PERJETA pertuzumab (rch) 30mg/mL concentrate injection vial

Main information

  • Trade name:
  • PERJETA pertuzumab (rch) 30mg/mL concentrate injection vial
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • PERJETA pertuzumab (rch) 30mg/mL concentrate injection vial
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Registered
  • Authorization number:
  • 196218
  • Last update:
  • 21-05-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

196218

PERJETA pertuzumab (rch) 30mg/mL concentrate injection vial

ARTG entry for

Medicine Registered

Sponsor

Roche Products Pty Ltd

Postal Address

PO Box 255,DEE WHY, NSW, 2099

Australia

ARTG Start Date

6/05/2013

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. PERJETA pertuzumab (rch) 30mg/mL concentrate injection vial

Product Type

Single Medicine Product

Effective date

6/09/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Metastatic Breast Cancer:

PERJETA is indicated in combination with trastuzumab and docetaxel for patients with metastatic HER2-positive breast cancer who have not received

prior anti-HER2 therapy or chemotherapy for their metastatic disease.,PERJETA is indicated in combination with trastuzumab and chemotherapy for the

neoadjuvant treatment of patients with inflammatory or locally advanced HER2-positive breast cancer as part of a complete treatment regimen.

Note to the Indication: this approval is based on improvement in pathological complete response rate. No improvement in disease-free, progression-free

or overall survival has been shown.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Vial

Glass Type I Clear

24 Months

Store at 2 to 8

degrees Celsius

Not recorded

Do not Freeze

Protect from Light

Do not Shake

Pack Size/Poison information

Pack Size

Poison Schedule

420 mg/14 mL (30 mg/mL) single-use vial

(S4) Prescription Only Medicine

Components

1. PERJETA

Dosage Form

Injection, intravenous infusion

Route of Administration

Intravenous Infusion

Visual Identification

Clear to opalescent, colourless to slightly brownish solution

Active Ingredients

Pertuzumab

420 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 28.11.2017 at 02:24:43 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: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

Perjeta

®

Contains the active ingredient pertuzumab (rch)

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common

questions about Perjeta. 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 Perjeta

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.

You may need to read it again.

What Perjeta is given

for

Perjeta contains an active ingredient

called pertuzumab.

Perjeta belongs to a group of

medicines known as anti-neoplastic

(or anti-cancer) agents. There are

many different classes of anti-

neoplastic agents. Perjeta 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.

Perjeta recognises and attaches 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 Perjeta attaches to HER2

cancer cells it may kill them or slow/

stop the cancer cells from growing.

Perjeta is used to treat the following

stages of breast cancer;

metastatic (spreading) breast

cancer

early breast cancer, either before

or after surgery

It is only used for patients whose

tumour has tested positive for HER2.

For metastatic breast cancer Perjeta

is used with Herceptin and the

chemotherapy medicine, docetaxel.

For early breast cancer Perjeta is

used with Herceptin and

chemotherapy medicines.

For further information about

Herceptin and other chemotherapy

medicines please ask your doctor,

nurse or pharmacist for the

Consumer Medicine Information

(CMI) leaflets for these medicines.

Ask your doctor if you have any

questions why Perjeta has been

prescribed for you.

This medicine is available only with

a doctor's prescription.

Before you are given

Perjeta

If you are not sure if you should

start receiving Perjeta, talk to your

doctor.

When you must not be given

Perjeta

Do not use Perjeta:

if you have had an allergic

reaction to Perjeta or 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

if the package is torn or shows

signs of tampering

if the expiry date (EXP) printed

on the pack has passed

If you take this medicine after the

expiry date has passed it may not

work as well.

Before you are given it

Tell your doctor if:

you have a history of heart

problems such as;

-

heart failure (where the

heart muscle cannot pump

blood strongly enough)

-

cardiac arrhythmias

(abnormal beating of the

heart)

-

poorly controlled high blood

pressure or

-

recent heart attack

you have previously been

treated with chemotherapy

medicines known as

anthracyclines (e.g.

doxorubicin); these medicines

can damage heart muscle and

increase the risk of heart

problems with Perjeta

you have ever had heart

problems during previous

treatment with Herceptin

PERJETA 180903

Your doctor will monitor your

heart function closely before, and

during your treatment with

Perjeta.

you have inflammation of the

digestive tract, for e.g. sore

mouth or diarrhoea

When Perjeta is given with other

cancer treatments the number of

white blood cells may drop and

fever may develop. If you have

inflammation of the digestive

tract (e.g sore mouth or

diarrhoea) you may be more

likely to develop this side effect

you are allergic to any other

medicines or any other

substances such as foods,

preservatives or dyes

Allergic or anaphylactic (more

severe allergic) reactions can

occur with Perjeta treatment

(known as infusion related

reactions). Your doctor or nurse

will check for side effects during

your infusion and for 30 - 60

minutes afterwards. If you get

any serious reactions, your doctor

may stop treatment with Perjeta.

See "side effects" for symptoms

to look out for.

you are pregnant or intend to

become pregnant

Do not use Perjeta if you are

pregnant. Perjeta may be harmful

to your unborn baby.

Your doctor will advise you about

using effective contraception to

avoid becoming pregnant while

you are being treated with Perjeta

and for 7 months after stopping

treatment.

you are breast-feeding or plan

to breast-feed

It is not known if Perjeta passes

into breast milk. You should talk

to your doctor about whether you

can breast feed while you are

being treated with Perjeta.

If you have not told your doctor

about any of the above, tell them

before you are given Perjeta.

