Daprodustat

What it is used for

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. 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.

The most important thing to know

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 “

How to take it

Take JESDUVROQ exactly as your healthcare provider tells you to take it. Do not change your dose or stop JESDUVROQ without talking to your healthcare provider. 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 possible side effects of JESDUVROQ? JESDUVROQ may cause serious side effects, including: Risk of hospitalization for heart failure. People who have a history of heart failure have an increased risk of hospitalization for heart failure with JESDUVROQ.

Tell your healthcare provider right away if you get worsening signs and symptoms of heart failure, including: ○shortness of breath or trouble breathing ○sudden weight gain ○swelling of your feet, ankles or legs ○feeling tired or weak High blood pressure. High blood pressure is common with JESDUVROQ. Your blood pressure may go up or worsen, and may be difficult to treat during treatment with JESDUVROQ.

Your healthcare provider should check your blood pressure regularly during treatment with JESDUVROQ. If your blood pressure increases, your healthcare provider may prescribe a new medicine or may change the dose of your current blood pressure medicine. 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 a history of gastrointestinal erosion, stomach ulcers (peptic ulcer disease), 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 ○black, tarry stools ○nausea or vomiting ○trouble 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.

The most common side effects of JESDUVROQ include: high blood pressure. See “ High blood pressure” above. heart attack, stroke, and blood clots in the dialysis access, legs, or lungs. above. stomach area (abdominal) pain. These are not all the possible side effects of JESDUVROQ. Call your doctor for medical advice about side effects.

You may report side effects to FDA at 1-800-FDA-1088.

Side effects, and when to stop

” 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. What is JESDUVROQ? 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. 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. It is not known if JESDUVROQ is safe and effective in children.

Who should not take it

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) Before taking JESDUVROQ, tell your healthcare provider about all of your medical conditions, including if you: have heart disease have had a stroke have a history of heart failure have high blood pressure have a history of damage to the lining of the stomach, the tube that connects the mouth and stomach (esophagus), or intestines have a history of stomach ulcers (peptic ulcer disease) smoke tobacco or drink alcohol have cancer have liver problems are pregnant or plan to become pregnant.

JESDUVROQ may cause harm to your unborn baby. Tell your healthcare provider right away if you become pregnant or think you might be pregnant during treatment with JESDUVROQ. are breastfeeding or plan to breastfeed. It is not known if JESDUVROQ passes into your breast milk. Do not breastfeed during treatment with JESDUVROQ and for 1 week after your final dose.

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.

Storing it

Store JESDUVROQ at room temperature between 68°F to 77°F (20°C to 25°C). Keep JESDUVROQ and all medicines out of the reach of children.