Enaroy Enarodustat Tablets

1. Indications and Usage
Enarodustat tablets are indicated for the treatment of anemia in adult patients with chronic kidney disease (CKD) who are not on dialysis.
2. Dosage and Administration
Recommended Dosage: The recommended starting dosage for adult patients is 2 mg taken orally once daily, before a meal or at bedtime. The maximum dosage is 8 mg once daily.
Dosage Adjustment: Dosage adjustments should be made based on hemoglobin (Hb) levels. If Hb rises too rapidly (e.g., exceeding 20 g/L within 4 weeks), the dose should be reduced or the drug temporarily withheld.
Administration: If a dose is missed, do not make up for it; resume with the next scheduled dose.
3. Mechanism of Action
Enarodustat inhibits hypoxia-inducible factor prolyl hydroxylase (HIF-PHI). This inhibition stabilizes hypoxia-inducible factors (HIFs), leading to increased endogenous production of erythropoietin (EPO) in the liver and kidney, which stimulates red blood cell production.
4. Safety and Warnings
Hemoglobin Risks: There is a risk of Hb levels becoming too high or rising too rapidly, which may increase the risk of death, cardiovascular events, and stroke.
Cardiovascular Risks: Hypertension, thromboembolic events, angina, and heart failure have been observed.
Retinal Hemorrhage: As HIF stabilization promotes angiogenesis, patients with proliferative diabetic retinopathy or other retinal vascular diseases may be at risk of retinal hemorrhage.
Tumor Progression: In patients with malignancies, enarodustat may potentially promote tumor progression due to the pro-angiogenic effects of HIF activation.
5. Adverse Reactions and Clinical Research
Common Adverse Reactions: The most common adverse reactions include hypertension, anemia, arthralgia, increased blood creatine phosphokinase, pyrexia, and increased blood creatinine.
Clinical Research: Clinical trials have demonstrated that enarodustat effectively increases hemoglobin levels and reduces the need for exogenous erythropoiesis-stimulating agents (ESAs) in non-dialysis CKD patients.
6. Drug Interactions
ESAs: Enarodustat should not be used concomitantly with erythropoiesis-stimulating agents (ESAs).
Iron Supplements: As erythropoiesis requires iron, patients may need iron supplementation; iron status should be monitored and managed accordingly.
7. Pharmaceutical Information
Composition: The active ingredient is enarodustat.
Appearance: Film-coated tablets, typically white to off-white.
Storage: Store at controlled room temperature in the original container to protect from moisture and light.