PEMETREXED

Main information

  • Trade name:
  • PEMETREXED ACCORD pemetrexed (as disodium) 100 mg powder for injection vial
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • PEMETREXED ACCORD pemetrexed (as disodium) 100 mg powder for injection vial
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 222420
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

222420

PEMETREXED ACCORD pemetrexed (as disodium) 100 mg powder for 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

28/05/2015

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. PEMETREXED ACCORD pemetrexed (as disodium) 100 mg powder for injection vial

Product Type

Single Medicine Product

Effective date

25/10/2016

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Malignant Pleural Mesothelioma,Pemetrexed, in combination with cisplatin, is indicated for the treatment of patients with malignant pleural

mesothelioma.,Non-Small Cell lung Cancer,Pemetrexed in combination with cisplatin is indicated for initial treatment of patients with locally advanced or

metastatic non-small cell lung cancer other than predominantly squamous cell histology.,Pemetrexed as monotherapy is indicated for the treatment of

patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology after prior platinum-based

chemotherapy.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Vial

Glass Type I Clear

36 Months

Store below 25

degrees Celsius

Not recorded

Store in a Dry Place

Pack Size/Poison information

Pack Size

Poison Schedule

1 vial per carton

(S4) Prescription Only Medicine

Components

1. PEMETREXED ACCORD pemetrexed (as disodium) 100 mg powder for injection vial

Dosage Form

Injection, powder for

Route of Administration

Intravenous

Visual Identification

A white to either light yellow or greenish yellow lyophilized solid in a clear

glass vial

Active Ingredients

pemetrexed disodium

110.29 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 11:19:44 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

v 2.0

PEMETREXED ACCORD powder for injection

pemetrexed (as disodium)

CONSUMER MEDICINES INFORMATION

What is in this leaflet

This leaflet answers some common

questions about Pemetrexed Accord.

It does not contain all the available

information. It does not take the place

of talking to your doctor or

pharmacist.

The information in this leaflet was

last updated on the date shown on the

final page. More recent information

on this medicine may be available.

Make sure you speak to your

pharmacist, nurse or doctor to obtain

the most up to date information on

this medicine. The updated leaflet

may contain important information

about Pemetrexed Accord and its use

that you should be aware of.

All medicines have risks and benefits.

Your doctor has weighed the risks of

you taking Pemetrexed Accord

against the benefits this medicine is

expected to have for you.

If you have any concerns about

taking this medicine, ask your

doctor or pharmacist.

Keep this leaflet. You may need to

read it again.

What Pemetrexed

Accord is used for

Pemetrexed Accord is used to treat:

mesothelioma, a rare cancer of

the lungs often related to

exposure to asbestos

non-small cell lung cancer, a

type of lung cancer.

It belongs to a group of medicines

called cytotoxic or antineoplastic

agents. They may also be called

chemotherapy medicines.

It affects enzymes within cancer cells

to kill cancer cells or prevent them

growing and multiplying.

Your doctor may have prescribed it

for another reason.

Ask your doctor if you have any

questions about why this medicine

has been prescribed for you.

This medicine is available only with a

doctor's prescription.

Pemetrexed Accord may be used in

combination with other chemotherapy

drugs.

Before you are given

Pemetrexed Accord

When you must not be given it

Do not take Pemetrexed Accord if

you have an allergy to:

any medicine containing

pemetrexed disodium

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 you are not sure whether you

should be given this medicine, talk

to your doctor.

Before you are given it

Tell your doctor if you have or

have had any of the following

medical conditions:

kidney problems

Tell your doctor if you are

pregnant or plan to become

pregnant or are breast-feeding.

Pregnancy and breast-feeding should

be avoided during Pemetrexed

Accord treatment. Your doctor can

discuss with you the risks and

benefits involved.

This medicine is not recommended

for use in children under the age of

18 years.

Safety and effectiveness in children

younger than 18 years have not been

established.

