Pemetrexed-DRLA

Main information

  • Trade name:
  • Pemetrexed-DRLA Pemetrexed Disodium 500 mg injection vial
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Pemetrexed-DRLA Pemetrexed Disodium 500 mg injection vial
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 209348
  • Last update:
  • 10-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

209348

Pemetrexed-DRLA Pemetrexed Disodium 500 mg injection vial

ARTG entry for

Medicine Registered

Sponsor

Dr Reddys Laboratories Australia Pty Ltd

Postal Address

Level 9 / 492 St Kilda Road,MELBOURNE, VIC, 3004

Australia

ARTG Start Date

19/05/2014

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-DRLA Pemetrexed Disodium 500 mg injection vial

Product Type

Single Medicine Product

Effective date

10/11/2015

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

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

mesothelioma.,Non-Small Cell lung Cancer:,Pemetrexed-DRLA 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-DRLA 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

24 Months

Store below 25

degrees Celsius

Not recorded

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

1 X 500 mg/vial

(S4) Prescription Only Medicine

Components

1. Pemetrexed-DRLA Pemetrexed Disodium 500 mg injection vial

Dosage Form

Injection, powder for

Route of Administration

Intravenous

Visual Identification

Pemetrexed disodium for injection 500 mg/vial is a white to either

light-yellow or green-yellow lyophilised powder packed in 50 mL glass vial

with 20 mm rubber stopper and sealed with 20 mm aluminium flip-off seal

Active Ingredients

pemetrexed disodium

551.4 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 10:24:27 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-DRLA v2

PEMETREXED-DRLA

Contains the active ingredient pemetrexed disodium

Consumer Medicine Information

What is in this leaflet

Read this leaflet carefully before

taking your medicine.

This leaflet answers some of the

common questions about

pemetrexed. It does not contain all

the information that is known about

pemetrexed.

It does not take the place of talking to

your doctor and pharmacist.

All medicines have risks and

benefits. Your doctor will have

weighed the risks of you taking this

medicine against the benefits they

expect it will have for you.

If you have any concerns about

taking this medicine, ask your

doctor or pharmacist.

Keep this leaflet with the medicine.

You may need to read it again.

What this medicine is

used for

The name of your medicine is

Pemetrexed-DRLA. It contains the

active ingredient pemetrexed

disodium.

Pemetrexed 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 purpose.

Ask your doctor or pharmacist if

you have any questions about why

it has been prescribed for you.

This medicine is available only with

a doctor's prescription.

Pemetrexed may be used in

combination with other

chemotherapy drugs.

Before you are given

this medicine

When you must not be given

it

Do not take this medicine if you

are allergic to any medicine

containing pemetrexed disodium

or any of the ingredients listed at

the end of this leaflet.

Some symptoms of an allergic

reaction include skin rash, itching,

shortness of breath or swelling of the

face, lips or tongue, which may cause

difficulty in swallowing or breathing.

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

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 this

medicine.

Taking Premediciation

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 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

PEMETREXED-DRLA v2

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, including any that you

buy without a prescription from

your pharmacy, supermarket or

health food store.

Some medicines maybe affected by

pemetrexed 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

this medicine.

How this medicine will

be given

Follow all directions given to you

by your doctor or pharmacist

carefully.

Their instructions may be different to

the information in this leaflet.

How much is given

Your doctor will decide the dosage of

pemetrexed 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 yourself. Always let

your doctor or nurse do this.

How often it is given

Pemetrexed-DRLA 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 take too much

(overdose)

As this medicine 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 go to the

Emergency Department at your

nearest hospital.

You may need urgent medical

attention.

While you are taking

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 receiving pemetrexed.

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 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 using this

medicine.

This medicine is to help people with

mesothelioma or non-small cell lung

cancer, but it may have unwanted

side effects in a few people.

All medicines have some unwanted

side effects. Sometimes they are

serious, but most of the time they are

not. Your doctor has weighed the

risks of using this medicine against

PEMETREXED-DRLA v2

the benefits they expect it will have

for you.

Do not be alarmed by this list of

possible side effects. You may not

experience any of them.

Tell your doctor or pharmacist 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, 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 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 Pemetrexed-DRLA

looks like

Pemetrexed-DRLA is a white to off

white powder and is available in a

glass vial container with a rubber

stopper.

Ingredients

Each Pemetrexed-DRLA vial

contains 100 mg or 500 mg of

pemetrexed disodium as the active

ingredient.

It also contains the following inactive

ingredients:

mannitol

hydrochloric acid and/or sodium

hydroxide may have been added

to adjust pH.

This medicine is gluten-free, sucrose-

free, tartrazine-free and free of other

azo dyes.

Pemetrexed-DRLA is available packs

containing 1 vial.

Australian Registration

Numbers

AUST R 209348 – 500 mg

AUST R 236053 – 100 mg

Sponsor

Dr Reddy’s Laboratories (Australia)

Pty Ltd

Level 9, 492 St Kilda Road,

Melbourne, Victoria, 3004

Australia

This leaflet was prepared in May

2016.

22-10-2018

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