LIDAVEG

Main information

  • Trade name:
  • LIDAVEG aflibercept 100mg/4mL injection, concentrated
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • LIDAVEG aflibercept 100mg/4mL injection, concentrated
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 195970
  • Last update:
  • 12-11-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

195970

LIDAVEG aflibercept 100mg/4mL injection, concentrated

ARTG entry for

Medicine Registered

Sponsor

Sanofi-Aventis Australia Pty Ltd

Postal Address

Locked Bag 2227,NORTH RYDE BC, NSW, 1670

Australia

ARTG Start Date

2/04/2013

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. LIDAVEG aflibercept 100mg/4mL injection, concentrated

Product Type

Single Medicine Product

Effective date

18/08/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Lidaveg in combination with irinotecan-fluoropyrimidine-based chemotherapy is indicated in adults with metastatic colorectal cancer previously treated

with an oxaliplatin-containing regimen.,[See clinical trials for results of Lidaveg in combination with FOLFIRI. Other combinations have not been

evaluated].

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Vial

Glass Type I Clear

36 Months

Store at 2 to 8

degrees Celsius

Not recorded

Protect from Light

Do not Freeze

Refrigerate

Pack Size/Poison information

Pack Size

Poison Schedule

3 vial

(S4) Prescription Only Medicine

1 vial

(S4) Prescription Only Medicine

Components

1. LIDAVEG aflibercept 100mg/4mL injection, concentrated

Dosage Form

Injection, concentrated

Route of Administration

Intravenous Infusion

Visual Identification

Clear liquid, essentially free of visible particulate, colorless to pale yellow.

Active Ingredients

Aflibercept

25 mg/mL

© 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 03:19:23 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

LIDAVEG

LIDAVEG

®

(LID-AR-VEG)

Aflibercept (rch) (a-flib-er-cept)

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common

questions about Lidaveg.

It does not contain all the available

information. It does not take the

place of talking to your doctor.

All medicines have risks and

benefits. Your doctor has weighed

the risks of you taking Lidaveg

against the benefits they expect it

will have for you.

If you have any concerns about

taking this medicine, ask your

doctor.

Keep this leaflet as you may need to

read it again.

What Lidaveg is used

for

Lidaveg is used to treat advanced

large bowel cancer (that is, cancer in

the colon or rectum) in combination

with chemotherapy agents.

Ask your doctor if you have any

questions about why this medicine

has been prescribed for you.

Lidaveg contains the active

ingredient aflibercept.

Lidaveg is an anti-cancer medicine

that blocks the growth of blood

vessels that provide nutrients and

oxygen to cancer cells. This prevents

the growth of the cancer cells.

Your doctor may have prescribed

Lidaveg for another purpose.

This medicine is only available with

a doctor's prescription.

Lidaveg is not addictive.

Before you are given

Lidaveg

Do not receive Lidaveg if you are

allergic to Lidaveg or any of the

ingredients listed at the end of this

leaflet.

Some symptoms of an allergic

reaction include: skin rash, hives,

itching or redness of the skin;

shortness of breath, wheezing or

difficulty breathing; or swelling of

the face, lips, tongue or other parts of

the body.

Lidaveg should not be used in your

eye, since it may severely damage

it.

Do not receive Lidaveg:

after the expiry date (EXP)

printed on the vial.

if the packaging is damaged or

shows signs of tampering.

Tell your doctor if you are

pregnant or are planning on

having a baby.

Do not use Lidaveg if you are

pregnant unless otherwise advised by

your doctor. Lidaveg may harm your

unborn baby.

Your doctor will advise you about

using effective contraception during

treatment with Lidaveg and for at

least six months after your last dose

of Lidaveg.

Tell your doctor if you plan to start

a family in the future.

Lidaveg may affect your ability to

become pregnant. Your doctor will

advise you of your options prior to

starting treatment.

Tell your doctor if you are breast-

feeding or plan to breast-feed.

You should not breast-feed while

using Lidaveg and for at least six

months after the last dose of Lidaveg.

Lidaveg may affect the growth and

development of your baby.

