2. What should I know before I use EVOLTRA?
Do not use if you have ever had an allergic reaction to EVOLTRA 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 use EVOLTRA? in the full CMI.
3. What if I am taking other medicines?
4. How do I use EVOLTRA?
EVOLTRA is given as a slow injection (or infusion) into a vein. EVOLTRA should only
be given by a nurse or doctor.
5. What should I know while using EVOLTRA?
|
Things you should do
|
If you are a female and can get pregnant, you must use effective contraception during
treatment with EVOLTRA and for 6 months following completion of treatment. Call your
doctors straight away if you become pregnant while you are being treated with EVOLTRA.
If you are breast-feeding, you must stop breast-feeding before starting the treatment,
and must not breast-feed during your treatment and for 2 weeks after completion of
treatment.
If you are a man, you must also use effective contraception and do not father a child
while receiving EVOLTRA, and for 3 months following completion of treatment.
Drink plenty of water while you are being treated with EVOLTRA to avoid dehydration.
Avoid people with infections, and check with your doctor immediately if you think
you may be getting an infection, or if you get a fever, chills, cough, hoarse throat,
lower back or side pain, or find it painful or difficult to urinate.
Check with your doctor immediately if you notice any unusual bleeding or bruising,
black stools, blood in urine or stools, or pinpoint red spots on your skin.
Be careful when using a toothbrush, toothpick or dental floss. Check with your doctor
before having any dental work.
Avoid contact sports or other situations where you may bruise or get injured.
|
|
Driving or using machines
|
Be careful before you drive or use any machines or tools until you know how EVOLTRA
affects you. You may feel dizzy or light-headed while you are receiving a cycle of
EVOLTRA.
|
|
Drinking alcohol
|
Tell your doctor if you drink alcohol. Be careful when drinking alcohol while you
are being given this medicine.
|
|
Looking after your medicine
|
EVOLTRA will be stored in the pharmacy or on the ward. The injection is kept in a
cool, dry place where the temperature stays below 25°C.
|
6. Are there any side effects?
Active ingredient:
clofarabine (CLOE-fa-ra-been)
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using EVOLTRA. 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 EVOLTRA.
Where to find information in this leaflet:
1. Why am I using EVOLTRA?
EVOLTRA contains the active ingredient clofarabine. EVOLTRA belongs to a group of medicines known as antineoplastic or cytotoxic agents.
You may also hear it referred to as a chemotherapy medicine.
This medicine is thought to work by interfering with the growth and/or repair of some
cells that are multiplying rapidly, such as cancer cells, which are eventually destroyed.
EVOLTRA is used to treat young patients with Acute Lymphoblastic Leukaemia (ALL) when
previous treatments have not worked or have stopped working. ALL is caused by abnormal
growth of some types of white blood cells.
There is not enough information to recommend the use of this medicine for children
under the age of one year, or adults over the age of 65 years.
2. What should I know before I use EVOLTRA?
Warnings
Do not use EVOLTRA if:
you are allergic to clofarabine, 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 have or have had any of the following medical conditions:
severe kidney problems
severe liver problems
Check with your doctor if you:
have an infection or high temperature. Your doctor may decide to delay your treatment
until the infection has gone. A mild illness, such as a cold, is not usually a reason
to delay treatment.
have allergies to any other medicines, foods, preservatives or dyes.
have or have had any other medical conditions, especially the following:
any blood disorders, or conditions which cause a reduced number of red blood cells,
white blood cells, or platelets
bone marrow disease
kidney disease
liver disease
hypotension (low blood pressure)
gout
bowel problems such as colitis (inflammation of the colon)
lowered immunity due to diseases including HIV/AIDS
heart disease.
have been given EVOLTRA before, and you became unwell. You may be given another medicine
instead.
if you are on a controlled sodium diet as it could affect how you will be given your
medicine. EVOLTRA contains 180mg of sodium chloride in each vial. This is equivalent
to 3.08 mmol (or 70.77mg) of sodium. You need to allow for this if you are on a controlled
sodium diet.
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
EVOLTRA should not be used during pregnancy unless clearly necessary.
If you are a female and can get pregnant, you must use effective contraception during
treatment with EVOLTRA and for 6 months following completion of treatment. EVOLTRA may cause harm to unborn babies when used by pregnant women. If you are pregnant or become pregnant during treatment with EVOLTRA, call your doctor
immediately.
If you are breast-feeding, you must stop breast-feeding before starting the treatment,
and must not breast-feed during your treatment and for 2 weeks after completion of
treatment.
Males
Use effective contraception and do not father a child while receiving EVOLTRA, and
for 3 months following completion of treatment.
EVOLTRA may cause birth defects if either the male or female is using it at the time
of conception. Your doctor can discuss this with you.
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 EVOLTRA and affect how it works. These may include:
other medicines used to treat cancer
some vaccines
medicines which can affect the kidneys
medicines which can affect the liver
medicines which can affect blood pressure or the heart.
These medicines may be affected by EVOLTRA or may affect how well it works. You may
need different amounts of your medicine, or you may need to use different medicines.
Your doctor or pharmacist will advise you.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect EVOLTRA.
4. How do I use EVOLTRA?
How much is given
Your doctor will decide what dose of EVOLTRA you will receive. This depends on your
condition and other factors, such as your weight, height and other chemotherapy medicines
you are being given.
Your doctor will monitor your health and may change your dose depending on your response
to the treatment.
EVOLTRA may be given alone or in combination with other drugs.
