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Vafseo is a brand name for Vadadustat. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Vafseo is indicated for the treatment of symptomatic anaemia associated with chronic kidney disease (CKD) in adults on chronic maintenance dialysis.
Verbatim from this product's EMA label. Tap a section to expand.
3 Vadadustat should be initiated by a physician experienced in the management of anaemia. All other causes of anaemia should be evaluated prior to initiating therapy with Vafseo, and when deciding to increase the dose. Anaemia symptoms and sequelae may vary with age, gender, and overall burden of disease; a physician’s evaluation of the individual patient’s clinical course and condition is necessary.
In addition to the presence of symptoms of anaemia, criteria such as rate of fall of haemoglobin (Hb) concentration, prior response to iron therapy, and the risk of needing of red blood cell (RBC) transfusion could be considered in the evaluation of the individual patient’s clinical course and condition.
Posology Evaluation before administration Evaluation of iron stores and nutritional factors Iron status should be evaluated in all patients before and during treatment. Supplemental iron therapy should be administered when serum ferritin is less than 100 mcg/L or when serum transferrin saturation is less than 20%.
Dose initiation The recommended starting dose is 300 mg once daily. Do not increase the dose more frequently than once every 4 weeks. Decreases in dose can occur more frequently. Patients converting from an erythropoiesis-stimulating agent (ESA) When converting from an ESA to Vafseo, the recommended starting dose is 300 mg once daily.
1 for course Hb during treatment in individual studies). 4). Patients receiving RBC transfusions are recommended to continue Vafseo treatment during the transfusion period. Vafseo should be paused for those patients receiving temporary ESA rescue treatment and may be resumed when Hb levels are ≥10 g/dL.
Depending on the ESA employed, the pause in Vafseo treatment should be extended to: • 2 days after last dose of epoetin • 7 days after last dose of darbepoetin alfa • 14 days after last dose of methoxy polyethylene glycol-epoetin beta.
Following ESA rescue, Vafseo should be resumed at the prior dose or one dose higher, with subsequent titration according to the dose titration guidelines given below in this section. Dose titration When initiating or adjusting therapy, monitor Hb levels every two weeks until stable, then monitor at least monthly.
Dose adjustment should be done in increments of 150 mg within the range of 150 mg to a maximum recommended daily dose of 600 mg to achieve or maintain Hb levels within 10 to 12 g/dL. Do not increase the dose more frequently than once every 4 weeks.
Summary of the safety profile The adverse reactions are based on pooled data from two active-controlled studies in DD-CKD of 1947 patients treated with Vafseo and 1955 treated with darbepoetin alfa, including 1514 exposed for at least 6 months and 1047 exposed for greater than one year to Vafseo.
1%). 1%). Tabulated list of adverse reactions All adverse reactions (ADRs) are listed by system organ class (SOC) and frequency: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1 000 to < 1/100), rare (≥ 1/10 000 to < 1/1 000), very rare (< 1/10 000) and not known (cannot be estimated from the available data) and are shown in Table 3.
Table 3:
Adverse reactions Very common Common Uncommon Nervous systems disorders Headache Convulsionsa Vascular disorders Hypertension Thromboembolic eventsa Hypotension Hypersensitivity Respiratory, thoracic and mediastinal disorders Cough Gastrointestinal disorders Diarrhoea Constipation Nausea Vomiting Abdominal pain upper Investigations Elevated liver enzymesb Blood bilirubin increased a) for further details, please refer to “Thromboembolic events” and “Convulsions” below.
5 events/100 PY) in the vadadustat and darbepoetin alfa groups respectively. 3 events/100 PY) in the vadadustat and darbepoetin alfa groups respectively. 3 events/100 PY) in the vadadustat and darbepoetin alfa groups respectively. 3 events/100 PY) in the vadadustat and darbepoetin alfa groups respectively.
9 events/100 PY) in the vadadustat and darbepoetin alfa groups respectively. 0 events/100 PY) in the vadadustat and darbepoetin alfa groups respectively. 6 events/100 PY) in the vadadustat and darbepoetin alfa groups respectively. 1. 2% of patients).
The majority of events were non-serious, asymptomatic and resolved after discontinuation of Vafseo. The time to onset was generally within the first 3 months of treatment. 3% of patients treated with Vafseo, respectively. There was one serious adverse event of hepatocellular injury with jaundice in an NDD-CKD clinical trial patient which occurred approximately 8 weeks after initiating Vafseo.
