Consumer Medicine Information (CMI) summary
The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.
1. Why am I being treated with Arsenic trioxide Juno?
Arsenic trioxide Juno contains the active ingredient arsenic trioxide. Arsenic trioxide Juno is used to treat acute promyelocytic leukaemia also known as APL.
For more information, see Section 1. Why am I being treated with Arsenic trioxide Juno? in the full CMI.
2. What should I know before I am treated with Arsenic trioxide Juno?
Do not use if you have ever had an allergic reaction to Arsenic trioxide or any of the ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.
For more information, see Section 2. What should I know before I am treated with Arsenic trioxide Juno? in the full CMI.
3. What if I am taking other medicines?
Some medicines may interfere with Arsenic trioxide Juno and affect how it works.
A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.
4. How is Arsenic trioxide Juno used?
Arsenic trioxide Juno is diluted and then given as a slow infusion into a vein by a doctor or nurse experienced in managing patients with acute leukaemia.
More instructions can be found in Section 4. How is Arsenic trioxide Juno used? in the full CMI.
5. What should I know while I am being treated with Arsenic trioxide Juno?
Things you should do |
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Things you should not do |
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Driving or using machines |
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Looking after your medicine |
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For more information, see Section 5. What should I know while I am being treated with Arsenic trioxide Juno? in the full CMI.
6. Are there any side effects?
Some of the serious side effects include tiredness, fever, nausea, vomiting, diarrhoea, stomach pain, sore mouth, unusual bleeding or bruising, blood clotting, sore throat, cough, difficulty breathing, headache, difficulty sleeping, fast heartbeat, skin rash, itching, bone or joint pain, numbness, aching or weakness of the arm and leg or other muscles, tingling in the hands and feet, fits or convulsions, mood change, liver dysfunction, low potassium level, low white blood cell and platelet count, infection, signs of high blood sugar like large amounts of urine, excessive thirst, dry mouth and skin. Very serious side effects include chest pain, difficulty or pain when breathing, stroke, passing little or no urine, signs of APL differentiation syndrome like unexplained fever, shortness of breath, weight gain.
For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.
Arsenic trioxide Juno
Active ingredient: arsenic trioxide 10 mg in 10 mL
Consumer Medicine Information (CMI)
This leaflet provides important information about using Arsenic trioxide Juno. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using Arsenic trioxide Juno.
Where to find information in this leaflet:
1. Why am I being treated with Arsenic trioxide Juno?
2. What should I know before I am treated with Arsenic trioxide Juno?
3. What if I am taking other medicines?
4. How is Arsenic trioxide Juno used?
5. What should I know while I am being treated with Arsenic trioxide Juno?
6. Are there any side effects?
7. Product details
1. Why am I being treated with Arsenic trioxide Juno?
Arsenic trioxide Juno contains the active ingredient arsenic trioxide. Arsenic trioxide Juno is an anticancer drug.
Arsenic trioxide Juno is used to treat acute promyelocytic leukaemia also known as APL.
2. What should I know before I am treated with Arsenic trioxide Juno?
Warnings
You should not be given Arsenic trioxide Juno if:
- you are allergic to any medicine containing arsenic or arsenic trioxide, or any of the ingredients listed at the end of this leaflet
Always check the ingredients to make sure you can use this medicine. - you are pregnant or breastfeeding
- the solution is cloudy, discoloured, turbid, or a precipitate or particles are present. The solution is normally clear and colourless
- when diluted with another solution, it causes the solution to precipitate, become cloudy, turbid, discolour, or particles are visible
- the expiry date printed on the pack has passed or if the packaging is torn or shows signs of tampering.
Check with your doctor if you have or have had:
- low levels of potassium or magnesium in the body (electrolyte imbalance)
- taken any medicines for any other condition
- congestive heart failure
- rapid or irregular heartbeat
- liver problems
- a history of kidney problems.
During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?
Pregnancy and breastfeeding
Check with your doctor if you are pregnant or intend to become pregnant.
Your doctor can discuss with you the risks and benefits involved in using Arsenic trioxide Juno.
You should not be given this medicine if you are pregnant.
It may affect your developing baby if you are given it during pregnancy.
Women of childbearing age must use effective birth control while they are being treated with Arsenic trioxide Juno and for 6 months following completion of treatment.
Pregnancy tests should be done in women of childbearing age prior to treatment with Arsenic trioxide Juno.
Men must use effective contraceptive measures and not father a child while receiving Arsenic trioxide Juno and for 3 months following completion of treatment.
Do not breastfeed if you are being given this medicine.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
The active ingredient in Arsenic trioxide Juno passes into breast milk and there is a possibility that your baby may be affected.
Do not breastfeed prior to and throughout all cycles of administration and for two weeks after the last dose of the final cycle.
If you have not told your doctor about any of the above, tell him/her before you are given Arsenic trioxide Juno.
3. What if I am taking other medicines?
Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.
Some medicines may interfere with Arsenic trioxide Juno and affect how it works.
