DOCETAXEL

Main information

  • Trade name:
  • DOCETAXEL KABI docetaxel anhydrous 80 mg/4 mL concentrated injection vial
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • DOCETAXEL KABI docetaxel anhydrous 80 mg/4 mL concentrated injection vial
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 208711
  • Last update:
  • 10-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

208711

DOCETAXEL KABI docetaxel anhydrous 80 mg/4 mL concentrated injection vial

ARTG entry for

Medicine Registered

Sponsor

Fresenius Kabi Australia Pty Ltd

Postal Address

Level 2, 2 Woodland Way,Mount Kuring-gai, NSW, 2080

Australia

ARTG Start Date

21/10/2014

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 KABI docetaxel anhydrous 80 mg/4 mL concentrated injection vial

Product Type

Single Medicine Product

Effective date

21/10/2014

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Breast Cancer,Metastatic Breast Cancer,Docetaxel is indicated for the treatment of patients with locally advanced or metastatic breast cancer in whom

previous chemotherapy has failed.,Docetaxel in combination with capecitabine is indicated for the treatment of patients with locally advanced or

metastatic breast cancer after failure of prior anthracycline containing chemotherapy.,Docetaxel in combination with trastuzumab is indicated for the

treatment of patients with metastatic breast cancer whose tumours overexpress HER2 and who previously have not received chemotherapy for

metastatic disease.,Adjuvant Treatment of Breast Cancer,Docetaxel in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant

treatment of patients with node-positive breast cancer.,Doxorubicin and cyclophosphamide followed by docetaxel in combination with trastuzumab

(ACTH) is indicated for the adjuvant treatment of patients with operable breast cancer whose tumours overexpress HER2.,Docetaxel in combination with

carboplatin and trastuzumab (TCH) is indicated for the adjuvant treatment of patients with operable breast cancer whose tumours overexpress

HER2.,Docetaxel in combination with cyclophosphamide is indicated for the adjuvant treatment of operable breast cancer with a primary tumour of ?1cm

and <7cm.,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 firstline 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

Carton - 1's

(S4) Prescription Only Medicine

Components

1. DOCETAXEL KABI docetaxel anhydrous 80 mg/4 mL concentrated injection vial

Dosage Form

Injection, concentrated

Route of Administration

Intravenous

Visual Identification

Colourless to pale yellow solution

Active Ingredients

Docetaxel

80 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 11:01:40 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

CMI for Docetaxel Kabi

Feb, 2013

Page 1 of 4

Docetaxel Kabi

Docetaxel

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common

questions about Docetaxel Kabi.

It does not contain all the available

information. It does not take the

place

talking

your

doctor,

nurse or pharmacist.

medicines

have

risks

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 Kabi is

used for

Docetaxel

Kabi

used

treat

breast

cancer,

ovarian

cancer,

some types of lung cancer, head

neck

cancer

prostate

cancer.

Docetaxel Kabi works by stopping

cells from growing and multiplying.

Docetaxel Kabi belongs to a group

of medicines called antineoplastic

cytotoxic

medicines.

also

hear

these

being

called

chemotherapy medicines.

Your

doctor,

however,

prescribe

Docetaxel

Kabi

another purpose.

Ask

your

doctor,

nurse

or

pharmacist

if

you

have

any

questions about why Docetaxel

Kabi

has

been

prescribed

for

you.

have

probably

taken

another

medicine

treat

your

breast,

ovarian,

lung,

head

neck or prostate cancer. However,

your

doctor

decided

treat you with Docetaxel Kabi.

Docetaxel Kabi may be used alone

combination

with

other

medicines to treat cancer.

This medicine is only available with

a doctor’s prescription.

Docetaxel Kabi is not addictive.

Before

you

are

given

Docetaxel Kabi

When you must not be given it

Docetaxel

Kabi

recommended for use in children.

Do not receive Docetaxel Kabi 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

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 Kabi 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 Kabi.

Like most medicines used to treat

cancer,

Docetaxel

Kabi

recommended

during

pregnancy,

unless

your

doctor

have

discussed

risks

and benefits involved.

