FDA Approves JESDUVROQ for Anemia in Chronic Kidney Disease Patients on Dialysis on February 1, 2023

Jul 22, 2024

What is JESDUVROQ prescribed for?  

To treat anemia caused by chronic kidney disease for adults on dialysis for at least four months. 

What is the name of the drug and what does it do? 

JESDUVROQ  (generic name: daprodustat), pronounced “jez–DOOV–rok,” is a type of medicine that helps people with chronic kidney disease (CKD) who have been on dialysis for at least four months and are experiencing anemia. 

Anemia is a condition where the body has fewer red blood cells than normal, which can lead to tiredness and weakness. 

Dialysis is a medical procedure that helps clean the blood of waste and extra fluids when the kidneys are not working well.

How does it work? 

JESDUVROQ works by stopping a certain protein in the body that deals with how the body reacts to low oxygen levels (HIF PH). 

By doing this, JESDUVROQ helps control how the body handles oxygen levels, which can be helpful for managing conditions like anemia in people with chronic kidney disease who are on dialysis.

What did the research discover?

In a big study called ASCEND-D, 2,964 adults with anemia from chronic kidney disease (CKD) on dialysis were given a new medicine called JESDUVROQ. 

The study compared JESDUVROQ to other common treatments for anemia in CKD patients. 

They looked at how much the hemoglobin levels changed and watched for major heart-related events. 

Patients had to be on dialysis for at least four months before starting JESDUVROQ. Some patients were given JESDUVROQ by mouth, while others received it through injections. 

The study lasted around 26 months on average, with most patients staying on the treatment for more than 6 months. 

The study found that most patients were on JESDUVROQ for more than 6 months, with the average being 26 months.

Overall, the study results suggest that JESDUVROQ was beneficial in managing anemia in CKD patients on dialysis.

What are some of the side effects?

The side effects listed are from the product manufacturer. As health scientists, we share this information to keep you informed without causing undue worry. Many side effects diminish over time, and not all patients experience them. If prescribed medication, take it as directed and consult your healthcare professional if you have any concerning side effects.

  • Increased risk of thrombotic vascular events including death, heart attack, stroke, blood clots in the lung, blood clots in the legs, and blood clots in the dialysis access site
  • Risk of hospitalization for heart failure
  • Worsening increase of blood pressure
  •  Stomach erosions
  •  Gastrointestinal bleeding
  •  Potential unfavorable effects on cancer growth
  • high blood pressure
  • abdominal pain
  • dizziness
  • allergic reactions
  • Contraindicated with certain drugs that increase levels of JESDUVROQ
  • Contraindicated in patients with uncontrolled high blood pressure

What are the dosage recommendations and how is it prescribed? 

JESDUVROQ is a tablet that is administered orally and is taken once daily, with or without food.

Consult your doctor for dosage information because it is dependent on the level of hemoglobin in the body. 

Source:

Drug Trials Snapshots: JESDUVROQ [Internet]. U.S. Food and Drug Administration. 2023 [cited 2024 Jun 29]. Available from: https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-jesduvroq

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