Active Ingredient: Dasatinib
Dasatinib is indicated for the treatment of adult patients with:
Dasatinib is indicated for the treatment of paediatric patients with:
For this indication, competent medicine agencies globally authorize below treatments:
Oral
100 - 140 mg
From 100 To 140 mg once every day
100 mg
The recommended starting dose for chronic phase CML is 100 mg dasatinib once daily.
The recommended starting dose for accelerated, myeloid or lymphoid blast phase (advanced phase) CML or Ph+ ALL is 140 mg once daily.
In clinical studies, treatment with dasatinib in adults with Ph+ CML-CP, accelerated, myeloid or lymphoid blast phase (advanced phase) CML, or Ph+ ALL and paediatric patients with Ph+ CML-CP was continued until disease progression or until no longer tolerated by the patient. The effect of stopping treatment on long-term disease outcome after the achievement of a cytogenetic or molecular response [including complete cytogenetic response (CCyR), major molecular response (MMR) and MR4.5] has not been investigated.
In clinical studies, treatment with dasatinib in paediatric patients with Ph+ ALL was administered continuously, added to successive blocks of backbone chemotherapy, for a maximum duration of two years. In patients that receive a subsequent stem cell transplantation, dasatinib can be administered for an additional year post-transplantation.
In clinical studies in adult CML and Ph+ ALL patients, dose escalation to 140 mg once daily (chronic phase CML) or 180 mg once daily (advanced phase CML or Ph+ ALL) was allowed in patients who did not achieve a haematologic or cytogenetic response at the recommended starting dose.
The following dose escalations shown in the table are recommended in paediatric patients with Ph+ CML-CP who do not achieve a haematologic, cytogenetic and molecular response at the recommended time points, per current treatment guidelines, and who tolerate the treatment.
Dose escalation for paediatric patients with Ph+ CML-CP:
| Dose (maximum dose per day) | ||
|---|---|---|
| Starting dose | Escalation | |
| Tablets | 40 mg | 50 mg |
| 60 mg | 70 mg | |
| 70 mg | 90 mg | |
| 100 mg | 120 mg | |
Dose escalation is not recommended for paediatric patients with Ph+ ALL, as dasatinib is administered in combination with chemotherapy in these patients.
Dasatinib can be taken with or without a meal and should be taken consistently either in the morning or in the evening.
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