DOCETAXEL

Main information

  • Trade name:
  • DOCETAXEL ACCORD 160 mg/8 mL docetaxel concentrated injection 160 mg/8 mL glass vial
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • DOCETAXEL ACCORD 160 mg/8 mL docetaxel concentrated injection 160 mg/8 mL glass vial
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 209465
  • Last update:
  • 10-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

209465

DOCETAXEL ACCORD 160 mg/8 mL docetaxel concentrated injection 160 mg/8 mL glass vial

ARTG entry for

Medicine Registered

Sponsor

Accord Healthcare Pty Ltd

Postal Address

Level 24 570 Bourke Street,Melbourne, VIC, 3000

Australia

ARTG Start Date

17/02/2015

Product category

Medicine

Status

Active

Approval area

Drug Safety Evaluation Branch

Conditions

Conditions applicable to all therapeutic goods as specified in the document "Standard Conditions Applying to Registered or Listed Therapeutic Goods

Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Standard Conditions Applying to Registered

or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Products

1. DOCETAXEL ACCORD 160 mg/8 mL docetaxel concentrated injection 160 mg/8 mL glass vial

Product Type

Single Medicine Product

Effective date

4/10/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Breast Cancer: Docetaxel is indicated for the treatment of patients with locally advanced or metastatic breast cancer in whom previous chemotherapy

has failed. ,Adjuvant Treatment of Breast cancer: Docetaxel in combination with cyclophosphamide is indicated for the adjuvant treatment of operable

breast cancer with a primary tumour of greater than or equal to 1cm and less than 7 cm.,Non Small Cell Lung Cancer: Docetaxel is indicated for the

treatment of patients with locally advanced or metastatic non-small cell lung cancer, including those who have failed platinum-based

chemotherapy.,Ovarian Cancer: Docetaxel is indicated for the treatment of metastatic carcinoma of the ovary after failure of first-line or subsequent

chemotherapy.,Prostate Cancer: Docetaxel is indicated for the treatment of patients with androgen independent (hormone refractory) prostate

cancer.,Head and Neck Cancer: Docetaxel, in combination with cisplatin and fluorouracil, is indicated as induction treatment prior to chemoradiotherapy,

for the treatment of patients with locally advanced, squamous cell carcinoma of the head and neck, who have low probability of surgical cure, require

organ preservation or where the,tumour is technically unresectable.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Vial

Glass Type I Clear

24 Months

Store below 25

degrees Celsius

Not recorded

Protect from Light

Pack Size/Poison information

Pack Size

Poison Schedule

Pack of 1 vial

(S4) Prescription Only Medicine

Components

1. DOCETAXEL ACCORD 160 mg/8 mL docetaxel concentrated injection 160 mg/8 mL glass vial

Dosage Form

Injection, concentrated

Route of Administration

Intravenous

Visual Identification

Supplied in single-dose vials as a sterile, pyrogen-free, non-aqueous,pale

yellow to brownish-yellow solution.

Active Ingredients

Docetaxel

160 mg

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 27.11.2017 at 10:21:17 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

Patient Information leaflet

Version 2.0

Page 1 of 5

DOCETAXEL ACCORD

Docetaxel Concentrated Injection 20 mg/1 mL, 80 mg/4 mL and 160 mg/8 mL

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common

questions about Docetaxel Accord.

It does not contain all the available

information. It does not take the place of

talking to your doctor, nurse or

pharmacist.

All medicines have risks and benefits.

Your doctor has weighed the risks of you

being given this medicine against the

benefits they expect it will have for you.

If you have any concerns about being

given this medicine, ask your doctor,

nurse or pharmacist.

Keep this leaflet with the medicine.

You may need to read it again.

What Docetaxel Accord

is used for

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 belongs to a group of

medicines called antineoplastic or

cytotoxic medicines. You may also hear

of these being called chemotherapy

medicines.

Your doctor, however, may prescribe

Docetaxel Accord for another purpose.

Ask your doctor, nurse or pharmacist

if you have any questions about why

Docetaxel Accord has been prescribed

for you.

You may have probably 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 Docetaxel Accord.

Docetaxel Accord may be used alone or

in combination with other medicines to

treat cancer.

This medicine is only available with a

doctor's prescription.

Docetaxel Accord is not addictive.

Before you are given it

When you must not be given

it

Docetaxel Accord is not recommended

for use in children.

Do not receive Docetaxel Accord 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 Docetaxel Accord 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

Docetaxel Accord.

Like most medicines used to treat

cancer, Docetaxel Accord 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 Docetaxel Accord

passes into breast milk and therefore

there is a possibility that the breast-fed

baby may be affected.

