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Overview: Vafseo is a tablet that you swallow. It is used to increase red blood cell levels in certain people with kidney problems. Common side effects include high blood pressure and diarrhea. Talk to your health care provider if you drink alcohol or smoke tobacco as both of these can increase your risk for serious side effects. Serious side effects are less common, but they can include heart or liver problems, stroke, seizures, and allergic reactions. Notify your health care provider right away if you have chest pain, a sudden and severe headache, stomach pain, nausea, vomiting, or muscle twitches, jerking, or spasms.

Uses

What is Vafseo used for?

Vafseo (vadadustat) is commonly used to treat anemia from chronic kidney disease.

Vafseo may also be used for other conditions as determined by your health care provider.

How does Vafseo work (mechanism of action)?

If you have anemia, it means you have low levels of red blood cells. Anemia is a common problem in people who have chronic kidney disease. Vafseo is a hypoxia-inducible factor (HIF) inhibitor. It blocks certain enzymes in your body, called HIF-prolyl-4-hydroxylases (PH)1, PH2, and PH3. This increases the levels of HIF-1α and HIF-2α and tells your body to make erythropoietin (EPO). EPO is a hormone that tells your body to make more red blood cells. 

How is Vafseo supplied (dosage forms)?

Brands and other names

  • Vafseo

Dosage forms and strengths

  • 150 mg oral tablets
  • 300 mg oral tablets
  • 450 mg oral tablets

How should I store Vafseo?

Vafseo should be stored at room temperature, between 68 F and 77 F (20 C and 25 C). It can be exposed to temperatures between 59 F and 86 F (15 C and 30 C) for shorter periods of time, such as when transporting it. Store in a cool, dry place.

Side Effects

What are the most common side effects of Vafseo?

The most common side effects of Vafseo are listed below. Tell your health care provider if you have any of these side effects that bother you.

  • High blood pressure (see below)
  • Diarrhea

There may be other side effects of Vafseo that are not listed here. Contact your health care provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088 (800-332-1088). In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.

What are the serious side effects of Vafseo?

While less common, the most serious side effects of Vafseo are described below, along with what to do if they happen.

Severe Allergic Reactions. Vafseo may cause allergic reactions, which can be serious. Stop taking Vafseo and get help right away if you have any of the following symptoms of a serious allergic reaction.

  • Breathing problems or wheezing
  • Racing heart
  • Fever or general ill feeling
  • Swollen lymph nodes
  • Swelling of the face, lips, mouth, tongue, or throat
  • Trouble swallowing or throat tightness
  • Itching or skin rash
  • Bumps on the skin called hives that can be red, pink, white, or brown depending on your skin tone
  • Nausea or vomiting
  • Dizziness, feeling lightheaded, or fainting
  • Stomach cramps
  • Joint pain

Heart Attack and Stroke. Vafseo can increase your risk of a blood clot (including deep vein thrombosis or pulmonary embolism), heart attack, or stroke that can lead to death. This risk is higher in people who already have heart disease and with longer use of Vafseo and higher doses. Do not take Vafseo if you have had a recent (within the last three months) heart attack, stroke, transient ischemic attack (TIA), or acute coronary syndrome without talking to your health care provider. This could increase your risk of having these problems. Get emergency help if you have any of the following symptoms of a heart attack, stroke, or other blood clot.

  • Chest pain or pressure
  • Fast or abnormal heartbeat
  • Trouble breathing
  • Pain in your back, jaw, throat, or arm
  • Sweating, upset stomach, vomiting, or dizziness
  • Sudden weakness on one side of your body
  • Sudden and severe headache
  • Slurred speech or trouble understanding speech
  • Sudden dizziness, trouble walking, or coordination or balance problems
  • Sudden vision changes, like trouble seeing 
  • Fainting
  • Pain, swelling, or tenderness in your arm or leg
  • Swelling or color changes near your dialysis access site
  • No longer feel any movement or vibration at your dialysis access site during dialysis

Liver Damage. Liver damage, also called hepatotoxicity, can happen when taking Vafseo. Your health care provider may check lab work before and while you are taking Vafseo to watch for this. Keep any appointments, including those for lab work, while you are taking this medicine. Call your health care provider right away if you have any of the following symptoms of liver damage.

  • Nausea or vomiting
  • Stomach or belly pain
  • Fever
  • Weakness or unusual tiredness
  • Itching
  • Loss of appetite
  • Light-colored poop
  • Dark-colored urine (pee)
  • Your skin or the whites of your eyes turning yellowish in color (also called jaundice)

Increased Blood Pressure (Hypertension). Vafseo may increase your blood pressure or make it worse if you have a history of high blood pressure. Follow your health care provider’s instructions about checking your blood pressure at home or any medicine changes to keep your blood pressure under control. Call your health care provider if your blood pressure increases while taking this medicine.

If you measure your blood pressure and the top number (systolic) is 180 or higher or the bottom number (diastolic) is 120 or higher, get medical attention right away. Increases in blood pressure may not be noticeable, but look out for and tell your health care provider right away if you have any of the following symptoms of severely high blood pressure.

  • Sudden severe headache
  • Chest pain
  • Dizziness or confusion
  • Trouble breathing
  • Nausea or vomiting
  • Blurry or other changes to vision
  • Anxiety
  • Buzzing in the ears
  • Nosebleed
  • Feeling of skipped heartbeats

Seizures. Some people who have taken Vafseo have reported having seizures. There are many different types of seizures and some of them are not easy to recognize. Stop taking Vafseo and call your health care provider if you have any of the following signs that a seizure is happening or could happen.

