Indications And Dose
Acute promyelocytic leukaemia (specialist use only) ▶BY INTRAVENOUS INFUSION ▶Adult: (consult product literature or local protocols)
PDF page 1005
Loading InternPractice…
Drug reference
Acute promyelocytic leukaemia (specialist use only) ▶BY INTRAVENOUS INFUSION ▶Adult: (consult product literature or local protocols)
PDF page 1005
Hypokalaemia (correct before treatment). hypomagnesaemia (correct before treatment). previous treatment with anthracyclines (increased risk of QT interval prolongation)
PDF page 1005
NICE decisions ▶Arsenic trioxide for treating acute promyelocytic leukaemia (June 2018) NICE TA526 Arsenic trioxide (Trisenox ®) is recommended, within its marketing authorisation, as an option for inducing remission and consolidation in acute promyelocytic leukaemia (characterised by the presence of the t[15;17] translocation or the PML/RAR-alpha gene) in adults with: . untreated, low-to-intermediate risk disease (defined as a white blood cell count of 10x103 per microlitre or less), when given with all-trans-retinoic acid (ATRA) Immune system and malignant disease . relapsed or refractory disease, after a retinoid and chemotherapy. www.nice.org.uk/guidance/ta526 Scottish Medicines Consortium (SMC) decisions SMC No. SMC2181 The Scottish Medicines Consortium has advised (July 2019) that arsenic trioxide (Trisenox ®) is accepted for use within NHS Scotland in combination with all-trans-retinoic acid (ATRA [tretinoin]) for the induction of remission, and consolidation in adults with newly diagnosed, low-to- intermediate risk acute promyelocytic leukaemia (characterised by the presence of the t[15;17] translocation and/or the presence of the Pro Myelocytic Leukaemia/Retinoic-Acid-Receptor-alpha [PML/RAR- alpha] gene).
PDF page 1005
→Appendix 1: arsenic trioxide
PDF page 1005
▶Common or very common Abdominal pain. alveolar haemorrhage. anaemia. arrhythmias. arthralgia. chest pain. chills. diarrhoea. differentiation syndrome. dizziness. dyspnoea. electrolyte imbalance. fatigue. fever . headache. hyperbilirubinaemia. hyperglycaemia. hypotension. hypoxia. increased risk of infection. ketoacidosis. leucocytosis. myalgia. nausea. neutropenia . oedema. pain. pancytopenia. paraesthesia. pericardial effusion. QT interval prolongation. renal failure. respiratory disorders. seizure. skin reactions. thrombocytopenia. vasculitis. vision blurred. vomiting. weight increased ▶Frequency not known Confusion. decreased leucocytes. encephalopathy. fluid imbalance. heart failure. hepatotoxicity. peripheral neuropathy. sepsis SIDE-EFFECTS, FURTHER INFORMATION Signs and symptoms of differentiation syndrome (leucocyte activation syndrome) include unexplained fever, dyspnoea, weight gain, pulmonary infiltrates, pleural or pericardial effusions, with or without leucocytosis—treat with high dose corticosteroids, consult product literature.
PDF page 1005
Manufacturer advises effective contraception during treatment in men and women.
PDF page 1005
Avoid (teratogenic and embryotoxic in animal studies). See also Pregnancy and reproductive function in Cytotoxic drugs p. 938.
PDF page 1005
Discontinue breast-feeding.
PDF page 1005
Manufacturer advises use with caution—no information available.
PDF page 1005
Manufacturer advises caution— limited information available.
PDF page 1005
ECG required before and during treatment—consult product literature.
PDF page 1005
There can be variation in the licensing of different medicines containing the same drug. Solution for infusion ▶Arsenic trioxide (Non-proprietary) Arsenic trioxide 1 mg per 1 ml Arsenic 10mg/10ml concentrate for solution for infusion vials | 10 vial P £2,700.00 (Hospital only) ▶Trisenox (Teva UK Ltd) Arsenic trioxide 1 mg per 1 ml Trisenox 10mg/10ml concentrate for solution for infusion ampoules | 10 ampoule P £2,920.00 (Hospital only)
PDF page 1005
(consult product literature or local protocols)
First-line fragment. Read the complete Indications and Dose section above.
PDF page 1005