Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: AKEBIA EUROPE Limited, 70 Sir John Rogersons Quay, Dublin 2, Co. Dublin, D02 R296, Ireland
Vafseo is indicated for the treatment of symptomatic anaemia associated with chronic kidney disease (CKD) in adults on chronic maintenance dialysis.
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.
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%.
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.
When converting from an ESA to Vafseo, the recommended starting dose is 300 mg once daily.
Those patients converting from a high baseline dose of ESA may experience an initial decline in Hb levels before gradually returning to baseline Hb levels by Weeks 16 to 20 (see section 5.1 for course Hb during treatment in individual studies). Taking into account the gradual rise in Hb with Vafseo, rescue therapy in the form of RBC transfusion or ESA treatment may be considered during the transition phase if Hb values fall below 9.0 g/dL or response is considered not acceptable (see section 4.4). 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:
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.
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. 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:
| 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.
When initiating or adjusting therapy, monitor Hb levels every two weeks until stable, then monitor at least monthly.
ALT, AST, and bilirubin must be evaluated prior to the initiation of Vafseo, monthly for three months after initiation and as clinically indicated thereafter (see section 4.4).
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.
No dose adjustment is recommended for elderly patients (see section 5.2).
No dose adjustment is needed in patients with renal impairment (see section 5.2).
No dose adjustment is needed in patients with mild or moderate hepatic impairment. Vafseo is not recommended for use in patients with severe hepatic impairment (Child-Pugh class C) as the safety and efficacy has not been evaluated in this population (see sections 4.4 and 5.2).
The safety and efficacy of Vafseo in the paediatric population have not been established. No data are available.
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. As vadadustat may form a chelate with multivalent cations, Vafseo should be administered at least 1 hour before or 2 hours after noniron-containing phosphate binders or other medicinal products whose primary component consists of multivalent cations such as calcium, magnesium or aluminium (see section 4.5).
Vadadustat overdose may result in extensions of the pharmacologic effects such as increased Hb and secondary polycythemia. Symptoms of vadadustat overdose should be managed as clinically appropriate (eg, reduction of Vafseo dose or discontinuation) and careful monitoring and treated as clinically indicated. Approximately 16% of the vadadustat dose is removed by dialysis.
3 years.
This medicinal product does not require any special storage conditions.
Vafseo 150 mg film-coated tablets:
28 tablets in 2 PVC/aluminium foil blisters with 14 × 150 mg film-coated tablets
98 tablets in 7 PVC/aluminium foil blisters with 14 × 150 mg film-coated tablets
Vafseo 300 mg film-coated tablets:
28 tablets in 2 PVC/aluminium foil blisters with 14 × 300 mg film-coated tablets
98 tablets in 7 PVC/aluminium foil blisters with 14 × 300 mg film-coated tablets
Vafseo 450 mg film-coated tablets:
28 tablets in 2 PVC/aluminium foil blisters with 14 × 450 mg film-coated tablets
98 tablets in 7 PVC/aluminium foil blisters with 14 × 450 mg film-coated tablets
Not all pack sizes may be marketed.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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