LIXISENATIDE

Main information

  • Trade name:
  • LIXISENATIDE WINTHROP lixisenatide 10 mcg (0.05mg/mL) solution for injection injector pen
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • LIXISENATIDE WINTHROP lixisenatide 10 mcg (0.05mg/mL) solution for injection injector pen
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 192716
  • Last update:
  • 13-11-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

192716

LIXISENATIDE WINTHROP lixisenatide 10 mcg (0.05mg/mL) solution for injection injector pen

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

10/04/2013

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. LIXISENATIDE WINTHROP lixisenatide 10 mcg (0.05mg/mL) solution for injection injector pen

Product Type

Single Medicine Product

Effective date

31/08/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

LIXISENATIDE WINTHROP is indicated for the treatment of adults with type 2 diabetes mellitus to achieve glycaemic control in combination with

metformin, metformin and sulphonylurea, basal insulin and metformin, basal insulin and sulphonylurea when these, together with diet and exercise, do

not provide adequate glycaemic control (see sections CLINICAL TRIALS and PRECAUTIONS (Risk of Hypoglycemia)) for available data on the different

combinations.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Cartridge

Glass Type I Clear

24 Months

Store at 2 to 8

degrees Celsius

Neither child resistant

closure nor restricted

flow insert

Do not Freeze

Do Not use if Colour

Changes

Do NOT use if there is

crystallisation

Protect from direct

sunlight

Protect from Light

Protect from light after

opening

Pack Size/Poison information

Pack Size

Poison Schedule

(S4) Prescription Only Medicine

Components

1. LIXSENATIDE WINTHROP lixisenatide 10 mcg (0.05mg/mL) solution for injection injector pen

Dosage Form

Injection, solution

Route of Administration

Subcutaneous

Visual Identification

clear, colourless solution

Active Ingredients

Lixisenatide

.05 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 08:50:47 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

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LIXISENATIDE

WINTHROP

®

lixisenatide

Consumer Medicine

Information

What is in this leaflet

This leaflet answers some common

questions about Lixisenatide

Winthrop.

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 taking Lixisenatide

Winthrop 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 Lixisenatide

Winthrop Is Used For

Lixisenatide Winthrop contains the

active substance lixisenatide.

Lixisenatide Winthrop is a

medicine used to control the blood

sugar level when it is too high in

adult patients with type 2 diabetes

mellitus.

Lixisenatide Winthrop is used with

other antidiabetic medicines for

diabetes when they are not enough

to control your blood sugar levels.

Your doctor will prescribe the best

combination to manage your type 2

diabetes mellitus.

It is also important to control your diet

and exercise while using Lixisenatide

Winthrop.

Check with your doctor or

healthcare professional if you are

not sure whether your antidiabetic

medicines contain a sulfonylurea or

basal insulin.

Diabetes mellitus is a condition in

which your pancreas does not produce

enough insulin to control your blood

sugar (glucose) level. Lixisenatide

Winthrop helps to control your blood

sugar levels only when it is too high.

Lixisenatide Winthrop is not a

substitute for insulin in patients who

require insulin treatments for their

diabetes. In some cases it may be used

as well as insulin.

Your doctor, however, may have

prescribed Lixisenatide Winthrop for

another purpose.

Ask your doctor if you have any

questions about why it has been

prescribed for you.

This medicine is only available with a

doctor's prescription.

Before You Use

Lixisenatide Winthrop

When you must not use it

Do not use Lixisenatide Winthrop if

:

you have type 1 diabetes or

diabetic ketoacidosis (often caused by

very high blood glucose levels).

you are allergic to lixisenatide or

meta-cresol or any of the ingredients

listed at the end of this leaflet

You must not become pregnant

while using Lixisenatide Winthrop.

It is not known if Lixisenatide

Winthrop increases the risk of birth

defects in humans.

Do not use it if you are

breastfeeding.

Lixisenatide Winthrop may pass

into breast milk and therefore there

is a possibility that the breastfed

baby may be affected.

Do not give Lixisenatide

Winthrop to a child or adolescent.

Lixisenatide Winthrop has not been

studied for use in children or

adolescents under 18 years old.

Do not use it after the expiry date

(EXP) printed on the pack.

If you use it after the expiry date

has passed, it may not work as well.

Do not use it if the packaging is

torn or shows signs of tampering

or if the pen appears damaged.

Return the product to your

pharmacist if it has expired or is

damaged.

Do not use Lixisenatide Winthrop

if you see solid particles or if the

solution is cloudy or coloured.

Talk to your doctor if you are not

sure if you should start using

Lixisenatide Winthrop.

Before you start to use it

Tell your doctor if you have

allergies to any other medicines,

foods, preservatives or dyes.

Tell your doctor if you are also

taking a sulfonylurea (such as

glimepiride or glibenclamide).

Your doctor may tell you to test

your blood sugar levels. This

will help your doctor to decide

if the dose of the sulfonylurea

needs to be changed.

Tell your doctor if you have or

have had any of the following

medical conditions:

kidney problems

pancreatitis

a history of persistent, severe

abdominal pain.

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Tell your doctor if you have

severe problems with your

stomach or food digestion.

Lixisenatide Winthrop slows

stomach emptying so food passes

more slowly through your stomach.

Tell your doctor if you are

pregnant or plan to become

pregnant.

It is not known if Lixisenatide

Winthrop may harm your unborn

child. Lixisenatide Winthrop should

not be used during pregnancy.

Tell your doctor if you are

breastfeeding or planning to

breastfeed.

Lixisenatide Winthrop may pass

into breast milk and therefore there

is a possibility that this may affect

your baby.