1). Patients with signs and symptoms of serious adverse cardiovascular reactions or stroke should be promptly evaluated and treated according to standard of care. The decision to interrupt or discontinue treatment should be based on a benefit-risk consideration for the individual patient.
8). , deep venous thrombosis, pulmonary embolism, and cerebral vascular accident) should be monitored carefully. Patients with signs and symptoms of thromboembolic events should be promptly evaluated and treated according to standard of care.
The decision to interrupt or discontinue treatment should be based on a benefit-risk consideration for the individual patient. 2). 8). 2). 8). 8). Blood pressure should be monitored before initiation and regularly thereafter at a frequency determined by a patient’s individual situation and local clinical practice.
Patients should be advised on the importance to comply with antihypertensive therapy and monitoring of blood pressure. 8). Vadadustat should be used with caution in patients with a history of convulsions or fits, epilepsy or medical conditions associated with a predisposition to convulsion activity such as central nervous system (CNS) infections.
The decision to interrupt or discontinue treatment should be based on a benefit-risk consideration for the individual patient. Initial decrease in Hb levels in patients converting from ESA Hb levels may initially decrease when converting patients from an ESA to Vafseo especially in patients who were on high baseline ESA doses.
1 for course of Hb during treatment in individual studies). 0 g/dL or if response is considered not acceptable. Patients receiving RBC transfusions are recommended to continue Vafseo treatment during the transfusion period. 2). Inadequate response to therapy Inadequate response to therapy with vadadustat should prompt a search for causative factors.
1.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Decreases in dose can occur more frequently. Treatment should not be continued beyond 24 weeks of therapy if a clinically meaningful increase in Hb levels is not achieved. Alternative explanations for an inadequate response should be sought and treated before re-starting Vafseo (see Table 1).
Table 1:
Vafseo dose titration 4 Change in Hb Value Less than 10 g/dL 10 to 12 g/dL Greater than 12 g/dL but less than 13 g/dL 13 g/dL or greater No rise in Hb greater than 1 g/dL in 2-week period or more than 2 g/dL in 4 weeks 150 mg increase if no dose increase in past 4 weeks Maintain dose 150 mg reduction Interrupt the dose of Vafseo until Hb is less than or equal to 12 g/dL then resume with dose that is 150 mg less than dose prior to interruption.
If patient was on 150 mg prior to interruption, then resume with 150 mg. Hb rise more than 1 g/dL in any 2-week period or more than 2 g/dL in 4 weeks 150 mg reduction or maintain* dose 150 mg reduction or maintain* dose 150 mg reduction * Dose reduction may not be required in case of a single Hb value.
Monitoring When initiating or adjusting therapy, monitor Hb levels every two weeks until stable, then monitor at least monthly. 4). Missed dose If a dose is missed, patients should take the dose as soon as they remember during the same day and then patients should take the next dose at the usual time the next day.
Patients should not take a double dose. 2). 2). Hepatic impairment No dose adjustment is needed in patients with mild or moderate hepatic impairment. 2). Paediatric population The safety and efficacy of Vafseo in the paediatric population have not been established.
No data are available. Method of administration 5 The film-coated tablet is administered orally with or without food and should be swallowed whole without chewing. Vafseo can be taken at any time before, during, or after dialysis. Vafseo should be administered at least 1 hour before oral iron supplements, products whose primary component consists of iron or iron-containing phosphate binders.
5).
This case was multifactorial and resolved after Vafseo and other concomitant medicinal products were discontinued. This single case did not meet Hy’s law criteria due to a significantly elevated alkaline phosphatase (ALP), which preceded the bilirubin elevation, indicating cholestasis as a contributing factor to the elevated bilirubin.
4). Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
A reticulocyte count should be considered as part of the evaluation. If typical causes of non-response are excluded, and the patient has reticulocytopenia, an examination of the bone marrow should be considered. In the absence of an addressable cause for an inadequate response by 24 weeks of therapy, Vafseo should be discontinued.
Misuse Misuse may lead to an excessive increase in red blood cell volume. This may be associated with life- threatening complications. Excipients This medicinal product contains less than 1 mmol sodium (23 mg) per film-coated tablet, that is to say essentially 'sodium-free'.