Jesduvroq

Pronunciation: jez–DOOV–rok
Generic name: daprodustat
Dosage form: Tablet
Drug class: Miscellaneous uncategorized agents

Medically reviewed by Melisa Puckey, BPharm. Last updated on Aug 23, 2023.

What is Jesduvroq?

Jesduvroq (daprodustat) tablets are used to treat anemia (low red blood cells) that is caused by chronic kidney disease (CKD) in patients who have been on dialysis. Jesduvroq is used to reduce or avoid the need to have red blood cell (RBC) transfusions. 

Jesduvroq works by increasing the hormone erythropoietin which tells the body to make more red blood cells.  Jesduvroq is a hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI).

Jesduvroq tablets are taken orally once daily. Jesduvroq is the first oral treatment that is FDA approved to treat anemia that is caused by CKD, other FDA-approved treatments for this condition need to be injected into the blood or under the skin.

Clinical studies of 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 Jesduvroq work?

Chronic kidney disease patients may need dialysis, which is a treatment that filters the blood and removes excess fluid. Kidneys also produce a hormone called erythropoietin, which tells the body to make red blood cells. When patients with chronic kidney disease are on dialysis, their kidneys often cannot produce enough erythropoietin, and this means their number of red blood cells becomes low. Jesduvroq treats anemia by increasing the levels of erythropoietin, which messages the body to make more red blood cells. The blood test for anemia measures the level of hemoglobin, which is a protein in red blood cells.

At a more technical level Jesduvroq works as it is a hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI). Inhibition of oxygen-sensing prolyl hydroxylase enzymes stabilises hypoxia-inducible factors, and this can lead to transcription of erythropoietin and other genes involved in treating the anemia.

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. 

Who can take Jesduvroq?

Jesduvroq is FDA approved to treat adults with anemia (low red blood cells) caused by chronic kidney disease who have been having dialysis for at least four months. 

Jesduvroq is only FDA approved for patients on dialysis - it is not approved for patients who are not on dialysis. 

Warning

Jesduvroq may cause serious side effects, including: 

Increased risk of death, heart attack, stroke, and blood clots. These risks may happen if you are treated with Jesduvroq to increase red blood cells (RBCs) to near the same level found in healthy people. These risks may be increased if you have heart or blood vessel problems or problems with blood flow to your brain (cerebrovascular disease). Blood clots can form in the blood vessels (veins), including in your legs (deep vein thrombosis or DVT), lungs (pulmonary embolism or PE), and in your dialysis access (vascular access thrombosis or VAT). Get medical help right away if you get any of the following symptoms: 

• chest pain  
• sudden trouble seeing
• trouble breathing or shortness of breath
• sudden trouble walking, dizziness, loss of balance or coordination
• pain in your leg or arm, with or without swelling
• lightheadedness or fainting
• unusual coolness or warmth in arm or leg
• dialysis access stops working
• sudden confusion, trouble speaking, or trouble understanding others’ speech
• do not feel a vibration (“thrill”) over the dialysis access area
• sudden numbness or weakness in your face, arm, or leg, especially on one side of your body

See “What are the side effects of Jesduvroq?” for more information about side effects.

If you decide to take Jesduvroq, your healthcare provider should prescribe the lowest dose of Jesduvroq that is necessary to reduce your chance of needing red blood cell transfusions.

Who should not use Jesduvroq

Do not take Jesduvroq if you: 

• take certain medicines called strong CYP2C8 inhibitors such as gemfibrozil. Ask your healthcare provider if you are not sure.
• have high blood pressure that is not controlled (uncontrolled hypertension) 

Jesduvroq is not recommended in severe liver impairment.

Jesduvroq is not approved to be used in children.

What should I tell my doctor before taking Jesduvroq?

Before taking this medicine you should tell your healthcare provider about all of your current or past medical conditions, including: 

• heart disease
• stroke
• a history of heart failure
• high blood pressure
• a history of damage to the lining of the stomach, esophagus (the tube that connects the mouth and stomach), or intestines
• have a history of stomach ulcers (peptic ulcer disease)
• drink alcohol or smoke tobacco 
• have cancer
• have liver problems
• are planning to become pregnant or are pregnant.

Pregnancy

Jesduvroq may harm your unborn baby. 

You should tell your healthcare provider right away if you become pregnant or think you might be pregnant while being treated with this medicine.

