HERCEPTIN

Main information

  • Trade name:
  • HERCEPTIN SC trastuzumab (rch) 600mg/5mL solution for injection
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • HERCEPTIN SC trastuzumab (rch) 600mg/5mL solution for injection
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 220402
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

220402

HERCEPTIN SC trastuzumab (rch) 600mg/5mL solution for injection

ARTG entry for

Medicine Registered

Sponsor

Roche Products Pty Ltd

Postal Address

PO Box 255,DEE WHY, NSW, 2099

Australia

ARTG Start Date

19/03/2015

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. HERCEPTIN SC trastuzumab (rch) 600mg/5mL solution for injection

Product Type

Single Medicine Product

Effective date

17/02/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

EARLY BREAST CANCER: HERCEPTIN SC is indicated for the treatment of HER2-positive localised breast cancer following surgery, and in association

with chemotherapy and, if applicable, radiotherapy.,LOCALLY ADVANCED BREAST CANCER: HERCEPTIN SC is indicated for the treatment of

HER2-positive locally advanced breast cancer in combination with neoadjuvant chemotherapy followed by adjuvant HERCEPTIN.,METASTATIC

BREAST CANCER: HERCEPTIN SC is indicated for the treatment of patients with metastatic breast cancer who have tumours that overexpress HER2:,-

as monotherapy for the treatment of those patients who have received one or more chemotherapy regimens for their metastatic disease;,- in combination

with taxanes for the treatment of those patients who have not received chemotherapy for their metastatic disease; or,- in combination with an aromatase

inhibitor for the treatment of post-menopausal patients with hormone-receptor positive metastatic breast cancer.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Vial

Glass Type I Clear

21 Months

Store at 2 to 8

degrees Celsius

Not recorded

Refrigerate

Do not Freeze

Protect from Light

Pack Size/Poison information

Pack Size

Poison Schedule

1 x vial

(S4) Prescription Only Medicine

Components

1. HERCEPTIN SC trastuzumab (rch)

Dosage Form

Injection, solution

Route of Administration

Subcutaneous

Visual Identification

Colourless to yellowish, clear to opalescent liquid solution

Active Ingredients

Trastuzumab

600 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 02:26:52 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

HERCEPTIN SC

®

Subcutaneous injection

Contains the active ingredient trastuzumab (rch)

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common

questions about HERCEPTIN SC. 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

HERCEPTIN SC against the benefits

they expect it will have for you.

If you have any concerns about

being given this medicine, ask your

doctor or pharmacist.

Keep this leaflet with the medicine.

You may need to read it again.

HERCEPTIN is also available as

an intravenous (IV) injection. For

more information on HERCEPTIN

IV product please refer to the

separate Consumer Medicine

Information (CMI) for

HERCEPTIN IV or speak with

your doctor or pharmacist.

What HERCEPTIN SC

is given for

HERCEPTIN SC contains an active

ingredient called trastuzumab.

HERCEPTIN SC belongs to a group

of medicines known as anti-

neoplastic (or anti-cancer) agents.

There are many different classes of

anti-neoplastic agents. HERCEPTIN

SC belongs to a class called

monoclonal antibodies.

Monoclonal antibodies are proteins

made in a laboratory. These proteins

are designed to recognise and bind to

other unique proteins in the body.

HERCEPTIN SC binds selectively to

a protein called human epidermal

growth factor receptor 2 (HER2).

HER2 is found in large amounts on

the surface of some cancer cells.

When HERCEPTIN SC binds to

HER2 receptors it stops the growth

and spread of the cancer cells.

HERCEPTIN SC is used to treat

breast cancer whose tumour has

tested positive to HER2.

HERCEPTIN may be used alone or

in combination with other medicines

that treat breast cancer, such as an

aromatase inhibitor (hormone

receptor positive breast cancer) or a

taxane (e.g. paclitaxel or docetaxel).

For further information about the

other medicines you are receiving

with HERCEPTIN SC, please ask

your doctor, nurse or pharmacist for

the CMI leaflet.

Ask your doctor if you have any

questions why HERCEPTIN SC

has been prescribed for you.

This medicine is available only with

a doctor's prescription.

