Dahlia Medical Communications

Vadadustat Basics for Patients

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by

Rachael Hills
in

Disclaimer: Patients should review this guide before discussing vadadustat with their healthcare provider. Patients should always discuss potential medication changes and additions with their healthcare provider.

What is vadadustat?

Vadadustat (Vafseo®) is a new drug from Akebia Therapeutics, Inc. The FDA approved it for the treatment of anemia caused by chronic kidney disease (CKD).1 Vadadustat is for patients who have been receiving dialysis for at least 3 months.1

How does vadadustat work?

Anemia occurs when the body does not have enough red blood cells. In advanced CKD, the kidneys cannot produce enough erythropoietin (EPO).2 The body needs EPO and iron to produce red blood cells.3

 Vadadustat inhibits an enzyme called HIF PF. Inhibiting HIF PF helps make more EPO.1 This allows for red blood cell formation.

If my body needs both EPO and iron to create red blood cells, then do I need to take iron while receiving vadadustat?

Healthcare providers must order labs to check iron levels. Patients with low iron stores will need to take iron supplements while receiving vadadustat.

How do I know if vadadustat will work for me?

There are no guarantees that vadadustat will benefit everyone. Patients that are like the trials’ participants are more likely to benefit.

In clinical trials patients needed to be at least 18 years old, on dialysis, and at least 8 weeks from their last blood transfusion.4 Most eligible patients were in their 50s-60s.4

The trials excluded anyone experiencing anemia from other causes, such as blood loss.4 The trial excluded patients with uncontrolled high blood pressure or recent cardiac events.4 The trial excluded these patients due to potential safety risks. Patients matching these criteria may not experience relief.

What are the alternatives to vadadustat?

Daprodustat and vadadustat are the only HIF PF inhibitors approved in the U.S.1,5 Both are oral medications. They share similar risks and side effects.1,5

Erythropoietin stimulating agents (ESAs) are approved for anemic CKD patients. Patients or nurses inject ESAs either through an IV or under the skin.6 Examples of ESAs include darbepoetin (Aranesp®) and epoetin (Epogen® or Procrit®). These medications have similar risks and side effects compared to HIF PF inhibitors.6

Who should not receive vadadustat?1

Vadadustat is not approved for patients with uncontrolled high blood pressure. It is also not approved for those allergic to vadadustat or its inactive ingredients.

Vadadustat may cause severe events. In patients that are at high risk for these events should avoid vadadustat or use with caution. These events include:

  • Cardiac events, such as heart attack, stroke, or blood clots.
  • Liver impairment
  • Controlled high blood pressure
  • Epilepsy or history of seizures
  • Digestive tract erosion
  • CKD patients not receiving dialysis
  • Cancer

What are vadadustat’s side effects?1

The most common side effects are high blood pressure, diarrhea, nausea/vomiting, abdominal pain, and fatigue. See the “Who should not receive vadadustat?” section to learn about more severe side effects.

References

  1. Vafseo. Prescribing Information. Akebia Therapeutics Inc. Accessed April 15, 2024. https://www.vafseo.com/pdf/prescribing-information.pdf
  2. Berns J, Cavanaugh K. Anemia in chronic kidney disease. National Institute of Diabetes and Digestive and Kidney Diseases. Updated September 2020. Accessed April 15, 2024. https://www.niddk.nih.gov/health-information/kidney-disease/anemia#CKD
  3. Veterans Affairs. Iron and EPO for anemia. Veterans Affairs eKidney Clinic. Updated February 2, 2021. Accessed April 15, 2024. https://www.va.gov/EKIDNEYCLINIC/rooms/pharmacy/topics/iron-and-epo-for-anemia/index.asp
  4. Eckardt K, Agarwal R, Aswad A, et al. Safety and efficacy of vadadustat for anemia in patients undergoing dialysis. N Engl J Med. 2021;384:1601-12. doi: 10.1056/NEJMoa2025956.
  5. Jesduvroq. Prescribing Information. GlaxoSmithKline. Accessed April 15, 2024. https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Jesduvroq/pdf/JESDUVROQ-PI-MG.PDF
  6. Kidney Disease Improving Global Outcomes (KDIGO). KDIGO clinical practice guideline for anemia in chronic kidney disease. Kidney Int. 2012;2(4, supplement):279-335. doi:10.1038/kisup.2012.37. https://kdigo.org/wp-content/uploads/2016/10/KDIGO-2012-Anemia-Guideline-English.pdf

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