Evrenzo Dosage/Direction for Use

The treatment with this product must be initiated under the supervision of healthcare professionals.
Recommended dose: The starting dose should be selected based on body weight: 70 mg (45 to < 60 kg) or 100 mg (≥ 60 kg) for dialysis-dependent (DD) chronic kidney disease (CKD) patients with anemia; 50 mg (40 to < 60 kg) or 70 mg (≥ 60 kg) for non-dialysis-dependent (NDD) CKD patients with anemia, administered orally three times per week (TIW). Physicians may adopt an individualized dosing regimen based on patients’ specific clinical condition. For example, for stage 5 CKD patients with anemia not on dialysis, the starting dose may be increased to 70 mg (40 to < 60 kg) or 100 mg (≥ 60 kg), administered orally three times per week. The product must not be taken on consecutive days.
Roxadustat treatment should not be continued beyond 24 weeks of therapy if a clinically meaningful increase in hemoglobin (Hb) levels is not achieved. Alternative explanations for an inadequate response should be sought and treated before re-starting roxadustat.
Patients currently treated with erythropoietin with stable hemoglobin levels within the target range may experience fluctuations in Hb levels after converting to roxadustat. Conversion should only be considered based on benefit-risk assessment when there is a valid clinical reason.
Conversion of non-dialysis patients otherwise stable on erythropoiesis-stimulating agent (ESA) treatment has not been investigated. A decision to treat these patients with roxadustat should be based on a benefit-risk consideration for the individual patient.
Research indicates that intake of food will not significantly affect the exposure of roxadustat, therefore the drug can be taken on an empty stomach or with food. For patients undergoing hemodialysis or peritoneal dialysis, roxadustat can be taken at any time before or after dialysis.
If a dose is missed, skip the missed dose and take the next dose at a regularly scheduled time.
Dose Adjustment: The symptoms and outcomes of anemia vary with age, gender, and the overall burden of the disease, assessment should be made in combination with patients' specific clinical condition for physicians. During the initial treatment period, it is recommended to monitor the hemoglobin (Hb) levels every 2 weeks until stabilized, and every 4 weeks thereafter. Roxadustat dose should be adjusted based on Hb levels to achieve and maintain an Hb level of 100 to 120 g/L, while minimizing the need for blood transfusion. The dose can be adjusted every 4 weeks, by taking into account both the current Hb level and the change in Hb level over the past 4 weeks. The recommended dose adjustment rules are shown in Table 7. (See Table 7.)

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Special Populations: Geriatric Patients: No starting dose adjustment is necessary for patients aged 65 and above.
Pediatric Patients: The safety and efficacy of roxadustat in pediatric patients under 18 years of age have not been established.
Patients with hepatic impairment: No adjustment of the starting dose level is required in patients with mild hepatic impairment (Child-Pugh Class A). The safety and efficacy of roxadustat have not been studied in patients with moderate or severe hepatic impairment (Child-Pugh Class B or C). It is recommended to closely monitor the hepatic function in these patients and reduce the starting dose.