Use in children

The safety and effectiveness of

Perjeta in children and adolescents

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.

Your doctor and pharmacist have

more information on medicines to be

careful with or avoid while receiving

Perjeta.

How Perjeta is given

Follow all directions given to you

by your doctor or nurse carefully.

They may differ from the

information contained in this leaflet.

Perjeta must be prepared by a

healthcare professional and will be

given in a hospital or clinic by a

doctor or nurse.

Perjeta is given by a drip into a vein

(intravenous (IV) infusion) once

every three weeks.

The amount of medicine you are

given, and how long the infusion will

last, are different for the first and

following doses.

The number of infusions you will be

given depends on how you respond

to treatment.

Perjeta is given with other anti-

cancer medicines.

The first infusion:

You will be given 840 mg of Perjeta

by IV drip over 60 minutes. You will

also be given Herceptin and

chemotherapy medicines.

For following infusions:

If the first infusion was well

tolerated, you will be given 420 mg

of Perjeta by IV drip over 30 - 60

minutes. You will also be given

Herceptin and chemotherapy

medicines.

For further information about the

dose of other anti-cancer medicines

given, please ask your doctor,

nurse or pharmacist for the

Consumer Medicine Information

(CMI) leaflets for these medicines.

If you miss a dose

As Perjeta 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 Perjeta, make another

appointment as soon as possible.

If it has been 6 weeks or more since

your last Perjeta treatment, the high

dose of Perjeta (840 mg) will be

given. You will also be given

Herceptin and docetaxel.

Your doctor will decide when and

how much your next dose of

Perjeta will be.

If you are given too much

(overdose)

As Perjeta is given under the

supervision of your doctor, it is

unlikely that you will be given too

much. However, if you experience

any side effects after being given

Perjeta, tell your doctor immediately.

While you are

receiving Perjeta

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

PERJETA 180903

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 your doctor or nurse

immediately if you develop severe

or persistent diarrhoea.

Tell all doctors, dentists and

pharmacists who are treating you,

that you are receiving Perjeta.

Tell your doctor if you become

pregnant or intend to start a family

while receiving Perjeta or within 7

months after your last Perjeta

treatment.

Be sure to keep all of your

appointments with your doctor so

that your progress can be checked.

Your doctor may perform regular

tests.

Things you must not do

Do not stop your Perjeta treatment

without talking to your doctor

first.

Tell your doctor if you feel that

Perjeta 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

Perjeta affects you.

It is not known whether Perjeta may

impair your ability to drive or operate

machinery.

Side effects

Tell your doctor as soon as possible

if you do not feel well while you are

receiving Perjeta.

Perjeta 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 Perjeta may be used with

other medicines that treat breast

cancer, it may be difficult for your

doctor to tell whether the side effects

are due to Perjeta or due to the other

medicines.

For further information about the

side effects of Herceptin and

chemotherapy, please ask your

doctor, nurse or pharmacist for the

Consumer Medicine Information

(CMI) leaflets for these medicines.

During an infusion

Tell your doctor or nurse

immediately if you notice any of

the following while receiving an

infusion (particularly during the

first infusion):

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)

diarrhoea

fever or chills

headache

fatigue or tiredness

cough

These may be serious side effects.

You may need medical attention.

After an infusion

Tell your doctor immediately or go

to Accident and Emergency at

your nearest hospital if you notice

any of the following:

swelling of your face, lips, tongue

or throat with difficulty breathing,

severe swelling of your hands or

feet

severe shortness of breath,

wheezing or trouble breathing

severe chest pain, spreading out

to the arms, neck, shoulder or

back

abnormal or irregular heartbeat

rash, itching or hives on the skin

fever or chills

severe coughing

Tell your doctor or nurse as soon

as possible if you notice any of the

following:

any of the side effects listed

above

diarrhoea or constipation

indigestion or stomach pain

sore mouth, throat or gut

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

nail problems especially

inflammation where the nail

meets the skin

hair loss

feeling dizzy, tired, looking pale

hot flushes

PERJETA 180903

frequent infections such as fever,

severe chills, sore throat or mouth

ulcers

nose bleeds

eye problems such as producing

more tears

insomnia (trouble sleeping)

weak, numb, tingling, prickling or

painful sensations mainly

affecting the feet and legs

loss of appetite, loss of or altered

taste

joint or muscle pain, muscle

weakness

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, nurse or

pharmacist if you don't understand

anything in this list.

Do not be alarmed by this list of

possible side effects. You may not

experience any of them.

Product description

Storage

Perjeta will be stored in the

pharmacy or on the hospital ward in

a refrigerator at a temperature

between 2°C and 8°C.

Availability

Perjeta is supplied as a single-dose

glass vial containing 14 mL of

solution for intravenous infusion (30

mg/mL). It is diluted before infusion

into a vein.

What PERJETA looks like

Perjeta is a clear to pearly

(opalescent), colourless to slightly

brownish solution.

Ingredients

Each vial of Perjeta contains 420

mg of the active ingredient

pertuzumab

It also contains:

glacial acetic acid

histidine

sucrose

polysorbate 20

The pertuzumab protein is made

using Chinese hamster ovary cells.

Distributor

Perjeta is distributed by:

Roche Products Pty Limited

ABN 70 000 132 865

Level 8, 30-34 Hickson Road

Sydney, NSW 2000

AUSTRALIA

Medical enquiries: 1800 233 950

Please check with your pharmacist

for the latest Consumer Medicine

Information (CMI).

Australian Registration Number:

AUST R 196218

This leaflet was prepared on 3

September 2018

PERJETA 180903