If you have not told your doctor

about any of the above, tell him/

her before you take Pemetrexed

Accord.

Taking Premedication

Your doctor should advise you to

take certain medicines or vitamin

while taking Pemetrexed Accord.

These may help to minimise side

effects.

Your doctor should advise you to

take a folate supplement or a

multivitamin containing folate once

daily for at least five days in the

week before your first Pemetrexed

Accord dose. This should be

continued throughout your therapy

cycles and for at least three weeks

following completion of

Pemetrexed Accord treatment.

Your doctor should also advise you

to have a vitamin B12 injection

during the week before your first

dose of Pemetrexed Accord. A

vitamin B12 injection should be

given once every three treatment

cycles.

Your doctor may also advise you to

take an oral corticosteroid such as

dexamethasone to reduce the

likelihood and severity of skin

rashes.

Ask your doctor if you have any

questions about why these other

medicines have been prescribed for

you.

Taking other medicines

Tell your doctor or pharmacist if

you are taking any other medicines,

v 2.0

including any that you buy without

a prescription from your

pharmacy, supermarket or health

food shop.

Some medicines maybe affected by

Pemetrexed Accord or may affect

how it works. These include:

medicines used to treat arthritis

or pain from inflammation such

as ibuprofen or other non-

steroidal anti-inflammatory

medicines (NSAIDs).

You may need different amounts of

your medicines or to stop taking them

for a few days 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

Pemetrexed Accord.

How Pemetrexed Accord

will be given

Follow all directions given to you

by your doctor or pharmacist

carefully.

How much is given

Your doctor will decide the dosage of

Pemetrexed Accord you should take.

This will depend on your condition

and other factors, such as your

weight.

How it is given

Pemetrexed Accord is given as an

infusion (drip) into your veins over a

10 minute period.

When treating certain cancers, you

may also be given other

chemotherapy medicines.

Your doctor or nurse will inject

Pemetrexed Accord for you.

Never inject Pemetrexed Accord

yourself. Always let your doctor or

nurse do this.

How often it is given

Pemetrexed Accord is given once

every three weeks (1 treatment cycle).

Your doctor will advise how many

treatment cycles you need. Before

each infusion you will have samples

of your blood taken to check that you

have enough blood cells to receive

Pemetrexed Accord. Your doctor may

decide to change your dose or delay

treating you depending on your

general condition and if your blood

cell counts are too low.

Overdose

As Pemetrexed Accord is given to

you under the supervision of your

doctor, it is unlikely that you will

have too much.

However, if you experience any side

effects after being given

Pemetrexed Accord, immediately

tell your doctor or nurse or go to

the Emergency Department at your

nearest hospital.

You may need urgent medical

attention.

While you are taking

Pemetrexed Accord

Things you must do

Always take your daily folate

supplement until your doctor tells

you to stop.

Always check with your doctor that

your vitamin B12 injections are up

to date.

If you are about to be started on

any new medicine, remind your

doctor and pharmacist that you are

receiving Pemetrexed Accord.

Tell any other doctors, dentists and

pharmacists who treat you that you

are receiving this medicine.

If you are going to have surgery,

tell the surgeon or anaesthetist that

you are receiving this medicine.

It may affect other medicines used

during surgery.

If you become pregnant while

receiving this medicine, tell your

doctor immediately.

If you are about to have any blood

tests, tell your doctor that you are

receiving this medicine.

Keep all of your doctor's

appointments so that your progress

can be checked.

Your doctor may do some tests from

time to time to make sure the

medicine is working and to prevent

unwanted side effects.

Things to be careful of

Be careful driving or operating

machinery until you know how

Pemetrexed Accord affects you.

This medicine may cause tiredness or

drowsiness in some people. If you

have any of these symptoms, do not

drive, operate machinery or do

anything else that could be

dangerous.

Side effects

Tell your doctor or pharmacist as

soon as possible if you do not feel

well while you are taking

Pemetrexed Accord.

