Daprodustat

Daprodustat is a prescription medication used for the treatment of anemia due to chronic kidney disease.

• Daprodustat is available under the following different brand names: Jesduvroq

Common side effects of Daprodustat include:

• high blood pressure, 
• stomach pain, 
• nausea, 
• vomiting, 
• black or tarry stools, 
• difficulty swallowing, 
• vomit that looks like coffee grounds, 
• sore throat, and 
• chest pain

Serious side effects of Daprodustat include:

• hives, 
• difficulty breathing, 
• swelling of the face, lips, tongue, or throat, 
• shortness of breath, 
• swelling of the legs, ankles, or feet, 
• sudden weight gain, 
• tiredness, 
• weakness, 
• chest pain, 
• difficulty seeing, 
• loss of balance or coordination, 
• difficulty walking, 
• dizziness, 
• pain in a leg or arm, with or without swelling, 
• warmth in an arm or leg, 
• fainting, 
• lightheadedness, 
• confusion, 
• trouble speaking or understanding what others are saying, 
• sudden numbness or weakness in your face, arm or leg, especially on one side of the body, and
• abdominal pain

Rare side effects of Daprodustat include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out. 

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Tablet

• 1 mg
• 2 mg
• 4 mg
• 6 mg
• 8 mg

Anemia of Chronic Kidney Disease

Adult dosage

• Dosing in patients not treated with an erythropoietin-stimulating agent (ESA)
• Starting dose is based on the pretreatment hemoglobin (Hgb) level
• Hgb below 9 g/dL: Start at 4 mg orally every day
• 9-10 g/dL: Start at 2 mg orally every day
• Above 10 g/dL: Start at 1 mg orally every day

Switching from an ESA

• Starting dose of daprodustat is based on the dosing regimen of ESA at the time of substitution

Epoetin alfa IV

• Note: For patients on SC epoetin alfa, convert epoetin alfa SC dose to IV dose equivalent by multiplying SC dose received per week by 1.42 to obtain the weekly IV dose
• Below 2,000 units/week: Start daprodustat at 4 mg orally every day
• More than 2,000 to less than 10,000 units/week: Start daprodustat at 6 mg orally every day
• More than 10,000 to less than 20,000 units/week: Start daprodustat at 8 mg orally every day
• Above 20,000 units/week: Start daprodustat at 12 mg orally every day

Darbepoetin alfa IV/SC

• 20-30 mcg/4 weeks: Start daprodustat at 4 mg orally every day
• Above 30 to 150 mcg/4 weeks: Start daprodustat at 6 mg orally every day
• Above 150 to 300 mcg/4 weeks: Start daprodustat at 8 mg orally every day
• Above 300 mcg/4 weeks: Start daprodustat at 12 mg orally every day

Methoxy polyethylene glycol (PEG)-epoetin beta SC/IV

• 30-40 mcg/month: Start daprodustat at 4 mg orally every day
• Above 40 to 180 mcg/month: Start daprodustat at 6 mg orally every day
• Above 180 to 360 mcg/month: Start daprodustat at 8 mg orally every day
• Above 360 mcg/month: Start daprodustat at 12 mg orally every day

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Daprodustat has severe interactions with no other drugs.
• Daprodustat has serious interactions with no other drugs.
• Daprodustat has serious interactions with no other drugs.
• Daprodustat has serious interactions with no other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• Strong CYP2C8 inhibitors (eg, gemfibrozil)
• Uncontrolled hypertension

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Daprodustat?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Daprodustat?”

Cautions

• Increased risk of cardiovascular mortality, stroke, thromboembolism, serious acute kidney injury, hospitalization for heart failure, and serious gastrointestinal erosions observed
• Advise patients to seek immediate medical attention if signs or symptoms of MI, stroke, VTE, or thrombosis of vascular access develop; evaluate and manage promptly if these occur (see Black Box Warning)
• Hospitalization for heart failure reported; consider patient’s history of heart failure before prescribing; advise patients on signs and symptoms of heart failure and to immediately their healthcare provider if these symptoms worsen
• Contraindicated in uncontrolled hypertension; periodically monitor blood pressure and adjust or initiate antihypertensive therapy as needed
• Safety not established for the treatment of anemia due to CKD in adults not on dialysis; use not recommended in this setting
• Not studied and not recommended in patients with active malignancies; malignancies reported
• Gastrointestinal erosion
  • Gastric or esophageal erosions occurred
  • Consider this risk, particularly in patients with risk factors for gastrointestinal (GI) erosions, such as a history of GI erosion, peptic ulcer disease, concomitant use of medications that increase the risk of GI erosion, current tobacco smoking, and alcohol use
  • Advise patients of symptoms and signs of gastric and esophageal erosions and GI bleeding and to seek prompt medical care if these occur
• Drug interaction overview
  • CYP2C8 substrate
  • Strong CYP2C8 inhibitors (eg, gemfibrozil)
• Contraindicated
  • Strong CYP2C8 inhibitors are contraindicated due to a marked increase in daprodustat exposure
  • Moderate CYP2C8 inhibitors (eg, clopidogrel)
  • Reduce daprodustat dose by half when initiating moderate CYP2C8 inhibitors, except with a starting dose of 1 mg/day
  • Monitor Hgb and adjust daprodustat dose when initiating or stopping moderate CYP2C8 inhibitor
  • Moderate CYP2C8 inhibitors increase daprodustat exposure
  • CYP2C8 inducers (eg, rifampin)
  • Monitor Hgb and adjust the dose when initiating or stopping therapy with CYP2C8 inducers during treatment
  • CYP2C8 inducers may decrease exposure and efficacy of daprodustat

Pregnancy and Lactation

• Available data are insufficient in pregnant females to establish a drug-associated risk of major birth defects, miscarriages, or adverse maternal or fetal outcomes
• Clinical consideration
  • CKD during pregnancy increases the risk for maternal hypertension, preeclampsia, miscarriage, stillbirth, preterm delivery, low birth weight infants, and polyhydramnios
• Lactation
  • There are no data on drug presence in human milk, effects on breastfed infants, or effects on milk production
  • Daprodustat is present in the milk of lactating rats
  • When a drug is present in animal milk, the drug will likely be present in human milk
  • Advise patients not to breastfeed during treatment and for 1 week after the final dose