Active Ingredient: Vadadustat
Vadadustat is indicated for the treatment of symptomatic anaemia associated with chronic kidney disease (CKD) in adults on chronic maintenance dialysis.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Oral, 300 milligrams vadadustat, once daily. Afterwards, oral, between 150 milligrams vadadustat and 600 milligrams vadadustat, once daily. The maximum allowed total dose is 600 milligrams vadadustat daily.
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 vadadustat, 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. Taking into account the gradual rise in Hb with vadadustat, 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. Patients receiving RBC transfusions are recommended to continue vadadustat treatment during the transfusion period. Vadadustat 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 vadadustat treatment should be extended to:
Following ESA rescue, vadadustat 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 vadadustat (see table).
Vadadustat 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 vadadustat 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 vadadustat, monthly for three months after initiation and as clinically indicated thereafter.
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.
With or without food.
Vadadustat can be taken at any time before, during, or after dialysis.
Vadadustat 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, vadadustat 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.
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