This medicine is to help people with

mesothelioma or non-small cell lung

cancer, but it may have 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 attention if you get some of

the side effects.

Do not be alarmed by the following

lists of side effects. You may not

experience any of them.

Ask your doctor or pharmacist to

answer any questions you may have.

Tell your doctor or pharmacist if you

notice any of the following and they

worry you:

fatigue, drowsiness, fainting

feeling dehydrated

pain in the stomach, upset

stomach, nausea, loss of

appetite, vomiting

v 2.0

diarrhoea, constipation, dark

urine

muscle weakness

skin irritation, burning or

prickling sensation

hair loss

conjunctivitis (red and itchy

eyes with or without discharge

and crusty eyelids)

coughing, difficulty breathing,

wheezing caused by

inflammation of the lung

abdominal, chest, back or leg

pain.

Additional side effects when used in

combination with other chemotherapy

agents include:

taste change

loss of feeling

kidney problems where you pass

little or no urine.

The above lists include the more

common side effects of your

medicine. When used in combination

with other chemotherapy medicine,

also refer to the other product's

consumer medicine information

leaflet for a list of other possible side

effects.

Tell your doctor as soon as possible if

you notice any of the following:

fever or infection with a

temperature, sweating or other

signs of infection

pain, redness, swelling or sores

in your mouth

sudden signs of allergy such as

rash, itching or hives on the

skin, swelling of the face, lips or

tongue or other parts of the

body, shortness of breath,

wheezing or trouble breathing

tiredness, feeling faint or

breathless, if you look pale

bleeding or bruising more easily

than normal.

The above list includes serious side

effects which may require medical

attention.

In rare cases Pemetrexed Accord

can cause inflammation of the

colon (large bowel). Tell your

doctor as soon as possible if you

experience any of the following

symptoms:

diarrhoea with blood and mucus

stomach pain

fever

If any of the following happen, tell

your doctor immediately or go to

the Emergency Department at your

nearest hospital:

chest pain or fast heart beat

bleeding from the gums, nose or

mouth, any bleeding that will

not stop, reddish or pinkish

urine, unexpected bruising.

The above list includes very serious

side effects. You may need urgent

medical attention or hospitalisation.

Tell your doctor or pharmacist if

you notice anything that is making

you feel unwell.

Other side effects not listed above

may also occur in some people.

Some of these side effects (for

example, abnormal blood tests

showing low cell counts) can only be

found when your doctor does tests to

check your progress.

Storage

This medicine will be stored in the

hospital pharmacy or on the ward. It

will be kept in a cool dry place where

the temperature stays below 25°C.

Product description

What it looks like

Pemetrexed Accord is a white to off

white powder and is available in a

glass vial container with a rubber

stopper.

Ingredients

Pemetrexed Accord is supplied in

1000 mg, 500 mg and 100 mg glass

vials.

The 1000 mg vial of Pemetrexed

Accord contains pemetrexed

disodium equivalent to 1000 mg

pemetrexed and 1000 mg of mannitol.

The 500 mg vial of Pemetrexed

Accord contains pemetrexed

disodium equivalent to 500 mg

pemetrexed and 500 mg of mannitol.

The 100 mg vial of Pemetrexed

Accord contains pemetrexed

disodium equivalent to 100 mg

pemetrexed and 100 mg of mannitol.

Hydrochloric acid and/or sodium

hydroxide may be added to adjust pH.

Name and Address of the

Sponsor

Accord Healthcare Pty Ltd

Lvl 24, 570 Bourke Street

Melbourne, VIC, 3000

Australia

Australian Registration Numbers

Pemetrexed Accord 1000 mg, AUST

R 222419

Pemetrexed Accord 500 mg, AUST R

222415

Pemetrexed Accord 100 mg, AUST R

222420

Date of preparation

This leaflet was prepared on 25

October 2016.

22-10-2018

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