Abraxane

Main information

  • Trade name:
  • Abraxane 100 mg Powder for injection
  • Dosage:
  • 100 mg
  • Pharmaceutical form:
  • Powder for injection
  • Units in package:
  • Vial, glass, 50 mL Type I 20 mm with bromobutyl rubber stopper and flip-cap aluminium crimp seal, 1 dose unit
  • Class:
  • Prescription
  • Prescription type:
  • Prescription
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug
  • Manufactured by:
  • ScinoPharm Taiwan Ltd

Documents

Localization

  • Available in:
  • Abraxane 100 mg Powder for injection
    New Zealand
  • Language:
  • English

Therapeutic information

  • Therapeutic indications:
  • ABRAXANE is indicated for the treatment of metastatic carcinoma of the breast after failure of anthracycline therapy.

Other information

Status

  • Source:
  • Medsafe - Medicines Safety Authority - New Zealand
  • Authorization number:
  • 14039
  • Authorization date:
  • 11-06-2009
  • Last update:
  • 27-09-2017

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

June 2017

CMI for ABRAXANE

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ABX_CMI_AUNZ_New Sponsor_Final_20Jun17

ABRAXANE

Paclitaxel

(pak-li-TAX-el)

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common

questions about ABRAXANE.

It does not contain all the available

information. It does not take the

place of talking to your doctor or

pharmacist.

All medicines have risks and

benefits. Your doctor has weighed

the risks of you being given

ABRAXANE against the benefits

they expect it will have for you.

If you have any concerns about

being given this medicine, ask

your doctor. Your doctor or

pharmacist can provide you with

more information about

ABRAXANE.

Keep this leaflet

You may need to read it again.

What ABRAXANE is used for

This medicine is used to treat:

Breast cancer

Lung Cancer

Pancreatic Cancer

This medicine belongs to a group

of medicines called antineoplastic

or cytotoxic medicines. You may

also hear of these being called

chemotherapy medicines.

It works by killing cancer cells and

stopping them from multiplying.

Ask your doctor if you have any

questions about why this

medicine has been prescribed for

you.

Your doctor may have prescribed it

for another reason.

This medicine is not addictive.

This medicine is available only

with a doctor’s prescription

.

Before you are given

ABRAXANE

When you must not be given it

You must not be given

ABRAXANE if you have an

allergy to:

any medicine containing

paclitaxel

any of the ingredients listed at

the end of this leaflet

Some of the symptoms of an

allergic reaction may include

shortness of breath, wheezing or

difficulty breathing; swelling of the

face, lips, tongue or other parts of

the body; rash, itching or hives on

the skin.

You must not be given this

medicine if you have a very low

white blood cell (WBC) count.

Tell your doctor if you have an

infection or high temperature.

Your doctor may decide to delay

your treatment until the infection is

gone. A mild illness, such as a cold,

is not usually a reason to delay

treatment.

You must not be given this

medicine if you have severe liver

damage. Tell your doctor you

have liver disease or damage.

You must not be given this

medicine if you are pregnant or

plan to become pregnant.

Like

most cytotoxic medicines

ABRAXANE is not recommended

for use during pregnancy. If there is

any need to consider this medicine

during your pregnancy, your doctor

will discuss with you the benefits

and risks of using it.

Males: tell your doctor if your

partner plans to become

pregnant while you are being

treated with this medicine or

shortly after you have stopped

treatment with it.

ABRAXANE

may cause birth defects if either the

male or female is being treated with

it at the time of conception. It is

recommended that you use some

kind of birth control while you are

being treated with ABRAXANE

and for at least 12 weeks after you

stop using it. Your doctor will

discuss this with you.

Do not breast-feed if you are

taking this medicine.

The active ingredient in

ABRAXANE passes into breast

milk and there is a possibility that

your baby may be affected.

If you are not sure whether you

should be given this medicine,

talk to your doctor.

The safety and effectiveness of

ABRAXANE in children (under

18 years) has not been

established.

Before you are given it

Tell your doctor if you have

allergies to any other medicines,

foods, preservatives or dyes.

