Hypoxia-inducible Factor Prolyl Hydroxylase InhibitorPrescription OnlyPregnancy Cat. Not classifiedFDA Yes
Jesduvroq
DAPRODUSTAT
1 INDICATIONS AND USAGE JESDUVROQ 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. Limitations of Use JESDUVROQ has not been shown to improve quality of life, fatigue, or patient well-being. JESDUVROQ 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 ar...
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Brand names:Jesduvroq
Quick Reference
Medicine ClassHypoxia-inducible Factor Prolyl Hydroxylase Inhibitor
FDA ApprovedYes
PregnancyCategory Not classified
Quick Facts
- Active ingredient
- DAPRODUSTAT
- Medicine class
- Hypoxia-inducible Factor Prolyl Hydroxylase Inhibitor
- Brand names
- Jesduvroq
- Availability
- Prescription only (Rx)
- Pregnancy category
- Not classified
- Half-life
- half-life of daprodustat is approximately 1 hour to 4 hours
- FDA approved
- Yes
What Is Jesduvroq?
1 INDICATIONS AND USAGE JESDUVROQ 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. Limitations of Use JESDUVROQ has not been shown to improve quality of life, fatigue, or patient well-being. JESDUVROQ 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 ar...
Jesduvroq (DAPRODUSTAT) belongs to the Hypoxia-inducible Factor Prolyl Hydroxylase Inhibitor class of medications. It was first approved by the FDA in Yes. This medication requires a prescription from a licensed healthcare provider.
Key Safety Information
- •Always follow the dose recommended by your healthcare professional. Taking more than prescribed increases the risk of side effects including serious complications.
- •Seek emergency care if you experience signs of an allergic reaction — hives, swelling, difficulty breathing, or rash. Stop the medication and call your doctor immediately.
- •Some medications can increase the risk of cardiovascular events. Tell your doctor if you have high blood pressure, a history of heart attack or stroke, or any pre-existing health condition.
- •Avoid or limit alcohol while taking Jesduvroq. Do not drink alcohol without first discussing it with your healthcare provider as it may increase adverse effects.
- •Take Jesduvroq with food or a full glass of water if stomach upset occurs. Stop use and talk to your doctor if you experience persistent stomach pain or GI symptoms.
- •Tell your doctor about all medications, supplements, and vitamins you take. Some combinations significantly increase the risk of harm.
This is a summary only. Always read the full prescribing information and consult your healthcare provider for personalized medical advice.
Uses & Indications
Jesduvroq is prescribed for the following conditions. Some uses are FDA-approved indications; others may be evidence-based off-label uses. Consult your healthcare provider for personalized guidance.
1 INDICATIONS AND USAGE JESDUVROQ 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.
Limitations of Use JESDUVROQ has not been shown to improve quality of life, fatigue, or patient well-being.
JESDUVROQ 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.
JESDUVROQ is a hypoxia-inducible factor prolyl hydroxylase (HIF PH) inhibitor indicated for the treatment of anemia due to chronic kidney disease in adults who have been receiving dialysis for at least four months.
( 1 ) Limitations of Use Not shown to improve quality of life, fatigue, or patient well-being.
Not indicated for use: • As a substitute for transfusion in patients requiring immediate correction of anemia.
• In patients not on dialysis.
Dosage Guide
The following are general dosing guidelines only. Your actual dose should be determined by your healthcare provider based on your condition, renal/hepatic function, and other medications.
