Active Ingredient: Ponatinib
Iclusig is indicated as monotherapy in paediatric patients 6 years of age or older with chronic phase chronic myeloid leukaemia (CP-CML) who are resistant to dasatinib or nilotinib; who are intolerant to dasatinib or nilotinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Regimen A, in the case that patient age in years is ≥ 6 and patient weight is > 45 kg :
Oral, 45 milligrams ponatinib, once daily. Afterwards, oral, 15 milligrams ponatinib, once daily.
Regimen B, in the case that patient age in years is ≥ 6 and patient weight is > 30 kg and patient weight is ≤ 45 kg :
Oral, 30 milligrams ponatinib, once daily. Afterwards, oral, 10 milligrams ponatinib, once daily.
Regimen C, in the case that patient age in years is ≥ 6 and patient weight is ≥ 15 kg and patient weight is ≤ 30 kg :
Oral, 15 milligrams ponatinib, once daily. Afterwards, oral, 5 milligrams ponatinib, once daily.
The recommended starting dose is individualized for each paediatric patient on the basis of body weight (see Table 1):
Table 1. Recommended starting dose and reduced dose after achieving a molecular response for paediatric patients with CP-CML:
| Body weight | Recommended starting dose in mg (once daily) | Recommended reduced dose in mg (once daily) |
| >45 kg | 45 mg | 15 mg |
| >30 kg to 45 kg | 30 mg | 10 mg |
| 15 to 30 kg | 15 mg | 5 mg |
Treatment should be continued as long as the patient does not show evidence of disease progression or unacceptable toxicity.
Patients should be monitored for response according to standard clinical guidelines.
As in adults, the risk of arterial occlusive events is likely to be dose related. Reducing the dose of ponatinib according to Table 1 should be considered for paediatric CP-CML patients who have achieved a molecular response taking the following factors into account in the individual patient assessment: cardiovascular risk, side effects of ponatinib therapy, time to response, and BCR-ABL transcript levels. If dose reduction is undertaken, close monitoring of response is recommended. In patients with loss of response the dose of ponatinib can be re escalated to a previously tolerated daily dose. Ponatinib should be continued until loss of response at the re escalated dose or unacceptable toxicity.
Ponatinib dose modifications or interruption of dosing should be considered for the management of haematological and non-haematological toxicities. In the case of severe adverse reactions, treatment should be withheld.
For patients whose adverse reactions are resolved or attenuated in severity, ponatinib may be restarted and escalation of the dose back to the daily dose used prior to the adverse reaction may be considered, if clinically appropriate.
Ponatinib may be taken with or without food.
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