Taxol

Paclitaxel
Consumer Medicine Information
 

NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia. This page contains answers to some common questions about Taxol. It does not contain all the information that is known about Taxol. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risk of you using this medicine against the benefits he/she expects it will have for you. If you have any concerns about using this medicine, ask your doctor or pharmacist. Bookmark or print this page, you may need to read it again.

What Taxol is used for

Taxol is used to treat cancer of the ovary, the breast, and non small cell cancer of the lung. Taxol may be used alone or in combination with other anticancer agents.
Taxol is not recommended for use in children as its safety and effectiveness in patients under 18 years of age has not been established.
Ask your doctor if you have any questions about why Taxol was prescribed for you.

How Taxol works

Taxol belongs to a class of anticancer agents known as taxanes. These agents prevent the division of cells, particularly cancer cells.
The use of Taxol to treat your cancer can lead to side-effects, which are discussed below.

How Taxol is used

Taxol will be administered as an infusion in a hospital clinic. Taxol may be used alone or with other anticancer medicines.
The dose is worked out based on your body weight and height, and so may be different from the dose chosen for other people. Taxol is administered as an intravenous infusion over a 3 hour period. Administration will occur at 3 week intervals. The administration of Taxol requires all patients to be given premedication prior to Taxol.
The premedication consists of three other drugs which work by reducing the likelihood of an allergic reaction occurring when you receive your Taxol. They are given as tablets 12 and 6 hours before the Taxol is given and two injections into the vein given 30 to 60 minutes prior to the Taxol being given.

Before you take Taxol

When you must not take Taxol

You have a history of severe allergic reactions to Taxol or other drugs formulated in PEG-35 castor oil (Cremophor EL).
You have a severe neutropenia (reduced numbers of the white blood cells that fight infections), before treatment with Taxol.
Do not take Taxol if you are pregnant or intend to become pregnant.
Taxol may cause harm to the unborn baby if it is given to a pregnant woman.
If you are breast feeding
Do not take Taxol after the expiry date printed on the pack.
If you take this medicine after the expiry date has passed, it may not work as well.
It is important that you inform your doctor about the following:
If you are taking any other medicines or treatment;
If you have ever been anaemic or suffered from other problems with your blood;
If you have had kidney or liver problems;
If you have received radiation therapy;
If you have high or low blood pressure;
If you have a heart problem;
If you have ever suffered from neuropathy (numbness, tingling and pain in feet or hands);
If you are a sexually active man. Men who receive Taxol are advised to use a condom to avoid pregnancy in their partner.

While you are receiving Taxol

Things you must do

You must tell your doctor immediately if you become pregnant while receiving Taxol treatment.
Tell all of the doctors, dentists and pharmacists who are treating you that you are receiving treatment with Taxol
If you are about to be started on any new medicine, tell your doctor and pharmacist that you are receiving Taxol
Have any tests recommended by your doctor done as soon as possible.

Things to be careful of

Taxol contains ethanol (alcohol). You should not drive, operate machinery, or do anything else that could be dangerous after receiving treatment with Taxol.
You should wear sun protection on your hands and feet after receiving treatment with Taxol

If you take too much (overdose)

As your dose of Taxol will be determined and administered by a medical specialist, the chance of receiving an overdose is most unlikely. However, if an overdose should be given your specialist will give the appropriate treatment.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Taxol.
Like all medicines, it is possible that Taxol will cause you some unwanted side effects in some people. During Taxol therapy you will require close medical supervision.
The more common side effects of Taxol are:
Infections, including of the lungs, upper respiratory tract, inner lining of the abdomen, blood and urinary tract
flushing and rash
itchiness
bone marrow suppression (primarily neutropenia)
thrombocytopenia (reduced numbers of the white blood cells that are responsible for blood clotting)
leucopenia (low numbers of white blood cells)
bleeding, blood clots
fever
anaemia (reduced numbers of red blood cells)
hypotension (low blood pressure)
disturbances of heart rate and rhythm
heart problems which can cause shortness of breath or ankle swelling
chest pain
increased sweating
nausea and vomiting
diarrhoea
mucositis (inflammation on the lining of the mouth or throat)
arthralgia (pain in the joints ) and myalgia (muscle pain)
peripheral neuropathy (numbness, tingling and pain in feet and hands)
abnormal liver blood tests
alopecia (hair loss)
seizures and convulsions
headache
visual disturbances
hearing loss
weight loss
nail loss
reactions at the injection site including localised swelling, pain, redness, hardening of the skin and skin discolouration
Tell your doctor immediately, or go to accident and emergency at your nearest hospital if you notice any of the following:
swelling to the face, lips, tongue or throat which may cause difficulty in swallowing or breathing
severe and sudden onset of pinkish, itchy swellings or welts
gastrointestinal bleeding (blood in your stool)
blistering of the skin, mouth, eyes and genitals
Tell your doctor immediately if you notice any of the following:
fever
disturbances of heart rate and rhythm
numbness, tingling and pain in feet and hands
unexpected bleeding
abdominal pain
The use of Taxol is also associated with a reduction in certain types of blood cells in the body:
a reduction in red blood cells, which may result in fatigue or dizziness
a reduction in white blood cells, which are used to fight infection
a reduction in cells that help your blood to clot after injury
These are serious side effects. You may need urgent medical attention or hospitalisation.
Other side effects not listed above may also occur in some patients. Tell your doctor if you notice anything else that is making you feel unwell.

Product Description

Taxol is a concentrated solution which will be diluted with a saline (sodium chlorine) or glucose solution and given as an intravenous infusion.
30mg paclitaxel (5mL) vials (AUST R 43924)
100mg paclitaxel (16.7mL) vials (AUST R 53248)
300mg paclitaxel (50mL) vials (AUST R 67821)

Ingredients

Active Ingredient: paclitaxel
Inactive Ingredients: PEG-35 castor oil and ethanol.

Storage

Taxol concentrate for intravenous infusion should be stored in the original carton below 25°C and protected from light.

Sponsored by

Bristol-Myers Squibb Australia Pty Ltd,
4 Nexus Court, Mulgrave,
Victoria 3170, Australia

Where to get further information

Your doctor is the best person to answer any further questions you may have about Taxol.
Anything your doctor tells you about Taxol should be followed even if it is different from what is in this leaflet.
 
Date of Preparation: November 2012
 
TAXOL® is a trademark of Bristol-Myers Squibb Company.
CREMOPHOR® EL is a registered trademark of BASF Aktiengesellschaft.
 
AU_CMI_Taxol_V12.0_Nov12.docx