Daprotab 2

• Anemia due to chronic kidney disease (CKD) in adults on dialysis for at least 4 months

Daprodustat is a HIF-PHI. The activity of HIF-PH enzymes controls intracellular levels of HIF, a transcription factor that regulates the expression of genes involved in erythropoiesis. Through the reversible inhibition of HIF-PH, Daprodustat stimulates a coordinated erythropoietic response that includes the increase of plasma endogenous EPO levels, regulation of iron transporter proteins and reduction of hepcidin. This results in improved iron bioavailability, increased Hb production and increased red cell mass.

Not on ESA: Hb <9 g/dL: 4 mg once daily; Hb 9-10 g/dL: 2 mg once daily; Hb >10 g/dL: 1 mg once daily.

Switching from ESA: Based on prior ESA dose, dose ranges from 4-12 mg once daily. Maximum dose: 24 mg once daily.

Moderate hepatic impairment: Reduce starting dose by half. Not recommended in severe hepatic impairment.

Serious: Risk of hospitalization due to heart failure, high blood pressure, gastrointestinal erosion (damage to the lining of the stomach, esophagus, and intestines).

May cause fetal harm. No adequate data in pregnant women. Use during pregnancy only if potential benefit justifies potential risk to the fetus.

Increased risk of death, MI, stroke, VTE, & vascular access thrombosis; hospitalization for heart failure; hypertension; gastrointestinal erosion; serious adverse events in non-dialysis CKD patients; malignancy. May affect driving ability.

Acute overdose may cause headache and gastrointestinal adverse reactions (e.g., nausea). No specific antidote. Hemodialysis will not substantially remove daprodustat (highly protein bound).

Store below 30°C, in a cool and dry place. Keep away from light. Keep out of reach of children.