DOCETAXEL-RZ

Main information

  • Trade name:
  • DOCETAXEL-RZ docetaxel 80 mg/4 ml Concentrated Solution for Infusion vial
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • DOCETAXEL-RZ docetaxel 80 mg/4 ml Concentrated Solution for Infusion vial
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 215834
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

215834

DOCETAXEL-RZ docetaxel 80 mg/4 ml Concentrated Solution for Infusion vial

ARTG entry for

Medicine Registered

Sponsor

Dr Reddys Laboratories Australia Pty Ltd

Postal Address

Level 9 / 492 St Kilda Road,MELBOURNE, VIC, 3004

Australia

ARTG Start Date

22/12/2014

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-RZ docetaxel 80 mg/4 ml Concentrated Solution for Infusion vial

Product Type

Single Medicine Product

Effective date

22/09/2015

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Breast Cancer,Metastatic Breast Cancer,DOCETAXEL-RZ is indicated for the treatment of patients with locally advanced or metastatic breast cancer in

whom previous chemotherapy has failed.,DOCETAXEL-RZ 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-RZ 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-RZ 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-RZ in

combination with trastuzumab (AC-TH) is indicated for the adjuvant treatment of patients with operable breast cancer whose tumours overexpress

HER2,DOCETAXEL-RZ in combination with carboplatin and trastuzumab (TCH) is indicated for the adjuvant treatment of patients with operable breast

cancer whose tumours overexpress HER2.,DOCETAXEL-RZ 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-RZ 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-RZ is indicated for the treatment of metastatic carcinoma of the ovary after failure of firstline or subsequent

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

cancer.,Head and Neck Cancer,DOCETAXEL-RZ, 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

1 vial

(S4) Prescription Only Medicine

Components

1. DOCETAXEL-RZ docetaxel 80 mg/4 ml Concentrated Solution for Infusion vial

Dosage Form

Injection, concentrated

Route of Administration

Intravenous Infusion

Visual Identification

Sterile pale yellow to brownish yellow solution in 5 ml tubular glass vial

stoppered with chlorobutyl rubberstopper and sealed with flip off seal.

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

Public Summary

Page 1 of

Produced at 26.11.2017 at 08:04:43 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

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

Public Summary

Page 2 of

Produced at 26.11.2017 at 08:04:43 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

DOCETAXEL-DRLA

DOCETAXEL-RZ

DOCETERE DOTAX

Contains the active ingredient docetaxel

Consumer Medicine Information

What is in this leaflet

Read this leaflet carefully before

taking your medicine.

This leaflet answers some of the

common questions about docetaxel.

It does not contain all the

information. It does not take the

place of talking to your doctor, nurse

or pharmacist.

All medicines have risks and

benefits. Your doctor will have

weighed the risks of you taking this

medicine against the benefits they

expect it will have for you.

If you have any concerns about

taking this medicine, ask your

doctor or pharmacist.

Keep this leaflet with the medicine.

You may need to read it again.

What this medicine is

used for

The name of your medicine is

Docetaxel-DRLA Docetaxel-RZ

Docetere Dotax. It contains the active

ingredient docetaxel.

Docetaxel is used to treat breast

cancer, ovarian cancer, some types of

lung cancer, head and neck cancer

and prostate cancer.

Docetaxel works by stopping cells

from growing and multiplying.

Docetaxel 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 for another purpose.

Ask your doctor, nurse or

pharmacist if you have any

questions about why this medicine

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.

Docetaxel may be used alone or in

combination with other medicines to

treat cancer.

This medicine is only available with

a doctor's prescription.

Docetaxel is not addictive.

Your doctor may prescribe this

medicine for another use. Ask your

doctor if you want more information.

Rosuvastatin is not addictive.

Use in children

Docetaxel is not recommended for

use in children.

Before you given this

medicine

When you must not be given

it

Do not receive docetaxel 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 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.

Like most medicines used to treat

cancer, docetaxel is not

recommended for use during

DOCETAXEL-DRLA DOCETAXEL-RZ DOCETERE DOTAX

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 passes

into breast milk and therefore there is

a possibility that the breast-fed baby

may be affected.

Do not receive after the use by

(expiry) date printed on the pack.

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, talk to

your doctor or pharmacist.

Before you are given it

Tell your doctor if you have

allergies to:

any 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,

docetaxel 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

breastfeeding or planning to

breast-feed.

