Renustat is indicated for the treatment of adult patients with symptomatic anemia associated with chronic kidney disease (CKD).
Renustat is a frst-in-class, orally administered HIF-PH inhibitor that promotes erythropoiesis through increasing endogenous production of erythropoietin, as well as improving iron regulation and overcoming the EPO-suppressive efects of infammation on hemoglobin syntheses and red blood cell production by downregulating hepcidin.
Roxadustat is an orally bioavailable, hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), with potential anti-anemic activity. Upon administration, roxadustat binds to and inhibits HIF-PH, an enzyme responsible for the degradation of transcription factors in the HIF family under normal oxygen conditions. This prevents HIF breakdown and promotes HIF activity.
The common adverse reactions associated with Renustat are hypertension, vascular access thrombosis, diarrhoea, peripheral oedema, hyperkalaemia and nausea.
Pregnancy & Lactation
Do not administered to women that may be pregnant or pregnant. Roxadustat is contraindicated during breast-feeding.
Renustat 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. Renustat should be used with caution in patients with a history of seizures. Renustat should not be administered if the patient has serious signs and symptoms of an infection. Renustat should not be administered if the patient has liver disorder. Renustat should not be initiated in pregnant women.
Children: Renustat is not indicated in children.liver dysfunction patients: Renustat is not recommended for use in patients with severe hepatic impairment.
Symptoms: When Renustat was administered 5 mg/kg (510 mg) to a single healthy adult, increased heart rate transient have been reported. Hemoglobin concentration by overdosage of Renustat is likely to increase more than necessary.Treatment: Appropriate measures of dose reduction or interruption, etc. of Renustat. Renustat is not removed by dialysis.
Drugs for Haemolytic Hypoplastic & Renal Anemia
Store in a cool (below 30°C), dry place, away from light and moisture. Keep out of the reach of children.