Vadadustat Dosage

Medically reviewed by Drugs.com. Last updated on Apr 22, 2025.

Usual Adult Dose for Anemia Associated with Chronic Renal Failure

Initial dose: 300 mg orally once a day
Maximum dose: 600 mg orally once a day

Comments:

• Dose adjustments should be in increments of 150 mg to maintain hemoglobin (Hb) levels of 10 to 11 g/dL. Adjustments should be made according to the titration schedule based on changes in Hb (doses may range from 150 to 600 mg per day).
• Dosing should be individualized, using the lowest dose sufficient to reduce the need for red blood cell transfusions. Do not target Hb level higher than 11 g/dL.
• Increase the dose no more frequently than once every 4 weeks. Decreases can occur more frequently.
• Therapy should not be continued beyond 24 weeks if a clinically meaningful increase in hemoglobin levels is not achieved. An alternative explanation for an inadequate response should be sought and treated before re-starting this drug.

Use: For the treatment of anemia due to chronic kidney disease in patients who have been in dialysis for at least 3 months

Renal Dose Adjustments

No adjustment recommended.

Liver Dose Adjustments

Mild or Moderate Liver Dysfunction (Child-Pugh Class A or B): No adjustment recommended.
Severe Liver Dysfunction (Child-Pugh Class C): Not recommended.

Dose Adjustments

Dose adjustment should be done in increments of 150 mg within the range of 150 mg to a maximum daily dose of 600 mg orally once a day to achieve or maintain hemoglobin (Hb) levels within 10 to 11 g/dL. A single Hb excursion may not require a dosing change.

Consider the following conditions when adjusting the dose:

• The patient's clinical condition
• Hb variability
• Hb rate of rise and decline
• Drug responsiveness

For Hb levels that rapidly rise (e.g., more than 1 g/dL in any 2-week period or more than 2 g/dL in 4 weeks): Therapy should be interrupted, or the dose reduced.

For Hb level exceeding 11 g/dL: Therapy should be interrupted until Hb is 11 g/dL or less. This drug should be restarted at a dose that is 150 mg less than the dose prior to interruption.

CONVERTING FROM ERYTHROPOIESIS-STIMULATING AGENT (ESA):

• Initial dose: 300 mg orally once a day

• Rescue therapy in the form of RBC transfusion or ESA treatment may be considered during the transition phase if Hb values fall below 9 g/dL or if there is an unacceptable response.
• Patients receiving RBC transfusions are recommended to continue treatment with this drug during the transfusion period.
• Treatment with this drug should be paused for patients receiving temporary ESA rescue treatment and then resumed when Hb levels are 10 g/dL or greater.
• Depending on the ESA rescue treatment used, the pause in treatment with this drug should be extended to:
• 2 days after the last dose of epoetin
• 7 days after the last dose of darbepoetin alfa
• 14 days after the last dose of methoxy polyethylene glycol-epoetin beta
• Following ESA rescue treatment, this drug should be restarted at the prior dose or a dose 150 mg higher, with subsequent titration according to the dose titration schedule.

DOSE ADJUSTMENT TO PREVENT DRUG INTERACTIONS
Oral Iron and Phosphate Binders:

• This drug should be administered at least 1 hour before oral iron supplements, products containing iron, or iron-containing phosphate binders.
• This drug should be administered at least 1 hour before or 2 hours after dosing non-iron-containing phosphate binders.

Precautions

US BOXED WARNING(S):
Increased Risk of Death, Myocardial Infarction, Stroke, Venous Thromboembolism, and Thrombosis of Vascular Access:

• This drug increases the risk of thrombotic vascular events, including major adverse cardiovascular events.
• Targeting a Hb level greater than 11 g/dL can further increase the risk of death and arterial and venous thrombotic events, as occurs with erythropoietin stimulating agents, which also increase erythropoietin levels.
• No trial has identified a Hb target level, dose of this drug, or dosing strategy that does not increase these risks.
• Use the lowest dose of this drug sufficient to reduce the need for red blood cell transfusions.

CONTRAINDICATIONS:

• Hypersensitivity to the active substance or to any of its excipients
• Uncontrolled hypertension

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

• Approximately 16% of this drug is removed by dialysis.

Other Comments

Administration advice:

• It is important to assess for other causes of anemia before initiating treatment with this drug.
• Evaluate iron status and administer supplemental iron therapy when serum ferritin is less than 100 mcg/L or when serum transferrin saturation is less than 20%.
• This drug may be administered with or without food and should be swallowed whole without cutting, crushing, or chewing.
• This drug may be taken without regard to the timing or the type of dialysis.
• This drug should be administered at least 1 hour before oral iron supplements, products whose primary component consists of iron or iron-containing phosphate binders.
• If a dose is missed, patients should take the dose as soon as possible on the same day then the next dose should be taken the next day at the usual time. Patients should not take a double dose.

Storage requirements:

• Store between 20C to 25C (68F to 77F), with excursions permitted between 15C to 30C (59F to 86F)
• Keep out of reach of children

General:

• Limitations of use:
• This drug has not shown to improve quality of life, fatigue, or patient well-being.
• Not indicated for use as a substitute for red blood cell transfusions in patients who require immediate correction of anemia.
• Not indicated for patients with anemia due to CKD NOT on dialysis.
• Health care professionals should report any suspected adverse reactions at www.fda.gov/medwatch

Monitoring:

• Cardiovascular: Blood pressure (prior to initiation and as clinically needed)
• Hematologic: Hemoglobin levels at baseline and every 2 weeks when initiating or adjusting therapy until stable, then monthly thereafter
• Hepatic: ALT, AST, and bilirubin (prior to initiation, monthly for 3 months, and as clinically indicated thereafter)
• Metabolic: Iron status (prior to and during treatment)

Patient advice:

• Read the Patient Information and Instructions for Use.
• Inform your healthcare provider of all medications, herbal and dietary supplements.
• This drug should be taken 1 hour before iron supplements or medicines that contain calcium, magnesium, or aluminum.
• Contact your healthcare provider immediately if you have:
• History of seizures or fits, epilepsy, or any medical condition that can cause a seizure
• Worsening or sudden rise in blood pressure
• Gastrointestinal discomfort or pain, nausea, vomiting, blood in your vomit or stool

See also:

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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