Vafseo

Vafseo (vadadustat) is an oral, once daily, reversible HIF PH inhibitor that may be used to treat adults with anemia due to chronic kidney disease (CKD) who have been receiving dialysis for at least three months.

• Vafseo has not been shown to improve quality of life, fatigue, or patient well-being.
• Is not intended as a substitute for transfusion in patients requiring immediate correction of their anemia.
• Is not for use in patients with anemia due to CKD who are not on dialysis.

Vafseo (vadadustat) works by reversibly inhibiting hypoxia-inducible factor (HIF)-prolyl-4-hydroxylases (PH)1, PH2, and PH3, which stabilizes the HIF complex and stimulates erythropoietin production. This increases the production of red blood cells and improves renal anemia.

Vafeso was FDA-approved on 27 March 2024.

Vafseo increases the risk of potentially fatal vascular events caused by blood clots, such as heart attacks and strokes. The risk may be higher if hemoglobin levels greater than 11 g/dL are targeted. Your healthcare provider will use the lowest dose that reduces your need for a blood transfusion.

Liver toxicity has been reported in patients taking Vafseo. Your healthcare provider will measure your liver function and bilirubin levels before starting Vafseo, monthly after initiation for the first 6 months, then as clinically indicated.

Vafseo may worsen high blood pressure and a hypertensive crisis may occur. Your healthcare provider will monitor your blood pressure and adjust your high blood pressure medication as needed.

Seizures have occurred in patients with CKD taking Vafseo. Tell your healthcare provider if you experience any new seizures, premonitory symptoms, or a change in seizure frequency.

Gastric or esophageal erosions and gastrointestinal bleeding have been reported, and Vafseo may have unfavorable effects on cancer growth. It is not recommended in people with active cancer.

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

May cause harm to an unborn baby.

Do not take Vafseo if you:

• are allergic to Vafseo, vadadustat, or any of its inactive ingredients
• have high blood pressure that is not controlled (uncontrolled hypertension).

Before taking Vafseo, tell your 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
• are breastfeeding or plan to breastfeed.

Pregnancy

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.

Breastfeeding

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.

Vafseo may cause serious side effects, including:

• An increased risk of death, heart attack, stroke, and blood clots. 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:
• Liver problems. Tell your healthcare provider if you get any of these symptoms:
• 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 the 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:
• 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 affecting 10% or more of the population include high blood pressure and diarrhea.

These are not all of 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 the FDA at 1-800-FDA-1088.

Take Vafseo exactly as your healthcare provider tells you to take it. Do not change your dose unless your healthcare provider tells you to.

• Vafseo is taken once a day. It may be taken with or without food.
• The recommended starting dose is 300mg. Your healthcare provider will do certain blood tests before you start Vafseo and during treatment as needed, and may change your dose based on the results of these tests.
• Swallow the tablets whole. Do not cut, crushed, or chewed.
• It 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.

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.

Vafseo may also increase the risk of side effects associated with BCRP substrates (such as methotrexate, irinotecan, or nitrofurantoin) or statins (such as atorvastatin, simvastatin, and pravastatin).

Know the medicines you take and the vaccines you receive. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine. See the prescribing information for a full list of interactions.

Store at room temperature between 68°F to 77°F (20°C to 25°C).

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

Active ingredient: vadadustat.

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

Tablet film coating: 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

Available as 150 mg, 300 mg, and 450 mg tablets.

Akebia Therapeutics, Inc.