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 ABRAXANE?
ABRAXANE contains the active ingredient paclitaxel. ABRAXANE is used to treat breast
cancer, lung cancer or pancreatic cancer.
2. What should I know before I use ABRAXANE?
Do not use if you have ever had an allergic reaction to paclitaxel 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 (for males, if your partner plans to become
pregnant) or are breastfeeding.
3. What if I am taking other medicines?
4. How do I use ABRAXANE?
Your doctor will decide what dose of ABRAXANE you will receive. This depends on your
condition and other factors, such as your weight, kidney function and other chemotherapy
medicines you are being given.
ABRAXANE is usually given as an infusion (drip) into a vein over 30 minutes.
5. What should I know while using ABRAXANE?
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Things you should do
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Call your doctor straight away if you become pregnant while you are being treated
with this medicine
Tell any other doctors, dentists, and pharmacists who are treating you that you are
being given this medicine, especially if you are about to be started on any new medicine
If you are going to have surgery, tell the surgeon or anaesthetist that you are being
treated with this medicine. It may affect other medicines used during surgery.
Keep all your doctor's appointments so your progress can be checked.
Your body breaks down ABRAXANE and uses it to fight cancer. The breakdown products
may be excreted in body fluids and waste, including blood, urine, faeces, vomitus
and semen. Precautions to protect other people should be taken while you are receiving
chemotherapy and for one week after the treatment period; see Section 5. What should I know while using ABRAXANE? in the full CMI. |
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Driving or using machines
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Some people may feel tired or dizzy after being given Abraxane. If this happens to
you, do not drive or use any tools or machines.
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6. Are there any side effects?
Like all medicines, ABRAXANE can cause side effects. Your doctor will discuss potential
side effects with you and will explain the risks and benefits of your treatment. Some
side effects can be serious and you may require medical attention. 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.
Active ingredient: paclitaxel (pak-li-tax-el)
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using ABRAXANE. 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 ABRAXANE.
Where to find information in this leaflet:
1. Why am I using ABRAXANE?
ABRAXANE contains the active ingredient paclitaxel.
ABRAXANE used to treat:
Breast cancer
Lung Cancer
Pancreatic Cancer
ABRAXANE belongs to a group of medicines called antineoplastic or cytotoxic medicines.
You may also hear of these being called chemotherapy medicines.
It works by killing cancer cells and stopping them from multiplying.
2. What should I know before I use ABRAXANE?
Warnings
Do not use ABRAXANE if:
you are allergic to paclitaxel or human albumin, or any of the ingredients listed
at the end of this leaflet.
Always check the ingredients to make sure you can use this medicine.
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.
you have a very low white blood cell (WBC) count.
you are pregnant or plan to become pregnant. Like most cytotoxic medicines ABRAXANE
is not recommended for use during pregnancy. If there is any need to consider this
medicine during your pregnancy, your doctor will discuss with you the benefits and
risks of using it.
Males: tell your doctor if your partner plans to become pregnant while you are being
treated with this medicine or shortly after you have stopped treatment with it. ABRAXANE
may cause birth defects if either the male or female is being treated with it at the
time of conception. It is recommended that you use some kind of birth control while
you are being treated with ABRAXANE and for at least 12 weeks after you stop using
it. Your doctor will discuss this with you.
are breastfeeding.
The active ingredient in ABRAXANE passes into breast milk and there is a possibility
that your baby may be affected.
Check with your doctor if you:
kidney disease
liver disease. You must not be given this medicine if you have severe liver damage.
heart problems
any blood disorder with a reduced number of blood cells, or platelets
any disease of the nerves
you have an infection or high temperature. Your doctor may decide to delay your treatment
until the infection is gone. A mild illness, such as a cold, is not usually a reason
to delay treatment.
lowered immunity due to diseases such as HIV/AIDS
lowered immunity due to treatment with medicines such as cyclosporine, or other medicines
used to treat cancer (including radiation therapy)
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?
Use in children or adolescents
The safety and effectiveness of ABRAXANE in children (under 18 years) has not been
established.
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 and ABRAXANE may interfere with each other.
Some medicines may be affected by ABRAXANE or may affect how well it works. You may
need different amounts of your medicines, or you may need to take different medicines.
