SUMMARY CMI
BUSULFAN ARX
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 using BUSULFAN ARX?
BUSULFAN ARX contains the active ingredient busulfan. BUSULFAN ARX is used as part of a conditioning regimen prior to transplantation of either bone marrow or blood stem cells. BUSULFAN ARX destroys the original bone marrow before the transplant.
For more information, see Section 1. Why am I using BUSULFAN ARX? in the full CMI.
2. What should I know before I am given BUSULFAN ARX?
You must not be given BUSULFAN ARX if you have ever had an allergic reaction to busulfan 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 given BUSULFAN ARX? in the full CMI.
3. What if I am taking other medicines?
Some medicines may interfere with BUSULFAN ARX 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 BUSULFAN ARX given?
- BUSULFAN ARX is given by a qualified healthcare professional as a central intravenous infusion.
- For adults, the dose will be calculated according to your body weight.
- For new-born-infants, children and adolescents (0 to 17 years), the recommended dose is based on body weight and may be up to 4.8 mg/kg/day.
More instructions can be found in Section 4. How is BUSULFAN ARX given? in the full CMI.
5. What should I know while using BUSULFAN ARX?
Things you should do |
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Driving or using machines |
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Drinking alcohol |
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Looking after your medicine |
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For more information, see Section 5. What should I know while using BUSULFAN ARX? in the full CMI.
6. Are there any side effects?
There are a number of side effects associated with BUSULFAN ARX. It is important to be aware of them so that you can identify any symptoms if they occur.
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.
FULL CMI
BUSULFAN ARX
Active ingredient: busulfan
Consumer Medicine Information (CMI)
This leaflet provides important information about using BUSULFAN ARX. 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 BUSULFAN ARX.
Where to find information in this leaflet:
1. Why am I using BUSULFAN ARX?
2. What should I know before I am given BUSULFAN ARX?
3. What if I am taking other medicines?
4. How is BUSULFAN given?
5. What should I know while using BUSULFAN ARX?
6. Are there any side effects?
7. Product details
1. Why am I using BUSULFAN ARX?
BUSULFAN ARX contains the active ingredient busulfan.
BUSULFAN ARX is used in adults, new-born infants, children and adolescents as a treatment prior to transplantation of either bone marrow or blood stem cells. It is used in combination with other chemotherapeutic drugs, namely cyclophosphamide, melphalan or fludarabine.
BUSULFAN ARX destroys the original bone marrow before the transplant.
Your doctor may have prescribed this medicine for another use.
2. What should I know before I am given BUSULFAN ARX?
Warnings
You must not be given BUSULFAN ARX if:
- You are allergic to busulfan, or any of the ingredients listed at the end of this leaflet.
- Some of the symptoms of an allergic reaction may include:
- shortness of breath
- wheezing or difficulty breathing
- swelling of the face, lips, tongue or other parts of the body
- rash, itching or hives on the skin. - Always check the ingredients to make sure you use this medicine.
- You are pregnant, or you think you may be pregnant or are breastfeeding.
Check with your doctor if you:
- Have or had any of the following medical conditions:
- Liver, kidney, heart or lung problems.
- History of seizures. - Take any medicines for any other condition.
- Been taking other drugs.
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.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
Women should avoid becoming pregnant during treatment with BUSULFAN ARX and up to 6 months after treatment.
Women must not breastfeed during their treatment with BUSULFAN ARX.
It may no longer be possible for you to achieve a pregnancy after treatment with busulfan. If you are concerned about having children, you should discuss this with your doctor before treatment. BUSULFAN ARX can also produce symptoms of menopause and in pre-adolescent girls it can prevent the onset of puberty.
Men treated with BUSULFAN ARX are advised not to father a child during and up to 6 months after treatment.
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 BUSULFAN ARX and affect how it works.
These include:
- Itraconazole/metronidazole (used for certain types of infections).
- Ketobemidone (used to treat pain) because this may increase the side-effects.
Your doctor may ask you to stop taking medicines before receiving BUSULFAN ARX. This may include iron chelating agents (medicines used to reduce iron levels).
Paracetamol should be used with caution during the 72 hours prior to being given, and while being given BUSULFAN ARX.
