Daprosis Tablet

Daprosis Tablet is used for: Anemia of Chronic Kidney Disease

Anemia of Chronic Kidney Disease Indicated for treatment of anemia due to chronic kidney disease (CKD) in adults on dialysis for ?4 months Individualize dosing and use lowest dose sufficient to reduce need for red blood cell (RBC) transfusions Do not target a hemoglobin >11 g/dL Dosing in patients not treated with an erythropoietin-stimulating agent (ESA) Starting dose is based on pretreatment hemoglobin (Hgb) level Hgb <9 g/dL: Start at 4 mg PO qDay (once daily) 9-10 g/dL: Start at 2 mg PO qDay (once daily) >10 g/dL: Start at 1 mg PO qDay (once daily)

Renal impairment Steady-state exposure of daprodustat is similar in patients with normal renal function and those with varying degrees of renal impairment Hemodialysis or peritoneal dialysis Daprodustat exposure not significantly impacted Systemic exposure of daprodustat metabolites was higher in patients with Stage 3-5 CKD than in those with normal renal function Exposures of metabolites were higher on non-dialysis days than on dialysis days

Oral Administration May take with or without food May take without regard to concomitant administration of iron or phosphate binders Swallow tablet whole; do NOT cut, crush, or chew Administer without regard to timing or type of dialysis

Strong CYP2C8 inhibitors (eg, gemfibrozil) Uncontrolled hypertension

Increased risk of death, myocardial infarction, stroke, venous thromboembolism, and thrombosis of vascular access Increased risk of thrombotic vascular events, including major adverse cardiovascular events (MACE) Hemoglobin rise >1 g/dL over 2 weeks may contribute to these risks Target hemoglobin level >11 g/dL is expected to further increase risk of death and arterial venous thrombotic events, as occurs with erythropoietin-stimulating agents (ESAs), which also increase erythropoietin levels No trial has identified a hemoglobin target level, daprodustat dose, or dosing strategy that avoids these risks Use lowest dose to reduce need for red blood cell transfusion Avoid use in patients with a history of myocardial infarction, cerebrovascular event, or acute coronary syndrome within 3 months before starting Increased risk of cardiovascular mortality, stroke, thromboembolism, serious acute kidney injury, hospitalization for heart failure, and serious gastrointestinal erosions observed Advise patients to seek immediate medical attention if signs or symptoms of MI, stroke, VTE, or thrombosis of vascular access develop; evaluate and manage promptly if these occur (see Black Box Warning) Hospitalization for heart failure reported; consider patient’s history of heart failure before prescribing; advise patients on signs and symptoms of heart failure and to immediately their healthcare provider if these symptoms worsen Contraindicated in uncontrolled hypertension; periodically monitor blood pressure and adjust or initiate antihypertensive therapy as needed Safety not established for treatment of anemia due to CKD in adults not on dialysis; use not recommended in this setting Not studied and not recommended in patients with active malignancies; malignancies reported Gastrointestinal erosion Gastric or esophageal erosions occurred Consider this risk particularly in patients with risk factors for gastrointestinal (GI) erosions, such as history of GI erosion, peptic ulcer disease, concomitant use of medications that increase the risk of GI erosion, current tobacco smoking, and alcohol use Advise patients of symptoms and signs of gastric and esophageal erosions and of GI bleeding and to seek prompt medical care if these occur

Pregnancy Available data are insufficient in pregnant females to establish a drug-associated risk of major birth defects, miscarriages, or adverse maternal or fetal outcomes Animal data Oral administration to pregnant rats and rabbits during organogenesis was associated with adverse fetal outcomes (eg, embryonic and fetal loss, reduced fetal weight) at doses that caused maternal toxicity and polycythemia Advise pregnant females regarding potential risk to fetus Clinical consideration CKD during pregnancy increases risk for maternal hypertension, preeclampsia, miscarriage, stillbirth, preterm delivery, low birth weight infants, and polyhydramnios Lactation There are no data on drug presence in human milk, effects on breastfed infants, or effects on milk production Daprodustat is present in the milk of lactating rats When a drug is present in animal milk, it is likely that drug will be present in human milk Advise patients not to breastfeed during treatment and for 1 week after final dose

Moderate CYP2C8 Inhibitors: Reduce starting dose. CYP2C8 Inducers: Monitor hemoglobin and adjust the dose of Daprodustat as appropriate.

Side effects of Daprodustat : >10% Hypertension (24%) Abdominal pain (11%) 1-10% Dizziness (7%) Hypersensitivity (7%) Vascular access thrombosis (5%) Myocardial infarction (3.4%) Stroke (1.2%) <1% Deep vein thrombosis (0.7%) Pulmonary embolism (0.3%)

Reversible inhibitor of hypoxia inducible factor (HIF)-PH1, PH2, and PH3 Inhibition of oxygen-sensing prolyl hydroxylase enzymes stabilizes hypoxia-inducible factors, which can lead to transcription of erythropoietin and other genes involved in the correction of anemia Daprodustat increases endogenous erythropoietin in a dose-dependent manner Also increases serum transferrin and total iron binding capacity (TIBC) and decreased serum ferritin, transferrin saturation, and hepcidin when administered for 52 weeks in adults on dialysis with anemia due to CKD

Daprosis 2 mg Tablet manufactured by Beacon Pharmaceuticals Ltd.. Its generic name is Daprodustat. Daprosis is availble in Bangladesh. Farmaco BD drug index information on Daprosis Tablet is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.