It is not known whether docetaxel

passes into breast milk. Your doctor

will discuss the risks and benefits of

being given it if you are

breastfeeding 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.

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 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

medicines used to treat or prevent

viral infections, including

ritonavir

These medicines and treatments may

be affected by docetaxel, 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.

How it is given

Docetaxel should only be

administered by trained

professionals, with appropriate

handling, in a hospital or clinic

environment.

Before you are given your

docetaxel 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

docetaxel infusion at that time.

Ask your doctor or pharmacist if

you have any questions on these

medicines or tests.

How to 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 is 75

to 100 mg/m

which is based on your

body size (m

When docetaxel is given in

combination with capecitabine

(another medicine used for the

treatment of breast cancer) the usual

dose of docetaxel is 75 mg/m

DOCETAXEL-DRLA DOCETAXEL-RZ DOCETERE DOTAX

Ask your doctor if you want to

know more about the dose of

docetaxel you receive.

How it is given

Docetaxel is given as an infusion

(drip) into your veins, over 1 hour.

How long it will be given

Docetaxel 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 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, tell your doctor

immediately or go to Accident and

Emergency at your nearest

hospital.

You may need urgent medical

attention.

While you are taking

this medicine

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 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.

If you are about to be started on

any new medicine, tell your doctor

or pharmacist that you are being

given docetaxel.

If you plan to have surgery that

needs a general anaesthetic, tell

your doctor or dentist that you are

being docetaxel.

If you become pregnant while you

are being given docetaxel, tell your

doctor immediately.

Docetaxel 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 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 to treat any

other complaints unless your

doctor tells you to.

Possible 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.

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

DOCETAXEL-DRLA DOCETAXEL-RZ DOCETERE DOTAX

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

These are the more common side

effects of docetaxel.

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 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 in combination with

another chemotherapy agent.

Please consult your doctor for

possible side effects that may be

caused by using docetaxel 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 may take some time to

occur. Therefore even after you

have finished your docetaxel

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

The docetaxel 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.

Product description

What Docetaxel-DRLA

Docetaxel-RZ Docetere

Dotax looks like

The Docetaxel-DRLA Docetaxel-RZ

Docetere Dotax single-dose vials

contain a clear yellowish to brown

thick liquid. The docetaxel

concentrate vial is mixed into the

clear diluent by the pharmacy. This is

then injected into an infusion

bag/glass bottle ready for your

DOCETAXEL-DRLA DOCETAXEL-RZ DOCETERE DOTAX

infusion in the Chemotherapy Unit.

The infusion bag/glass bottle is then

sent to the Chemotherapy Unit ready

for your infusion.

Ingredients

Each Docetaxel-DRLA Docetaxel-

RZ Docetere Dotax vial contains 20

mg or 80 mg of docetaxel as the

active ingredient.

The concentrate also contains

polysorbate 80.

The diluent vials contains water for

injections and ethanol.

This medicine is gluten-free, sucrose-

free, tartrazine-free and free of other

azo dyes.

Australian Registration

Numbers

Docetaxel-DRLA 20 mg:

AUST R 215837

Docetaxel-DRLA 80 mg:

AUST R 215836

Docetaxel-RZ 20 mg:

AUST R 215838

Docetaxel-RZ 80 mg:

AUST R 215834

Docetere 20 mg:

AUST R 215835

Docetere 80 mg:

AUST R 215839

Dotax 20 mg:

AUST R 215840

Dotax 80 mg:

AUST R 215841

Sponsor

Dr Reddy’s Laboratories Australia

Pty Ltd

Level 9, 492 St. Kilda Road

Melbourne, VIC 3004

Australia

This leaflet was updated in January

2015.

DOCETAXEL-DRLA DOCETAXEL-RZ DOCETERE DOTAX

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Docetaxel Teva (Teva B.V.)

Docetaxel Teva (Teva B.V.)

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Docetaxel Accord (Accord Healthcare Limited)

Docetaxel Accord (Accord Healthcare Limited)

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Docetaxel Kabi (Fresenius Kabi Deutschland GmbH)

Docetaxel Kabi (Fresenius Kabi Deutschland GmbH)

Docetaxel Kabi (Active substance: Docetaxel) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3053 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2325/T/19

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Docetaxel

Docetaxel

Docetaxel (Active substance: Docetaxel) - Centralised - Art 28 - (PSUR - Commission Decision (2017)7984 of Mon, 27 Nov 2017 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/1152/201611

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