Pemetrexed

Main information

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

Documents

Localization

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

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 210429
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

210429

Pemetrexed APOTEX pemetrexed 100 mg (as disodium) powder for injection vial

ARTG entry for

Medicine Registered

Sponsor

Apotex Pty Ltd

Postal Address

PO Box 280,NORTH RYDE BC, NSW, 1670

Australia

ARTG Start Date

4/09/2014

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 APOTEX pemetrexed 100 mg (as disodium) powder for injection vial

Product Type

Single Medicine Product

Effective date

7/07/2017

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 (NSCLC),Pemetrexed, in combination with cisplatin, is indicated for initial treatment of patients with locally

advanced or metastatic NSCLC other than predominantly squamous cell histology.,Pemetrexed, as monotherapy, is indicated for the treatment of

patients with locally advanced or metastatic NSCLC 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

24 Months

Store below 25

degrees Celsius

Not recorded

Store in Original

Container

Pack Size/Poison information

Pack Size

Poison Schedule

(S4) Prescription Only Medicine

Components

1. Pemetrexed APOTEX pemetrexed 100 mg (as disodium) powder for injection vial

Dosage Form

Injection, powder for

Route of Administration

Intravenous Infusion

Visual Identification

White to either light yellow or green-yellow powder.

Active Ingredients

pemetrexed disodium hemipentahydrate

120.8 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 27.11.2017 at 09:50:52 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

Pemetrexed APOTEX

Powder for Injection

Contains the active ingredient pemetrexed (as disodium)

Consumer Medicine Information

For a copy of a large print leaflet, Ph: 1800 195 055

What is in this leaflet

Read this leaflet carefully before

taking your medicine.

This leaflet answers some common

questions about pemetrexed. 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 listed on the

last page. More recent information on

this medicine may be available.

Ask your doctor or pharmacist:

if there is anything you do not

understand in this leaflet,

if you are worried about taking

your medicine, or

to obtain the most up-to-date

information.

You can also download the most up

to date leaflet from

www.apotex.com.au.

All medicines have risks and

benefits. Your doctor has weighed

the risks of you using this medicine

against the benefits they expect it

will have for you.

Pharmaceutical companies cannot

give you medical advice or an

individual diagnosis.

Keep this leaflet with your medicine.

You may want to read it again.

What this medicine is

used for

The name of your medicine is

Pemetrexed APOTEX Powder for

Injection, which is given as an

intravenous infusion. It contains the

active ingredient pemetrexed, as the

disodium salt.

It 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.

Ask your doctor if you have any

questions about why this medicine

has been prescribed for you. Your

doctor may have prescribed this

medicine for another reason.

This medicine is available only with

a doctor's prescription.

How it works

Pemetrexed 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.

Pemetrexed may be used in

combination with other

chemotherapy drugs.

There is no evidence that this

medicine is addictive.

Use in children

This medicine should not be used in

children.

Before you are given

this medicine

When you must not be given

it

Do not take this medicine if you

are hypersensitive to, or have had

an allergic reaction to pemetrexed

or any of the ingredients listed at

the end of this leaflet.

Symptoms of an allergic reaction

may include: cough, shortness of

breath, wheezing or difficulty

breathing; swelling of the face,

lips, tongue, throat or other parts

of the body; rash, itching or hives

on the skin; fainting; or hay

fever-like symptoms.

Before you are given it

Before you are given this medicine,

tell your doctor if:

You have allergies to:

any other medicines

any other substances, such as

foods, preservatives or dyes.

You have or have had any

medical conditions, especially the

following:

kidney problems.

PEMETREXED APOTEX POWDER FOR INJECTION

You are currently pregnant or you

plan to become pregnant. This

medicine should not be given

during pregnancy. You and your

doctor should discuss the risks

and benefits involved.

You are currently breastfeeding

or you plan to breast-feed. This

medicine should not be given

whilst breastfeeding. You and

your doctor should discuss the

risks and benefits involved.

You are taking or are planning to

take any other medicines. This

includes vitamins and

supplements that are available

from your pharmacy, supermarket

or health food shop.

Some medicines may interact with

pemetrexed. These include:

medicines used to treat arthritis or

pain from inflammation such as

ibuprofen or other non-steroidal

anti-inflammatory medicines

(NSAIDs).

If you are taking any of these you

may need a different dose or you

may need to take different medicines.

Other medicines not listed above

may also interact with pemetrexed.

Taking pre-medication

Your doctor should advise you to

take certain medicines or vitamin

while taking pemetrexed. 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

dose. This should be continued

throughout your therapy cycles and

for at least three weeks following

completion of pemetrexed treatment.

Your doctor should also advise you

to have a vitamin B12 injection

during the week before your first

dose of pemetrexed. 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.

How this medicine will

be given

Follow carefully all directions given

to you by your doctor. Their

instructions may be different to the

information in this leaflet.

How much will be given

Your doctor will decide the dosage of

is Pemetrexed APOTEX you should

take. This will depend on your

condition and other factors, such as

your weight.

How it is given

Pemetrexed 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 for you.

Never inject pemetrexed yourself.

Always let your doctor or nurse do

this.

How often it is given

Pemetrexed 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. 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.

If you are given too much

(overdose)

As pemetrexed 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, immediately tell your

doctor or nurse or telephone your

doctor or the Poisons Information

Centre (Tel: 13 11 26 in Australia)

for advice. Alternatively, go to the

Accident and Emergency

department at your nearest

hospital.

You may need urgent medical

attention.

While you are being

treated with this

medicine

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 be

treated with pemetrexed.

