Patients with renal or hepatic impairment: Caution is advised as no data available.
Elderly: Caution is advised as data is limited.
Hyperleukocytosis: Hyperleukocytosis has been reported in some newly diagnosed and relapsed/refractory APML patients.
Development of second primary malignancies: Arsenic trioxide is a human carcinogen; patients should be monitored for second primary malignancies.
Encephalopathy: Cases of encephalopathy have been reported. Patients at risk of B1 deficiency should be closely monitored.
Sodium content: Arsenic Trioxide Phebra contains less than 1 mmol sodium (23mg) per 10mL.
Interactions: Caution should be observed when arsenic trioxide is combined with medical products that prolong QT/QTc interval, cause hepatotoxic effects, and other antileukaemic agents.
Fertility, Pregnancy and Lactation: Arsenic trioxide has been shown to be embryotoxic and teratogenic in animal studies. No available data in pregnant women. Breast-feeding is contra-indicated during treatment with arsenic trioxide. No fertility studies have been performed.
Effects on ability to drive and use machines: Negligible influence. U
ndesirable Effects: Adverse reactions in patients receiving arsenic trioxide:
very common (≥ 1/10) hyperglycaemia, hypokalaemia, hypomagnesaemia, paraesthesia, dizziness, headache, tachycardia, differentiation syndrome, dyspnoea, diarrhoea, vomiting, myalgia, nausea, pruritus, rash, pyrexia, pain, fatigue, oedema, alanine amino transferase increased, aspartate amino transferase increased, electrocardiogram QT prolonged;
common (≥ 1/100 to < 1/10) herpes zoster, febrile neutropenia, leucocytosis, neutropenia, pancytopenia, thrombocytopenia, anaemia, hypernatraemia, ketoacidosis, hypermagnesaemia, convulsion, vision blurred, pericardial effusion, ventricular extrasystoles, vasculitis, hypotension, hypoxia, pleural effusion, pleuritic pain, pulmonary alveolar haemorrhage, abdominal pain, erythema, face oedema, arthralgia, bone pain, renal failure, chest pain, chills, hyperbilirubinaemia, blood creatinine increased, weight increased. Please consult the Summary of Product Characteristics for a full description of adverse reactions.
Overdose: If acute arsenic toxicity symptoms appear, arsenic trioxide must be immediately discontinued and chelating therapy with penicillamine considered. Refer to SmPC for full details.
Pharmaceutical Precautions: Do not mix or administer as an infusion with other medicinal products. Store at 2°C to 8°C (in a refrigerator). Do not freeze. Dilute with 100 to 250 ml of glucose 50 mg/ml (5%) solution for injection or sodium chloride 9 mg/ml (0.9%) solution for injection. Diluted solutions may be stored at 15°C – 30°C for up to 48 hours or at 2°C – 8°C for up to 72 hours. Inspect visually before administration; do not administer if any discoloration or particulate matter is observed.
Legal Category: POM.
Packs size and NHS price: 10 x 10ml vials £2700.00.
Marketing Authorisation number: PL 42973/0007
Marketing Authorisation Holder: Phebra Limited, 24-25 New Bond Street, 1st Floor, London, England, W1S 2RR.
Distributed in the UK by Flexipharm Austrading Limited, Farnborough, GU14 7XA. Prescribers should consult the Summary of Product Characteristics for full prescribing information.
Further information on request: Flexipharm Austrading Limited via
inquiries@flexipharmaustrading.com or 01628 290433. For medical information please contact 01480 273425 or medinfo@cambreg.co.uk
Date of preparation/last revised: May 2020.
References: Arsenic Trioxide Phebra 1 mg/ml concentrate for solution for infusion Summary of Product Characteristics.