What is the complete set of instructions for Dapinostat tablets?

Daprodustat is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), developed by GSK with the trade name Jesduvroq. In February 2023, the U.S. Food and Drug Administration (FDA) approved it for the treatment of anemia caused by adult chronic kidney disease (CKD) patients who have received dialysis for at least four months. This drug improves the symptoms of anemia by stimulating the production of endogenous erythropoietin (EPO) and promoting red blood cell production.

Before using daprostat, other causes of anemia need to be ruled out, such as vitamin deficiency, metabolic abnormalities, chronic inflammation or bleeding. At the same time, the patient's iron reserve status should be assessed. If the serum ferritin is less than 100 ng/mL or the transferrin saturation is less than 20%, iron supplementation should be given. In addition, liver function needs to be assessed before initiating treatment, including alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase, and total bilirubin levels.

Daprostat can be taken once daily with or without food, and the dose should be individually adjusted to achieve the lowest effective dose that reduces the need for red blood cell transfusions. For patients not receiving erythropoiesis stimulating agents (ESAs), the starting dose is determined based on baseline hemoglobin levels: if hemoglobin is <9 g/dL, the starting dose is 4 mg daily; if hemoglobin is 9-10 g/dL, the starting dose is 2 mg daily; and >10 g/dL, the starting dose is 1 mg daily. For patients switching from an ESA, the starting dose is based on the previously used ESA dose, ranging from 4 to 12 mg daily. The maximum recommended dose of dapostat is 24 mg daily.

Hemoglobin levels should be monitored regularly during treatment, every two weeks for the first four weeks after the initial dose adjustment, and every four weeks thereafter. If hemoglobin rises more than 1g/dL within two weeks, or rises more than 2g/dL within four weeks, or exceeds 11g/dL, the dose should be reduced; if it exceeds 12g/dL, treatment should be suspended, and treatment should be restarted at a lower dose after the hemoglobin returns to the target range. If a clinically significant increase in hemoglobin levels is not observed within 24 weeks, other causes should be considered and managed accordingly.

During the use of daprexostat, please pay attention to possible side effects, including abdominal pain, dizziness, nausea, vomiting, black or tarry stools, difficulty swallowing, throat or chest pain, etc. If these symptoms occur, you should contact your doctor immediately.

Daprostat should be stored at room temperature, away from heat and moisture, and away from children. Unused medicines should be properly disposed of through a medicine take-back program to avoid environmental impact.

Reference materials:https://en.wikipedia.org/wiki/Daprodustat