Daprodustat

Daprodustat
Black Box Warning
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

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

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.

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

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.

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.