now
approved

MOST IMPORTANT INFORMATION YOU 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. Blood clots can form in the blood vessels, including your legs, lungs, and in your dialysis access.

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.

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.

DO NOT USE VAFSEO IF YOU:

• are allergic to vadadustat or any of the ingredients in VAFSEO. Refer to the Medication Guide for a complete list of ingredients in VAFSEO.

• have high blood pressure that is not controlled (uncontrolled hypertension).

WARNINGS

VAFSEO may cause other serious side effects, including:

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 experience: tiredness; loss of appetite; pain in your right upper stomach area (abdomen); dark urine; yellowing of your skin or the white part of your eyes.

High blood pressure. VAFSEO may cause you to develop new or worsening high blood pressure. Monitor your blood pressure regularly, follow any instructions from your healthcare provider about controlling your blood pressure, and tell your healthcare provider about any changes.

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 experience signs or symptoms that a seizure may happen: headache, irritability, fear, confusion, or unusual feelings.

Damage to the lining of the esophagus, stomach, or intestines (such as ulcers). Your risk of damage to the lining of the esophagus, stomach, or intestines may increase if you have a prior history, stomach ulcers (peptic ulcer disease), use certain medicines that increase the risk of damage, or currently smoke tobacco or drink alcohol. Get medical care right away if you experience stomach-area (abdominal) discomfort or pain; nausea or vomiting; blood in your vomit or stool; black, tarry stools; trouble swallowing; pain in your throat or chest.

Cancer. Cancers have happened in people treated with VAFSEO. Talk to your healthcare provider if you have any concerns about cancer.

Ask a healthcare provider before use 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.

• are breastfeeding or plan to breastfeed. 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.

WHEN USING VAFSEO, YOU MAY HAVE

• high blood pressure

• diarrhea

The risk information provided here is not complete. To learn more, talk about VAFSEO with your healthcare provider. The FDA-approved product labeling, including BOXED WARNING and Medication Guide can be found here.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.