These medicines may be affected by BUSULFAN ARX, or may affect how well it works. Your doctor may need to adjust your dose of BUSULFAN ARX or of the other medicine.
Your doctor or pharmacist may have more information on medicines to be careful with or avoid while taking BUSULFAN ARX.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect BUSULFAN ARX.
4. How is BUSULFAN ARX given?
How much is given
Adults
- The dose will be calculated according to your body weight.
- The recommended dose of BUSULFAN ARX is up to 3.2 mg per kg of body weight per day, in combination with cyclophosphamide, melphalan or fludarabine
When is BUSULFAN ARX given
New-born infants, children and adolescents (0 to 17 years)
- The recommended dose is based on body weight and may be up to 4.8 mg/kg/day.
BUSULFAN ARX is given by a qualified healthcare professional as a central intravenous infusion, after dilution of the individual vial. Each infusion will last 2 to 3 hours. Blood samples may be taken for testing the levels of BUSULFAN ARX in your blood.
BUSULFAN ARX will be given 1 to 4 times a day for up to 4 days prior to transplant.
Before receiving BUSULFAN ARX you will be given a medicine to prevent seizures (anticonvulsive drugs) (for example phenytoin and antiemetic drugs to prevent vomiting).
If you are given too much BUSULFAN ARX
As BUSULFAN ARX is given to you in hospital under the supervision of your doctor, it is unlikely that you will receive an overdose.
However, if you experience any side effects after being given BUSULFAN ARX, you should immediately:
- phone the Poisons Information Centre
(by calling 13 11 26), or - contact your doctor, or
- go to the Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning.
Symptoms of a BUSULFAN ARX overdose include the side effects listed below in the Side Effects section but are usually of a more severe nature.
5. What should I know while using BUSULFAN ARX?
Things you should do
Remind any doctor, dentist or pharmacist you visit that you are using BUSULFAN ARX.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how BUSULFAN ARX affects you.
BUSULFAN ARX may cause dizziness in some people
Drinking alcohol
Tell your doctor if you drink alcohol.
Storage
BUSULFAN ARX will be stored at 2°C - 8°C in a refrigerator (do not freeze) in the Pharmacy.
Getting rid of any unwanted medicine
Any unused medicine must be disposed of appropriately by the medical staff.
Do not use this medicine after the expiry date.
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.
Less serious side effects
Less serious side effects | What to do |
Gastrointestinal Related:
| Speak to your doctor if you have any of these less serious side effects and they worry you. |
Serious side effects
Serious side effects | What to do |
Brain Related:
| Call your doctor straight away, or go straight to the Emergency Department at your nearest hospital if you notice any of these serious side effects. |
The most serious side effects may include decrease in circulating blood cell counts (intended effect of the drug to prepare you for your transplant infusion), infection, liver disorders including blocking of a liver vein, graft versus host disease (the graft attacks your body) and complications relating to the lung. Your doctor will monitor your blood counts and liver enzymes regularly to detect and manage these events.
Lack of white blood cells associated with high fever (febrile neutropenia), metabolic disturbances (tumor lysis syndrome), unusual bleeding or bruising under the skin (thrombotic micro-angiopathy (TMA)), severe bacterial, viral and fungal infections, sepsis and changes in tooth hardness (tooth hypoplasia) have also been observed during treatment.
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 BUSULFAN ARX contains
Active ingredient (main ingredient) | Each vial contains 60 mg of busulfan as the active ingredient. |
Other ingredients (inactive ingredients) |
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Potential allergens | N/A |
This medicine is gluten-free, lactose-free, sucrose-free, tartrazine-free and free of other azo dyes.
Do not take this medicine if you are allergic to any of these ingredients.
What BUSULFAN ARX looks like
Busulfan ARX appears as a clear colourless solution. It is a sterile solution that contains no antimicrobial agent.
Busulfan ARX is for single use in one patient only and is supplied in cartons each containing 8 single-dose 10 mL clear glass vials (type I).
AUST R 210228.
Who distributes BUSULFAN ARX
Arrotex Pharmaceuticals Pty Ltd
15-17 Chapel St,
Cremorne VIC 3121
This leaflet was prepared in July 2024.
Published by MIMS September 2024