Daprodustat
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Alen Antony Pathil, M.D.[2]
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Black Box Warning
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JESDUVROQ increases the risk of thrombotic vascular events like MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, AND THROMBOSIS OF VASCULAR ACCESS
See full prescribing information for complete Boxed Warning.
Avoid the use of JESDUVROQ in patients with a history of myocardial infarction, cerebrovascular event, or acute coronary syndrome within the 3 months prior to starting JESDUVROQ.
An increase of more than 1 g/dL over 2 weeks may contribute to these risks, also targeting hemoglobin greater than 11g/dl is further expected to increase the risk of above mentioned thrombotic events just like other Erythropoietin Stimulating Agents.
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Overview
Daprodustat is a reversible inhibitor of HIF-PH1, PH2 and PH3. that is FDA approved for the treatment of anemia due to chronic kidney disease (CKD) in adults who have been receiving dialysis for at least four months.. There is a Black Box Warning for this drug as shown here. Common adverse reactions include Hypertension, Abdominal pain, Dizzines, Hypersensitivity, and thrombotic vascular events like Myocardial infarction, stroke, pulmonary embolism, deep vein thrombosis and vascular access thrombosis..
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
daprodustat is indicated for the treatment of anemia due to chronic kidney disease who has been receiving dialysis for last 4 months
Off-Label Use and Dosage (Adult)
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Daprodustat FDA-Labeled Indications and Dosage (Pediatric) in the drug label.
Off-Label Use and Dosage (Pediatric)
Contraindications
There is limited information regarding Daprodustat Contraindications in the drug label.
Warnings
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JESDUVROQ increases the risk of thrombotic vascular events like MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, AND THROMBOSIS OF VASCULAR ACCESS
See full prescribing information for complete Boxed Warning.
Avoid the use of JESDUVROQ in patients with a history of myocardial infarction, cerebrovascular event, or acute coronary syndrome within the 3 months prior to starting JESDUVROQ.
An increase of more than 1 g/dL over 2 weeks may contribute to these risks, also targeting hemoglobin greater than 11g/dl is further expected to increase the risk of above mentioned thrombotic events just like other Erythropoietin Stimulating Agents.
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There is limited information regarding Daprodustat Warnings' in the drug label.
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Daprodustat Clinical Trials Experience in the drug label.
Postmarketing Experience
There is limited information regarding Daprodustat Postmarketing Experience in the drug label.
Drug Interactions
There is limited information regarding Daprodustat Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Daprodustat in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Daprodustat in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Daprodustat during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Daprodustat in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Daprodustat in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Daprodustat in geriatric settings.
Gender
There is no FDA guidance on the use of Daprodustat with respect to specific gender populations.
Race
There is no FDA guidance on the use of Daprodustat with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Daprodustat in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Daprodustat in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Daprodustat in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Daprodustat in patients who are immunocompromised.
Administration and Monitoring
Administration
There is limited information regarding Daprodustat Administration in the drug label.
Monitoring
There is limited information regarding Daprodustat Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Daprodustat and IV administrations.
Overdosage
There is limited information regarding Daprodustat overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
There is limited information regarding Daprodustat Pharmacology in the drug label.
Mechanism of Action
There is limited information regarding Daprodustat Mechanism of Action in the drug label.
Structure
There is limited information regarding Daprodustat Structure in the drug label.
Pharmacodynamics
There is limited information regarding Daprodustat Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Daprodustat Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding Daprodustat Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Daprodustat Clinical Studies in the drug label.
How Supplied
There is limited information regarding Daprodustat How Supplied in the drug label.
Storage
There is limited information regarding Daprodustat Storage in the drug label.
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
There is limited information regarding Daprodustat Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Daprodustat interaction has not been established. Talk to your doctor regarding the effects of taking alcohol with this medication.
Brand Names
There is limited information regarding Daprodustat Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Daprodustat Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.