Daprodustat

What is Daprodustat?

• Daprodustat (Jesduvroq), an inhibitor of hypoxia inducible factor (HIF), prolyl 4-hydroxylases (PH)1, PH2 and PH3.

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Daprodustat

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Daprodustat v2

What are the uses of this medicine?

• Daprodustat (Jesduvroq) is a prescription medicine used to treat anemia that is caused by chronic kidney disease (CKD) in adults who have been on dialysis for at least 4 months.

• People with anemia have a lower-than-normal number of RBCs.
• Jesduvroq works by increasing a protein called erythropoietin to help your body make more RBCs.
• Jesduvroq is used to reduce or avoid the need for RBC transfusions.
• If your hemoglobin level stays too high or if your hemoglobin goes up too quickly, this may lead to serious health problems which may result in death.
• These serious health problems may happen if you take Jesduvroq, even if you do not have an increase in your hemoglobin levels.

Limitations of use:

• Jesduvroq has not been proven to improve quality of life, tiredness (fatigue), or well-being.

Jesduvroq should not be used:

• in place of emergency treatment for anemia (red blood cell transfusions).
• for the treatment of anemia that is caused by CKD in people who are not on dialysis.

How does this medicine work?

• Daprodustat is a drug which acts as a HIF prolyl-hydroxylase inhibitor and thereby increases endogenous production of erythropoietin, which stimulates production of hemoglobin and red blood cells.
• It is a reversible inhibitor of HIF-PH1, PH2 and PH3 (IC50 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.

Who Should Not Use this medicine ?

• This medicine have no usage limitations.

What drug interactions can this medicine cause?

• Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
• Taking Jesduvroq with certain other medicines may affect the way Jesduvroq works.

Be sure to mention any of the following:

• CYP2C8 inducers (e.g., rifampin)
• CYP2C8 inhibitors (e.g., gemfibrozil)

Is this medicine FDA approved?

• Daprodustat was approved for medical use in Japan in June 2020, and in the United States in February 2023.

How should this medicine be used?

• 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 mcg/mL or when serum transferrin saturation is less than 20%.
• Assess serum alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase, and total bilirubin prior to initiation of Jesduvroq.

Recommended dosage:

• Individualize dosing and use the lowest dose of Jesduvroq sufficient to reduce the need for red blood cell transfusions. Do not target a hemoglobin higher than 11 g/dL.

Starting Dose of JESDUVROQ for Adults on Dialysis not Receiving an Erythropoiesis-Stimulating Agent

Pre-Treatment Hemoglobin Level (g/dL)	Starting Dose of JESDUVROQ
<9	4 mg
≥9 to ≤10	2 mg
>10	1 mg

Administration:

• Take your prescribed dose of Jesduvroq 1 time a day.
• Swallow Jesduvroq tablets whole. Do not cut, crush, or chew the tablet.
• Jesduvroq can be taken with or without food.
• Jesduvroq can be taken at the same time as iron supplements or medicines that control the amount of phosphorus in your blood (phosphate binders), if necessary.
• If you miss a dose of Jesduvroq, take it as soon as you remember. If it is the same day as your next dose, skip the missed dose and take your next dose at your usual time. Do not take 2 doses at the same time to make up for the missed dose.
• If you take more than your prescribed dose of Jesduvroq, contact your healthcare provider or go to the nearest hospital emergency room right away.
• Your healthcare provider will do certain blood tests before you start Jesduvroq and during treatment as needed. Your healthcare provider may change your dose of Jesduvroq based on the results of your blood tests.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Tablets: 1 mg, 2 mg, 4 mg, 6 mg, and 8 mg.

This medicine is available in fallowing brand namesː

• Jesduvroq

What side effects can this medication cause?

The most common side effects of this medicine include:

• high blood pressure
• heart attack, stroke, and blood clots in the dialysis access, legs, or lungs
• stomach area (abdominal) pain.

Less common, but serious side effects may include:

• Increased risk of death, heart attack, stroke, and blood clots
• Risk of hospitalization for 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)

What special precautions should I follow?

• Jesduvroq increases the risk of arterial and venous thrombotic events, that may be fatal, including myocardial infarction, stroke, venous thromboembolism and vascular access thrombosis. Patients with cardiovascular or cerebrovascular disease are at increased risk of these events. Avoid use in patients with a history of myocardial infarction, cerebrovascular event, or acute coronary syndrome within the 3 months prior to starting Jesduvroq.
• Hospitalization for heart failure was observed in patients on dialysis receiving Jesduvroq. Consider the patient’s history of heart failure when deciding whether to prescribe Jesduvroq. Advise patients of the symptoms and signs of heart failure and to immediately report any worsening to their healthcare provider.
• Jesduvroq is contraindicated in patients with uncontrolled hypertension. Worsening hypertension, including hypertensive crisis may occur. Monitor blood pressure. Adjust anti-hypertensive therapy as needed.
• Gastric or esophageal erosions and gastrointestinal bleeding have been reported. Advise patients of the symptoms and signs of gastric and esophageal erosions and of gastrointestinal bleeding and to seek prompt medical care if these occur.
• The safety of Jesduvroq has not been established for the treatment of anemia due to CKD in adults not on dialysis and its use is not recommended in this setting.
• Jesduvroq has not been studied and is not recommended in patients with active malignancies.
• Advise females not to breastfeed during treatment with Jesduvroq and for one week after the final dose.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• Headache and gastrointestinal adverse reactions (e.g., nausea) may be seen with acute overdose with Jesduvroq.

Management of overdosage:

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.
• There is no specific antidote.
• Hemodialysis will not substantially remove daprodustat because it is highly protein bound.

Can this medicine be used in pregnancy?

• Available data with Jesduvroq use in pregnant women are insufficient to establish a drug associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.
• Advise pregnant women of the potential risk to the fetus.

Can this medicine be used in children?

• Safety and effectiveness of Jesduvroq in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

• Active Ingredient: daprodustat.
• Inactive Ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose, magnesium stearate, mannitol, and microcrystalline cellulose.
• Tablet film-coating: hypromellose, iron oxide black (1 mg, 2 mg, and 6 mg tablets), iron oxide red and iron oxide yellow (1 mg, 2 mg, 6 mg, and 8 mg tablets), polyethylene glycol, and titanium dioxide.

Who manufactures and distributes this medicine?

Manufactured by:

• GlaxoSmithKline
• Durham, NC

What should I know about storage and disposal of this medication?

• Store Jesduvroq at room temperature between 68°F to 77°F (20°C to 25°C).

• Dailymed label info on Daprodustat
• FDA Daprodustat

Daprodustat Resources
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Daprodustat Resources
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