VADADUSTAT TAB

Clinical Criteria Summary

Uncontrolled Hypertension
History of myocardial infarction, cerebrovascular event or acute coronary syndrome in prior 3 months
Cirrhosis or active, acute liver disease
Unmanageable drug-drug interaction
Patient risk of gastrointestinal erosion (i.e. history of GI bleed, peptic ulcer disease, current tobacco and alcohol use) outweighs potential benefit of vadadustat

Anemia related to chronic kidney disease receiving dialysis chronically (>3 months)
Insufficient response to or unable to use ESA’s
Care provided by a VHA dialysis provider (for contracted care/Community Care patients, medication is supplied by the contracted care provider as part of a bundled payment)

Anemia in Chronic Kidney Disease (CKD) in patients receiving dialysis for at least 3 months
Dialysis-dependent CKD (DD-CKD)

ESAs should remain the standard for treatment of anemia due to CKD
Use restricted to patients with anemia due to CKD receiving maintenance dialysis AND who have failed to respond to treatment with a formulary ESA
Not indicated as a substitute for transfusion in patients requiring immediate correction of anemia
Not recommended for anemia due to CKD in patients not on dialysis

Initial dose 300mg once daily, with dose adjusted in 150mg increments (increases occurring no sooner than at 4-week intervals)
Recommended doses range 150mg to 600mg/day
Dose adjusted to reduce need for RBC transfusions while maintaining Hgb 10-11g/dL
Use lowest dose sufficient to reduce the need for RBC transfusions

Contraindicated in uncontrolled hypertension and known hypersensitivity to vadadustat or its components
Boxed warning: Increased risk of thrombotic vascular events including MACE; targeting a Hgb level > 11g/dL is expected to further increase risk of death and thrombotic events
No trial has identified a Hgb target level, dose of vadadustat, or dosing strategy that does not increase these risks
May cause a worsening of hypertension
Increased risk of hepatotoxicity (use not recommended in patients with active liver disease)
Increased risk of venous or arterial thrombus including thrombus of vascular access
Seizures, gastrointestinal erosions, and malignancies have all been reported

Has not been shown to improve quality of life, fatigue, or patient well-being
FDA review notes risks of hepatotoxicity and gastrointestinal erosions that are not risks of ESAs
Expected to fill a niche role for patients who are non-responsive or unable to utilize ESAs