MEDICATION GUIDE

VAFSEO® (VAFF-see-oh)
(vadadustat)
tablets, for oral use

What is the most important information I should know about VAFSEO?

VAFSEO may cause serious side effects, including:

• Increased risk of death, heart attack, stroke, and blood clots. These risks may happen if you are treated with VAFSEO to increase red blood cells (RBCs) to near the same level found in healthy people. These risks may be increased if you have heart or blood vessel problems, or problems with blood flow to your brain (cerebrovascular disease). Blood clots can form in the blood vessels (veins), including your legs (deep vein thrombosis or DVT), lungs (pulmonary embolism or PE), and in your dialysis access (vascular access thrombosis or VAT).
  Get medical help right away if you get any of the following signs or symptoms:
  • chest pain
  • trouble breathing or shortness of breath
  • cold sweat
  • sudden numbness or weakness in your face, arm or leg, especially on one side of your body
  • sudden confusion, trouble speaking, or trouble understanding others’ speech
  • sudden trouble seeing
  • sudden trouble walking, dizziness, loss of balance or coordination
  • loss of consciousness (fainting)
  • severe headache
  • pain in your legs, with or without swelling
  • a cool or pale arm or leg
  • changes to your dialysis access site, including swelling or discoloration near the site
  • do not feel a vibration (“thrill”) over the dialysis access area

See “What are the possible side effects of VAFSEO?” for more information about side effects.
If you decide to take VAFSEO, your healthcare provider should prescribe the lowest dose of VAFSEO that is necessary to reduce your chance of needing red blood cell transfusions.

What is VAFSEO?

VAFSEO is a prescription medicine used to treat anemia caused by chronic kidney disease (CKD) in adults on dialysis for at least 3 months. People with anemia have a lower-than-normal number of red blood cells (RBCs). VAFSEO works by increasing a protein called erythropoietin to help your body make more RBCs. VAFSEO is used to reduce or avoid the need for RBC transfusions.
If your hemoglobin level stays too high or if your hemoglobin goes up too quickly, this may lead to serious health problems which may result in death. These serious health problems may happen if you take VAFSEO, even if you do not have an increase in your hemoglobin levels.
VAFSEO has not been proven to improve quality of life, tiredness (fatigue), or well-being.

VAFSEO should not be used:

• in place of emergency treatment for anemia (red blood cell transfusions).
• for the treatment of anemia that is caused by CKD in people who are not on dialysis.

It is not known if VAFSEO is safe and effective in children.

Who should not take VAFSEO?

Do not take VAFSEO if you:

• are allergic to VAFSEO or to any of its ingredients. See the end of this Medication Guide for a complete list of ingredients in VAFSEO.
• have high blood pressure that is not controlled (uncontrolled hypertension).

Before taking VAFSEO, tell you healthcare provider about all of your medical conditions, including if you:

• have heart disease.
• have had a stroke.
• have liver problems.
• have high blood pressure.
• have had a seizure.
• have a history of damage, such as ulcers, to the lining of the esophagus, stomach, or intestine.
• smoke tobacco or drink alcohol.
• have cancer.
• are pregnant or plan to become pregnant. It is not known if VAFSEO may harm your unborn baby. Talk to your healthcare provider if you become pregnant or think you may be pregnant during treatment with VAFSEO.
• are breastfeeding or plan to breastfeed. It is not known if VAFSEO passes into breast milk. Do not breastfeed during treatment with VAFSEO and for 2 days after your final dose.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

• Especially tell your healthcare provider if you take iron supplements, products containing iron or phosphate binders by mouth. These products affect how VAFSEO works and should not be taken at the same time you take VAFSEO. Ask your healthcare provider if you are not sure if you take any of these products. See “How should I take VAFSEO?” for more information.

How should I take VAFSEO?

