Presentation and Status in Health Basket
Presentation | Basket | Yarpa | Pharmasoft |
---|---|---|---|
Ampoule 1 X 10 mg / 10 ml |
49052 | 20771 | |
Ampoule 10 X 10 mg / 10 ml |
12472 | 20724 |
Dosage
The same dose is recommended for adults and elderly.
Newly diagnosed low-to-intermediate risk acute promyelocytic leukaemia (APL)
Induction treatment schedule: TRISENOX must be administered intravenously at a dose of 0.15 mg/kg/day, given daily until complete remission is achieved. If complete remission has not occurred by day 60, dosing must be discontinued.
Consolidation schedule: TRISENOX must be administered intravenously at a dose of 0.15 mg/kg/day, 5 days per week. Treatment should be continued for 4 weeks on and 4 weeks off, for a total of 4 cycles.
Relapsed/refractory acute promyelocytic leukaemia (APL)
Induction treatment schedule: TRISENOX must be administered intravenously at a fixed dose of 0.15 mg/kg/day given daily until complete remission is achieved (less than 5% blasts present in cellular bone marrow with no evidence
of leukaemic cells). If complete remission has not occurred by day 50, dosing must be discontinued.
Consolidation schedule: Consolidation treatment must begin 3 to 4 weeks after completion of induction therapy. TRISENOX is to be administered intravenously at a dose of 0.15 mg/kg/day for 25 doses given 5 days per week,
followed by 2 days interruption, repeated for 5 weeks.
Dose delay, modification and reinitiation: Treatment with TRISENOX must be temporarily interrupted before the scheduled end of therapy at any time that a toxicity grade 3 or greater on the National Cancer Institute Common Toxicity Criteria is observed and judged to be possibly related to TRISENOX treatment. Patients who experience such reactions that are considered TRISENOX related must resume treatment only after resolution of the toxic event or after recovery to baseline status of the abnormality that prompted the interruption. In such cases, treatment must resume at 50% of the preceding daily dose. If the toxic event does not recur within 7 days of restarting treatment at the reduced dose, the daily dose can be escalated back to 100% of the original dose. Patients who experience a recurrence of toxicity must be removed from treatment.
Special populations
Patients with hepatic impairment: Since no data are available across all hepatic impairment groups and hepatotoxic effects may occur during the treatment with TRISENOX, caution is advised in the use of TRISENOX in patients with hepatic impairment.
Patients with renal impairment: Since no data are available across all renal impairment groups, caution is advised in the use of TRISENOX in patients with renal impairment.
Paediatric population: The safety and efficacy of TRISENOX in children aged up to 17 years has not been established. Currently available data for children aged 5 to 16 years are described in section 5.1 but no recommendation on a posology can be made. No data are available for children under 5 years.
Method of administration: TRISENOX must be administered intravenously over 1-2 hours. The infusion duration may be extended up to 4 hours if vasomotor reactions are observed. A central venous catheter is not required.
Patients must be hospitalised at the beginning of treatment due to symptoms of disease and to ensure adequate monitoring.
Indications
Induction of remission and consolidation in patients with acute promyelocytic leukemia (APL) who are refractory to or have relapsed from retinoid and anthracycline chemotherapy, and whose APL is characterized by the presence of the translocation of PML/RAR-alpha gene expression.
Contra-Indications
Hypersensitivity to arsenic.
Special Precautions
Should be administered under the supervision of a physician who is experienced in the management of patients with acute leukemia. Some patients treated have experienced symptoms similar to a syndrome called the retinoic-acid-Acute Promyelocytic Leukemia (RA-APL) or APL differentiation syndrome, characterized by fever, dyspnea, weight gain, pulmonary infiltrates and pleural or pericardial effusions with or without leukocytosis. This syndrome can be fatal. Treatment has been associated with the development of hyperleukocytosis. QT/QTc prolongation should be expected during treatment and torsade de pointes as well as complete heart block has been reported. The patients electrolyte, hematologic and coagulation profiles should be monitored at least 2 x weekly, and more frequently for clinically unstable patients during the induction phase and at least weekly during the consolidation phase. ECGs should be obtained weekly, and more frequently for clinically unstable patients, during induction and consolidation. Pregnancy and lactation: If this drug is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential harm to the fetus. Women of childbearing potential should be advised to avoid becoming pregnant.
See prescribing information for full details.
Side Effects
Most patients experienced some drug-related toxicity, most commonly leukocytosis, GI (nausea, vomiting, diarrhea, and abdominal pain), fatigue, edema, hyperglycemia, dyspnea, cough, rash or itching, headaches and dizziness. These were not observed to be permanent or irreversible, nor do they usually require interruption of therapy.
See prescribing information for full details.
Drug interactions
No formal assessments of pharmacokinetic drug-drug interactions have been conducted.
See prescribing information for full details.