Vadadustat Application Scope

Treatment of anemia due to chronic kidney disease (CKD) in adults who have been receiving dialysis for at least 3 months.

Vadadustat Characteristics

Ingredients: Vadadustat (active ingredient)
Properties: Hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor that stimulates endogenous erythropoietin production, leading to increased red blood cell levels.
Packaging Specification: Supplied in bottles containing 60 tablets.
Storage: Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F).
Expiry Date: Refer to the packaging for the expiration date.
Executive Standard: Approved by the U.S. Food and Drug Administration (FDA) in March 2024.
Approval Number: Refer to the FDA approval documentation for specific details.
Date of Revision: Refer to the latest prescribing information for the most recent revision date.
Manufacturer: Akebia Therapeutics, Inc.

Dosage and Administration:
- Initial Dose: 300 mg orally once daily.
- Maintenance Dose: Adjust in 150 mg increments to maintain hemoglobin levels between 10 to 11 g/dL.
- Maximum Dose: 600 mg orally once daily.
- Administration: Can be taken with or without food; may be taken before, during, or after dialysis sessions.
- Dose Adjustments: Increase dose no more frequently than once every 4 weeks; decreases can occur more frequently based on hemoglobin levels.
Adverse Reactions:
- Common (≥10%): Hypertension and diarrhea.
- Serious: Increased risk of death, myocardial infarction, stroke, venous thromboembolism, and thrombosis of vascular access.
Contraindications:
- Known hypersensitivity to vadadustat or any of its components.
- Uncontrolled hypertension.
Precautions:
- Monitor liver function tests (ALT, AST, bilirubin) before initiation, monthly for the first 6 months, and as clinically indicated thereafter.
- Not recommended in patients with cirrhosis or active, acute liver disease.
- Monitor blood pressure regularly; adjust antihypertensive therapy as needed.
- Monitor for new-onset seizures or changes in seizure frequency.
- Advise patients about the risk of gastrointestinal erosions and bleeding; instruct them to seek prompt medical attention if symptoms occur.

Iron Supplements and Iron-Containing Phosphate Binders: Administer vadadustat at least 1 hour before these products to avoid decreased drug exposure.
Non-Iron-Containing Phosphate Binders: Administer vadadustat at least 1 hour before or 2 hours after these products.
Statins: Vadadustat may increase plasma concentrations of certain statins (e.g., simvastatin, rosuvastatin); monitor for statin-related adverse reactions.
BCRP Substrates: Vadadustat may increase exposure to BCRP substrates; monitor for adverse reactions and adjust substrate dosage as needed.
OAT1/OAT3 Inhibitors: Concomitant use may increase vadadustat exposure; monitor hemoglobin response and for adverse reactions.

Note:

If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
It is only for internal discussion among medical staff and does not serve as a basis for medication. For specific medication guidelines, please consult the attending physician.