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Daprotab 4
Incepta Pharmaceuticals Ltd.
Generic: Daprodustat
Safety Advices
বাংলা
English
CAUTION
Caution is advised when consuming alcohol with Daprotab 4. Please consult your doctor.
UNSAFE
May cause fetal harm
UNSAFE
Breastfeeding not recommended until one week after the final dose.
CAUTION
It is not known whether Daprotab 4 alters the ability to drive. Do not drive if you experience any symptoms that affect your ability to concentrate and react.
SAFE IF PRESCRIBED
Daprotab 4 is safe to use in patients with kidney disease. No dose adjustment of Daprotab 4 is recommended.
SAFE IF PRESCRIBED
Daprotab 4 should be used with caution in patients with severe liver disease. Dose adjustment of Daprotab 4 may be needed. Please consult your doctor. A lower dose may be advised in patients with liver disease and who have to take this medicine for a long time.
Medicine Overview of Daprotab 4mg tablet
Introduction
_NAME_ 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 adaptive response to hypoxia to increase red blood cell production. Through the reversible inhibition of HIF-PH, Daprodustat 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...
... Show moreUses of Daprotab 4
Daprotab 4 is indicated for the treatment of anemia due to chronic kidney disease (CKD) in adults who have been receiving dialysis for at least four months. Daprotab 4 is not indicated for use: As a substitute for red blood cell transfusions in patients who require immediate correction of anemia. For treatment of anemia of chronic kidney disease in patients who are not on dialysis.
Side effects of Daprotab 4
Risk of hospitalization due to heart failure High blood pressure damage to the lining of the stomach, the tube that connects the mouth and stomach (esophagus), and intestines (gastrointestinal erosion).
How to use Daprotab 4
Daprotab 4 is to be taken orally.Take this medicine in the dose and duration as advised by your doctor. Do not chew, crush or break it.
How Daprotab 4 works
_NAME_ 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 adaptive response to hypoxia to increase red blood cell production. Through the reversible inhibition of HIF-PH, Daprodustat 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...
... Show moreWhat if you forget to take Daprotab 4?
If you miss a dose of _NAME_ Tablet, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular schedule. Do not double the dose.
Brief Description
Indication
_NAME_ is indicated for the treatment of anemia due to chronic kidney disease (CKD) in adults who have been receiving dialysis for at least four months.
_NAME_ is not indicated for use:
As a substitute for red blood cell transfusions in patients who require immediate correction of anemia.
For treatment of anemia of chronic kidney disease in patients who are not on dialysis.
Administration
_NAME_ is available in 1,2,4,6 and 8-mg tablet formulations administered orally once daily, with or without food.
Adult Dose
Adults Not Being Treated with an Erythropoiesis-Stimulating Agent (ESA): Pre-Treatment Hemoglobin Level less than 9 g/dL: 4 mg orally once daily Pre-Treatment Hemoglobin Level 9 to 10 g/dL: 2 mg orally once daily Pre-Treatment Hemoglobin Level greater than 10 g/dL: 1 mg orally once daily Dosing based on adults being switched from an ESA: Dose of _NAME_: 4 mg orally once daily Epoetin alfa intravenous less than or equal to 2,000 units/week Darbepoetin alfa subcutaneous/intravenous 20 to 30 mcg/4 weeks Methoxy PEG-epoetin beta subcutaneous/intravenous 30 to 40 mcg/month Dose of _NAME_: 6 mg orally once daily Epoetin alfa intravenous greater...
... Show moreChild Dose
Not recommended for children.
Renal Dose
Steady-state exposure of _NAME_ is similar in patients with normal renal function and those with varying degrees of renal impairment
Hemodialysis or peritoneal dialysis
_NAME_ exposure not significantly impacted
Systemic exposure of _NAME_ 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.
Contraindication
Receiving a strong CYP2C8 inhibitor such as gemfibrozil.
With uncontrolled hypertension.
Mode of Action
-NAME_ is a reversible inhibitor of the hypoxia-inducible factors (HIFs) polyhomeotic-like proteins 1 to 3 (IC50 in the low-nanomoles range), a set of enzymes that degrade HIFs in normal oxygen conditions. HIF inhibition results in the stabilization and nuclear accumulation of the HIF 1α and 2α transcription factors, leading to increased transcription of the HIF-responsive genes, including that encoding erythropoietin. -NAME_increases endogenous erythropoietin in a dose-dependent manner in 6 to 8 hours after administration. With repeated doses, the peak increase in reticulocyte count occurs in 7 to 15 days, with subsequent increases in red blood cell production. New hemoglobin steady-state...
... Show moreSide Effect
Risk of hospitalization due to heart failure
High blood pressure
Damage to the lining of the stomach, the tube that connects the mouth and stomach (esophagus), and intestines (gastrointestinal erosion).
Pregnancy Category Note
Not recommended in pregnancy. This drug resulted in fetal adverse outcomes in animal study.
Interaction
CYP2C8 Inhibitors: Concomitant administration of strong CYP2C8 inhibitors (e.g., gemfibrozil) with _NAME_ is contraindicated due to a marked increase in _NAME_ exposure.
CYP2C8 Inducers: CYP2C8 inducers (e.g., rifampin) may decrease _NAME_ exposure, which may result in loss of efficacy.
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