Tell any other doctors, dentists and

pharmacists who treat you that you

are being treated with 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

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.

PEMETREXED APOTEX POWDER FOR INJECTION

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 when driving or

operating machinery until you

know how this medicine 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.

Possible side effects

Tell your doctor as soon as possible

if you do not feel well while you are

being treated with pemetrexed or if

you have any questions or concerns.

Do not be alarmed by the following

lists of side effects. You may not

experience any of them. All

medicines can have side effects.

Sometimes they are serious but most

of the time they are not.

Tell your doctor if you notice any

of the following:

fatigue, drowsiness, fainting

feeling dehydrated

pain in the stomach, upset

stomach, nausea, loss of appetite,

vomiting

diarrhoea, constipation

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

swelling

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.

These may be serious side effects

and you may need medical

attention:

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.

In rare cases pemetrexed 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 you experience any of the

following, contact your doctor

immediately or go to the Accident

and Emergency department at

your nearest hospital.

These are very serious side effects

and you may need urgent medical

attention or hospitalisation:

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.

Tell your doctor if you notice

anything that is making you feel

unwell.

Other side effects not listed above

may occur in some patients.

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 and disposal

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 will stay

below 25°C.

Product description

What Pemetrexed APOTEX

Powder for Injection looks

like

100 mg and 500 mg strengths: white

to either light yellow or green-yellow

powder.

Pack of 1 vial.

Ingredients

Each vial contains 100 mg or 500 mg

of pemetrexed as the active

ingredient.

Each vial also contains the following

inactive ingredients:

mannitol.

hydrochloric acid and/or sodium

hydroxide may have been added

to both strengths to adjust pH.

PEMETREXED APOTEX POWDER FOR INJECTION

This medicine is gluten-free, lactose-

free, sucrose-free, tartrazine-free and

free of other azo dyes.

Australian Registration

Numbers

Pemetrexed APOTEX 100 mg

Powder (vial): AUST R 210429.

Pemetrexed APOTEX 500 mg

Powder (vial): AUST R 210440.

Sponsor

Apotex Pty Ltd

16 Giffnock Avenue

Macquarie Park NSW 2113

APO and APOTEX are registered

trade marks of Apotex Inc.

This leaflet was last updated in May

2017.

PEMETREXED APOTEX POWDER FOR INJECTION

22-10-2018

Pemetrexed Hospira (Pfizer Europe MA EEIG)

Pemetrexed Hospira (Pfizer Europe MA EEIG)

Pemetrexed Hospira (Active substance: pemetrexed) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6971 of Mon, 22 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3970/T/14

Europe -DG Health and Food Safety

2-10-2018

Pemetrexed Pfizer (Pfizer Europe MA EEIG)

Pemetrexed Pfizer (Pfizer Europe MA EEIG)

Pemetrexed Pfizer (Active substance: pemetrexed) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6464 of Tue, 02 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4488/T/04

Europe -DG Health and Food Safety

10-7-2018

Pemetrexed Sandoz (Sandoz GmbH)

Pemetrexed Sandoz (Sandoz GmbH)

Pemetrexed Sandoz (Active substance: pemetrexed) - Centralised - Yearly update - Commission Decision (2018)4485 of Tue, 10 Jul 2018

Europe -DG Health and Food Safety

10-7-2018

Pemetrexed Fresenius Kabi (Fresenius Kabi Deutschland GmbH)

Pemetrexed Fresenius Kabi (Fresenius Kabi Deutschland GmbH)

Pemetrexed Fresenius Kabi (Active substance: pemetrexed) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)4472 of Tue, 10 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3895/T/7

Europe -DG Health and Food Safety

11-6-2018

Pemetrexed Accord (Accord Healthcare Limited)

Pemetrexed Accord (Accord Healthcare Limited)

Pemetrexed Accord (Active substance: pemetrexed) - Centralised - Yearly update - Commission Decision (2018)3761 of Mon, 11 Jun 2018

Europe -DG Health and Food Safety

28-5-2018

Armisarte (Actavis Group PTC ehf.)

Armisarte (Actavis Group PTC ehf.)

Armisarte (Active substance: pemetrexed) - Centralised - Yearly update - Commission Decision (2018)3348 of Mon, 28 May 2018

Europe -DG Health and Food Safety

24-5-2018

Pemetrexed Krka (KRKA, d.d., Novo mesto)

Pemetrexed Krka (KRKA, d.d., Novo mesto)

Pemetrexed Krka (Active substance: pemetrexed) - Centralised - Authorisation - Commission Decision (2018)3278 of Thu, 24 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3958

Europe -DG Health and Food Safety

15-5-2018

Pemetrexed Fresenius Kabi (Fresenius Kabi Oncology Plc.)

Pemetrexed Fresenius Kabi (Fresenius Kabi Oncology Plc.)

Pemetrexed Fresenius Kabi (Active substance: pemetrexed) - Centralised - Yearly update - Commission Decision (2018)3060 of Tue, 15 May 2018

Europe -DG Health and Food Safety

15-5-2018

Pemetrexed Hospira (Hospira UK Limited)

Pemetrexed Hospira (Hospira UK Limited)

Pemetrexed Hospira (Active substance: pemetrexed) - Centralised - Yearly update - Commission Decision (2018)3059 of Tue, 15 May 2018

Europe -DG Health and Food Safety

23-3-2018

Pending EC decision:  Pemetrexed Krka, pemetrexed, Opinion date: 22-Mar-2018

Pending EC decision: Pemetrexed Krka, pemetrexed, Opinion date: 22-Mar-2018

Europe - EMA - European Medicines Agency