Iclusig Overdosage







Otsuka (Philippines)
Full Prescribing Info
Isolated reports of unintentional overdose with Ponatinib (Iclusig) were reported in clinical trials. Single doses of 165 mg and an estimated 540 mg in two patients did not result in any clinically significant adverse reactions. Multiple doses of 90 mg per day for 12 days in a patient resulted in pneumonia, systemic inflammatory response, atrial fibrillation, and asymptomatic, moderate pericardial effusion. Treatment was interrupted, the events resolved, and Ponatinib (Iclusig) was restarted at 45 mg, once daily. In the event of an overdose of Ponatinib (Iclusig), the patient should be observed and appropriate supportive treatment given.
Management of toxicities: 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 (Iclusig) 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.
For a dose of 30 mg or 15 mg once daily, 15 mg film-coated tablets are available.
Myelosuppression: Dose modifications for neutropenia (ANC* < 1.0 x 109/L) and thrombocytopenia (platelet < 50 x 109/L) that are unrelated to leukaemia are summarized in Table 7. (See Table 7.)

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Arterial occlusion and venous thromboembolism: In a patient suspected of developing an arterial occlusive event or a venous thromboembolism, Ponatinib (Iclusig) should be immediately interrupted. A benefit-risk consideration should guide a decision to restart Ponatinib (Iclusig) therapy (see Precautions and Adverse Reactions) after the event is resolved.
Hypertension may contribute to risk of arterial occlusive events. Ponatinib (Iclusig) treatment should be temporarily interrupted if hypertension is not medically controlled.
Pancreatitis: Recommended modifications for pancreatic adverse reactions are summarized in Table 8. (See Table 8.)

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Hepatic toxicity: Dose interruption or discontinuation may be required as described in Table 9. (See Table 9.)

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Elderly patients: Of the 449 patients in the clinical study of Ponatinib (Iclusig), 155 (35%) were ≥ 65 years of age. Compared to patients <65 years, older patients are more likely to experience adverse reactions.
Hepatic impairment: Patients with hepatic impairment may receive the recommended starting dose. Caution is recommended when administering Ponatinib (Iclusig) to patients with hepatic impairment (see Precautions and Pharmacology: Pharmacokinetics under Actions).
Renal impairment: Renal excretion is not a major route of ponatinib elimination. Ponatinib (Iclusig) has not been studied in patients with renal impairment. Patients with estimated creatinine clearance of ≥50 mL/min should be able to safely receive Ponatinib (Iclusig) with no dosage adjustment. Caution is recommended when administering Ponatinib (Iclusig) to patients with estimated creatinine clearance of <50 mL/min, or end-stage renal disease.
Paediatric population: The safety and efficacy of Ponatinib (Iclusig) in patients less than 18 years of age have not been established. No data are available.
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