Do not receive it after the expiry date

(EXP) printed on the carton.

If you receive it after the expiry date has

passed, it may not work as well.

Do not receive it if the packaging is

damaged or shows signs of tampering.

If you are not sure whether you

should start having Docetaxel Accord,

talk to your doctor or pharmacist.

Before you are given it

Tell your doctor if you have allergies

to:

any of the ingredients listed at the

end of this leaflet

Version 2.0

Page 2 of 5

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,

Docetaxel Accord 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 Docetaxel

Accord 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 Docetaxel Accord.

Taking other medicines or

treatments

Tell your doctor, nurse or pharmacist if

you are taking any other medicines,

including any 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.

Your doctor, nurse or pharmacist has

more information on medicines to be

careful with or to avoid while being

given Docetaxel Accord.

How it is given

Docetaxel Accord should only be

administered by trained professionals,

with appropriate handling, in a hospital

or clinic environment.

Docetaxel Accord is for single use in one

patient only. Any unused residue should

be discarded.

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.

breast,

lung,

ovarian,

and head and neck, this medicine is

usually

taken

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,

hours

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.

these

levels

high

your doctor may reduce your dose

decide

should

have

Docetaxel

Accord 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 Docetaxel Accord

is 75 to 100mg/m

which is based on

your body size (m

Ask your doctor if you want to know

more about the dose of Docetaxel

Accord you receive.

How it is given

Docetaxel Accord is given as an infusion

(drip) into your veins, over 1 hour.

How long it will be given

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

(Overdose)

As Docetaxel Accord 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 Docetaxel

Accord, tell your doctor immediately

Version 2.0

Page 3 of 5

or go to Accident and Emergency at

your nearest hospital.

You may need urgent medical attention.

While you are being

given it

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 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.

Tell all the doctors, dentists, and

pharmacists who are treating you that

you are being given Docetaxel Accord.

If you are about to be started on any

new medicine, tell your doctor or

pharmacist 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.

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.

Things you must not do

Do not have Docetaxel Accord to treat

any other complaints unless your

doctor tells you to.

Side Effects

All medicines have some unwanted side

effects. Sometimes they are serious, but

most of the time they are not. Your

doctor has weighed the risks of using

this medicine against the benefits they

expect it will have for you.

Do not be alarmed by this list of

possible side effects.

You may not experience any of them.

Tell your doctor, nurse or pharmacist

as soon as possible if you do not feel

well while you are being given

Docetaxel Accord.

It helps most people with breast, ovarian,

lung, head and neck or prostate cancer,

but it may have unwanted side effects in

a few people.

Tell your doctor, nurse or pharmacist

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 Docetaxel

Accord

Version 2.0

Page 4 of 5

These are the more common side effects

of Docetaxel Accord.

Tell your doctor, nurse or pharmacist

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 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

These may be serious side effects.

You may need medical attention.

If any of the following happen, tell

your doctor or nurse immediately, or

go to Accident and Emergency at your

nearest hospital:

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

Docetaxel Accord in combination with

another chemotherapy agent.

Please consult your doctor for possible

side effects that may be caused by

using Docetaxel Accord with another

chemotherapy agent.

Tell your doctor, nurse or pharmacist

if you notice anything that is making

you feel unwell.

Other side effects not listed above may

occur in some patients.

Do not be alarmed by this list of

possible side effects.

You may not experience any of them.

Ask your doctor to answer any

questions you may have.

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.

After being given it

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, nurse or pharmacist.

Storage

Docetaxel Accord concentrated injection

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.

Product Description

What it looks like

Docetaxel Accord single-dose vials

contain a pale yellow to brownish-

yellow solution. It is available in 3

presentations; 20 mg/1 mL, 80 mg/4 mL

and 160 mg/8 mL in single packs.

Docetaxel Accord concentrate vial is

injected into an infusion bag. The

infusion bag is then sent to the

Chemotherapy Unit ready for your

infusion.

Ingredients

Active Ingredient: docetaxel

Inactive ingredients:

Citric acid

Ethanol anhydrous

Polysorbate 80.

Your doctor, nurse or pharmacist can

inform you what other ingredients are in

your infusion bag.

Docetaxel Accord does not contain

gluten, sucrose, lactose, tartrazine or any

other azo dyes.

Version 2.0

Page 5 of 5

Name and Address of the

Sponsor

Accord Healthcare Pty Ltd.

Level 24, 570 Bourke Street

Melbourne, VIC, 3000

Australia

Australian Registration Number

20 mg/1 mL: AUST R 209471

80 mg/4 mL: AUST R 209473

160 mg/8 mL: AUST R 209465

Date of preparation

This leaflet was prepared on 27 January

2017.

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