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

Limitations: 1. It is not used as a substitute for blood transfusion for immediate correction of anemia 2. It is not used in patients with CKD with no history of dialysis.

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

1.Contraindicated in patients receiving a strong CYP2C8 inhibitor such as gemfibrozil

2.contraindicated in patients with uncontrolled hypertension

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.

1. Increased risk of thrombotic vascular events JESDUVROQ increseas the risk of Myicardial infatcion, Stroke, Pulmonary embolism and thus is avoided in patients with prior history of cardiovascular events. Furthermore, we also avoid rapid rise of hemoglobin greater than 1g/dl over 2weeks. Also targeting a hemoglobin more than 11 g/dl using this medication can also further the risk of vascular thrombotic events

2. Risk of hospitalization due to heart failure Patients with prior history of heart failure are advised to not use JESDUVROQ as it further increases the risk of heart failure

3. Hypertention JESDUVROQ is contraindicated in patients with uncontrolled hypertension. As cases of hypertensive crisis due to Hypertensive encephalopathy and seizures have been reported, therefore periodic monitoring of blood pressure and usage of antihypertensive to control the blood pressure maybe required.

4. Gastrointestinal erosion This drug has cases of gastric and esophageal erosion been reported. Thus this with increased risk for gastrointestinal erosions, such as history of gastrointestinal erosion, peptic ulcer disease, use of concomitant medications that increase the risk of gastrointestinal erosion, and current tobacco smokers and alcohol drinkers are recommended to avoid this medication.

5. Adverse events in patients with CKD and not on dialysis- In a large cardiovascular outcomes trial in adults with anemia of CKD who were not on dialysis, an increased risk of cardiovascular mortality, stroke, thromboembolism, serious acute kidney injury, hospitalization for heart failure, and serious gastrointestinal erosions was observed in patients treated with JESDUVROQ compared to recombinant EPO.

6. Malignancy Since JESDUVROQ increases hypoxia inducible factor (HIF)-1 levels which is associated with unfavourable effects of cancer growth. This it is not indicated with patients with history of malignancy.

Adverse Reactions

Clinical Trials Experience

In the clinical train Hypertention, Thrombotic vascular events and Abdominal pain as are the most common adverse effects

Other adverse effects include dizziness and hypersensitivity presenting as rash, urticaria and dermatitis.

Postmarketing Experience

There is limited information regarding Daprodustat Postmarketing Experience in the drug label.

Drug Interactions

1. Concomitant administration of strong CYP2C8 inhibitors (e.g., gemfibrozil) with JESDUVROQ is contraindicated due to a marked increase in daprodustat exposure.

2.Concomitent administration of CYP2C8 inducers (e.g., rifampin) may decrease daprodustat exposure, which may result in loss of efficacy.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): C There is insufficient available data to establish a drug associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. There are risks to the mother and the fetus associated with CKD.
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

We advise patients not to breastfeed during treatment with JESDUVROQ, and for one week after the final dose because JESDUVROQ was found in rat milk which means it will also be present in human milk , and high possiblity the infant being exposed during lactation process

Pediatric Use

There is no FDA guidance on the use of Daprodustat in pediatric settings.

Geriatic Use

No overall differences in safety or effectiveness were observed between older patients of age 65 or more and younger patients.

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

Headache and gastrointestinal adverse reactions (e.g., nausea) has been associated with JESDUVROQ overdose.

there is no specific antidote and hemodialysis doesn't remover JESDUVROQ as it is protein bound.

Pharmacology

There is limited information regarding Daprodustat Pharmacology in the drug label.

Mechanism of Action

It is a reversible inhibitor of HIF-PH1, PH2 and PH3 which results in the stabilization and nuclear accumulation of HIF-1α and HIF-2α transcription factors, leading to increased transcription of the HIF-responsive genes, including erythropoietin.

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

JESDUVROQ tablets are available as 1 mg, 2 mg, 4 mg, 6 mg or 8 mg of daprodustat.

1 mg, gray, biconvex, round film-coated tablets debossed with “GS KF” on one face. 2 mg, yellow, biconvex, round film-coated tablets debossed with “GS V7” on one face. 4 mg, white, biconvex, round film-coated tablets debossed with “GS 13” on one face. 6 mg, pink, biconvex, round film-coated tablets debossed with “GS IM” on one face. 8 mg, orange, biconvex, round film-coated tablets debossed with “GS 5E” on one face.

Storage

Stored at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F to 86°F).

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.