Breastfeeding

If you are breastfeeding or plan to breastfeed, it is not known if this medicine passes into your breast milk. Do not breastfeed during treatment with Jesduvroq and for 1 week after your final dose. 

Dosage Information

Take this medicine exactly as your healthcare provider tells you to take it.

• Jesduvroq is an oral tablet that is available in five strengths: 1mg, 2mg, 4mg, 6mg, 8mg.
• Take your prescribed dose of Jesquvroq once a day, it can be taken with or without food.
• Swallow tablets whole, you should not cut, crush, or chew the tablet.
• 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 required.
• Jesduvroq can be administered without regard to the timing or type of dialysis.
• Do not change your dose or stop this medicine without talking to your healthcare provider. 

Your healthcare provider will do certain blood tests before you start Jesduvroq and during treatment as needed. Based on the results of your blood tests your healthcare provider may change your dose of this medicine.

What happens if I miss a dose?

If you miss a dose of this medicine, take it as soon as you remember, unless it the same day as your next dose. 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.

What happens if I overdose?

If you take more than your prescribed dose of Jesduvroq, you should contact your healthcare provider, or go to the nearest hospital emergency room right away.

What are the side effects of Jesduvroq?

Serious side effects of Jesduvroq include: 

• Also see “Warnings” section above.
• Risk of hospitalization for heart failure. People who have a history of heart failure have an increased risk of hospitalization for heart failure when taking this medicine. It is important to tell your healthcare provider right away if you get worsening signs and symptoms of heart failure, including:
• trouble breathing or shortness of breath
• swelling of your legs, ankles, or feet
• sudden weight gain
• feeling tired or weak

High blood pressure. High blood pressure is a common side effect of Jesduvroq. Your blood pressure may go up and may be harder to treat while being treated with Jesduvroq.  Your blood pressure should be checked regularly by your healthcare provider during treatment with this medicine. If your blood pressure increases, your healthcare provider may prescribe you a new medicine or may change the dose of the blood pressure medicine you are currently taking.

Damage to the lining of the stomach, the tube that connects the mouth and stomach (esophagus), and intestines (gastrointestinal erosion). Your risk of gastrointestinal erosion may increase if you have had gastrointestinal erosion, or stomach ulcers (peptic ulcer disease) in the past, or if you use certain medicines that increase the risk of gastrointestinal erosion, or currently smoke tobacco or drink alcohol. Some people who have bleeding in the stomach and intestines may need to receive transfusions. Tell your healthcare provider if you have any of these symptoms:

• stomach-area (abdominal) discomfort or pain
• nausea or vomiting
• stools that are black and tarry
• difficulty swallowing
• blood in your vomit or stool
• pain in your throat or chest 

• Cancer. Cancers have happened in people treated with Jesduvroq. Talk to your healthcare provider if you have any concerns about cancer.

Most common side effects of Jesduvroq include:

• high blood pressure. See information on “High blood pressure” above.
• heart attack, stroke, and blood clots in the dialysis access, legs, or lungs. See information in “Warnings” above.
• stomach area (abdominal) pain. 

These are not all the possible side effects of this medicine. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800- FDA-1088.

Jesduvroq side effects (more detail)

What other drugs will affect Jesduvroq?

Tell your healthcare provider about all medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Taking Jesduvroq with certain other medicines may affect how Jesduvroq or the other medicines work and can cause side effects. Jesduvroq interacts with other drugs that are metabolized in a certain way. Tell your doctor if you are taking medicines that contain any of the following drugs:

CYP2C8 Inhibitors: gemfibrozil (Lopid), clopidogrel (Plavix)

CYP2C8 Inducers: rifampin (Rifadin)

This list is not complete. Many other drugs may interact with Jesduvroq, not all possible interactions are listed in this medicine guide.

Jesduvroq drug interactions (more detail)

General information about the safe and effective use of Jesduvroq.

Medications are sometimes prescribed for purposes other than those listed in the Drug Information Leaflet. Do not use Jesduvroq for a condition for which it was not prescribed. Do not give this medicine to other people, even if they have the same symptoms that you have, as it may harm them. You can ask your pharmacist, doctor, or healthcare provider for information about this medicine that is written for health professionals.

Storage 

• Jesduvroq should be stored at room temperature between 68°F to 77°F (20°C to 25°C).
• All medicines including Jesduvroq should be stored out of the reach of children.

What are the ingredients in Jesduvroq?

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.

Manufacturer

GlaxoSmithKline Durham, NC 27701

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