Lidaveg should not be given to a

child or adolescent.

Talk to your doctor if you have any

other health problems, especially

if:

you or anyone if your family have

a history of bleeding problems

you have any bleeding problems

or if you notice any bleeding after

treatment or if you feel extreme

tiredness, weakness, dizziness or

have changes in the colour of

your stool. If the bleeding is

severe, your doctor will stop your

treatment with Lidaveg. This is

because Lidaveg may increase the

risk of bleeding

you have a history of blood clots

or stroke, or you are taking

medicines to thin the blood to

prevent blood clots (e.g.

warfarin). The signs of a blood

clot may vary depending on

where it appears (e.g. lungs, leg,

heart or brain) but may include

symptoms such as chest pain,

coughing, being short of breath or

having difficulty breathing. Other

LIDAVEG

signs may include swelling in one

or both legs, pain or tenderness in

one or both legs, discolouration

and warmth of the skin on the

affected leg or visible veins. It

may also present itself as a

sudden numb or weak feeling in

the face, arms or legs.

you have high blood pressure.

Lidaveg may increase blood

pressure and your doctor will

need to monitor your blood

pressure and may adjust your

blood pressure medicines or dose

of Lidaveg.

you have had heart or circulation

problems, such as stroke

you have conditions causing

inflammation or bleeding or the

bowel. Symptoms may include

fever, vomiting, diarrhoea and

stomach pain

you have stomach ulcers

you have kidney problems

(protein in the urine)

you have ever had any allergies

or are allergic to any other

medicines, foods, dyes, or

preservatives.

you have had seizures, or cancer

which has spread to your brain or

spine

you are 65 years of age or older

and experience diarrhoea,

dizziness, weakness, weight loss

or severe loss of body fluids

(called dehydration). Your doctor

should monitor you carefully

Tell your doctor if you are going to

have an operation or you have had

a dental procedure or any other

surgery within the last 4 weeks.

Tell your doctor if you have a

surgical wound that has not healed.

Tell your doctor if you have recently

received, or are receiving,

radiotherapy.

If you have not already told your

doctor about any of the above, tell

them before you are given Lidaveg.

Taking other medicines

Tell your doctor if you are taking any

other medicines including herbal

supplements and vitamins and those

that you buy without a prescription

from your pharmacy, supermarket or

health food store.

This is because some medicines can

affect the way Lidaveg works or

Lidaveg can affect how other

medicines work.

How Lidaveg is given

Lidaveg will be given by a drip

(infusion) into one of your veins

(intravenous use) in hospital by a

doctor or nurse for about an hour.

Lidaveg will be administered to you

in combination with other

chemotherapy medicines.

Lidaveg should not be used if you

notice the solution is cloudy and/or

visible particles are present in the

vial or in the infusion bag.

Lidaveg must not be injected into the

eye, since it may severely damage it.

How much is given

The recommended dose of Lidaveg is

4 mg per kilogram of your body

weight.

How often is Lidaveg given

You will usually have an infusion

once every 2 weeks. Each 2 week

period is called one cycle of

chemotherapy. Your doctor will

decide how many of these cycles you

will need.

Your doctor will decide how often

you will receive Lidaveg and if you

need adjustment in the dose.

If you have any further questions on

the use of this medicine, ask your

doctor, pharmacist or nurse.

If you take too much

(overdose)

As Lidaveg is given to you under the

supervision of your doctor, it is very

unlikely that you will receive too

much. However, if you experience

any unexpected or worrying side

effects after being given Lidaveg

immediately telephone your doctor,

or the Poisons Information Centre

(telephone 13 11 26) or go to

Accident and Emergency at your

nearest hospital.

While you are using it

Things you must do

Tell all the doctors, dentists and

pharmacists who are treating you that

you are taking Lidaveg.

If you are about to be started on any

new medicine, tell your doctor and

pharmacist that you are taking

Lidaveg.

Men and women of childbearing

potential should use effective

contraception during treatment with

Lidaveg and up to 6 months after the

last dose of treatment.

