Renesis Tablet

Renesis Tablet is used for: Anemia of Chronic Kidney Disease (CKD)

Oral Adult Symptomatic anaemia of chronic kidney disease (CKD) Treatment of anemia of chronic kidney disease in adults with stage 3 to 5 CKD with no iron deficiency and are not on dialysis at the start of treatment. The appropriate dose of roxadustat must be taken orally 3 times per week and not on consecutive days. The dose should be individualised to achieve and maintain target Hb levels of 10 to 12 g/dL as described below. Roxadustat treatment should not be continued beyond 24 weeks of therapy if a clinically meaningful increase in Hb levels is not achieved. Starting dose at treatment initiation Adequate iron stores should be ensured prior to initiating treatment. Patients not currently treated with an erythropoiesis-stimulating agent (ESA) For patients initiating anaemia treatment not previously treated with ESA 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 converting from an ESA Patients currently treated with an ESA can be converted to roxadustat, however, conversion of dialysis patients otherwise stable on ESA treatment is only to be considered when there is a valid clinical reason. The recommended starting dose of roxadustat is based on the average prescribed ESA dose in the 4 weeks before conversion. The first roxadustat dose should replace the next scheduled dose of the current ESA. Dose adjustment and Hb monitoring The individualised maintenance dose ranges from 20 mg to 400 mg three times per week. Hb levels should be monitored every two weeks until the desired Hb level of 10 to 12 g/dL is achieved and stabilised, and every 4 weeks thereafter, or as clinically indicated. The dose of roxadustat can be adjusted stepwise up or down from the starting dose 4 weeks after treatment start, and every 4 weeks thereafter except if the Hb increases by more than 2 g/dL, in which case the dose should be reduced by one step immediately. When adjusting the dose of roxadustat, Consider the current Hb level and the recent rate of change in Hb level over the past 4 weeks. 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). Maximum recommended dose Patients not on dialysis do not exceed a roxadustat dose of 3 mg/kg body weight or 300 mg three times per week, whichever is lower. Patients on dialysis do not exceed a roxadustat dose of 3 mg/kg body weight or 400 mg three times per week, whichever is lower. Patients with hepatic impairment No adjustment of the starting dose level is required in patients with mild hepatic impairment (Child-Pugh class A) Caution is recommended when prescribing roxadustat to patients with moderate hepatic impairment. The starting dose is to be reduced by half or to the dose level that is closest to half the starting dose when initiating treatment in patients with moderate hepatic impairment (Child-Pugh class B). Roxadustat is not recommended for use in patients with severe hepatic impairment (Child-Pugh class C) as the safety and efficacy has not been evaluated in this population.

May be taken orally with or without food.

Hypersensitivity to the active substance, peanut, soya or to any of the excipients. Third trimester of pregnancy. Breast-feeding.

Cardiovascular and mortality risk Overall, the cardiovascular and mortality risk for treatment with roxadustat has been estimated to be comparable to the cardiovascular and mortality risk for ESA therapy based on data from direct comparison of both therapies. Since, for patients with anaemia associated with CKD and not on dialysis, this risk could not be estimated with sufficient confidence versus placebo, a decision to treat these patients with roxadustat should be based on similar considerations that would be applied before treating with an ESA . Further, several contributing factors have been identified that may impose this risk, including treatment non-responsiveness, and converting stable ESA treated dialysis patients. In the case of non-responsiveness, treatment with roxadustat should not be continued beyond 24 weeks after the start of treatment. Conversion of dialysis patients otherwise stable on ESA treatment is only to be considered when there is a valid clinical reason. For stable ESA treated patients with anaemia associated with CKD and not on dialysis, this risk could not be estimated as these patients have not been studied. A decision to treat these patients with roxadustat should be based on a benefit risk consideration for the individual patient. Thrombotic vascular events The reported risk of thrombotic vascular events (TVEs) should be carefully weighed against the benefits to be derived from treatment with roxadustat particularly in patients with pre-existing risk factors for TVE, including obesity and prior history of TVEs (e.g., deep vein thrombosis [DVT] and pulmonary embolism [PE]). Deep vein thrombosis was reported as common and pulmonary embolism as uncommon amongst the patients in clinical studies. The majority of DVT and PE events were serious. Vascular access thrombosis (VAT) was reported as very common amongst the CKD patients on dialysis in clinical studies. In CKD patients on dialysis, rates of VAT in roxadustat-treated patients were highest in the first 12 weeks following initiation of treatment, at Hb values more than 12 g/dL and in the setting of Hb rise of more than 2 g/dL over 4 weeks. It is recommended to monitor Hb levels and adjust the dose using the dose adjustment rules to avoid Hb levels of more than 12 g/dL and Hb rise of more than 2 g/dL over 4 weeks. Patients with signs and symptoms of TVEs should be promptly evaluated and treated according to standard of care. The decision to interrupt or discontinue treatment should be based on a benefit-risk consideration for the individual patient. Seizures Seizures were reported as common amongst the patients in clinical studies receiving roxadustat (see section 4.8). Roxadustat should be used with caution in patients with a history of seizures (convulsions or fits), epilepsy or medical conditions associated with a predisposition to seizure activity such as central nervous system (CNS) infections. The decision to interrupt or discontinue treatment should be based on a benefit-risk consideration of the individual patient. Serious infections The most commonly reported serious infections were pneumonia and urinary tract infections. Patients with signs and symptoms of an infection should be promptly evaluated and treated according to standard of care. Sepsis Sepsis was one of the most commonly reported serious infections and included fatal events. Patients with signs and symptoms of sepsis (e.g., an infection that spreads throughout the body with low blood pressure and the potential for organ failure) should be promptly evaluated and treated according to standard of care.