Do

not

receive

it

if

you

are

breastfeeding

or

planning

to

breastfeed.

It is not known if Docetaxel Kabi

passes

into

breast

milk

therefore there is a possibility that

breast-fed

baby

affected.

Do not receive it after the expiry

date (EXP) printed on the vial.

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

Kabi,

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

any other medicines

any other substances, such as

foods, preservatives or dyes

Tell

your

doctor

if

you

are

pregnant

or

intend

to

become

pregnant.

CMI for Docetaxel Kabi

Feb, 2013

Page 2 of 4

Like most medicines of this kind,

Docetaxel

Kabi

recommended to be used during

pregnancy. Your doctor will discuss

risks

benefits

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

Kabi passes into breast milk. Your

doctor

will

discuss the risks and

benefits of being given it if you are

breast-feeding

planning

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

infection

has gone. A mild illness, such as a

cold,

usually

reason

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

Kabi.

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

Docetaxel

Kabi may interfere with each other.

These include:

other

medicines

used

treat

cancer, radiation therapy or any

other

treatment

which

lowers

your immune system, including

cyclosporine

some medicines used to treat

bacterial

infections,

including

erythromycin

ketoconazole - a medicine used

to treat fungal infections

nifedipine

medicine

used

treat high blood pressure and

angina

These

medicines

treatments

may be affected by Docetaxel Kabi,

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

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 Kabi.

How it is given

Docetaxel

Kabi

should

only

administered

trained

professionals,

with

appropriate

handling,

hospital

clinic

environment.

Docetaxel Kabi is for single use in

patient

only.

unused

residue should be discarded.

Before

you

are

given

your

Docetaxel

Kabi

infusion

your

doctor should:

Prescribe

oral

corticosteroid

(e.g.

dexamethasone) to help stop or

reduce

severity

certain

side

effects.

breast,

lung

ovarian,

head

neck

cancer, this medicine is usually

taken for three days (one day

before, the day of and the day

after

your

infusion).

These

medicines

very

important.

prostate

cancer,

this

usually taken on the day of the

infusion (12 hours, 3 hours and

1 hour before your infusion).

Test

your

blood

many

white

blood

cells

have. If they are too low, your

infusion may be delayed.

Test

your

blood

levels

liver

enzymes.

these

levels

high

your

doctor

reduce your dose or decide you

should

have

Docetaxel

Kabi 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

other

factors,

such as your weight and height.

standard

dose

Docetaxel

Kabi is 75 to 100 mg/m

which is

based on your body size (m

When Docetaxel Kabi is given in

combination

with

capecitabine

(another

medicine

used

treatment

breast

cancer)

usual

dose

Docetaxel

Kabi

75 mg/m

Ask your doctor if you want to

know

more

about

the

dose

of

Docetaxel Kabi you receive.

How it is given

Docetaxel

Kabi

given

infusion (drip) into your veins, over

1 hour.

How long it will be given

Docetaxel

Kabi

given

every

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

Kabi

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 Kabi, tell your doctor

immediately

or

go

to

Accident

and Emergency at your nearest

hospital.

need

urgent

medical

attention.

CMI for Docetaxel Kabi

Feb, 2013

Page 3 of 4

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-

doses/cycles/infusions

Docetaxel Kabi at the appropriate

times to get the best effects from

your treatments.

Your

doctor

also

want

check your blood pressure and do

some blood and other tests from

time

time

check

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 Kabi.

If you are about to be started on

any

new

medicine,

tell

your

doctor

or

pharmacist

that

you

are being given Docetaxel Kabi.

If you plan to have surgery that

needs a general anaesthetic, tell

your doctor or dentist that you

are being given Docetaxel Kabi.

If

you

become

pregnant

while

you are being given Docetaxel

Kabi,

tell

your

doctor

immediately.

Docetaxel

Kabi

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

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.

careful

when

using

toothbrush, toothpick or dental

floss. Your doctor, dentist, nurse

or pharmacist may recommend

other ways to clean your teeth

gums.

Check

with

your

doctor before having any dental

work.