Tell your doctor if you are taking any of the following:
medicines for treating infections (i.e. antibiotics such erythromycin, rifampicin,
etc.; ask your doctor, nurse or pharmacist if you are unsure whether the medicine
you are taking is an antibiotic), and including medicines for treating fungal infections
(e.g. ketoconazole)
medicines used to help you stabilize your mood also sometimes referred to as anti-depressants
(e.g. fluoxetine)
medicines used to treat seizures (epilepsy) (e.g. carbamazepine, phenytoin)
medicines used to help you lower blood lipid levels (e.g. gemfibrozil)
medicine used for heartburn or stomach ulcers (e.g. cimetidine)
medicines used to treat HIV and AIDS (e.g. ritonavir, saquinavir, indinavir, nelfinavir,
efavirenz, nevirapine)
a medicine called clopidogrel used to prevent blood clots.
Your doctor and pharmacist have more information on medicines to be careful with or
avoid while taking this medicine.
4. How am I given ABRAXANE?
How ABRAXANE is given
ABRAXANE is usually given as an infusion (drip) into a vein over 30 minutes.
Your doctor will decide what dose of ABRAXANE you will receive. This depends on your
condition and other factors, such as your weight, kidney function and other chemotherapy
medicines you are being given.
ABRAXANE may be given alone or in combination with other drugs.
Several courses of ABRAXANE therapy 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 ABRAXANE you receive.
How long it will be given
Breast Cancer
ABRAXANE is usually given once every three weeks (i.e. on day 1 of a 21-day cycle).
Each infusion is called one 'cycle' of chemotherapy.
Your doctor will decide how many of these cycles you will need.
Lung Cancer
ABRAXANE is given every week (i.e. on days 1, 8 and 15 of each 21-day cycle). Another
medicine called carboplatin is also given on day 1 only of each 21-day cycle.
Your doctor will decide how many of these cycles you will need.
Pancreatic Cancer
ABRAXANE is given every week (i.e. on days 1, 8 and 15 of each 28-day cycle). Every
28 days is called one ‘cycle’ of chemotherapy. Another medicine called gemcitabine
is also given on days 1, 8 and 15 after ABRAXANE has been given.
Your doctor will decide how many of these cycles you will need.
If you miss a dose
It is very important for you to keep all appointments to receive ABRAXANE. If you
miss an appointment, ask your doctor when to schedule your next dose.
If you are given too much ABRAXANE
As ABRAXANE is given to you under the supervision of your doctor, it is very unlikely
that you will receive too much. However, if you experience severe side effects after
being given this medicine, tell your doctor or nurse immediately. You may need urgent
medical attention.
Symptoms of an ABRAXANE overdose include the side effects listed below under Section
6. Are there any side effects?, but are usually of a more severe nature.
5. What should I know while using ABRAXANE?
Call your doctor straight away if you:
become pregnant while you are being treated with this medicine
Things you should do
If you are about to be started on any new medicine, remind your doctor and pharmacist
that you are being treated with ABRAXANE.
Tell any other doctors, dentists, and pharmacists who are treating you that you are
being given this medicine.
If you are going to have surgery, tell the surgeon or anaesthetist that you are being
treated with this medicine. It may affect other medicines used during surgery.
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 ABRAXANE at the appropriate times to get the best effects from your treatments.
Infections or bleeding
This medicine 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 who have 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.
Be careful when using a toothbrush, toothpick or dental floss. Your doctor, dentist,
nurse or pharmacist 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.
Body fluids and waste
Your body breaks down ABRAXANE and uses it to fight cancer. The breakdown products
may be excreted in body fluids and waste, including blood, urine, faeces, vomitus
and semen.
In general, precautions to protect other people should be taken while you are receiving
chemotherapy and for one week after the treatment period by:
Flushing the toilet twice to dispose of any body fluids and waste.
Wearing gloves to clean any spill of body fluid or waste. Use paper towels or old
rags, a strong solution of non-bleaching detergent and large amounts of water to mop
up the spill. Discard the towels or rags into a separate waste bag and dispose of
fluids in the toilet.
Wash linen or clothing that is heavily contaminated by body fluids or waste separately
from other items. Use a strong solution of non-bleaching detergent and large amounts
of water.
Place soiled disposable nappies and other pads in a plastic bag, seal and dispose
into the garbage.
