Active Ingredient: Luspatercept
Luspatercept is indicated for the treatment of adult patients with transfusion-dependent anaemia associated with beta-thalassaemia.
For this indication, competent medicine agencies globally authorize below treatments:
Subcutaneous
1 - 1.25 mg per kg of body weight
From 1 To 1.25 mg per kg of body weight once every 21 day(s)
The recommended starting dose of luspatercept is 1.0 mg/kg administered once every 3 weeks.
In patients who do not achieve a response, defined as a reduction in RBC transfusion burden of at least a third after ≥2 consecutive doses (6 weeks), at the 1.0 mg/kg starting dose, the dose should be increased to 1.25 mg/kg. The dose should not be increased beyond the maximum dose of 1.25 mg/kg every 3 weeks.
If a patient loses response (if the RBC transfusion burden increases again after an initial response) the dose should be increased by one dose level.
In case of Hb increase >2 g/dL within 3 weeks of luspatercept treatment in absence of transfusion, the luspatercept dose should be reduced by one dose level.
If the Hb is ≥11.5 g/dL in the absence of transfusion for at least 3 weeks, the dose should be delayed until the Hb is ≤11.0 g/dL. If there is also a concomitant rapid increase in Hb (>2 g/dL within 3 weeks in absence of transfusion), a dose reduction to one step down (minimum 0.8 mg/kg) should be considered after the dose delay.
Dose should not be reduced below 0.8 mg/kg.
Dose reductions during treatment with luspatercept are provided below
Dose reductions for β-thalassaemia:
| Current dose | Dose reduction |
|---|---|
| 1.25 mg/kg | 1 mg/kg |
| 1 mg/kg | 0.8 mg/kg |
If patients experience persistent treatment-related Grade 3 or higher adverse reactions, the treatment should be delayed until toxicity has improved or returned to baseline.
After a dose delay, patients should be re-started at their previous dose or at reduced dose as per dose reduction guidance.
In case of a missed or delayed scheduled treatment administration, the patient should be administered luspatercept as soon as possible and dosing continued as prescribed with at least 3 weeks between doses.
If patients experience a loss of response to luspatercept, causative factors (e.g. a bleeding event) should be assessed. If typical causes for a loss of haematological response are excluded, dose increase should be considered as described above for the respective indication being treated.
Luspatercept should be discontinued if patients do not experience a reduction in transfusion burden after 9 weeks of treatment (3 doses) at the maximum dose level if no alternative explanations for response failure are found (e.g. bleeding, surgery, other concomitant illnesses) or if unacceptable toxicity occurs at any time.
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