Before you are given

HERCEPTIN SC

When you must not be given

it

Do not use HERCEPTIN if:

you have had an allergic

reaction to;

-

HERCEPTIN,

-

any ingredient listed at the

end of this leaflet or

-

any protein of Chinese

hamster origin

Some symptoms of an allergic

reaction may include shortness of

breath; wheezing or difficulty

breathing; rash, itching or hives

on the skin or swelling of the

face, lips, tongue or other parts of

the body.

you have breast cancer that has

not spread (non-metastatic) and

-

you have had an LVEF test

result (which measures how

well your heart can pump

blood) of less than 45% or

-

you have symptoms of heart

failure

Symptoms of heart failure may

include:

shortness of breath or tire

easily after light physical

activity (such as walking)

shortness of breath at night,

especially when lying flat

swelling of the hands or feet

due to fluid build up

abnormal or irregular

heartbeat

If you are not sure if you should start

receiving HERCEPTIN SC, talk to

your doctor.

Before you are given it

Tell your doctor if:

HERCEPTIN SC 150817

you have a history of heart

disease with:

angina (chest pain)

cardiac arrhythmias (abnormal

beating of the heart)

heart failure (where the heart

cannot pump blood normally)

coronary artery disease (also

known as CAD, a condition

where plaque builds up inside

the arteries)

poorly controlled high blood

pressure

you have previously been

treated with chemotherapy

medicines known as

anthracyclines (e.g.

doxorubicin); these medicines

can damage the heart muscle

and increase the risk of heart

problems with HERCEPTIN

SC.

Your doctor will monitor your

heart function closely before and

during your treatment with

HERCEPTIN SC. Your heart

function may also be monitored

for years after ceasing

HERCEPTIN SC treatment.

if you have any breathing or

lung problems

you are allergic to any other

medicines or any other

substances such as foods,

preservatives or dyes

Allergic or anaphylactic reactions

can occur with HERCEPTIN SC

treatment (known as

administration related reactions).

Your doctor or nurse will monitor

you for side effects during

treatment. See "Side effects" for

symptoms to look out for.

you are pregnant or intend to

become pregnant

HERCEPTIN SC may be harmful

to an unborn baby. If there is a

need for HERCEPTIN SC

treatment when you are pregnant

your doctor will discuss the risks

and benefits to you and the

unborn baby.

You should use effective

contraception to avoid becoming

pregnant while you are being

treated with HERCEPTIN SC and

for 7 months after stopping

treatment.

you are breast-feeding or plan

to breast-feed

It is not known if HERCEPTIN

SC passes into breast milk. It is

recommended that you

discontinue breast-feeding while

you are being treated with

HERCEPTIN SC and not restart

breast-feeding until 7 months

after completing HERCEPTIN

SC treatment.

If you have not told your doctor

about any of the above, tell them

before you are given HERCEPTIN

SC.

Use in children

The safety and effectiveness of

HERCEPTIN SC in children under

18 years of age have not been

established.

Taking other medicines

Tell your doctor if you are taking

any other medicines including any

that you have bought without a

prescription from a pharmacy,

supermarket or health food shop.

HERCEPTIN SC treatment with

gemcitabine, vinorelbine, a taxane or

radiation therapy can increase the

chance of lung problems (interstitial

lung disease).

Your doctor and pharmacist have

more information on medicines to be

careful with or avoid while receiving

HERCEPTIN SC.

Tell your doctor or pharmacist

that you have had HERCEPTIN

SC if you start any new medication

in the seven months after stopping

treatment.

It may take up to seven months for

HERCEPTIN SC to be removed

from your body

How HERCEPTIN SC

is given

Follow all directions given to you

by your doctor or nurse carefully.

They may differ from the

information contained in this leaflet.

HERCEPTIN SC must be prepared

by a healthcare professional and will

be given in a hospital or clinic by a

doctor or nurse.

The recommended dose is 600 mg (in

a solution of 5mL). HERCEPTIN SC

is given as a subcutaneous injection

(under the skin) over 2 to 5 minutes

every three weeks.

The injection site should be

alternated between the left and right

thigh. New injections should be

given at least 2.5 cm away from an

old site. The injection should not be

given into areas where the skin is red,

bruised, tender or hard.

If other medicines for subcutaneous

use are used during the treatment

course with HERCEPTIN SC, a

different injection site should be

used.

HERCEPTIN SC should not be

mixed or diluted with other products.

Your doctor will decide how long

you should receive HERCEPTIN SC;

this will depend on your response to

HERCEPTIN SC and the state of

your disease.

If you miss a dose

As HERCEPTIN SC is given under

the supervision of your doctor, you

are unlikely to miss a dose. However,

if you forget or miss your

appointment to receive

HERCEPTIN, make another

appointment as soon as possible.

