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Prescribing Information& Medication Guide Patient Site
Vafseo offers convenient oral, once-daily dosing1
The recommended starting dose is 300 mg regardless of prior ESA dose1
Pre-treatment and on-treatment evaluations of anemia, iron stores, and liver tests1:
Evaluating anemia and iron stores
- Correct and exclude other causes of anemia before initiating Vafseo
- Measure Hb at baseline and during treatment
- Evaluate iron status in all patients before and during treatment
- Administer supplemental iron therapy when serum ferritin is <100 mcg/L or when serum transferrin saturation is <20%
- The majority of patients with CKD will require supplemental iron during the course of therapy
Performing liver tests
- Assess serum ALT, AST, and bilirubin prior to initiating Vafseo and monthly after initiation for the first 6 months, and then monitor as clinically indicated
- Discontinue Vafseo if there are persistent ALT or AST elevations greater than 3 times upper limit of normal (ULN) or if ALT or AST elevations greater than 3 times ULN are accompanied by a bilirubin increase greater than 2 times ULN
ALT=alanine aminotransferase; AST=aspartate
aminotransferase; CKD=chronic kidney disease;
ESA=erythropoiesis-stimulating agent; Hb=hemoglobin;
ULN=upper limit of normal.
Not actual size.
Start Vafseo at 300 mg orally once daily1
Important dosing information1
- Individualize dosing and use the lowest dose of Vafseo sufficient to reduce the need for red blood cell transfusions. Do not target a hemoglobin level higher than 11 g/dL
- Vafseo can be taken with or without food
- Vafseo should be swallowed whole. Tablets should not be cut, crushed, or chewed
- Vafseo can be administered without regard to the timing or type of dialysis
- If a dose of Vafseo is missed, it should be taken as soon as possible, unless it is the same day as the next dose. In this case, the missed dose should be skipped, and the next dose taken at the usual time. Double doses should not be taken to make up for a missed dose
- Vafseo is available in 2 dosing strengths: 150-mg tablet and 300-mg tablet
- Vafseo doses may range from 150 mg to a maximum of 600 mg and may be titrated in 4 dosing increments: 150 mg, 300 mg, 450 mg, and 600 mg
Follow up to assess treatment responses1
- Monitor Hb levels every 2 weeks after therapy initiation and after each dose adjustment until stable, then at least monthly
Hb=hemoglobin.
Not actual size.
Vafseo dose titration1
- Increase the dose no more frequently than once every 4 weeks. Dose decreases can occur more frequently
- Titrate the dose of Vafseo by adjusting the dose in increments of 150 mg within the dose range of 150 mg to 600 mg to help achieve or sustain Hb level of 10 to 11 g/dL
- When adjusting the dose, consider the patient’s Hb variability, Hb rate of rise and rate of decline, and Vafseo responsiveness—a single Hb excursion may not require dosing change
- If the Hb rises rapidly (eg, more than 1 g/dL in any 2-week period or more than 2 g/dL in 4 weeks), interrupt or reduce the dose
- If Hb level exceeds 11 g/dL, interrupt the dose until Hb is ≤11 g/dL. Resume with a dose that is 150 mg less than the dose prior to interruption
- Treatment with Vafseo should not be continued beyond 24 weeks of therapy if a clinically meaningful increase in Hb level is not achieved. Alternative explanations for an inadequate response should be sought and treated before restarting therapy
Hb=hemoglobin.
Select drug interactions1
Interactions with iron and phosphate binders
Administer Vafseo at least 1 hour before or 2 hours after
- Non-iron-containing phosphate binders
Administer Vafseo at least 1 hour before
- Oral iron supplements
- Products containing iron
- Iron-containing phosphate binders
Interactions with statins
- Vafseo increases the Cmax and AUC of some statins when co-administered
- This means that when taken together, Vafseo increases the blood levels of certain statins, such as simvastatin and rosuvastatin
- The starting dose of simvastatin should be 5 mg/day. The maximum daily dose of simvastatin not to exceed 20 mg
- The maximum daily dose of rosuvastatin not to exceed 5 mg
AUC=area under the concentration curve;
Cmax=maximal concentration.
Cmax=maximal concentration.
Taking once-daily Vafseo at the same time each day may help your patients establish a consistent schedule2
IMPORTANT SAFETY INFORMATION AND INDICATION
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.
