Evrenzo

Roxadustat

Anemia caused by CKD, including dialysis-dependent (DD) & non-dialysis-dependent (NDD) patients.

Administer 3 times per wk. Must not be taken on consecutive days. Initial dose: DD CKD patient w/ anemia & weighing ≥60 kg 100 mg, 45 to <60 kg 70 mg. NDD CKD patient w/ anemia & weighing ≥60 kg 70 mg, 40 to <60 kg 50 mg. Stage 5 CKD patient w/ anemia not on dialysis & weighing ≥60 kg Starting dose may be increased to 100 mg, 40 to <60 kg Starting dose may be increased to 70 mg. Dose adjustment: Every 4 wk. Consider current Hb level & change in Hb level over past 4 wk. Dose steps: 20 mg, 40 mg, 50 mg, 70 mg, 100 mg, 120 mg, 150 mg, & 200 mg. Max dose: 2.5 mg/kg. Do not continue beyond 24 wk of therapy if clinically meaningful increase in Hb levels is not achieved.

May be taken with or without food.

Hypersensitivity. Pregnancy & lactation.

Adjust dose based on Hb level to maintain w/in range of 100-120 g/L during treatment. Monitor Hb level every 2 wk until it reaches & stabilizes w/in target range, then monitor every 4 wk. Reduce dose or suspend treatment if Hb level increases by >20 g/L w/in 4 wk. Possibility of BP increases during treatment cannot be ruled out. Monitor BP before starting, at the start, & during treatment. Caution in patients w/ uncontrolled HTN. Do not co-administer w/ erythropoiesis-stimulating agents. Should be used w/ caution by athletes. Women of childbearing age should use highly effective contraception during treatment & for 7 days after the last dose. Safety & efficacy have not been established in patients w/ moderate or severe hepatic impairment (Child-Pugh B or C) & in ped patients <18 yr. Serious infection: Consider benefit-risk balance prior to initiating treatment in patients w/ active severe or serious infection. Monitor patients for symptoms & signs of infection when receiving treatment. Advise patients to contact their healthcare provider for signs & symptoms of infection. Evaluate & treat promptly if infection is suspected. Sepsis: Patients w/ signs & symptoms of sepsis should be promptly evaluated & treated according to standard of care. DVT & vascular access thrombosis (VAT): Conduct treatment after careful assessment of the risk/benefit ratio to reduce risk of DVT or VAT. Patients who develop thrombosis should be evaluated & treated promptly. Seizures: Closely monitor the presence of premonitory neurologic symptoms during the 1st several mth following treatment initiation. Consider benefit-risk balance of treatment for each individual patient. Advise patients to contact their healthcare provider for new-onset seizures, premonitory symptoms, or increase in seizure frequency or severity. Secondary hypothyroidism: Reports of secondary hypothyroidism; reversible upon treatment w/drawal. Monitor thyroid function as clinically indicated.

HTN, VAT; nausea, diarrhea. Sepsis; seizures; DVT; constipation.

Decreased AUC & C_max w/ sevelamer carbonate or Ca acetate. Increased AUC & C_max w/ probenecid & gemfibrozil. Increased AUC & C_max of simvastatin, simvastatin acid, rosuvastatin, & atorvastatin. Potential interaction w/ other statins or OATP1B1 substrate (eg, glyburide). Caution when initiating or discontinuing concomitant treatment w/ OAT1/OAT3 inhibitors (eg, teriflunomide), UGT inhibitors (eg, valproic acid), UGT inducers (eg, rifampin), OATP1B1 inhibitors (eg, cyclosporine), CYP2C8 inhibitors, & CYP2C8 inducers (eg, rifampin). Take roxadustat at least 1 hr before or after use of phosphate binders, oral Fe, Mg/Al-containing antacids, or other multivalent cation-containing drugs & mineral supplements. Avoid statin overdose & potential skeletal muscle effects (eg, myalgia, myopathy, & rare rhabdomyolysis) by reducing statin dose & monitoring for adverse reactions when concomitantly used w/ roxadustat.

Haematopoietic Agents

B03XA05 - roxadustat ; Belongs to the class of other antianemic preparations. Used in the treatment of anemia.

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