, or neck, trouble breathing, unusual sweating, faintness
• Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
• Numbness or weakness in your arm or leg, or on one side of your body, pain in your lower leg
• Seizures
• Stomach pain, coughing up blood
• Sudden or severe headache, problems with vision, speech, or walking

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

• Diarrhea

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