Pregnancy, women of childbearing potential and contraception There are no data on the use of roxadustat in pregnant women. Studies in animals have shown reproductive toxicity. Roxadustat is contraindicated during the third trimester of pregnancy. Roxadustat is not recommended during the first and second trimester of pregnancy. If pregnancy occurs while Roxadustat is being administered, treatment should be discontinued and switched to alternative treatments, if appropriate. Breast-feeding It is unknown whether roxadustat/metabolites are excreted in human milk. Available animal data have shown excretion of roxadustat in milk . Roxadustat is contraindicated during breast-feeding. Fertility In animal studies, there were no effects of roxadustat on male and female fertility. However, changes in rat male reproductive organs were observed. The potential effects of roxadustat on male fertility in humans is currently unknown. At a maternally toxic dose, increased embryonic loss was observed. Women of childbearing potential must use highly effective contraception during treatment and for at least one week after the last dose of Roxadustat.

Co-administration of roxadustat with phosphate binders sevelamer carbonate or calcium acetate in healthy subjects decreased roxadustat AUC by 67% and 46% and Cmax by 66% and 52%, respectively. Roxadustat may form a chelate with multivalent cations such as in phosphate binders or other products containing calcium, iron, magnesium or aluminium. Staggered administration of phosphate binders (at least 1 hour apart) had no clinically significant effect on roxadustat exposure in patients with CKD. Roxadustat should be taken at least 1 hour after administration of phosphate binders or other medicinal products or supplements containing multivalent cations. Roxadustat is a substrate of CYP2C8 and UGT1A9. Co-administration of roxadustat with gemfibrozil (CYP2C8 and OATP1B1inhibitor) or probenecid (UGT and OAT1/OAT3 inhibitor) in healthy subjects increased roxadustat AUC by 2.3-fold and Cmax by 1.4-fold.

Side effects of Roxadustat : The most frequent (>10%) adverse reactions associated with roxadustat are hypertension (13.9%), vascular access thrombosis (12.8%), diarrhoea (11.8%), peripheral oedema (11.7%), hyperkalaemia (10.9%) and nausea (10.2%). The most frequent (>1%) serious adverse reactions associated with roxadustat were sepsis (3.4%), hyperkalaemia (2.5%), hypertension (1.4%) and deep vein thrombosis (1.2%).

Roxadustat is a hypoxia-inducible factor, prolyl hydroxylase inhibitor (HIF-PHI). The activity of HIF-PH enzymes controls intracellular levels of HIF, a transcription factor that regulates the expression of genes involved in erythropoiesis. Activation of the HIF pathway is important in the adaptative response to hypoxia to increase red blood cell production. Through the reversible inhibition of HIF-PH, roxadustat stimulates a coordinated erythropoietic response that includes the increase of plasma endogenous erythropoietin (EPO) levels, regulation of iron transporter proteins and reduction of hepcidin (an iron regulator protein that is increased during inflammation in CKD). This results in improved iron bioavailability, increased Hb production and increased red cell mass.

Renesis 100 mg Tablet generic name is Roxadustat. Renesis 100 mg Tablet is manufactured by Beacon Pharmaceuticals Ltd.Renesis is availble in all over Bangladesh. Mes BD drug index information on Renesis Tablet is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.