Your doctor will decide when your

next dose of HERCEPTIN SC will

If you are given too much

(overdose)

As HERCEPTIN SC is given to you

under the supervision of your doctor

it is unlikely that you will be given

HERCEPTIN SC 150817

too much. However, if you

experience any side effects after

being given HERCEPTIN SC, tell

your doctor immediately.

While you are

receiving HERCEPTIN

SC

Things you must do

Tell your doctor or nurse

immediately if you have any signs

and symptoms of an allergic or

anaphylactic reaction

Some signs and symptoms include;

swelling of your face, lips, tongue

or throat with difficulty breathing,

swelling of other parts of your

body

shortness of breath, wheezing or

trouble breathing

rash, itching or hives on the skin

feeling sick (nausea)

fever, chills

feeling tired

headache

Tell your doctor or nurse

immediately if you have any signs

and symptoms of heart problems.

Some signs and symptoms of heart

problems are

shortness of breath or getting

tired easily after light physical

activity (such as walking)

shortness of breath at night,

especially when lying flat

swelling of the hands or feet due

to fluid build up

cough

abnormal or irregular heartbeat

Please follow all your doctors'

instructions if any of these symptoms

require medication.

Tell all doctors, dentists and

pharmacists who are treating you

that you are receiving

HERCEPTIN SC.

Tell your doctor if you become

pregnant or intend to start a family

while receiving HERCEPTIN SC

or if you intend to breast feed

whilst receiving HERCEPTIN SC.

Be sure to keep all of your

appointments with your doctor so

that your progress can be checked.

Your doctor may perform regular

tests, including checking your heart

function whilst you are being treated

with HERCEPTIN SC.

Things you must not do

Do not stop your HERCEPTIN SC

treatment without talking to your

doctor first.

Tell your doctor if you feel that

HERCEPTIN SC is not helping your

condition.

Do not take any other medicines,

whether they require a

prescription or not, without first

telling your doctor or consulting

with a pharmacist.

Things to be careful of

Be careful driving or operating

machinery until you know how

HERCEPTIN SC affects you.

If you experienced symptoms during

your treatment with HERCEPTIN SC

you should not drive or operate

machinery.

Side effects

Tell your doctor as soon as possible

if you do not feel well while you are

receiving HERCEPTIN SC.

HERCEPTIN SC helps most people

with HER2 positive breast but it may

have some unwanted side effects in

some people.

All medicines can have side effects.

Sometimes they are serious, most of

the time they are not. You may need

medical treatment if you get some of

the side effects.

Ask your doctor or pharmacist to

answer any questions you may

have.

Because HERCEPTIN SC may be

used with other medicines that treat

breast, it may be difficult for your

doctor to tell whether the side effects

are due to HERCEPTIN SC or due to

the other medicines.

For further information about the

side effects of any other medicines

you are receiving, please ask your

doctor, nurse or pharmacist for the

CMI leaflets for these medicines

At time of injection

Tell your doctor or nurse

immediately if you notice any of

the following during, or soon after

your injection:

swelling of your face, lips, tongue

or throat with difficulty breathing

swelling of other parts of your

body such as your hands or feet

shortness of breath, wheezing or

trouble breathing

abnormal or irregular heartbeat

rash, itching or hives on the skin

feeling sick (nausea) or vomiting,

diarrhoea

pain or discomfort (including

stomach pain, back pain, chest or

neck pain)

fever or chills

headache

fatigue or tiredness

cough

These may be serious side effects.

You may require urgent medical

attention.

Your doctor may prescribe

medication to stop the side effects

from occurring while receiving your

HERCEPTIN SC injection.

After your treatment

Tell your doctor immediately or go

to Accident and Emergency at

your nearest hospital if you notice

any of the following:

HERCEPTIN SC 150817

swelling of your face, lips, tongue

or throat with difficulty breathing

severe shortness of breath,

wheezing or trouble breathing

severe chest pain spreading out to

the arms, neck, shoulder and/or

back

rash, itching or hives on the skin

fever or chills

abnormal or irregular beating of

the heart

severe swelling of the hands, feet

or legs

severe coughing

These are serious side effects. You

may need urgent medical attention.