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CMI for ABRAXANE

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Tell your doctor if you have or

have had any of the following

medical conditions:

kidney disease

liver disease

heart problems

any blood disorder with a

reduced number of blood cells,

or platelets

any disease of the nerves

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

(including radiation therapy)

If you have not told your doctor

about any of the above, tell

him/her before you start taking

ABRAXANE.

Taking other medicines

Tell your doctor or pharmacist if

you are taking any other

medicines, including any that you

get without a prescription from

your pharmacy, supermarket or

health food shop.

Some medicines and ABRAXANE

may interfere with each other.

Some medicines may be affected

by ABRAXANE or may affect how

well it works. You may need

different amounts of your

medicines, or you may need to take

different medicines.

Your doctor and pharmacist have

more information on medicines to

be careful with or avoid while

taking this medicine.

How to take ABRAXANE

How much is given

Your doctor will decide what dose

of ABRAXANE you will receive.

This depends on your condition and

other factors, such as your weight,

kidney function and other

chemotherapy medicines you are

being given.

ABRAXANE may be given alone

or in combination with other drugs.

Several courses of ABRAXANE

therapy may be needed depending

on your response to treatment.

Additional treatment may not be

repeated until your blood cell

numbers return to acceptable levels

and any uncontrolled effects have

been controlled.

Ask your doctor if you want to

know more about the dose of

ABRAXANE you receive.

How it is given

ABRAXANE is usually given as an

infusion (drip) into a vein over 30

minutes.

How long it will be given for

Breast Cancer:

ABRAXANE is usually given once

every three weeks (i.e. on day 1 of

a 21-day cycle). Each infusion is

called one 'cycle' of chemotherapy.

Your doctor will decide how many

of these cycles you will need.

Lung Cancer:

ABRAXANE is given every week

(i.e. on days 1, 8 and 15 of each 21-

day cycle). Another medicine

called carboplatin is also given on

day 1 only of each 21-day cycle.

Your doctor will decide how many

of these cycles you will need.

Pancreatic Cancer:

ABRAXANE is given every week

(i.e. on days 1, 8 and 15 of each 28-

day cycle). Every 28 days is called

one ‘cycle’ of chemotherapy.

Another medicine called

gemcitabine is also given on days

1, 8 and 15 after ABRAXANE has

been given. Your doctor will

decide how many of these cycles

you will need.

Overdose

As ABRAXANE is given to you

under the supervision of your

doctor, it is very unlikely that you

will receive too much. However, if

you experience severe side effects

after being given this medicine, tell

your doctor or nurse immediately.

You may need urgent medical

attention.

Symptoms of an ABRAXANE

overdose include the side effects

listed below in the 'Side Effects'

section, but are usually of a more

severe nature.

While you are being given

ABRAXANE

Things you must do

If you are about to be started on

any new medicine, remind your

doctor and pharmacist that you

are being treated with

ABRAXANE.

Tell any other doctors, dentists,

and pharmacists who are treating

you that you are being given this

medicine.

If you are going to have surgery,

tell the surgeon or anaesthetist

that you are being treated with

this medicine

It may affect other medicines used

during surgery.

If you become pregnant while

you are being treated with this

medicine, tell your doctor

immediately

Keep all your doctor's

appointments so your progress

can be checked.

Your doctor may 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.

Keep follow-up appointments with

your doctor. It is important to have

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your follow-up cycles of

ABRAXANE at the appropriate

times to get the best effects from

your treatments.

This medicine 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 immediately if you think

you may be getting an infection,

or 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, 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.

Your body breaks down

ABRAXANE and uses it to fight

cancer. The breakdown products

may be excreted in body fluids and

waste, including blood, urine,

faeces, vomitus and semen.

In general, precautions to protect

other people should 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 towels or old rags, a

strong solution of non-bleaching

detergent and large amounts of

water to mop up the 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

fluids or waste separately from

other items. Use a strong

solution of non-bleaching

detergent and large amounts of

water.

Place soiled disposable nappies

and other pads in a plastic bag,

seal and dispose into the

garbage.

For sexual intercourse, use a

barrier method such as a

condom.

Things to be careful of

Be careful driving or operating

machinery until you know how

ABRAXANE affects you

. There is

no known reason why you cannot

continue driving or using machines

between courses of ABRAXANE

unless you feel tired or dizzy.