Continue using Lidaveg until your

doctor tells you to stop. If your

condition gets worse, you must tell

your doctor.

Things you must not do

Do not take any other medicines

whether they require a prescription or

not without first telling your doctor

or consulting a pharmacist.

Things to be careful of

Be careful driving or operating

machinery until you know how

Lidaveg affects you. Lidaveg has not

been shown to affect your ability to

drive or operate machinery.

LIDAVEG

Side effects

Lidaveg helps most people with

advanced large bowel cancer (that is,

cancer of the colon or rectum) but

like all medicines it can cause side

effects, although not everybody gets

them.

Sometimes they are serious, but most

of the time they are not. Your doctor

has weighed the risks of using this

medicine against the benefits they

expect it will have for you.

The side effects listed below were

seen when Lidaveg was given

together with chemotherapy.

Do not be alarmed by the list of

possible list effects. You may not

experience any of them.

If any of the following happen

while you are being given Lidaveg

in the hospital/clinic, tell your

doctor or nurse immediately:

skin rash

hives

itching

redness of skin

shortness of breath, wheezing or

difficulty breathing or swelling of

the face, lips tongue or other parts

of the body.

If you are outside of the

hospital/clinic go to Accident and

Emergency at your nearest

hospital.

These are very serious side effects

although they are uncommon.

If you have them, you may have had

a serious allergic reaction to Lidaveg

and you may need urgent medical

attention or hospitalisation.

Tell your doctor immediately if

you notice any of the serious side

effects below:

Stomach cramps or pains

Severe or bloody diarrhoea

Bleeding from the stomach or

bowel which may look like coffee

grounds or black, sticky bowel

motions (stools)

Vomiting blood or material that

looks like coffee grounds

Coughing or spitting blood

Blocking of the arteries or veins

by a blood clot

Problems with your wounds

healing after surgery

Headache, vision changes,

confusion and/or seizures

Other side effects are described

below.

Very common (may affect more

than 1 in 10 people)

Decrease in the number of white

blood cells

Decrease in the number of cells in

the blood that help the blood to

clot

Decrease in appetite

Headache

Nose bleeds

Difficulty in speaking or

hoarseness

Difficulty in breathing

Painful sores in the mouth

Stomach pain

Swelling and numbness of the

hands and feet that occurs with

chemotherapy

Feeling tired or weak

Loss of weight

Changes in liver or kidney

function

High blood pressure

Common (may affect up to 1 in 10

people)

Fever

Dehydration

Urinary tract infection

Inflammation of the nasal

passages

Pain in the mouth and/or throat

Runny nose

Haemorrhoids, rectal bleeding,

pain at the anus or in the rectum

Inflammation of the mouth

Toothache

Changes in the colour of skin

Other side effects not listed above

may occur in some patients.

Ask your doctor or pharmacist to

answer any questions you may have.

After taking it

If you have any queries about any

aspect of your medicine, or any

questions regarding the information

in this leaflet, discuss them with your

doctor, nurse or pharmacist.

Storage

Store at 2°C to 8°C (Refrigerate. Do

not freeze). Protect from light.

Product description

What Lidaveg looks like

Lidaveg is a clear, colourless to pale

yellow solution.

Availability

Lidaveg is available as 4mL and 8mL

vials.

Ingredients

Active ingredient

Aflibercept (25mg/mL)

Inactive ingredients

sucrose

sodium chloride

sodium citrate (dihydrate)

citric acid monohydrate

polysorbate 20

sodium phosphate dibasic

(heptahydrate)

sodium phosphate monobasic

monohydrate

sodium hydroxide

hydrochloric acid and

water for injections.

LIDAVEG

Manufacturer/Sponsor

Lidaveg is made in Germany.

Lidaveg is supplied in Australia by:

sanofi-aventis australia pty ltd

12-24 Talavera Road

Macquarie Park NSW 2113

This leaflet was prepared in June

2013.

Australian Register Number(s):

Lidaveg 100mg/4mL AUST R

195970

Lidaveg 200mg/8mL AUST R

195976