DOCETAXEL ACCORD

DOCETAXEL ACCORD

Active ingredient(s): Docetaxel

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Consumer Medicine Information (CMI)

This leaflet provides important information about using Docetaxel Accord. 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 Docetaxel Accord.

Where to find information in this leaflet:

1. Why am I being given Docetaxel Accord?
2. What should I know before I am given Docetaxel Accord?
3. What if I am taking other medicines?
4. How will I be given Docetaxel Accord?
5. What should I know while being given Docetaxel Accord?
6. Are there any side effects?
7. Product details

1. Why am I being given Docetaxel Accord?

Docetaxel Accord contains the active ingredient Docetaxel. Docetaxel Accord belongs to a group of medicines known as antineoplastic or cytotoxic agents. You may also hear of these being called chemotherapy medicines.

Docetaxel Accord is used to treat breast cancer, ovarian cancer, some types of lung cancer, head and neck cancer and prostate cancer.

Docetaxel Accord works by stopping cells from growing and multiplying.

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

Your doctor, however, may prescribe Docetaxel Accord for another purpose.

2. What should I know before I am given Docetaxel Accord?

Warnings

You must not be given Docetaxel Accord if:

• you have an allergy to docetaxel, paclitaxel or any of the ingredients listed at the end of this leaflet.
• severe liver problems
• you are pregnant or intend to become pregnant either during treatment or in the three months following the last dose of Docetaxel Accord

Docetaxel Accord is not recommended for use in children.

Tell your doctor if you have or have had:

• liver problems
• blood disorder with a reduced number of white blood cells
• epilepsy
• an infection or high temperature. Your doctor may decide to delay your treatment until the infection has gone

Tell your doctor if you plan to have surgery.

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

Tell your doctor if you:

• are pregnant, or intend to become pregnant
• are breastfeeding or plan to breastfeed

Like most medicines used to treat cancer, Docetaxel Accord is not recommended for use during pregnancy. Your doctor will discuss with you the risks and benefits of having Docetaxel Accord during pregnancy.

You should not breast-feed your child during your treatment with Docetaxel Accord. Docetaxel Accord may pass into breast milk and therefore there is a possibility that the breast-fed baby may be affected.

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 Docetaxel Accord may interfere with each other. 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

These medicines and treatments may be affected by Docetaxel Accord or may affect how well it works. You may need different amounts of your medicine, or you may need to have 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 Docetaxel Accord.

4. How will I be given Docetaxel Accord?

Before you are given your Docetaxel Accord infusion your doctor should:

• Prescribe you an oral corticosteroid (e.g. dexamethasone) to help stop or reduce the severity of certain side effects. For breast, lung, ovarian, and head and neck, 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 Docetaxel Accord infusion at that time

How much will be given

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

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

When will Docetaxel Accord be given

Docetaxel Accord is given as an infusion (drip) into your veins, over 1 hour.

Docetaxel Accord 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 Docetaxel Accord

Since Docetaxel Accord is usually given to you in hospital under the supervision of your doctor, it is very unlikely that you will be given too much of the medicine. If you think that you have been given too much Docetaxel Accord.

You should immediately:

• phone the Poisons Information Centre (by calling 13 11 26), or
• contact your doctor, nurse or pharmacist.

5. What should I know while being given Docetaxel Accord?

Things you must do

Be sure to keep all your doctor’s appointments.

It is important to have your follow-up doses/cycles of Docetaxel Accord 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.

Docetaxel Accord 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.

Docetaxel Accord 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.

If you are about to be started on any new medicine, remind your doctor and pharmacist that you are being given Docetaxel Accord.

Tell any other doctors, dentists, and pharmacists who treat you that you are being given Docetaxel Accord.

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

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

Driving or using machines

Be careful driving or operating machinery until you know how Docetaxel Accord affects you.

Looking after your medicine

The hospital will store Docetaxel Accord under the correct conditions.

Getting rid of any unwanted medicine

Your doctor or pharmacist will dispose of any Docetaxel Accord that may be left over.

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.

Common side effects

Less serious side effects

What to do

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 Docetaxel Accord

Speak to your doctor if you have any of these common side effects and they worry you

Serious side effects

Serious side effects

What to do

infections frequent infections with fever, severe chills, sore throat or mouth ulcers – especially 5-7 days after receiving a Docetaxel Accord 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, wheezing 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

Call your doctor straight away

Very Serious side effects

Very serious side effects

What to do

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

Call your doctor straight away or go straight to the Emergency Department at your nearest hospital

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

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed above may occur in some patients.

The benefits and side effects of Docetaxel Accord may take some time to occur. Therefore, even after you have finished your Docetaxel Accord treatment you should tell your doctor or nurse 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.

It is not addictive.

What Docetaxel Accord contains

Active ingredient (main ingredient)	docetaxel
Other ingredients (inactive ingredients)	citric acid ethanol anhydrous polysorbate 80

Do not take this medicine if you are allergic to any of these ingredients.

Docetaxel Accord does not contain gluten, sucrose, lactose, tartrazine or any other azo dyes.

What Docetaxel Accord looks like

Docetaxel Accord is a pale yellow to brownish-yellow solution supplied in a vial in single packs. (80 mg/4 mL: AUST R 209473, 160 mg/8 mL: AUST R 209465)

Who distributes Docetaxel Accord

Accord Healthcare Pty Ltd
Level 24, 570 Bourke Street
Melbourne, VIC, 3000
Australia

This leaflet was prepared in May 2022.