Oncotaxel Concentrate for infusion

Oncotaxel Concentrate for infusion is a brand of medicine containing the active ingredient docetaxel.

Find out more about active ingredients.

Consumer medicine information (CMI) leaflet

Developed by the pharmaceutical company responsible for this medicine in Australia, according to TGA regulations.

ONCOTAXEL

contains the active ingredient docetaxel


Consumer Medicine Information

What is in this leaflet

This leaflet answers some common questions about ONCOTAXEL.

It does not contain all of the available information. It does not take the place of talking to your doctor or pharmacist.

All medicines have benefits and risks. Your doctor has weighed the risks of you taking ONCOTAXEL against the benefits they expect it will have for you.

If you have any concerns about taking this medicine, talk to your doctor or pharmacist.

Keep this leaflet with your medicine. You may need to read it again.

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What ONCOTAXEL is used for

ONCOTAXEL is used to treat breast cancer, ovarian cancer, some types of lung cancer, head and neck cancer and prostate cancer. It works by stopping cells from growing and multiplying.

ONCOTAXEL belongs to a group of medicines called antineoplastic or cytotoxic medicines. You may also hear of these being called chemotherapy medicines.

Your doctor may have prescribed ONCOTAXEL for another reason. Ask your doctor if you have any questions about why ONCOTAXEL has been prescribed for you.

You may have taken another medicine to treat your breast, ovarian, lung, head and neck or prostate cancer. However, your doctor has now decided to treat you with ONCOTAXEL.

ONCOTAXEL may be used alone or in combination with other medicines to treat cancer.

ONCOTAXEL is available only with a doctor's prescription.

ONCOTAXEL is not addictive.

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Before you are given ONCOTAXEL

When you must not be given it

ONCOTAXEL is not recommended for use in children.

Do not receive ONCOTAXEL if you have an allergy to docetaxel or any of the ingredients listed at the end of this leaflet. Symptoms of an allergic reaction include:

  • shortness of breath, wheezing, difficulty breathing or a tight feeling in your chest
  • swelling of the face, lips, tongue or other parts of the body
  • rash, itching, hives or flushed, red skin
  • dizziness or light-headedness
  • back pain.

Do not receive ONCOTAXEL if you have, or have had, any of the following medical conditions:

  • severe liver problems
  • blood disorder with a reduced number of white blood cells.

Do not receive it if you are pregnant or intend to become pregnant either during treatment or in the three months following the last dose of ONCOTAXEL. Like most medicines used to treat cancer, ONCOTAXEL is not recommended for use during pregnancy, unless you and your doctor have discussed the risks and benefits involved.

Do not receive it if you are breastfeeding or planning to breastfeed. It is not known if ONCOTAXEL passes into breast milk and therefore there is a possibility that the breast-fed baby may be affected.

Do not receive ONCOTAXEL if the expiry date (Exp.) printed on the vial has passed.

Do not receive ONCOTAXEL if the packaging is torn or shows signs of tampering.

Before you are given it

Tell your doctor if you have allergies to:

  • any of the ingredients listed at the end of this leaflet
  • any other medicines
  • any other substances, such as foods, preservatives or dyes.

Tell your doctor if you are pregnant or intend to become pregnant. Like most medicines of this kind, ONCOTAXEL is not recommended to be used during pregnancy. Your doctor will discuss the risks and benefits of being given it if you are pregnant.

Tell your doctor if you are breast-feeding or planning to breast-feed. It is not known whether ONCOTAXEL passes into breast milk. Your doctor will discuss the risks and benefits of being given it if you are breast-feeding or planning to breast-feed.

Tell your doctor if you have or have had any medical conditions, especially the following:

  • liver problems
  • blood disorder with a reduced number of white blood cells.

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.

Tell your doctor if you plan to have surgery.

If you have not told your doctor about any of the above, tell them before you are given ONCOTAXEL.

Taking other medicines

Tell your doctor if you are taking any other medicines, including any that you buy without a prescription from a pharmacy, supermarket or health food shop. Some medicines may be affected by ONCOTAXEL, or may affect how well it works. These include:

  • other medicines used to treat cancer, radiation therapy or any other treatment which lowers your immune system, including cyclosporin
  • some medicines used to treat bacterial infections, including erythromycin
  • ketoconazole - a medicine used to treat fungal infections
  • nifedipine - medicine used to treat high blood pressure and angina
  • medicines used to used to treat or prevent viral infections, including ritonavir.