CONTRAINDICATIONS
- Known hypersensitivity to VAFSEO or any of its components
- Uncontrolled hypertension
WARNINGS AND PRECAUTIONS
- Increased Risk of Death, Myocardial Infarction (MI), Stroke, Venous Thromboembolism, and Thrombosis of Vascular AccessA rise in hemoglobin (Hb) levels greater than 1 g/dL over 2 weeks can increase these risks. Avoid in patients with a history of MI, cerebrovascular event, or acute coronary syndrome within the 3 months prior to starting VAFSEO. Targeting a Hb level of greater than 11 g/dL is expected to further increase the risk of death and arterial and venous thrombotic events. Use the lowest effective dose to reduce the need for red blood cell (RBC) transfusions. Adhere to dosing and Hb monitoring recommendations to avoid excessive erythropoiesis.
- HepatotoxicityHepatocellular injury attributed to VAFSEO was reported in less than 1% of patients, including one severe case with jaundice. Elevated serum ALT, AST, and bilirubin levels were observed in 1.8%, 1.8%, and 0.3% of CKD patients treated with VAFSEO, respectively. Measure ALT, AST, and bilirubin before treatment and monthly for the first 6 months, then as clinically indicated. Discontinue VAFSEO if ALT or AST is persistently elevated or accompanied by elevated bilirubin. Not recommended in patients with cirrhosis or active, acute liver disease.
- HypertensionWorsening of hypertension was reported in 14% of VAFSEO and 17% of darbepoetin alfa patients. Serious worsening of hypertension was reported in 2.7% of VAFSEO and 3% of darbepoetin alfa patients. Cases of hypertensive crisis, including hypertensive encephalopathy and seizures, have also been reported in patients receiving VAFSEO. Monitor blood pressure. Adjust anti-hypertensive therapy as needed.
- SeizuresSeizures occurred in 1.6% of VAFSEO and 1.6% of darbepoetin alfa patients. Monitor for new-onset seizures, premonitory symptoms, or change in seizure frequency.
- Gastrointestinal (GI) ErosionGastric or esophageal erosions occurred in 6.4% of VAFSEO and 5.3% of darbepoetin alfa patients. Serious GI erosions, including GI bleeding and the need for RBC transfusions, were reported in 3.4% of VAFSEO and 3.3% of darbepoetin alfa patients. Consider this risk in patients at increased risk of GI erosion. Advise patients about signs of erosions and GI bleeding and urge them to seek prompt medical care if present.
- Serious Adverse Reactions in Patients with Anemia Due to CKD and Not on DialysisThe safety of VAFSEO has not been established for the treatment of anemia due to CKD in adults not on dialysis and its use is not recommended in this setting. In large clinical trials in adults with anemia of CKD who were not on dialysis, an increased risk of mortality, stroke, MI, serious acute kidney injury, serious hepatic injury, and serious GI erosions was observed in patients treated with VAFSEO compared to darbepoetin alfa.
- MalignancyVAFSEO has not been studied and is not recommended in patients with active malignancies. Malignancies were observed in 2.2% of VAFSEO and 3.0% of darbepoetin alfa patients. No evidence of increased carcinogenicity was observed in animal studies.
ADVERSE REACTIONS
- The most common adverse reactions (occurring at ≥ 10%) were hypertension and diarrhea.
DRUG INTERACTIONS
- Iron supplements and iron-containing phosphate binders: Administer VAFSEO at least 1 hour before products containing iron.
- Non-iron-containing phosphate binders: Administer VAFSEO at least 1 hour before or 2 hours after non-iron-containing phosphate binders.
- BCRP substrates: Monitor for signs of substrate adverse reactions and consider dose reduction.
- Statins: Monitor for statin-related adverse reactions. Limit the daily dose of simvastatin to 20 mg and rosuvastatin to 5 mg.
USE IN SPECIFIC POPULATIONS
- Pregnancy: May cause fetal harm.
- Lactation: Breastfeeding not recommended until two days after the final dose.
- Hepatic Impairment: Not recommended in patients with cirrhosis or active, acute liver disease
INDICATION
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:
- 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.
Please note that this information is not comprehensive. Please click here for the Full Prescribing Information, including BOXED WARNING and Medication Guide.
References: 1. Vafseo® [Package Insert]. Cambridge, MA: Akebia Therapeutics, Inc. 2. Bussell JK, Cha E, Grant YE, Schwartz DD, Young LA. Ways health care providers can promote better medication adherence. Clin Diabetes. 2017;35(3):171-177. doi:10.2337/cd016-0029