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
40 - 100 mg
From 40 To 100 mg once every day
Dosing for children and adolescents is on the basis of body weight (see Table 1). Dasatinib is administered orally once daily. The dose should be recalculated every 3 months based on changes in body weight, or more often if necessary. There is no experience with dasatinib treatment in children under 1 year of age.
The recommended starting daily dosage of dasatinib tablets in paediatric patients is shown in Table 1.
Table 1. Dosage of dasatinib tablets for paediatric patients with Ph+ CML-CP or Ph+ ALL:
| Body weight (kg)a | Daily dose (mg) |
|---|---|
| 10 to less than 20 kg | 40 mg |
| 20 to less than 30 kg | 60 mg |
| 30 to less than 45 kg | 70 mg |
| at least 45 kg | 100 mg |
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 Table 2 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.
Table 2. 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.
Liability Disclaimer : RxReasoner has utilized reasonable care in providing content and services that are accurate, complete and up to date. However, RxReasoner does not accept any responsibility or liability about it. The content and services of RxReasoner are for informational purposes only and they are not intended to be a substitute for the knowledge, expertise, skill, and judgment of physicians, pharmacists, nurses, or other healthcare professionals involved in patient care. RxReasoner offers no medical advice. Users are responsible for the use of the provided content. A shown indication or treatment should not be construed to indicate that the medication is safe, appropriate, or effective in any given patient or under any particular circumstances. The absence of an indication or treatment should not roule out the existence of other appropriate medications. Always seek the advice of a physician or other qualified health provider with any questions you may have regarding a medical condition or medicament. RxReasoner is not liable for any damages allegedly sustained arising out of the use of its content and services.