For sexual intercourse, use a barrier method such as a condom.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how ABRAXANE
affects you.
Some people may feel tired or dizzy after being given Abraxane. If this happens to
you, do not drive or use any tools or machines.
If you are given other medication as part of your treatment, you should ask your doctor
for advice on driving and using machines.
Looking after your medicine
ABRAXANE will be stored in the pharmacy or on the ward. The injection is kept in a
cool, dry place, protected from light, where the temperature stays below 25°C.
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.
The benefits and side effects of ABRAXANE may take some time to occur. Therefore,
even after you have finished receiving your treatment, you should tell your doctor
immediately if you notice any of the side effects listed in this section.
Serious side effects
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Serious side effects
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What to do
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shortness of breath, coughing, wheezing or difficulty breathing
swelling of the face, lips, tongue, or other parts of the body
rash, itching or hives on the skin
extreme weakness or tiredness
seizures (fits)
fast, slow or irregular heart beat
chest pain
yellowing of the skin or eyes
unusual bleeding or bruising (including blood in your stools or urine)
fever, sore throat or other signs of infection
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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 serious side effects.
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pain, swelling, irritation and redness at the injection site
flushing
light-headedness, dizziness or fainting (due to low blood pressure)
numbness or tingling in the fingers and/or toes
changes in vision
abdominal pain
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Call your doctor or nurse as soon as possible
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Other side effects
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Other side effects
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What to do
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Very common
Abnormal decrease in the number of types of white blood cells (neutrophils, lymphocytes
or leukocytes) in the blood
Deficiency of red blood cells
Reduction in the number of platelets in the blood
Anorexia
Effect on peripheral nerves (pain, numbness, tingling or loss of feeling)
Nausea, diarrhoea, constipation, throat pain, loss of appetite
Vomiting
Loss of hair
Rash
Pain in a joint or joints
Pain in the muscles
Weakness and tiredness, fever
Common
Infection, including in the urinary tract, follicles, upper airways, thrush and sinuses
Fever with decrease in the number of a type of white blood cell (neutrophils) in the
blood, flushing, severe infection in your blood which may be caused by reduced white
blood cells
Dehydration
Decreased appetite
Low levels of potassium in the blood
Sleep problems
Depression, anxiety
Diminished muscular coordination or difficulty in reading, increased or decreased
tears, loss of eyelashes
Blurred vision
Taste disturbance
Headache, dizziness
Dry mouth, difficulty in swallowing
Muscle weakness
Changes in heart rate or rhythm
Decreased or increased blood pressure
Blood clot in the lungs
Swelling of mucosal and soft tissues
Flushing
Difficulty in breathing
Coughing up blood
Nose bleeds, stuffy nose
Chest or throat pain
Cough
Indigestion, abdominal discomfort or pain
Itching, dry skin, nail disorder
Pain in back or limb, bone pain, muscle cramps
Weight loss
Reduction in all blood cell counts
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Speak to your doctor if you have any of these side effects and they worry you.
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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 ABRAXANE contains
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Active ingredient
(main ingredient)
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paclitaxel
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Other ingredients
(inactive ingredients)
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human albumin solution, which contains sodium, sodium octanoate and sodium acetyltryptophanate
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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 ABRAXANE looks like
ABRAXANE is a white to yellow solid powder cake in a clear glass vial.
When it is reconstituted, it will be a milky liquid.
100 mg vial: AUST R 133500
250 mg vial: AUST R 297973
The 250 mg presentation is not approved by Medsafe and is therefore not marketed in
New Zealand.
Who distributes ABRAXANE
Sponsor in Australia
Abraxis BioScience Australia Pty Ltd
Level 2, 4 Nexus Court
Mulgrave, VIC 3170
Australia
Telephone: 1800 CELGENE (1800 235 4363)
Distributed by Specialised Therapeutics Australia Pty Ltd
Sponsor in New Zealand
Celgene Limited
PO Box 3035
Wellington
New Zealand.
Telephone: 0800 526 529
Abraxis BioScience Australia Pty Ltd is an affiliate of Celgene Corporation.
ABRAXANE® is a registered trademark of Celgene Corporation, a Bristol-Myers Squibb company.
This leaflet was prepared in June 2023.