PACLITAXEL

Main information

  • Trade name:
  • PACLITAXEL ACCORD paclitaxel 300 mg/50 mL concentrated injection vial
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • PACLITAXEL ACCORD paclitaxel 300 mg/50 mL concentrated injection vial
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 219556
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

219556

PACLITAXEL ACCORD paclitaxel 300 mg/50 mL concentrated injection 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

2/02/2016

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. PACLITAXEL ACCORD paclitaxel 300 mg/50 mL concentrated injection vial

Product Type

Single Medicine Product

Effective date

30/01/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

- Primary treatment of ovarian cancer in combination with a platinum agent.

- Treatment of metastatic carcinoma of the ovary after failure of standard therapy.

- Treatment of metastatic carcinoma of the breast after failure of standard therapy.

- Adjuvant treatment of node-positive breast cancer administered sequentially to doxorubicin and cyclophosphamide.

- Treatment of metastatic cancer of the breast, in combination with trastuzumab (Herceptin), in patients who have tumours that over-express HER-2 and

who have not received previous chemotherapy for their metastatic disease.

- in combination with gemcitabine (Gemzar), is indicated for the treatment of patients with unresectable, locally recurrent or metastatic breast cancer who

have relapsed following adjuvant/neoadjuvant chemotherapy. Prior chemotherapy should have included an anthracycline unless clinically

contraindicated.

- for the treatment of non-small cell lung cancer (NSCLC).

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Vial

Glass Type I Clear

24 Months

Store below 25

degrees Celsius

Neither child resistant

closure nor restricted

flow insert

Protect from Light

Pack Size/Poison information

Pack Size

Poison Schedule

(S4) Prescription Only Medicine

Components

1. PACLITAXEL ACCORD paclitaxel 300 mg/50 mL concentrated injection vial

Dosage Form

Injection, concentrated

Route of Administration

Intravenous Infusion

Visual Identification

A clear, colorless to slightly yellow solution in a clear glass vial with flip off

seal.

Active Ingredients

Paclitaxel

300 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 26.11.2017 at 03:35:11 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

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PACLITAXEL ACCORD

Paclitaxel Concentrated Injection 30 mg/5 mL, 100 mg/16.7 mL and 300 mg/50 mL

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common

questions about Paclitaxel Accord.

It does not contain all the available

information. It does not take the place of

talking to your doctor.

All medicines have risks and benefits.

Your doctor has 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.

Keep this leaflet.

You may need to read it again.

What Paclitaxel Accord

is used for

Paclitaxel Accord is used to treat cancer

of the ovary, the breast, and non small

cell cancer of the lung. Paclitaxel Accord

may be used alone or in combination with

other anticancer agents.

Paclitaxel Accord is not recommended

for use in children as its safety and

effectiveness in patients under 18 years

of age has not been established.

Ask your doctor if you have any

questions about why Paclitaxel Accord

was prescribed for you.

How Paclitaxel Accord works

Paclitaxel Accord belongs to a class of

anticancer agents known as taxanes.

These agents prevent the division of cells,

particularly cancer cells.

The use of Paclitaxel Accord to treat your

cancer can lead to side-effects, which are

discussed below.

How Paclitaxel Accord is

used

Paclitaxel Accord will be administered as

an infusion in a hospital clinic. Paclitaxel

Accord may be used alone or with other

anticancer medicines.

The dose is worked out based on your

body weight and height, and so may be

different from the dose chosen for other

people. Paclitaxel Accord is administered

as an intravenous infusion over a 3 hour

period. Administration will occur at 3

week intervals. The administration of

Paclitaxel Accord requires all patients to

be given premedication prior to Paclitaxel

Accord.

The premedication consists of three

other drugs which work by reducing the

likelihood of an allergic reaction

occurring when you receive your

Paclitaxel Accord. They are given as

tablets 12 and 6 hours before the

Paclitaxel Accord is given and two

injections into the vein given 30 to 60

minutes prior to the Paclitaxel Accord

being given.

Before Receiving

Paclitaxel Accord

When Paclitaxel Accord must

not be given

You have a history of severe

allergic reactions to paclitaxel or

other drugs formulated in PEG-35

castor oil (Cremophor EL).

You have a severe neutropenia

(reduced numbers of the white

blood cells that fight infections)

If you are pregnant or intend to

become pregnant.

Paclitaxel Accord may cause harm to the

unborn baby if it is given to a pregnant

woman.

If you are breast feeding

If you take this medicine after the expiry

date has passed, it may not work as well

(or it may make you feel sick).

Before you receive Paclitaxel

Accord

Before you receive Paclitaxel Accord for

the first time you should tell your doctor

If you are taking any other medicines

or treatment

If you have ever been anaemic or

suffered from other problems with

your blood

If you have had kidney or liver

problems

If you have received radiation therapy

If you have high or low blood

pressure

If you have a heart problem

Lowered immunity due to diseases

such as HIV/AIDS

Lowered immunity due to treatment

with medicines such as cyclosporine,

or other medicines used to treat

cancer

If you have ever suffered from

neuropathy (numbness, tingling and

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pain in feet or hands)

If you are a sexually active man. Men

who receive Paclitaxel Accord are

advised to use a condom to avoid

pregnancy in their partner.

Receiving Paclitaxel

Accord

Things you must do

You must tell your doctor

immediately if you become

pregnant while receiving Paclitaxel

Accord treatment.