  • Muscle twitching, jerking, spasms, tremors, or other uncontrolled movements
  • Stiffening of your arms and legs
  • Feeling anxious, nervous, confused, or a sense of dread
  • Feeling dizzy or lightheaded
  • Falling or losing consciousness

Stomach or Intestinal Bleeding. Vafseo can increase your risk for bleeding in your stomach and intestines, especially in the upper part. Your risk may be higher if you have a history of stomach or intestinal bleeding, take certain medicines, smoke tobacco, or drink alcohol. Call your health care provider right away if you have any of the following signs of bleeding while taking Vafseo.

  • Nausea and vomiting
  • Vomit with blood that looks like coffee grounds
  • Coughing up blood or blood clots
  • Black or tarry poop
  • Stomach, chest, or throat pain

Warnings & Precautions

Who should not use Vafseo?

Allergies to Ingredients. People who are allergic to any of the following should not take Vafseo.

  • Vadadustat
  • Vafseo
  • Any of the ingredients in the specific product dispensed

Your pharmacist can tell you all of the ingredients in Vafseo.

High Blood Pressure. You should not take Vafseo if you have high blood pressure and it is not well controlled.

What should I know about Vafseo before using it?

Do not take Vafseo unless it has been prescribed to you by a health care provider. Take it as prescribed. Do not change your dose without your health care provider telling you to do so. Taking too much may cause harm.

Do not share Vafseo with other people, even if they have the same condition as you. It may harm them.

Keep Vafseo out of the reach of children.

Do not cut, chew, or crush Vafseo. You should swallow the tablets whole.

Your health care provider will likely check lab work regularly while you are taking Vafseo. This is to make sure it is working, see if you are taking the right dose, and watch for side effects. Keep all appointments, including those for lab work, while you are on it.

If your health care provider tells you that you need a blood transfusion to bring your red blood cell levels up because they are very low, you cannot use Vafseo instead of getting a blood transfusion. It does not work quickly enough. Talk to your health care provider if you have concerns.

Certain medicines may affect how much Vafseo is absorbed by your body. You may need to separate Vafseo from other medicines or supplements that you take. Follow your health care provider’s or pharmacist’s recommendations for separating your doses of Vafseo from those of your other medicines or supplements.

What should I tell my health care provider before using Vafseo?

Tell your health care provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them know if Vafseo is right for you.

In particular, make sure that you discuss any of the following.

Cancer. Vafseo can increase the levels of a protein in your body, called hypoxia inducible factor (HIF-1). If you already have cancer, this protein may make it worse. Tell your health care provider if you have any type of cancer.

Current and Past Health Conditions. Tell your health care provider if you have any of the following.

Other Medicines and Supplements. Vafseo may interact with other medicines and supplements. Before taking Vafseo, tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. See the Interactions section for more details.

Pregnancy. It is not known if or how Vafseo could affect pregnancy or harm a fetus. Tell your health care provider if you are pregnant or plan to become pregnant. Your health care provider will let you know if you should take Vafseo while you are pregnant or trying to get pregnant.

Breastfeeding. It is not known if Vafseo passes into breast milk. You should not breastfeed while taking Vafseo or for two days after your last dose. Tell your health care provider if you are breastfeeding or plan to breastfeed.

How can I get more information about Vafseo?

For more information about Vafseo, you can visit the drugmaker’s website at www.vafseo.com or call them at 844-445-3799.

Interactions

Does Vafseo interact with foods or drinks?

There are no known interactions between Vafseo and foods or drinks.

Drinking alcohol while taking Vafseo may increase your risk of serious side effects. See the Side Effects section for more details. Tell your health care provider if you drink alcohol before you start taking Vafseo.

Does Vafseo interact with other medicines (drug interactions)?

Always tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.

In particular, make sure that you discuss if you are using any of the following before taking Vafseo.

  • An iron supplement or a supplement, medicine, or vitamin that has iron in it
  • A phosphate binder, such as calcium acetate (Phoslo, Phoslyra, and others), ferric citrate (Auryxia), sevelamer (Renagel, Renvela), or sucroferric oxyhydroxide (Velphoro), which is a medicine used to lower phosphate levels
  • Probenecid, which is a medicine commonly used for gout
  • Rifampin (Rifadin), which is a medicine commonly used to treat an infection called tuberculosis
  • Gemfibrozil (Lopid), which is a medicine for high cholesterol
  • Sulfasalazine (Azulfidine), which is a medicine used for certain inflammatory conditions, such as ulcerative colitis or rheumatoid arthritis
  • A statin, such as rosuvastatin (Crestor) or simvastatin (Flolipid, Zocor), which is a medicine to lower cholesterol
  • Teriflunomide (Aubagio), which is a medicine used to treat multiple sclerosis
  • Cefaclor (Ceclor, Raniclor) or penicillin, which is medicine used for bacterial infections 
  • Sitagliptin (Januvia, Zituvio), which is a medicine used to treat type 2 diabetes
  • Furosemide (Lasix), which is a medicine used to reduce edema (fluid retention) and blood pressure
  • Famotidine (Pepcid, Zantac), which is a medicine used to reduce stomach acid
  • Oseltamivir (Tamiflu), which is a medicine used to treat the flu

Many other medicines may alter the blood levels of Vafseo, and vice versa. Tell your health care provider about all medicines that you take or have recently taken.

This may not be a complete list of medicines that can interact with Vafseo. Always check with your health care provider.

Does interact with other drugs you are taking?

Enter your medication into the WebMD interaction checker

Overdose/Missed Dose

What should I do if I accidentally use too much Vafseo?

If you or someone else has used too much Vafseo, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.

What should I do if I miss a dose of Vafseo?

If you miss a dose, take it as soon as you remember, unless you remember the missed dose the next day. If you remember your missed dose the next day, just take your normal daily dose. Do not take more than one dose per day. Do not take double or extra doses.