- fluid or water tablets (diuretics)
- some medicines used to treat fungal infections such as amphotericin B
- medicines which affect heart rhythm (prolong the Q-T interval) for example:
– some antibiotics e.g. erythromycin
– antipsychotics e.g. thioridazine
– some types of antiarrhythmics e.g. quinidine
– antidepressants e.g. amitriptyline
– some antihistamines e.g. terfenadine.
Ask your doctor for more information on which medicines to be careful with or avoid while using Arsenic trioxide Juno.
These medicines may be affected by Arsenic trioxide Juno or may affect how well it works. You may need different amounts of your medicines, or you may need to take different medicines.
Your doctor and pharmacist have more information on medicines to be careful with or avoid while being given this medicine.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect Arsenic trioxide Juno.
4. How is Arsenic trioxide Juno used?
How much to use
- Arsenic trioxide Juno is diluted and then given as a slow infusion into a vein
- Your doctor will decide what dose of Arsenic trioxide Juno you will receive and for how long you will receive it. This depends on your medical condition and other factors, such as your weight.
Arsenic trioxide Juno must only be given by a doctor or nurse under the supervision of a doctor experienced in managing patients with acute leukaemia.
If you use too much Arsenic trioxide Juno
Arsenic trioxide Juno must only be given by a doctor or nurse, so an overdose is not likely to occur. Contact your doctor if you are concerned about the dose.
Symptoms of an overdose are similar to side effects but are more severe and are listed under Side effects below.
5. What should I know while I am being treated with Arsenic trioxide Juno?
Things you should do
If you are about to be started on any new medicine, remind your doctor and pharmacist that you have been given Arsenic trioxide Juno.
Tell any other doctors, dentists, and pharmacists who treat you that you have been given this medicine.
If you are going to have surgery, tell the surgeon or anaesthetist that you have been given this medicine.
It may affect other medicines used during surgery.
If you become pregnant while being given this medicine, tell your doctor immediately.
Women of childbearing age must use effective birth control while they are being treated with Arsenic trioxide Juno and for 6 months following completion of treatment. Pregnancy tests should be done in women of childbearing age prior to treatment with Arsenic trioxide Juno.
Men must use effective contraceptive measures and not father a child while receiving Arsenic trioxide Juno and for 3 months following completion of treatment.
If you are about to have any blood tests, tell your doctor that you are being given this medicine.
It may interfere with the results of some tests.
Keep all of your doctor’s appointments so that your progress can be checked.
Your doctor may do some tests from time to time to make sure the medicine is working and to prevent unwanted side effects.
If you feel light-headed, dizzy or faint when getting out of bed or standing up, get up slowly.
Standing up slowly, especially when you get up from bed or chairs, will help your body get used to the change in position and blood pressure. If this problem continues or gets worse, talk to your doctor.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how Arsenic trioxide Juno affects you.
This medicine may cause dizziness, tiredness or lightheadedness in some people. If you have any of these symptoms, do not drive, operate machinery or do anything else that could be dangerous.
Looking after your medicine
- Arsenic trioxide Juno will be stored in the surgery, pharmacy or ward of a hospital. The injection is kept in a cool dry place where the temperature stays below 30°C
- Once diluted the solution should be used as soon as possible. It is a sterile solution for single use. If storage is necessary, the prepared solution should be refrigerated between 2°C and 8°C and stored for no longer than 24 hours before discarding.
Keep it where young children cannot reach it.
6. Are there any side effects?
All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.
See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.
Serious side effects
Serious side effects | What to do |
Digestion related:
Bleeding related:
Muscle/bone related:
Nervous system related:
Other:
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Speak to your doctor if you have any of these serious side effects and they worry you. |
Very serious side effects
Very serious side effects | What to do |
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Call your doctor straight away, or go straight to the Emergency Department at your nearest hospital if you notice any of these very serious side effects. |
Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.
Other side effects not listed here may occur in some people.
Reporting side effects
After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.
Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.
7. Product details
This medicine is only available with a doctor’s prescription.
What Arsenic trioxide Juno contains
Active ingredient (main ingredient) |
Arsenic trioxide |
Other ingredients (inactive ingredients) |
Water for injections Sodium hydroxide (for pH adjustment) Hydrochloric acid (for pH adjustment). |
Do not take this medicine if you are allergic to any of these ingredients.
Arsenic trioxide Juno does not contain lactose, sucrose, gluten, tartrazine, or other azo dyes or preservatives.
What Arsenic trioxide Juno looks like
Arsenic trioxide Juno is a clear, colourless solution in a clear glass vial sealed with a rubber stopper and aluminium seal with a plastic flip off cap.
Arsenic trioxide Juno is available in 10 mL vials in cartons of 10 (Aust R 321027).
Who distributes Arsenic trioxide Juno
Juno Pharmaceuticals Pty Ltd
42 Kelso Street,
Cremorne, VIC – 3121
Australia.
www.junopharm.com.au
This leaflet was prepared in November 2023.
Published by MIMS December 2023