If you are given other medication as

part of your treatment, you should

ask your doctor for advice on

driving and using machines.

Side effects

Tell your doctor, nurse or

pharmacist as soon as possible if

you do not feel well while you are

being given ABRAXANE.

Like other medicines that treat

cancer, ABRAXANE may have

unwanted side effects, some of

which may be serious. You may

need medical treatment if you get

some of the side effects.

Do not be alarmed by the

following lists of side effects.

may not experience any of them.

Ask your doctor or pharmacist to

answer any questions you may

have.

Tell your doctor if you notice any

of the following and they worry

you:

muscle or joint pain on the arms

and legs

nausea and vomiting

hair loss

diarrhoea

changes in skin or nail

appearance

soreness or ulceration of the

mouth

tiredness

The above list includes the more

common side effects of your

medicine.

Tell your doctor or nurse as soon

as possible if you notice any of

the following:

pain, swelling, irritation and

redness at the injection site

flushing

light-headedness, dizziness or

fainting (due to low blood

pressure)

numbness or tingling in the

fingers and/or toes

changes in vision

abdominal pain

The above list includes serious side

effects which may require medical

attention.

If any of the following happen,

tell your doctor or nurse

immediately, or if you are not in

hospital, go to an Accident and

Emergency Room at your nearest

hospital

shortness of breath, coughing,

wheezing or difficulty breathing

swelling of the face, lips,

tongue, or other parts of the

body

rash, itching or hives on the skin

extreme weakness or tiredness

seizures (fits)

June 2017

CMI for ABRAXANE

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fast, slow or irregular heart beat

chest pain

yellowing of the skin or eyes

unusual bleeding or bruising

(including blood in your stools

or urine)

fever, sore throat or other signs

of infection

The above list includes very serious

side effects. You may need urgent

medical attention or hospitalisation.

Tell your doctor, nurse or

pharmacist if you notice anything

that is making you feel unwell.

Other side effects not listed above

may also occur in some people.

The benefits and side effects of

ABRAXANE may take some time

to occur. Therefore, even after you

have finished receiving your

treatment, you should tell your

doctor immediately if you notice

any of the side effects listed in this

section.

After being given ABRAXANE

Storage

ABRAXANE will be stored in the

pharmacy or on the ward. The

injection is kept in a cool, dry

place, protected from light, where

the temperature stays below 25°C.

Product description

What it looks like:

ABRAXANE is a white to yellow

solid powder cake in a clear glass

vial.

When it is reconstituted it will be a

milky liquid.

Ingredients

Each vial of ABRAXANE contains

100 mg of paclitaxel as the active

ingredient, and human albumin

solution (which contains sodium,

sodium octanoate and N-acetyl

tryptophan).

This medicine does not contain

lactose, sucrose, gluten, tartrazine

or any other azo dyes.

Manufacturer

ABRAXANE is manufactured in

the USA by:

Abraxis BioScience, LLC.

Sponsor

In Australia:

Abraxis BioScience Australia Pty

Level 1, 711 High Street

East Kew, Victoria 3102

Distributed by Specialised

Therapeutics Australia Pty Ltd

Ph: 1300 798 820

Fax: 1800 798 829

www.specialisedtherapeutics.com.au

In New Zealand:

Specialised Therapeutics Limited

Level 1, The Lane,

Botany Town Centre

588 Chapel Road, East Tamaki,

AUCKLAND 2013

New Zealand

Ph: +64 9801 0299

Fax: +64 9801 0118

100 mg vial AUST R 133500

Abraxis BioScience Australia Pty

Ltd is an indirect subsidiary of

Celgene Corporation

This leaflet was prepared in June

2017.

19-12-2018


Opinion/decision on a Paediatric investigation plan (PIP): Abraxane,paclitaxel, decision type: , therapeutic area: , PIP number: P/0257/2018

Opinion/decision on a Paediatric investigation plan (PIP): Abraxane,paclitaxel, decision type: , therapeutic area: , PIP number: P/0257/2018

Opinion/decision on a Paediatric investigation plan (PIP): Abraxane,paclitaxel, decision type: , therapeutic area: , PIP number: P/0257/2018

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