If you are going to have surgery,

tell the surgeon or anaesthetist that

you are being treated with this

medicine

Tell all of the doctors, dentists and

pharmacists who are treating you

that you are receiving treatment

with Paclitaxel Accord

If you are about to be started on

any new medicine, tell your doctor

and pharmacist that you are

receiving Paclitaxel Accord

Have any tests recommended by

your doctor done as soon as

possible.

Things to be careful of

Paclitaxel Accord contains absolute

ethanol (alcohol). You should not drive,

operate machinery, or do anything else

that could be dangerous after receiving

treatment with Paclitaxel Accord.

If you receive too much

Paclitaxel Accord (overdose)

As your dose of Paclitaxel Accord will

be determined and administered by a

medical specialist, the chance of

receiving an overdose is most unlikely.

However, if an overdose should be

given your specialist will give the

appropriate treatment.

Side Effects

Tell your doctor as soon as possible if

you do not feel well while you are

receiving Paclitaxel Accord.

All medicines can have side effects.

Sometimes they are serious, most of the

time they are not. You may need medical

attention if you get some of the side

effects.

Common side effects

The most common side effects include:

Infections

flushing and rash

bone marrow suppression (primarily

neutropenia)

thrombocytopenia (reduced numbers

of the white blood cells that are

responsible for blood clotting)

leucopenia (low numbers of white

blood cells)

bleeding

fever

anaemia (reduced numbers of red

blood cells)

hypotension (low blood pressure)

nausea and vomiting

diarrhoea

mucositis (inflammation on the lining

of the mouth or throat)

arthralgia (pain in the joints) and

myalgia (muscle pain)

peripheral neuropathy (numbness,

tingling and pain in feet and hands)

abnormal liver blood tests

alopecia (hair loss)

Tell your doctor immediately, or go to

accident and emergency at your

nearest hospital if you notice any of

the following:

swelling to the face, lips, tongue or

throat which may cause difficulty in

swallowing or breathing

severe and sudden onset of pinkish,

itchy swellings

gastrointestinal bleeding (blood in

your stool).

Tell your doctor immediately if you

notice any of the following:

fever

chest pain

seizures (fits)

disturbances of heart rate and rhythm

numbness, tingling and pain in feet

and hands

unexpected bleeding

abdominal pain.

The use of Paclitaxel Accord is also

associated with a reduction in certain

types of blood cells in the body:

a reduction in red blood cells, which

may result in fatigue or dizziness

a reduction in white blood cells,

which are used to fight infection

a reduction in cells that help your

blood to clot after injury.

These are serious side effects. You may

need urgent medical attention or

hospitalisation.

Other side effects not listed above may

also occur in some patients. Tell your

doctor if you notice anything else that

is making you feel unwell.

The following precautions should be

taken to reduce your risk of infection

or bleeding:

Avoid people who have infections.

Check with you doctor immediately

if you get a fever, chills, cough,

hoarse throat lower back or side

pain or find it painful or difficult to

urinate.

Be careful when using a

toothbrush, toothpick or dental

floss. Your doctor, 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

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you are using sharp objects such as

razor or nail cutters.

Avoid contact sports or other

situations where you may bruise or

get injured.

Your body breaks down Paclitaxel

Accord and uses it to fight cancer. The

break down products may be excreted

in body fluids and waste, including

blood, urine, faeces, vomitus and

semen.

In general, precautions to be taken

while you are receiving chemotherapy

and for one week after the treatment

period by:

Flushing the toilet twice to dispose

of any body fluids and waste.

Wearing gloves to clean any spill of

body fluid or waste. Use paper

towel or old rags, a strong solution

of non- bleaching detergent and

large amount of water to mop up

spill. Discard the towels or rags into

a separate waste bag and dispose of

fluids in the toilet.

Wash linen or clothing that is

heavily contaminated by body fluid

or waste separately from other

items. Use a strong solution of non-

bleaching detergent and large

amount of water

Place soiled disposable nappies and

other pads in a plastic bag, seal and

dispose into garbage.

For sexual intercourse, use a

barrier method such as condom.

Storage

Paclitaxel Accord should be stored below

25°C. Protect from light.

Product Description

What it looks like

Paclitaxel Accord is a concentrated

solution which will be diluted with a

glucose solution and given as an infusion

(drip). It comes in three sizes:

30 mg Paclitaxel (5mL vials)

100 mg Paclitaxel (16.7mL vials)

300 mg Paclitaxel (50mL vials)

Ingredients

Active Ingredient: paclitaxel

Inactive Ingredients: PEG-35 castor oil

and absolute ethanol.

Product is for single use in one patient

only. Discard any residue.

Where to get further

information

Your doctor is the best person to answer

any further questions you may have about

Paclitaxel Accord.

Anything your doctor tells you about

Paclitaxel Accord should be followed

even if it is different from what is in this

leaflet.

Name and Address of the

Sponsor

Accord Healthcare Pty Ltd

Level 24, 570 Bourke Street

Melbourne, VIC, 3000

Australia

Australian Register numbers

30 mg/5 mL: AUST R 219554

100 mg/16.7 mL: AUST R 219555

300 mg/50 mL: AUST R 219556

Date of Preparation

This leaflet was prepared on 30 January

2017.

21-9-2018

Pending EC decision:  Apealea, paclitaxel, Opinion date: 20-Sep-2018

Pending EC decision: Apealea, paclitaxel, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

1-8-2018

Abraxane (Celgene Europe B.V.)

Abraxane (Celgene Europe B.V.)

Abraxane (Active substance: paclitaxel) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5212 of Wed, 01 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/778/T/91

Europe -DG Health and Food Safety