Brand Name
Vafseo
Generic Name
Vadadustat
View Brand Information FDA approval date: March 28, 2024
Classification: Hypoxia-inducible Factor Prolyl Hydroxylase Inhibitor
Form: Tablet
What is Vafseo (Vadadustat)?
VAFSEO is indicated for the treatment of anemia due to chronic kidney disease in adults who have been receiving dialysis for at least three months. Limitations of Use VAFSEO has not been shown to improve quality of life, fatigue, or patient well-being. VAFSEO is not indicated for use: As a substitute for red blood cell transfusions in patients who require immediate correction of anemia In patients with anemia due to CKD not on dialysis [see Warnings and Precautions.
Approved To Treat
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Related Clinical Trials
A Randomized, Open-Label, Active-Controlled Study Evaluating the Efficacy of Three Times Weekly Vadadustat Compared to Standard of Care ESA in Patients With Anemia of CKD Receiving In-Center Hemodialysis
Summary: This is a multi-center, randomized (1:1), open-label, active-controlled, pragmatic study of the efficacy of vadadustat administered three times a week compared to standard of care erythropoiesis-stimulating agent for the treatment of anemia in in-center hemodialysis participants with end-stage kidney disease (ESKD). A subset of sites will participate in a red blood cell (RBC) sub-study where chang...
Safety of Three Times Weekly Oral Vadadustat for the Treatment of Anemia in Hemodialysis Subjects: Vafseo Outcomes In-Center Experience
Summary: This trial is an investigator-initiated, multi-center, randomized (1:1), open-label, active-controlled, pragmatic study of the safety of vadadustat administered three times per week for the treatment of anemia in in-center hemodialysis patients with End Stage Kidney Disease (ESKD). This study will obtain long-term safety data in a large sample of subjects receiving in-center hemodialysis to suppor...
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Brand Information
VAFSEO (Vadadustat)
WARNING: INCREASED RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, AND THROMBOSIS OF VASCULAR ACCESS
VAFSEO increases the risk of thrombotic vascular events, including major adverse cardiovascular events (MACE)
Targeting a hemoglobin level greater than 11 g/dL is expected to further increase the risk of death and arterial and venous thrombotic events, as occurs with erythropoietin stimulating agents (ESAs), which also increase erythropoietin levels
No trial has identified a hemoglobin target level, dose of VAFSEO, or dosing strategy that does not increase these risks
Use the lowest dose of VAFSEO sufficient to reduce the need for red blood cell transfusions [
1INDICATIONS AND USAGE
VAFSEO is indicated for the treatment of anemia due to chronic kidney disease (CKD) in adults who have been receiving dialysis for at least three months.
Limitations of Use
- VAFSEO has not been shown to improve quality of life, fatigue, or patient well-being.
- VAFSEO is not indicated for use:
2DOSAGE FORMS AND STRENGTHS
VAFSEO is available as a film-coated, immediate-release tablet in the following strengths:
3CONTRAINDICATIONS
VAFSEO is contraindicated in patients:
- with a known hypersensitivity to VAFSEO or any of its components
- with uncontrolled hypertension
4ADVERSE REACTIONS
The following clinically significant adverse reactions are discussed elsewhere in the labeling:
- Increased risk of death, myocardial infarction, stroke and venous thromboembolism, and thrombosis of vascular access
- Hepatotoxicity
- Hypertension
- Seizures
- Gastrointestinal erosion
- Serious adverse reactions in patients with anemia due to chronic kidney disease and not on dialysis
4.1Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The safety of VAFSEO was evaluated in adults with dialysis-dependent chronic kidney disease (DD-CKD) with anemia in the INNO
There were 1947 patients treated with VAFSEO and 1955 patients treated with darbepoetin alfa. In the pooled VAFSEO treatment arm, 71% of the participants were treated continuously for at least 6 months of VAFSEO and 44% of participants received VAFSEO for at least 1 year.
