FDA Approves Vafseo (vadadustat) for Anemia Due to Chronic Kidney Disease in Adults on Dialysis

VAFSEO is a hypoxia-inducible factor prolyl hydroxylase (HIF PH) inhibitor.

VAFSEO is indicated for the treatment of anemia due to chronic kidney disease (CKD) in adults who have been receiving dialysis for at least three months. Limitations of Use: VAFSEO has not been shown to improve quality of life, fatigue, or patient well-being. VAFSEO is not indicated for use: As a substitute for red blood cell transfusions in patients who require immediate correction of anemia. In patients with anemia due to CKD not on dialysis.

The recommended starting dose is 300 mg orally once daily, with or without food. The dose should be individualized and titrated to achieve or maintain hemoglobin levels of 10 g/dL to 11 g/dL. Doses may range from 150 mg to a maximum of 600 mg. Increase the dose no more frequently than once every 4 weeks; decreases can occur more frequently. Adjust dose in increments of 150 mg. Monitor hemoglobin levels when initiating or adjusting dose and then monthly. For patients switching from an ESA, the recommended starting dose is 300 mg orally once daily. VAFSEO should be swallowed whole; tablets should not be cut, crushed, or chewed. It can be administered without regard to the timing or type of dialysis. If a dose is missed, take it as soon as possible unless it is the same day as the next dose; do not take double doses.

Trial data not available in label.

Not reported in label.

VAFSEO is an oral HIF PH inhibitor approved for anemia due to CKD in adults on dialysis for at least three months. It is not a substitute for transfusion in patients requiring immediate correction. Treatment should not be continued beyond 24 weeks if a clinically meaningful increase in hemoglobin is not achieved. The label emphasizes it has not been shown to improve quality of life, fatigue, or patient well-being.