What is it prescribed for?
VAFSEO, Approved on March 27, 2024, 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.
What is the name of the drug and what does it do?
Vafseo (pronounced VAF-see-oh), (generic name: vadadustat), is a medication indicated for the treatment of anemia due to chronic kidney disease (CKD) in adults who have been receiving dialysis for at least three months. It helps increase hemoglobin levels, reducing the need for red blood cell transfusions.
How does it work?
Vafseo is a hypoxia-inducible factor prolyl hydroxylase (HIF PH) inhibitor.
This means it works by inhibiting enzymes that normally degrade HIF, a protein that helps regulate the body’s response to low oxygen levels. By inhibiting these enzymes, Vafseo increases the levels of HIF, which in turn boosts the production of erythropoietin (EPO), a hormone that stimulates the production of red blood cells.
What did the research discover?
Clinical trials, including the INNO2VATE-1 and INNO2VATE-2 studies, demonstrated that Vafseo is effective in treating anemia in patients with CKD on dialysis.
In these trials, Vafseo was shown to be non-inferior to darbepoetin alfa, a standard treatment, in maintaining hemoglobin levels.
Patients treated with Vafseo had similar improvements in hemoglobin levels compared to those treated with darbepoetin alfa, and the drug effectively reduced the need for red blood cell transfusions.
What are some of the side effects?
- Hypertension (high blood pressure)
- Diarrhea
- Headache
- Nausea
- Fatigue
- Abdominal pain
- Vomiting
- Gastrointestinal erosion
- Dizziness
- Dyspnea (difficulty breathing)
- Arteriovenous fistula thrombosis
- Dialysis-related complications
What are the dosage recommendations and how is it prescribed?
The recommended starting dose of Vafseo is 300 mg orally once daily, with or without food. The dose can be adjusted in increments of 150 mg to achieve or maintain hemoglobin levels of 10 g/dL to 11 g/dL.
The maximum dose is 600 mg per day. Monitoring of hemoglobin levels is essential when initiating or adjusting the dose, and it should be done monthly thereafter.
Dose adjustments should not be made more frequently than once every four weeks.
Source:
Akebia Therapeutics, Inc. Vafseo (vadadustat) tablets, for oral use. Prescribing Information. 2024. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/217900s000lbl.pdf