VAFSEO was non-inferior to darbepoetin alfa on the time to first occurrence of major adverse cardiovascular events (MACE) in adults with anemia due to CKD who were on dialysis
Permanent treatment discontinuation due to an adverse reaction was reported in 4.9% of patients treated with VAFSEO and 1.1% of patients treated with darbepoetin alfa. Gastrointestinal symptoms (nausea, vomiting and diarrhea) resulted in permanent treatment discontinuation in 1.8% of patients treated with VAFSEO.
The most common adverse reactions (>10% of VAFSEO-treated patients) were hypertension and diarrhea.
Table 1 lists the adverse reactions that occurred in at least 5% or greater of patients with DD-CKD treated with VAFSEO.
Table 1 Adverse Reactions (≥5%) in Patients with DD-CKD During INNO
Adjudicated fatal and non-fatal thrombotic vascular events were observed in 9.0 per 100 PY of patients in the pooled VAFSEO arm and in 8.7 per 100 PY of patients in the pooled darbepoetin alfa
Table 2 Adjudicated Thrombotic Vascular Events in Patients with DD-CKD (Fatal and Non-fatal Events)
5OVERDOSAGE
VAFSEO overdose may result in exaggeration of the pharmacologic effects such as increased Hb. VAFSEO overdose should be managed as clinically appropriate (e.g., reduction of VAFSEO dose or discontinuation). Approximately 16% of the vadadustat dose is removed by dialysis. There is no specific antidote.
6DESCRIPTION
VAFSEO contains vadadustat, a hypoxia-inducible factor prolyl hydroxylase (HIF PH) inhibitor. Vadadustat is 2-[[5-(3-chlorophenyl)-3-hydroxypyridine-2-carbonyl]amino]acetic acid. Vadadustat has a molecular weight of 306.70. The empirical formula is C
The chemical structure is:
Vadadustat is a white to off-white solid that is practically insoluble in water.
Vadadustat is formulated as a film-coated, immediate-release tablet for oral administration.
VAFSEO is available in 150 mg, 300 mg and 450 mg strengths. Inactive ingredients include: colloidal silicon dioxide, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate. The tablet film-coating contains polyvinyl alcohol, polyethylene glycol (PEG) and talc.
Colorants include:
7HOW SUPPLIED/STORAGE AND HANDLING
How SuppliedVAFSEO film-coated tablets are available in the following strengths and packages:
8PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (
Inform patients:
Of the increased risk of death, myocardial infarction, stroke, and thromboembolism including vascular access thrombosis
That hemoglobin levels will be monitored when initiating or adjusting therapy, every two weeks until stable, then at least monthly
Of the risk of hepatotoxicity and that liver tests will be measured prior to the initiation of VAFSEO, monthly after initiation for the first 6 months, then as clinically indicated
Of the risk of hypertension and advise patients of the importance to comply with antihypertensive therapy and monitoring of blood pressure
Of the risk of seizures and advise patients to contact their healthcare provider for new-onset neurologic symptoms or change in seizure frequency
Of the risk of gastrointestinal erosions and advise patients to contact their healthcare provider for signs and symptoms of gastric and esophageal erosions and of gastrointestinal bleeding
Manufactured for: Akebia Therapeutics®, Inc. Cambridge, MA 02142
VAFSEO
Version No. 1
9PRINCIPAL DISPLAY PANEL - NDC: 59922-641-60 - 150 mg Carton Label
10PRINCIPAL DISPLAY PANEL - NDC: 59922-641-60 - 150 mg Bottle Label
11PRINCIPAL DISPLAY PANEL - NDC: 59922-642-60 - 300 mg Carton Label
12PRINCIPAL DISPLAY PANEL - NDC: 59922-642-60 - 300 mg Bottle Label
13PRINCIPAL DISPLAY PANEL - NDC: 59922-643-60 - 450 mg Carton Label
14PRINCIPAL DISPLAY PANEL - NDC: 59922-643-60 - 450 mg Bottle Label
