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Precautions of Daprodustat

1. Increased Risk of Death, Myocardial Infarction, Stroke, Venous Thromboembolism,  and Thrombosis of Vascular Access

Advise patients to seek immediate medical attention if they develop signs or symptoms of myocardial infarction, stroke, venous thromboembolism, or thrombosis of vascular access. Evaluate and manage promptly if these occur.

2. Risk of Hospitalization for Heart Failure

Consider the patient’s history of heart failure when deciding whether to prescribe Daprodustat. Advise patients of the symptoms and signs of heart failure and to immediately report any worsening to their healthcare provider.

3. Hypertension

Periodically monitor blood pressure and adjust or initiate anti-hypertensive therapy as needed.

4. Gastrointestinal Erosion

Advise patients of the symptoms and signs of gastric and esophageal erosions and of gastrointestinal bleeding and to seek prompt medical care if these occur.

5. Serious Adverse Events in Patients with Anemia Due to Chronic Kidney Disease and Not on Dialysis

The safety of Daprodustat has not been established for the treatment of anemia due to CKD in  adults not on dialysis and its use is not recommended in this setting.

6. Malignancy

Because increased hypoxia inducible factor (HIF)-1 levels may be associated with unfavorable effects on cancer growth, Daprodustat has not been studied and is not recommended in patients with active malignancies.

from FDA，2023.02