Be careful not to cut yourself

when

using

sharp

objects such as a razor or nail

cutters.

Avoid

contact

sports

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

Kabi

cause

fluid

retention which means the body is

holding

extra

water.

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 Kabi 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

risks

using

this

medicine

against the benefits they expect it

will have for you.

Do not be alarmed by this list of

possible side effects.

experience

them.

Tell

your

doctor,

nurse

or

pharmacist as soon as possible

if you do not feel well while you

are being given Docetaxel Kabi.

It helps most people with breast,

ovarian,

lung, head

neck or

prostate cancer, but it may have

unwanted

side

effects

people.

Tell

your

doctor,

nurse

or

pharmacist if you notice any of

the

following

and

they

worry

you:

irritation,

pain,

swelling

colouring

around

needle

during infusion

high temperature

stomach pain or discomfort

feeling sick, upset stomach or

vomiting

mild diarrhoea

constipation

inflammation

food

pipe

(oesophagus)

whitening

darkening

skin or nails

loosening of the nails

unusual hair loss or thinning

joint pain or swelling

aching

muscles,

muscle

tenderness

weakness

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

rash

around

previous

radiation

site

have had radiotherapy)

back pain

decreased appetite

high

blood

pressure

(hypertension)

blood

pressure

(hypotension)

temporary

visual

disturbances

or feeling that you are about to

faint, which mostly occur when

being

infused

with

Docetaxel Kabi

These are the more common side

effects of Docetaxel Kabi.

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

mouth

ulcers

especially

days after receiving a Docetaxel

Kabi infusion

CMI for Docetaxel Kabi

Feb, 2013

Page 4 of 4

sore

mouth

vagina

swelling in these areas

severe diarrhoea

tiredness,

headaches,

being

short of breath when exercising,

dizziness and looking pale

breathing

problems,

shortness

breath

difficulty

breathing

coughing

change in the rhythm or rate of

your heart beats (palpitations)

pain in muscles

flushed, dry skin, irritability and

confusion

passing

little

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

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,

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

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

back

passage,

black

sticky

bowel

motions or bloody diarrhoea

difficulty in breathing

sudden swelling of the leg/arm

which

blood

clots.

These are very serious side effects.

need

urgent

medical

attention or hospitalisation.

These side effects may differ when

using

Docetaxel

Kabi

combination

with

another

chemotherapy agent.

Please consult your doctor for

possible side effects that may be

caused by using Docetaxel Kabi

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.

experience

them.

Ask your doctor to answer any

questions you may have.

The benefits and side effects of

Docetaxel Kabi may take some

time

to

occur.

Therefore

even

after

you

have

finished

your

Docetaxel

Kabi

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

Kabi

solution

infusion

will

stored

pharmacy

ward.

infusion is kept in a cool dry place,

protected

from

light,

where

temperature stays below 25

Product Description

What it looks like

Docetaxel

Kabi

single-dose

vials

contain a clear colourless to pale

yellow liquid.

Docetaxel

Kabi

concentrate

vial

injected

into

infusion

bag/glass bottle.

infusion

bag/glass

bottle

then sent to the Chemotherapy Unit

ready for your infusion.

Ingredients

Active ingredient:

Docetaxel Kabi 20 mg contains 20

mg of docetaxel per vial.

Docetaxel Kabi 80 mg contains 80

mg of docetaxel per vial.

Docetaxel

Kabi

160 mg contains

160 mg of docetaxel per vial.

Inactive ingredients:

Polysorbate 80, absolute ethanol

Your doctor, nurse or pharmacist

inform

what

other

ingredients

your

infusion

bag/glass bottle.

Taxotere does not contain gluten,

sucrose, lactose, tartrazine or any

other azo dyes.

Sponsor

Fresenius

Kabi

Australia

Limited

964 Pacific Highway

Pymble NSW 2073

Telephone: (02) 9391 5555

Australian Registration Number

20 mg/1 mL: AUST R 208712

80 mg/4 mL: AUST R 208711

160 mg/8 mL: AUST R 208713

This leaflet was prepared in

Feb, 2013

1-11-2018

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