AD
Adult Dosage
2 DOSAGE AND ADMINISTRATION • Administer orally once daily, with or without food. ( 2.2 , 2.3 ) • See Full Prescribing Information for starting dosage based on hemoglobin level, liver function and concomitant medications, and for dose titration and monitoring recommendations. ( 2.3 , 2.4 , 2.5 , 2.6 ) 2.1 Pre-Treatment and On-Treatment Evaluations of Anemia, Iron Stores, and Liver Tests Evaluation of Anemia and Iron Stores Correct and exclude other causes of anemia (e.g., vitamin deficiency, metabolic or chronic inflammatory conditions, bleeding) before initiating JESDUVROQ. Evaluate the iron status in all patients before and during treatment with JESDUVROQ. Administer supplemental iron therapy when serum ferritin is less than 100 ng/ml or when serum transferrin saturation is less than 20%. The majority of patients with CKD will require supplemental iron during the course of therapy. Liver Testing Assess serum alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline p
Available Forms
Available Strengths
Side Effects
Common
- 6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: • Increased Risk of Death, Myocardial Infarction, Stroke, Venous Thromboembolism, and Thrombosis of Vascular Access [see Boxed Warning, Warnings and Precautions ( 5.1 )] .
- • Risk of Hospitalization for Heart Failure [see Warnings and Precautions ( 5.2 )] .
- • Hypertension [see Warnings and Precautions ( 5.3 )] .
- • Gastrointestinal Erosion [see Warnings and Precautions ( 5.4 )] .
- Most common adverse reactions (incidence ≥10%) are hypertension, thrombotic vascular events, and abdominal pain.
- ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact GlaxoSmithKline at 1-888-825-5249 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
- 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Serious
- 5 WARNINGS AND PRECAUTIONS • Risk of Hospitalization for Heart Failure: Increased in patients with a history of heart failure.
- ( 5.2 ) • Hypertension: Worsening hypertension, including hypertensive crisis may occur.
- Monitor blood pressure.
- Adjust anti-hypertensive therapy as needed.
- ( 5.3 ) • Gastrointestinal Erosion: Gastric or esophageal erosions and gastrointestinal bleeding have been reported.
Rare
Medicine Interactions
Always inform your healthcare provider and pharmacist about ALL medications you take, including prescriptions, OTC medicines, vitamins, and supplements.
MajorModerateMinor
Warnings & Contraindications
5 WARNINGS AND PRECAUTIONS • Risk of Hospitalization for Heart Failure: Increased in patients with a history of heart failure. ( 5.2 ) • Hypertension: Worsening hypertension, including hypertensive crisis may occur. Monitor blood pressure. Adjust anti-hypertensive therapy as needed. ( 5.3 ) • Gastrointestinal Erosion: Gastric or esophageal erosions and gastrointestinal bleeding have been reported.
How Jesduvroq Works
12.1 Mechanism of Action Daprodustat is a reversible inhibitor of HIF-PH1, PH2 and PH3 (IC 50 in the low nM range). This activity 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.
Pharmacokinetics
Absorption
Absorption Following oral administration, daprodustat is readily absorbed with median time to peak concentration (T max ) in healthy subjects ranging from 1 hour to 4 hours
Half-Life
half-life of daprodustat is approximately 1 hour to 4 hours
Metabolism
Metabolism: In vitro, daprodustat is primarily metabolized by CYP2C8 (95% contribution), with a minor contribution by CYP3A4 (5%)
Excretion
Excretion: Mean clearance from plasma was 18
Pregnancy & Breastfeeding Safety
Not classified
Breastfeeding
Many medications pass into breast milk in varying amounts. Before using Jesduvroqwhile breastfeeding, discuss the benefits and risks with your healthcare provider or pharmacist — they can weigh your dose, your infant's age, and available lactation safety data to find the safest option for you and your baby.
Storage & Handling
Store at room temperature. Keep away from moisture and heat. Keep out of reach of children.
Frequently Asked Questions
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Sources & References
- • FDA Prescribing Information — Official labeling and package insert for Jesduvroq
- • U.S. National Library of Medicine — MedlinePlus drug information
- • American Hospital Formulary Service (AHFS) — Clinical pharmacology monograph
- • PubMed / MEDLINE — View clinical studies
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Medical Disclaimer
The information on this page is for educational purposes only and is not intended as medical advice, diagnosis, or treatment. Always consult your doctor, pharmacist, or qualified healthcare provider before starting, stopping, or changing any medication.