Your doctor can tell you what to do if you are taking any of these medicines.

If you are not sure whether you are taking any of these medicines, check with your doctor or pharmacist.

Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking ONCOTAXEL.

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How ONCOTAXEL is given

ONCOTAXEL should only be administered by trained professionals, with appropriate handling, in a hospital or clinic environment.

Before you are given your ONCOTAXEL infusion your doctor should:

  • prescribe you an oral corticosteroid (eg dexamethasone) to help stop or reduce the severity of certain side effects. For breast, lung ovarian, and head and neck cancer, this medicine is usually taken for three days (one day before, the day of and the day after your infusion). These medicines are very important. For prostate cancer, this is usually taken on the day of the infusion (12 hours, 3 hours and 1 hour before your infusion).
  • test your blood to see how many white blood cells you have. If they are too low, your infusion may be delayed
  • test your blood for levels of liver enzymes. If these levels are high your doctor may reduce your dose or decide you should not have a ONCOTAXEL infusion at that time.

Ask your doctor or pharmacist if you have any questions on these medicines or tests.

How much is given

Your doctor will decide what dose you will receive. This depends on your condition and other factors, such as your weight and height.

The standard dose of ONCOTAXEL is 75 to 100mg/m2 which is based on your body size (m2).

When ONCOTAXEL is given in combination with capecitabine (another medicine used for the treatment of breast cancer) the usual dose of ONCOTAXEL is 75 mg/m2.

Ask your doctor if you want to know more about the dose of ONCOTAXEL you receive.

How long ONCOTAXEL is given for

ONCOTAXEL is given every 3 weeks. This is called one cycle of chemotherapy. Your doctor will decide how many of these cycles you will need.

If you receive too much ONCOTAXEL (overdose)

As ONCOTAXEL is given to you under the supervision of your doctor, it is very unlikely that you will receive too much. However, if you experience any unexpected or worrying side effects after being given ONCOTAXEL, tell your doctor immediately or go to Accident and Emergency at your nearest hospital. You may need urgent medical attention.

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While you are being given ONCOTAXEL

Things you must do

Be sure to keep all your doctor's appointments. It is important to have your follow-up doses/cycles/infusions of ONCOTAXEL at the appropriate times to get the best effects from your treatments.

Your doctor may also 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.

Tell all the doctors, dentists and pharmacists who are treating you that you are being given ONCOTAXEL.

If you are about to be started on any new medicine, tell your doctor or pharmacist that you are being given ONCOTAXEL.

If you plan to have surgery that needs a general anaesthetic, tell your doctor or dentist that you are being given ONCOTAXEL.

If you become pregnant while you are being given ONCOTAXEL, tell your doctor immediately.

ONCOTAXEL 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 or nurse immediately if you think you may be getting an infection, or if you get a fever, chills, cough, hoarse throat, pain in the lower back or side or you 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.

If you notice swelling in the feet and legs or a slight weight gain, inform your doctor or nurse. ONCOTAXEL may cause fluid retention which means the body is holding extra water. If this fluid retention is in the chest or around the heart it can be life-threatening. In most cases, fluid retention will go away within weeks or months after your treatments are completed.

Things you must not do

Do not have ONCOTAXEL to treat any other conditions unless your doctor tells you to.

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Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking ONCOTAXEL.

Like all other medicines, ONCOTAXEL may have unwanted side effects in some people. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.

Do not be alarmed by this list of possible side effects. You may not experience any of them.

Ask your doctor or pharmacist to answer any questions you may have.

Tell your doctor if you notice any of the following and they worry you:

  • irritation, pain, swelling or colouring around the needle during infusion
  • high temperature
  • stomach pain or discomfort
  • feeling sick, upset stomach or vomiting
  • mild diarrhoea
  • constipation
  • inflammation of the food pipe (oesophagus)
  • whitening or darkening of the skin or nails
  • loosening of the nails
  • unusual hair loss or thinning
  • joint pain or swelling
  • aching muscles, muscle tenderness or weakness not caused by exercise
  • unusual tiredness or weakness
  • confusion
  • mild swelling of hands, ankles and feet
  • weight gain
  • pins and needles or a burning or tingling feeling in hands or feet
  • redness or rash around previous radiation site (if you have had radiotherapy)
  • back pain
  • decreased appetite
  • high blood pressure (hypertension)
  • low blood pressure (hypotension)
  • temporary visual disturbances or feeling that you are about to faint, which mostly occur when you are being infused with ONCOTAXEL.

