Vafseo® ▼ (vadadustat) tablets
Vafseo® (vadadustat) is indicated for the treatment of symptomatic anaemia associated with chronic kidney disease (CKD) in adults on chronic maintenance dialysis1.
Dosing & administration
- Vafseo® will be available in 150mg and 300mg film-coated tablets.
- 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 frequently1.
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%1.
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. As Vafseo® may form a chelate with multivalent cations, Vafseo® should be administered at least 1 hour before or 2 hours after non-iron-containing phosphate binders or other medicinal products whose primary component consists of multivalent cations such as calcium, magnesium or aluminium1.
Patients converting from an erythropoiesis-stimulating agent (ESA)
When converting from an ESA to Vafseo®, the recommended starting dose is 300 mg once daily1.
Those patients converting from a high baseline dose of ESA may experience an initial decline in haemoglobin levels before gradually returning to baseline Hb levels by Weeks 16 to 20.1
Please refer to the SPC for further information.
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.
| 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 1g/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 150mg 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 |
*A single Hb excursion may not require a dosing change
Safety and Monitoring
Access our full safety and monitoring information or please refer to section 4 of the SPC.
Availability
Vafseo® will be available to prescribe in the above patient population from Q1 2025. Below you can sign up to be contacted when Vafseo® is available.
▼This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare Professionals are asked to report any suspected adverse reactions.
Date of Preparation: August 2024 UK-VAF-2024-1645-v1
Adverse events should be reported. Reporting forms and information can be found at https://yellowcard.mhra.gov.uk/ or search for MHRA Yellow Card in the Google Play or Apple App Store.
Adverse events should be reported to MEDICE UK, Medical Information Tel: 0204 582 2845, medicalinformation@medice.co.uk