Tell your doctor or nurse as soon

as possible if you notice any of the

following:

any of the side effects listed

above

pain or reaction at the site of your

injection

getting tired more easily after

light physical activity. such as

walking

shortness of breath, especially

when lying down or being woken

from your sleep with shortness of

breath

runny or blocked nose, or

nosebleeds

insomnia (difficulty sleeping)

weakness, soreness in muscles

and/or joints

increased cough

feeling dizzy, tired, looking pale

flu and/or cold like symptoms,

frequent infections such as fever,

severe chills, sore throat or mouth

ulcers

hot flushes

diarrhoea

changes in weight (gain or loss)

redness, dryness or peeling of the

hands or feet (hand-foot

syndrome)

pain in hands or feet

unusual hair loss or thinning

nail problems

eye problems such as producing

more tears, swollen runny eyes or

conjunctivitis (discharge with

itching of the eyes and crusty

eyelids)

This is not a complete list of all

possible side effects. Your doctor or

pharmacist has a more complete list.

Others may occur in some people and

there may be some side effects not

yet known.

Tell your doctor if you notice

anything else that is making you

feel unwell, even if it is not on this

list.

Ask your doctor or pharmacist if

you don't understand anything on

this list.

Do not be alarmed by this list of

possible side effects.

You may not experience any of them.

Product description

Storage

HERCEPTIN SC will be stored in

the pharmacy or on the hospital ward

in a refrigerator at a temperature

between 2°C and 8°C.

The vial must be stored in the outer

carton to protect it from light.

Availability

HERCEPTIN is available in two

types (formulations);

Solution for subcutaneous

injection (under the skin).

Supplied as a single vial pack and

available in one strength, 600 mg

in 5 mL solution.

Powder for intravenous infusion

(drip into the vein). Supplied as a

single dose vial and available in

two strengths, 60 mg and 150 mg.

It is important to check the product

labels to ensure that the correct

formulation is being given as

prescribed. HERCEPTIN SC fixed

dose formulation is not for

intravenous use and should be given

as a subcutaneous injection only.

What HERCEPTIN SC looks

like

HERCEPTIN SC solution for

injection is a colourless to yellowish,

clear to opalescent solution. .

Ingredients

Each vial of HERCEPTIN SC

contains 600 mg of the active

ingredient trastuzumab.

It also contains;

Vorhyaluronidase alfa, an

enzyme used to increase the

dispersion and absorption of co-

administered drugs when

administered subcutaneously

histidine hydrochloride

histidine

trehalose dihydrate

polysorbate 20

methionine

water for injections

The trastuzumab protein is made

using Chinese hamster ovary cells.

Distributor

HERCEPTIN SC is distributed by:

Roche Products Pty Limited

ABN 70 000 132 865

4-10 Inman Road

Dee Why, NSW 2099

AUSTRALIA

Medical enquiries: 1800 233 950

Please check with your pharmacist

for the latest Consumer Medicine

Information (CMI)

Australian Registration Numbers:

HERCEPTIN solution for

subcutaneous injection:

AUST R 220402

HERCEPTIN SC 150817

HERCEPTIN powder for intravenous

infusion:

60 mg: AUST R 171014

150 mg: AUST R 73229

This leaflet was prepared on 17

August 2015.

HERCEPTIN SC 150817

1-6-2018

Pending EC decision:  Trazimera, trastuzumab, Opinion date: 31-May-2018

Pending EC decision: Trazimera, trastuzumab, Opinion date: 31-May-2018

Europe - EMA - European Medicines Agency

10-6-2014

Falsified cancer medicine not distributed in Denmark

Falsified cancer medicine not distributed in Denmark

Falsified batches of the cancer medicine Herceptin® from Roche have been identified in England, Germany and Finland. None of the affected batches have been distributed in Denmark.

Danish Medicines Agency

19-9-2018

Kadcyla (Roche Registration GmbH)

Kadcyla (Roche Registration GmbH)

Kadcyla (Active substance: Trastuzumab emtansine) - Centralised - Renewal - Commission Decision (2018)6100 of Wed, 19 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2389/R/39

Europe -DG Health and Food Safety

30-7-2018

Trazimera (Pfizer Europe MA EEIG)

Trazimera (Pfizer Europe MA EEIG)

Trazimera (Active substance: trastuzumab) - Centralised - Authorisation - Commission Decision (2018)5095 of Mon, 30 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4463

Europe -DG Health and Food Safety

18-5-2018

KANJINTI (Amgen Europe B.V.)

KANJINTI (Amgen Europe B.V.)

KANJINTI (Active substance: trastuzumab) - Centralised - Authorisation - Commission Decision (2018)3156 of Fri, 18 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4361

Europe -DG Health and Food Safety

23-3-2018

Pending EC decision:  Kanjinti, trastuzumab, Opinion date: 22-Mar-2018

Pending EC decision: Kanjinti, trastuzumab, Opinion date: 22-Mar-2018

Europe - EMA - European Medicines Agency