• Take VAFSEO exactly as your healthcare provider tells you to take it.
• Do not change your dose unless your healthcare provider tells you to.
• You may take VAFSEO with or without food.
• VAFSEO tablets should be swallowed whole. Tablets should not be cut, crushed, or chewed.
• VAFSEO can be taken at any time of the day, including before, during, or after dialysis.
• Take VAFSEO at least 1 hour before you take any of the following:
  • iron supplements
  • products containing iron
  • phosphate binders that contain iron
• Take VAFSEO at least 1 hour before or 2 hours after taking the following:
  • phosphate binders that do not contain iron
• If you miss a dose of VAFSEO, take it as soon as you remember during the same day and then take the next dose at the usual time the next day. Do not take more than 1 dose a day.
• Tell your healthcare provider right away if you take more than your prescribed dose of VAFSEO.
• Your healthcare provider will do certain blood tests before you start VAFSEO and during treatment as needed.
• Your healthcare provider may change your dose of VAFSEO based on the results of your blood tests.

What are the possible side effects of VAFSEO?

VAFSEO may cause serious side effects, including:

• See “What is the most important information I should know about VAFSEO?”
• Liver problems. VAFSEO may cause changes in blood liver tests, which may be a sign of liver injury. Your healthcare provider will do blood liver tests before starting treatment with VAFSEO, monthly for the first 6 months and then as needed. Your healthcare provider may stop treatment with VAFSEO if you have changes in your blood liver tests. Tell your healthcare provider if you get any of these symptoms:
  • tiredness
  • pain in your right upper stomach area (abdomen)
  • yellowing of your skin or the white part of your eyes
  • loss of appetite
  • dark urine
• High blood pressure. VAFSEO may cause you to develop new or worsening high blood pressure. It is important to check your blood pressure regularly and to follow any instructions from your healthcare provider about how to control your blood pressure. Tell your healthcare provider about any changes in your blood pressure.
• Seizures. Seizures have happened in people treated with VAFSEO. Tell your healthcare provider about new onset of seizures, change in how often you have seizures, or if you get any of the following signs or symptoms that a seizure may happen: headache, irritability, fear, confusion, or unusual feelings.
• Damage, such as ulcers, to the lining of the esophagus, stomach, or intestines (gastrointestinal erosion). Your risk of gastrointestinal erosion may increase if you have a history of gastrointestinal erosion, stomach ulcers (peptic ulcer disease), use certain medicines that increase the risk of gastrointestinal erosion, or currently smoke tobacco or drink alcohol. Get medical care right away if you get any of these signs or symptoms:
  • stomach-area (abdominal) discomfort or pain
  • black, tarry stools
  • nausea or vomiting
  • trouble swallowing
  • blood in your vomit or stool
  • pain in your throat or chest
• Cancer. Cancer was observed in people treated with VAFSEO. Talk to your healthcare provider if you have any concerns about cancer.

The most common side effects of VAFSEO include:

• high blood pressure
• diarrhea

These are not all the possible side effects of VAFSEO. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store VAFSEO?

• Store VAFSEO at room temperature between 68℉ to 77℉ (20℃ to 25℃).

Keep VAFSEO and all medicines out of the reach of children.

General information about the safe and effective use of VAFSEO.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use VAFSEO for a condition for which it was not prescribed. Do not give VAFSEO to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about VAFSEO that is written for health professionals.

What are the ingredients in VAFSEO?

Active ingredient: vadadustat.

Inactive ingredients: colloidal silicon dioxide, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate.

The tablet film-coating contains polyvinyl alcohol, polyethylene glycol (PEG) and talc.

Colorants include:

150 mg tablets: titanium dioxide

300 mg tablets: titanium dioxide and yellow iron oxide

450 mg tablets: titanium dioxide, iron oxide red and ferrosoferric oxide

Manufactured for: Akebia Therapeutics®, Inc., Cambridge, MA 02142

VAFSEO® is a registered trademark of Akebia Therapeutics, Inc.

©2024 Akebia Therapeutics, Inc. All rights reserved.

For more information, go to www.VAFSEO.com or call 1-844-445-3799.

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