What is it and how is it used?
TRISENOX is used in patients with acute promyelocytic leukaemia (APL) whose disease has not responded to other therapies. APL is a unique type of myeloid leukaemia, a disease in which abnormal white blood cells and abnormal bleeding and bruising occur.
What do you have to consider before using it?
TRISENOX must be injected under the supervision of a physician experienced in the treatment of acute leukaemias.
Do not use TRISENOX
Take special care with TRISENOX
Please tell your doctor immediately if you have any of the following symptoms: shortness of breath, fever, sudden weight gain, fainting, water retention or palpitations (strong heartbeat you can feel in your chest). .
Your doctor must check your blood to be sure that you do not have low amounts of potassium or magnesium before your first dose of TRISENOX. You should also have a 12-lead electrocardiogram performed before your first dose. Blood tests should be repeated twice weekly while you are receiving TRISENOX. In addition, you will receive electrocardiograms twice weekly. If you are at risk for a certain type of abnormal heart rhythm (e.g. torsade de pointes or QTc prolongation) your heart will be monitored continuously.
You must tell your doctor if you have impaired kidney or liver function.
Using other medicines
Please tell your doctor if you are taking any of various types of medicines which could cause a change in the rhythm of your heartbeat. These include:
Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without prescription.
Using TRISENOX with food and drink
Pregnancy
Ask your doctor or pharmacist for advice before taking any medicine. TRISENOX may cause harm to the foetus when used by pregnant women. If you are able to become pregnant, you must use effective birth control during treatment with TRISENOX. If you are pregnant or you become pregnant during the treatment with TRISENOX, you must ask your doctor for advice.
Men should also use effective contraception during treatment with TRISENOX.
Breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine. Arsenic will be present in the milk of TRISENOX patients who are breast-feeding. Because of the potential for serious side-effects in nursing infants from TRISENOX, do not breast-feed while on TRISENOX.
Driving and using machines
The effect of TRISENOX on your ability to drive is not known. If you experience discomfort or if you feel unwell after a TRISENOX injection, you should wait until the symptoms go away before driving or using machines.
Important information about some of the ingredients of TRISENOX
Trisenox contains less than 1 mmol sodium (23 mg) per dose i.e. essentially ‘sodium-free’.
How is it used?
Your doctor will dilute TRISENOX with 100 to 250 ml of glucose 50 mg/ml (5%) injection, or sodium chloride 9 mg/ml (0.9%) injection.
Your doctor will infuse TRISENOX through a tube into a blood vessel over 1-2 hours, but the infusion may last longer if side-effects like flushing and dizziness occur.
Your doctor will give you TRISENOX once every day as a single infusion each day. In your first treatment cycle, you may be treated every day up to 50 days at most, or until your doctor determines that your disease is better. If your disease responds to TRISENOX, you will be given a second treatment cycle of 25 doses, one infusion every weekday for 5 weeks. Your doctor will decide exactly how long you must continue on therapy with TRISENOX.
Each TRISENOX ampoule must be used only once and does not contain any preservatives. Unused portions of each ampoule must be discarded properly.
Do not save any unused portions for later use.
TRISENOX must not be mixed with, or infused through the same tube with other medicinal products.
If your doctor gives you more TRISENOX than he/she should
You may experience convulsions, muscle weakness and confusion. If this happens, treatment with TRISENOX must be stopped immediately and your doctor will treat the arsenic overdose.
What are possible side effects?
Like all medicines, TRISENOX can have side effects.
While on treatment with TRISENOX, you may experience some of the following reactions: common side effects (greater than or equal to 1 in 100 but less than 1 in 10): fatigue (weariness), increased blood sugar, shortness of breath, cough, headache.
uncommon side effects (greater than or equal to 1 in 1000 but less than 1 in 100): increased white blood cell count, Herpes zoster, pneumonia, sepsis, anaemia, dehydration, confusion, blurry vision, cardiac failure, hypotension, pneumonitis, chills, renal failure, increased weight, nausea, vomiting, diarrhoea, stomach ache, oedema (water retention), rash or itching, change in your heart rhythm or dizziness.
Frequency unknown: decreased blood cell counts, a syndrome including fever, together with difficulty in breathing, coughing and chest pain. If you experience these symptoms, you should inform your doctor immediately.
Other side effects not mentioned above may also occur in some patients.
Tell your doctor immediately if you experience shortness of breath, fever, sudden weight gain, water retention, fainting or palpitations (strong heartbeat you can feel in your chest).
If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.
How should it be stored?
Keep out of the reach and sight of children
Do not use after the expiry date stated on the ampoule label.
Do not freeze
After dilution, if not used immediately, in-use storage times and conditions before use are the responsibility of your doctor and would normally not be longer than 24 hours at 2ºC – 8ºC, unless dilution has taken place in a sterile environment.
Do not use TRISENOX if you notice foreign particulate matter or if discolouration is present.
