VAFSEO

What it is

Vafseo is available as film-coated tablets containing 150 mg, 300 mg, or 450 mg of vadadustat.

Approved indications

— Anaemia associated with chronic kidney disease in adults on chronic maintenance dialysis.

Dosing overview

The recommended starting dose is 300 mg once daily. Dose increases should not occur more frequently than once every 4 weeks. Dose adjustment should be made in increments of 150 mg within the range of 150 mg to a maximum recommended daily dose of 600 mg to achieve or maintain haemoglobin levels within 100 to 120 g/L. When initiating or adjusting therapy, monitor haemoglobin levels every two weeks until stable, then monitor at least monthly. If the haemoglobin level exceeds 130 g/L, interrupt the dose of Vafseo until haemoglobin is less than or equal to 120 g/L then resume with a dose that is 150 mg less than the dose prior to interruption. Treatment should not be continued beyond 24 weeks of therapy if a clinically meaningful increase in haemoglobin levels is not achieved. When converting from an erythropoiesis-stimulating agent to Vafseo, the recommended starting dose is 300 mg once daily, and the erythropoiesis-stimulating agent must be stopped before initiating Vafseo. Patients converting from a high baseline dose of erythropoiesis-stimulating agent may experience an initial decline in haemoglobin levels before gradually returning to baseline haemoglobin levels by weeks 16 to 20.

PBS listing

No PBS listing information is available in the provided sources.

Regulatory history

Vafseo vadadustat tablets in three strengths (150 mg, 300 mg, and 450 mg) were first listed on the Australian Register of Therapeutic Goods on 4 October 2023.