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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 MHRA label. Tap a section to expand.
Posology 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. 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. When adjusting the dose, consider the patient’s clinical condition; Hb variability; Hb rate of rise and rate of decline; and Vafseo responsiveness.
A single Hb excursion may not require a dosing change. If the Hb level exceeds 13 g/dL, 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.
, more than 1 g/dL in any 2-week period or more than 2 g/dL in 4 weeks), interrupt or adjust the dose as indicated in Table 1 below. 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 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 or greater 13 g/dL 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 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 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.
Summary of the safety profile The adverse reactions are based on pooled data from four active-controlled studies in CKD (DD and NDD patients) of 3686 patients treated with vadadustat and 3687 treated with darbepoetin alfa, including 2923 exposed for at least 6 months and 2011 exposed for greater than one year to vadadustat.
4%, respectively. 9%). Tabulated list of adverse reactions All adverse drug 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).
Within each frequency grouping, ADRs are presented in order of decreasing seriousness. Very common Common Uncommon Nervous systems disorders Headache Seizuresa Vascular disorders Hypertension Thromboem bolic eventsa Hypotension Hypersensiti vity Respiratory, thoracic and mediastinal disorders Cough Gastrointestin al disorders Diarrhoea Constipation Nausea Vomiting Investigations Elevated liver enzymesb Blood bilirubin increased aFor further details please refer to “Thromboembolic events” and “Seizures” below.
5 events/100 patient years [PY]) of the NDD-CKD population; in the vadadustat and the darbepoetin alfa groups respectively. 3 events/100 PY) of the NDD-CKD population; in the vadadustat and darbepoetin alfa groups respectively. 1 events/100 PY) of the NDD-CKD population; in the vadadustat and darbepoetin alfa groups respectively.
2 events/100 PY) of the NDD-CKD population; in the vadadustat and darbepoetin alfa groups respectively. 8 events/100 PY) of the NDD-CKD population, in the vadadustat and darbepoetin alfa groups respectively. 0 events/100 PY) of the DD-CKD population in the vadadustat and darbepoetin alfa groups respectively.
6 events/100 PY) of the DD-CKD population in the vadadustat and darbepoetin alfa groups respectively. 1. 2% of DD-CKD and NDD-CKD patients). The majority of the events were non-serious, and all events were asymptomatic and resolved after discontinuation of vadadustat.
1). 1). Since the safety of vadadustat has not been established in NDD patients with CKD, Vafseo should not be administered in patients with NDD-CKD. 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.
VAT is a common occurrence in patients receiving hemodialysis therefore patients 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). Worsening of hypertension Hypertension is one of the leading causes of CKD and is also a complication of CKD.
8). Blood pressure should be monitored before initiation and regularly thereafter at a frequency determined by a patient’s individual situation and local clinical practices. 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 seizures or fits, epilepsy or medical conditions associated with a predisposition to seizure 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).
1.
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If patient was on 150 mg prior to interruption, then resume with 150 mg. * 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). Important administration instructions Evaluation of iron stores and nutritional factors Evaluate the iron status in all patients before and during treatment. Administer supplemental iron therapy when serum ferritin is less than 100 mcg/L or when serum transferrin saturation is less than 20%.
Oral iron and phosphate binders 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). ) before initiating Vafseo. 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 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.
The time to onset was generally within the first 3 months of treatment. 3% of patients treated with vadadustat, 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 vadadustat.
This case was multifactorial and resolved after vadadustat 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). 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. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
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). Excipients This medicine contains less than 1 mmol sodium (23 mg) per dosage, that is to say essentially ‘sodium-free’.