Several courses of EVOLTRA may be needed depending on your response to treatment.
Additional treatment may not be repeated until your blood cell numbers return to acceptable
levels and any uncontrolled effects have been controlled.
Ask your doctor if you want to know more about the dose of EVOLTRA you receive.
How it is given
EVOLTRA is given as a slow injection (or infusion) into a vein. EVOLTRA should only
be given by a nurse or doctor.
How long it is given
EVOLTRA infusion lasts for two hours and is usually given every day for five days.
If you (or your child) weighs less than 20kg, the infusion time may be longer. Your
doctor will decide how many of these cycles you will need.
If you receive too much EVOLTRA
As EVOLTRA is given to you in a hospital under the supervision of your doctor, it
is very unlikely that you will receive an overdose.
Symptoms of an overdose may include the side effects listed below under Section
6. Are there any side effects?, but are usually of a more severe nature.
If you think that you have received too much EVOLTRA, you may need urgent medical
attention.
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.
5. What should I know while using EVOLTRA?
Things you should do
Drink plenty of water while you are being treated with EVOLTRA to avoid dehydration.
Be sure to keep all your doctor's appointments so your progress can be checked. Your
doctor may want to check your blood pressure and do some blood and other tests from
time to time to check on your progress and detect any unwanted side effects.
Keep follow up appointments with your doctor. It is important to have your follow-up
cycles of EVOLTRA at the appropriate times to get the best effects from your treatment.
EVOLTRA can lower the number of white blood cells and platelets in your blood. This
means that you have an increased chance of getting an infection or bleeding. The following
precautions should be taken to reduce your risk of infection or bleeding:
Avoid people with infections. Check with your doctor immediately if you think you
may be getting an infection, or if you get a fever, chills, cough, hoarse throat,
lower back or side pain, or find it painful or difficult to urinate.
Check with your doctor immediately if you notice any unusual bleeding or bruising,
black stools, blood in urine or stools or pinpoint red spots on your skin.
Be careful when using a toothbrush, toothpick or dental floss. Your doctor, dentist,
pharmacist or nurse may recommend other ways to clean your teeth and gums. Check with
your doctor before having any dental work.
Be careful not to cut yourself when you are using sharp objects such as a razor or
nail cutters.
Avoid contact sports or other situations where you may bruise or get injured.
Call your doctor straight away if you:
become pregnant while you are being treated with EVOLTRA.
Remind any doctor, dentist or pharmacist you visit that you are using EVOLTRA.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how EVOLTRA
affects you.
You may feel dizzy or light-headed while you are receiving a cycle of EVOLTRA.
Drinking alcohol
Tell your doctor if you drink alcohol.
Be careful when drinking alcohol while you are being given this medicine.
If you drink alcohol, dizziness or light-headedness may be worse.
Looking after your medicine
EVOLTRA will be stored in the pharmacy or on the ward. The injection is kept in a
cool, dry place where the temperature stays below 25°C.
Getting rid of any unwanted medicine
If you no longer need to use this medicine or it is out of date, take it to any pharmacy
for safe disposal.
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
|
|
Gut-related:
Nausea and vomiting
Diarrhoea
Brain-related:
Headache
Unusual tiredness or weakness
Anxiety or nervousness
Decreased or lost appetite, weight loss
Skin-related:
Flushing, itching and inflamed skin
Skin rashes or flaking
Inflammation of mucus (moist) linings, such as the mouth
Immune system-related:
Fever
Infections
Other:
Hair loss
|
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
|
|
Gut-related:
Severe nausea and vomiting
Severe diarrhoea
Vomiting blood, stomach ache
Airway and mouth-related:
Breathing difficulties, rapid breathing or breathlessness, cough
Nosebleeds, bleeding gums, mouth ulcers
Heart-related:
Changes in your heart beat
Fluid retention (oedema)
Immune system-related:
High fever
Head or brain-related:
Hearing problems
Dizziness, light-headedness or fainting
Kidney-related:
Feeling thirsty and producing concentrated (dark) urine
Blood in the urine
Liver-related:
Yellowing of the eyes and skin (jaundice)
Hair or skin-related:
Bruising, hair loss, changes to skin colour
Increased sweating or dry skin
Nerve-related:
Feeling numb
Aches and pains:
Pain in the chest wall or bones
Neck or back pain, pain in the muscles or joints
Allergic reaction-related:
Symptoms of an allergic reaction, such as 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
|
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.
|
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.
The benefits and side effects of EVOLTRA may take some time to occur. Therefore, even
after you have finished receiving your EVOLTRA treatment you should tell your doctor
immediately if you notice any of the side effects listed in this section.
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 EVOLTRA contains
|
Active ingredient
(main ingredient)
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clofarabine
|
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Other ingredients
(inactive ingredients)
|
sodium chloride
water for injections
|
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Potential allergens
|
This medicine does not contain lactose, sucrose, gluten, tartrazine or any other azo
dyes.
|
Do not take this medicine if you are allergic to any of these ingredients.
What EVOLTRA looks like
EVOLTRA is a concentrate for solution for infusion (sterile concentrate) that is prepared
and diluted before it is used.
It is a clear, colourless solution supplied in a glass vial.
EVOLTRA contains 20 mg of clofarabine in each 20 mL vial.
(Aust R 154991).
Who distributes EVOLTRA
Distributed by:
sanofi-aventis australia pty ltd
12-24 Talavera Road
Macquarie Park NSW 2113
Freecall: 1800 818 806
This leaflet was prepared in August 2023.
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