These are the more common side effects of ONCOTAXEL.

Tell your doctor as soon as possible if you notice any of the following:

  • infections
  • frequent infections with fever, severe chills, sore throat or mouth ulcers - especially 5-7 days after receiving a ONCOTAXEL infusion
  • sore red mouth or vagina or swelling in these areas
  • severe diarrhoea
  • tiredness, headaches, being short of breath when exercising, dizziness and looking pale
  • breathing problems, shortness of breath or difficulty in breathing
  • coughing
  • change in the rhythm or rate of your heart beats (palpitations)
  • pain in muscles
  • flushed, dry skin, irritability and confusion
  • passing little or no urine, drowsiness, nausea, vomiting and breathlessness
  • fainting
  • yellowing of the skin or eyes, also called jaundice
  • flaking of the skin
  • red, scaly patches of the skin especially around the cheeks and nose
  • raised lumps on the skin which looks like scalding
  • hardening of the skin
  • chest pain/heart attack
  • excessive watery discharge from the eyes
  • trouble with your hearing, or some loss of hearing
  • sudden and severe swelling or pain in the joints or rash

These may be serious side effects. You may need medical attention.

Tell your doctor immediately or go to Accident and Emergency at the nearest hospital if you notice any of the following:

  • sudden signs of allergy such as rash, itching, hives on the skin, swelling of the face, tongue or other parts of the body, shortness of breath, wheezing or trouble breathing
  • convulsions, fits or seizures
  • ulcer in the stomach or intestine - vomiting blood or material that looks like coffee grounds, bleeding from the back passage, black sticky bowel motions or bloody diarrhoea
  • difficulty in breathing
  • sudden swelling of the leg/arm which may be due to blood clots.

These are very serious side effects. You may need urgent medical attention or hospitalisation.

These side effects may differ when using ONCOTAXEL in combination with another chemotherapy agent.

Please consult your doctor for possible side effects that may be caused by using ONCOTAXEL with another chemotherapy agent.

The benefits and side effects of ONCOTAXEL may take some time to occur. Therefore even after you have finished your ONCOTAXEL treatment you should tell your doctor or nurse immediately if you notice any of the side effects listed in this section.

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After being given ONCOTAXE

If you have any queries about any aspect of your medicine, or any questions regarding the information in this leaflet, discuss them with your doctor or pharmacist.

Storage

The ONCOTAXEL solution for infusion will be stored in the pharmacy or on the ward. The infusion is kept in a cool dry place, protected from light, where the temperature stays below 25°C.

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Product description

What it looks like

ONCOTAXEL comes in vials of 3 different strengths:

  • ONCOTAXEL 20
  • ONCOTAXEL 80
  • ONCOTAXEL 140.

For each, the vial contains a clear, oily, pale yellow solution, the volume of solution is just different. The solution is injected into an infusion bag/glass bottle which is sent to the Chemotherapy Unit ready for your infusion.

Ingredients

The active ingredient in ONCOTAXEL is docetaxel.

  • each ONCOTAXEL 20 vial contains 20 mg of docetaxel in 1 mL of solution
  • each ONCOTAXEL 80 vial contains 80 mg of docetaxel in 4 mL of solution
  • each ONCOTAXEL 140 vial contains 140 mg of docetaxel in 7 mL of solution.

The solution also contains:

  • polysorbate 80
  • anhydrous citric acid
  • povidone
  • ethanol.

The solution does not contain gluten, lactose, sucrose, tartrazine or any other azo dyes.

Supplier

Actavis Australia Pty Ltd
Upper Ground Floor
183 Melbourne Street
North Adelaide SA 5006
Australia
Tel: 1300 881 893

Australian registration numbers:
ONCOTAXEL 20 - AUST R 167642
ONCOTAXEL 80 - AUST R 167645
ONCOTAXEL 140 - AUST R 167640

Date of preparation:
May 2011.

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CMI provided by MIMS Australia, June 2013  

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