2. What should I know before treatment with ANZATAX?
You should not be treated with ANZATAX if you have ever had an allergic reaction to
ANZATAX, other medicines similar to paclitaxel called taxanes, or any of the ingredients
listed at the end of the CMI including ethanol and PEG 35 castor oil.
Talk to your doctor if you have any other medical conditions including problems with
your liver, heart or nerves; lowered immunity or blood disorders; take any other medicines;
or are pregnant or plan to become pregnant or are breastfeeding.
3. What if I am taking other medicines?
Some medicines may interfere with ANZATAX and affect how it works.
4. How is ANZATAX given?
The dose of medicine given to you will depend on your condition and other factors,
such as your weight, kidney function and other chemotherapy medicines you are being
given.
5. What should I know while I am being treated with ANZATAX ?
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Things you should do
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Remind any doctor, dentist, pharmacist and nurse who are treating you that you are
being given this medicine.
Males should use effective contraception during and for at least 4 months after stopping
treatment. Females should use effective contraception while receiving this medicine
and for at least 7 months after stopping treatment. If you become pregnant while you
are being given ANZATAX, tell your doctor immediately.
Keep all of your doctor’s appointments so your progress can be checked.
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Things you should not do
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Do not breastfeed while you are being treated with ANZATAX and for 2 weeks following
the last dose of treatment.
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Driving or using machines
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Do not drive or operate machinery until you know how ANZATAX affects you. ANZATAX
may affect your ability to drive or operate machinery as it can cause dizziness or
light-headedness in some people.
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Drinking alcohol
|
ANZATAX contains alcohol. Discuss drinking alcohol with your doctor.
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6. Are there any side effects?
Side effects include flushing, light-headedness, dizziness, headache, nausea, vomiting,
diarrhoea, muscle or joint pain, changes in vision, hearing loss, tinnitus, hair loss,
soreness or ulceration of the mouth, pain or irritation at the injection site. Serious
side effects include severe allergic reaction; signs of infection (fever, sore throat);
unusual bleeding or bruising (including black stools, blood in your stools or urine);
red or purple rash with blisters; fast, slow or irregular heartbeat; seizures; tingling,
numbness of the skin or pins and needles sensation; severe abdominal pain; swelling
and yellowing of the skin or eyeballs.
Active ingredient(s):
paclitaxel
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using ANZATAX. 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 ANZATAX.
Where to find information in this leaflet:
1. Why am I being treated with ANZATAX?
ANZATAX contains the active ingredient paclitaxel. ANZATAX belongs to a group of medicines known as antineoplastic or cytotoxic agents.
You may also hear it referred to as a chemotherapy medicine. ANZATAX works by killing
cancer cells and stopping cancer cells from growing and multiplying.
ANZATAX is used to treat ovarian cancer, breast cancer and non-small cell lung cancer
(NSCLC).
2. What should I know before treatment with ANZATAX?
Warnings
You should not be given ANZATAX if:
you are allergic to paclitaxel, other medicines similar to paclitaxel called taxanes
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 an allergy to medicines containing PEG-35 castor oil, such as ciclosporin
injection.
you have an allergy to ethanol (alcohol)
you have a very low white blood cell count.
Check with your doctor if you have:
any other medical conditions such as:
kidney disease
Problems with your liver
heart problems
lowered immunity due to
diseases
treatment with medicines such as cyclosporin
other medicines/treatment used to treat cancer (including radiation therapy)
any blood disorder with a reduced number of red blood cells, white blood cells, or
platelets
any disease of the nerves or neuropathy (numbness, tingling or pain, especially in
the hands and feet, or muscle weakness or problems with bladder control)
had a previous serious reaction to a similar drug to ANZATAX (called taxanes)
You must not be given this medicine if you have a very low white blood cell (WBC)
count.
Tell 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.
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.
You must not be given this medicine if you are pregnant or plan to become pregnant.
Like most cytotoxic medicines ANZATAX 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.
Male patients should seek advice regarding storage of sperm prior to treatment with
paclitaxel due to the possibility of infertility. Female patients should seek advice
regarding potential fertility preservation options.
ANZATAX may cause birth defects if either the male or female is being treated with
it at the time of conception. It is recommended that males should use effective birth
control while you are being treated with ANZATAX and for at least 4 months after you
stop using it. It is recommended for females to use effective birth control while
undergoing treatment and for at least 7 months after you stop using it. Your doctor
will discuss this with you.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
Do not breast-feed if you being given this medicine and for 2 weeks following the
last dose of treatment.
ANZATAX may pass into breast milk and possibly cause serious effects to your baby.
Use in the elderly
There may be a greater chance of certain problems when using ANZATAX. Your doctor
may order extra tests and will monitor you closely.
Use in the children
ANZATAX is not recommended for use in children less than 18 years old.
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 ANZATAX and affect how it works.
Cisplatin, doxorubicin and trastuzumab, medicines used to treat cancer
erythromycin, trimethoprim and rifampicin, antibiotics used to treat some bacterial
infections
gemfibrozil, a medicine used to lower high cholesterol levels
deferasirox, a medicine used to treat iron overload
filgrastim, a medicine used for white blood cell disorders
fluoxetine, a medicine used to treat depression
carbamazepine, phenytoin and phenobarbital (phenobarbitone), medicines used for epilepsy
efavirenz and nevirapine, medicines used to treat HIV (Human Immunodeficiency Virus)
infection
herbal medicines containing St John's wort
You may need different amounts of your medicines, or you may need to take different
medicines.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect
ANZATAX.
