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. 

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.

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.

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. 

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

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.