Roxatat in combination with other medications may have drug-drug interaction.

Roxatat with Phosphate binders and other products containing multivalent cation (EXCEPT) lanthanum carbonate:

Risk: decreased Roxatat AUC by 67% and 46% and Cmax by 66% and 52%

Recommendation: Roxatat should be taken at least 1 hour after administration of phosphate binders or other medicinal products or supplements containing multivalent cations.

Roxatat with gemfbrozil (CYP2C8 and OATP1B1inhibitor) or probenecid (UGT and OAT1/OAT3 inhibitor)

Risk: increased Roxatat AUC by 2.3- fold and Cmax by 1.4-fold

Recommendation: Adjust the dose of Roxatat following dose adjustment rules based on Hb monitoring.

Roxatat with OATP1B1 or BCRP Substrates (simvastatin, rosuvastatin & atorvastatin)

Risk: AUC and Cmax increased

Recommendation: Adjust the dose of Roxatat following dose adjustment rules based on Hb monitoring.

The appropriate dose of roxadustat must be taken orally three times per week and not on consecutive days. The dose should be individualized to achieve and maintain target Hb levels of 10 to 12 g/dL as described below:

Patients not on erythropoiesis-stimulating agent treatment: For adults, the usual starting dose is 50 mg three times weekly. The recommended starting dose of roxadustat is 70 mg three times per week in patients weighing less than 100 kg and 100 mg three times per week in patients weighing 100 kg and over.

Patients switching from erythropoiesis-stimulating agents: For adults, the usual starting dose is 70 or 100mg three times weekly. The dosage thereafter should be adjusted according to the patient's condition.

Dose adjustment: When dose adjustments are required, increase or decrease the dose according to the "Dose increase/decrease table" and "stepwise Dose adjustment sequence" below. Once adjusted, maintain the dose level for ≥4 weeks. If the hemoglobin concentration increases rapidly (>2.0 g/dL) within 4 weeks of a dose increase, decrease the dose or suspend the treatment immediately.

The stepwise dose adjustments up or down should follow the sequence of the available doses: 20 mg-40 mg-50 mg-70 mg-100 mg-150 mg-200 mg-250 mg-300 mg-400 mg (only for CKD patients on dialysis).

Missed dose: When there is ≥ 24-hour interval until the next scheduled dosing time, take the missed dose immediately and follow the prescribed schedule for subsequent doses. If there is <24 hours until the next scheduled dosing time, skip the missed dose, and take the next dose as scheduled. Do not take 2 doses on the same day.

Method of administration: Roxadustat tablets are to be taken orally with or without food.

The common adverse reactions associated with Roxatat are hypertension, vascular access thrombosis, diarrhoea, peripheral oedema, hyperkalaemia and nausea.

Do not administered to women that may be pregnant or pregnant. Roxadustat is contraindicated during breast-feeding.

Roxatat tablets should be used in caution. It may initiate few thrombotic vascular events (TVEs) particularly in patients with pre-existing risk factors for TVE, including obesity and prior history of TVEs. Roxatat should be used with caution in patients with a history of seizures. Roxatat should not be administered if the patient has serious signs and symptoms of an infection. Roxatat should not be administered if the patient has liver disorder. Roxatat should not be initiated in pregnant women.

Use in Special Populations

Children: Roxatat is not indicated in children.

liver dysfunction patients: Roxatat is not recommended for use in patients with severe hepatic impairment.

Symptoms: When Roxatat was administered 5 mg/kg (510 mg) to a single healthy adult, increased heart rate transient have been reported. Hemoglobin concentration by overdosage of Roxatat is likely to increase more than necessary.

Treatment: Appropriate measures of dose reduction or interruption, etc. of Roxatat. Roxatat is not removed by dialysis.

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