Vadadustat (Vafseo) is a hypoxia-inducible factor prolyl hydroxylase (HIFPH) inhibitor, indicated for the treatment of anemia associated with chronic kidney disease (CKD) in adults who have been receiving dialysis for at least three months.
How to Use Vadadustat (Vafseo)
Recommended Administration Regimen
Dosage and Frequency: The recommended initial dose is 300 mg (1 × 300 mg tablet or 2 × 150 mg tablets), taken orally once daily. It can be administered with or without food. Tablets must be swallowed whole; do not split, crush, or chew them.
Management of Missed Doses: If a dose is missed, take it as soon as possible within the same day. On the next day, take the dose at the originally scheduled time. If it is nearly time for the next scheduled dose, skip the missed dose. Do not take a double dose.
Pre-Treatment Assessment
Anemia and Iron Status: Other causes of anemia (e.g., vitamin deficiency, bleeding) must be ruled out. Iron stores should be evaluated—iron supplementation is required if serum ferritin < 100 mcg/L or transferrin saturation < 20%.
Liver Function Monitoring: Alanine transaminase (ALT), aspartate transaminase (AST), and bilirubin should be tested before treatment and monthly for the first 6 months of treatment. Subsequent monitoring should be performed based on clinical needs.
Dosage Adjustment of Vadadustat (Vafseo)
Hemoglobin (Hb) Target
Maintain Hb levels between 10–11 g/dL. Avoid Hb levels > 11 g/dL to reduce the risk of thrombosis.
Principles of Dosage Adjustment
Initial Adjustment: Adjust the dose every 4 weeks, increasing by 150 mg each time. The maximum daily dose is 600 mg.
Management of Rapid Hb Rise: If Hb increases by > 1 g/dL within 2 weeks or > 2 g/dL within 4 weeks, suspend treatment or reduce the dose.
Management of Hb Exceeding Target: Suspend administration when Hb > 11 g/dL. After Hb levels return to the target range, resume treatment with a 150 mg dose reduction.
Discontinuation Indications
If there is no significant increase in Hb after 24 weeks of treatment, discontinue the drug and evaluate other causes of anemia.
Adjustment for Drug Interactions
Iron Supplements/Phosphate Binders: Administer with an interval of 1 hour (for iron-containing products) or 1–2 hours (for non-iron-containing phosphate binders).
Statins: The maximum daily dose of simvastatin is limited to 20 mg, and the maximum daily dose of rosuvastatin is limited to 5 mg.
Vadadustat (Vafseo) in Special Populations
Hepatic Impairment
Mild to Moderate Impairment: No dosage adjustment is required, but close monitoring of liver function is necessary.
Cirrhosis/Acute Liver Disease: Contraindicated.
Pregnancy and Lactation
Pregnancy: Animal studies indicate potential fetal risks. Women of childbearing age must use contraception during treatment and for 6 months after discontinuing the drug.
Lactation: Breastfeeding is prohibited during treatment and for 2 days after the last dose.
Geriatric Patients (≥ 65 Years Old)
No dosage adjustment is required, but enhanced monitoring of cardiovascular status and infections is necessary.
Pediatric Patients and Non-Dialysis Patients
Pediatric Patients: Safety has not been established; use is not recommended.
Non-Dialysis CKD Patients: Contraindicated (increases the risk of death, stroke, and acute kidney injury).
Other High-Risk Populations
Active Infections: Initiate treatment only after the infection is controlled.
Malignant Tumors: May promote tumor growth; contraindicated in patients with active cancer.