4. How is ANZATAX given?
How much is given
Your doctor will decide what dose of ANZATAX 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.
Before you are given ANZATAX, you must take some other medicines to prevent serious
allergic reactions occurring during your treatment.
You will need to take dexamethasone tablets 12 hours and 6 hours before your treatment,
which your doctor will prescribe for you. You will also be given 2 different injections
30 minutes prior to receiving ANZATAX. This will minimize the risk of serious allergic
reactions occurring.
ANZATAX may be given alone or in combination with other drugs.
Several courses of ANZATAX 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.
How it is given
ANZATAX is usually given as intravenous infusion (as a slow drip into a vein) over
3 hours.
How long will it be given for
ANZATAX is usually given once every three weeks. Each infusion is called one ‘cycle’
of chemotherapy. Your doctor will decide how many of these cycles you will need.
If you are given too much ANZATAX
As ANZATAX 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 ANZATAX overdose include the side effects listed below in the ‘Side
Effects’ section but are usually of a more severe nature. Alert your doctor immediately
if you experience redness, swelling, pain, sores, ulcers or bleeding in the mouth
or throat; or any numbness, pain or unusual sensations or problems with your muscles
or motor skills.
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 I am being treated with ANZATAX?
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 ANZATAX.
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.
If you become pregnant while taking this medicine, tell your doctor immediately.
Keep follow-up appointments with your doctor and have any tests as directed by your
doctor.
It is important to have your follow-up cycles of ANZATAX at the appropriate times
to get the best effects from your treatments.
Tell your doctor straight away if you:
have shortness of breath, feel dizzy or lightheaded, experience swelling of the face,
tongue, lips, mouth or throat, or itching
a cough with shortness of breath, and chest discomfort
severe pain on eating, drinking or swallowing, or difficulty talking due to pain
have stomach pain or severe or persistent diarrhoea during or after treatment
problems with vision discomfort with your infusion site at the time of treatment
Things you should not do
Do not breast-feed if you are being treated with this medicine and for 2 weeks following
the last dose of treatment.
Things to be careful of
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.
Your body fluids will contain ANZATAX and its associated breakdown products for a
number of days once you are given ANZATAX. Body fluids and waste, include 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 ANZATAX
affects you.
ANZATAX may cause dizziness or light-headedness in some people. If you have these
symptoms, do not drive, operate machinery or do anything else that could be dangerous.
Drinking alcohol
ANZATAX contains alcohol. Discuss drinking alcohol with your doctor.
Looking after your medicine
ANZATAX will be stored in the pharmacy or on the ward.
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.
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Side effects
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What to do
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flushing
light-headedness, dizziness, headache
nausea, vomiting
indigestion, heartburn, diarrhoea or constipation
muscle or joint pain, stiffness, swelling or reduced mobility
changes in vision
hearing loss, tinnitus
hair loss
changes in skin or nail appearance
soreness or ulceration of the mouth
irritation and inflammation of the throat, nose or vagina
redness, tightness, cracking, flaking or peeling of the skin
thick calluses and blisters on the palms of your hands and soles of your feet
difficulty walking or using your hands
weight loss
pain, swelling, irritation, redness or discolouration at the injection site
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Speak to your doctor if you have any of these side effects and they worry you.
|
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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 (severe allergic
reaction)
fever, sore throat or other signs of infection
tiredness, paleness, bruising or bleeding
warmth, tenderness, pain, swelling in arm or leg
rapid breathing or heart rate, confusion, fever, chills, not passing urine, discoloured
skin
red or purple rash with blisters, peeling and flu like symptoms
fast, slow or irregular heartbeat including palpitations
chest discomfort or pain
dry cough, shortness of breath during exercise or at rest
oedema of legs, feet and body
increase in weight
fatigue, yellowing of the skin or eyes, abdominal pain or swelling, nausea, vomiting,
dark urine, loss of appetite
seizures, fits, confusion
numbness, prickling, tingling, burning sensation on arms, legs and body
severe or persistent watery diarrhoea, with or without pus/mucus in stool
severe pain cramps, bleeding, fever, chills, bloating or swelling of abdomen
blood in urine, changes to urine output, swollen ankles, fatigue
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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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Tell your doctor or pharmacist if you notice anything else that may be making you
feel unwell.
Some side effects (for example, changes to blood cell counts, elevated liver enzymes,
blood pressure and heart abnormalities) can only be found when your doctor does tests
from time to time to check your progress.
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 have experienced,
you can report side effects to the Therapeutic Goods Administration online at
www.tga.gov.au/safety/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 ANZATAX 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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citric acid
PEG 35 castor oil
ethanol
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Do not take this medicine if you are allergic to any of these ingredients.
ANZATAX does not contain lactose, sucrose, gluten, tartrazine or any other azo dyes.
What ANZATAX looks like
ANZATAX is a clear to pale yellow solution, in a glass vial.
ANZATAX 30 mg/5 mL AUST R 50578
ANZATAX 100 mg/16.7 mL AUST R 106458
ANZATAX 150 mg/25 mL AUST R 50577
ANZATAX 300 mg/50 mL AUST R 91256
Who distributes ANZATAX
Pfizer Australia Pty Ltd
Sydney NSW
This leaflet was prepared in December 2025.