If you have not told your doctor

about any of the above, tell them

before you use Lixisenatide

Winthrop.

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 shop.

Tell your doctor or pharmacist if

you are taking a sulfonylurea (such

as glimepiride or glibenclamide).

This is because using Lixisenatide

Winthrop at the same time may

cause your blood sugar level to

become too low (hypoglycaemia or

a “hypo”).

When you first start using

these medicines together, your

doctor may tell you to lower the

dose of the sulfonylurea.

If you are not sure if the medicines

you are taking contain a

sulfonylurea, ask your doctor, diabetes

educator/nurse or pharmacist.

If you are taking a sulfonylurea as

well as Lixisenatide Winthrop your

doctor may ask you to test your blood

sugar levels to begin with. This will

help your doctor to decide if the dose

of the sulfonylurea needs to be

changed.

Some medicines maybe affected by

Lixisenatide Winthrop or may affect

how it works. You may need different

amounts of your medicines or you may

need to take your medicines at

different times.

This includes:

Medicines that need to pass

through the stomach quickly such

as antibiotics or stomach resistant

tablets or capsules. Lixisenatide

Winthrop slows stomach emptying

and can affect these medicines

Some medicines may need to be taken

an hour before or 11 hours after your

Lixisenatide Winthrop dose.

Your doctor and pharmacist have more

information on how to manage your

other medicines while using

Lixisenatide Winthrop.

How To Use

Lixisenatide Winthrop

How much to use

Carefully follow all the directions

given to you by your doctor or

health care professional.

They may differ from the

information contained in this leaflet.

Micrograms once a day for the first

14 days – injected using the green

pen.

The dose from then onwards will

be 20 micrograms once a day -using

the purple pen.

Make sure you are using the

correct injection pen.

Always

check the label on the pen before

each injection to make sure you

are using the right medicine.

Ask your doctor or pharmacist

if you are unsure of the correct

dose for you.

They will tell you exactly how

much to use.

Follow the instructions they give

you.

These directions may differ from

the information contained in this

leaflet. If you take the wrong dose,

Lixisenatide Winthrop may not

work as well or you may experience

side effects. Too much or too little

Lixisenatide Winthrop can cause

serious effects.

It is very important that you

manage your diabetes carefully.

How to use it

Before you use the injector pen

for the first time, your doctor or

nurse will show you how to inject

Lixisenatide Winthrop.

Your doctor will tell you how

much Lixisenatide Winthrop you

will need to use each day.

Read carefully the "Lixisenatide

Winthrop pen Instructions for

Use" provided in the carton.

must use the pen as described in

these Instructions for Use.

You must activate your

LXYUMIA Pen before you use it

for the first time

This will make sure that it is

working correctly and that the dose

for your first injection is correct.

Carefully follow the instructions

provided with your Lixisenatide

Winthrop pen for attaching a

needle.

Always use a new needle for each

injection. Carefully dispose of the

needles after each use .

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Your Lixisenatide Winthrop pen is

pre-filled and ready to use. Once all

the medicine is used you cannot

replace the cartridge. You will need

to use a new pen.

Injecting a dose

Do not use Lixisenatide Winthrop if

it is not clear and colourless or if it

contains particles.

Lixisenatide Winthrop should be

injected under the skin

(subcutaneously) of your stomach

area (abdomen), upper leg (thigh) or

the back of your upper arm. Be

careful not to inject it into a muscle

or vein. To reduce the chance of

local skin reaction, change the

injection site within each particular

area you are using so that the same

site is not used more often than

once a month.

Read the “instructions for use

leaflet” before beginning

Lixisenatide Winthrop therapy.

Read the instruction leaflet each

time you get a new pen in case

something has changed.

Refer to the instruction leaflet

each time you use this medicine.

After injecting

Using the outer needle cap, unscrew

the needle and dispose of it safely

into a sharps container.

Do not share needles or injection

devices. Do not reuse needles.

Do not attempt to replace the

cartridge in your Lixisenatide

Winthrop pen.

The cartridge in your Lixisenatide

Winthrop pen cannot be removed or

replaced. Empty pens must not be

reused and must be properly

discarded

Ask your pharmacist how to discard

the pen.

When to use it

Lixisenatide Winthrop should be

injected once a day.

Lixisenatide Winthrop should be

injected within the hour before your

first meal of the day or before your

evening meal.

If you are not sure when to use it,

ask your doctor or pharmacist.

How long to use it

Continue using your medicine for as

long as your doctor or pharmacist

tells you.

The medicine helps control your

condition, but it does not cure it.

Therefore, you must use it every day.

Ask your doctor or pharmacist if

you are not sure how long to use the

medicine for.

If you miss a dose

Lixisenatide Winthrop should be used

at approximately the same time each

day. If you miss taking your dose at

the regular scheduled time, your blood

sugar levels may become high

(hyperglycaemia).

If you miss a dose of Lixisenatide

Winthrop, you can inject the dose

within the hour before your next meal.

If you have missed a dose and are

not sure what you should do, contact

your doctor or healthcare

professional for specific advice.

Do NOT use a second dose of

Lixisenatide Winthrop on the same

day to make up for a dose you’ve

missed.

The risk of hyperglycaemia is

increased if you:

miss doses of Lixisenatide

Winthrop

have uncontrolled diabetes

exercise less than usual

eat more carbohydrates than usual

are ill or stressed

High blood sugar levels over a

period of time can lead to too much

acid in the blood (diabetic

ketoacidosis).

If you are not sure what to do, ask

your doctor or pharmacist.

If you use too much

(overdose)

Your Lixisenatide Winthrop pen

delivers a set dose of your

medicine. If you accidentally

inject a second dose on the same

day, you may feel sick or be sick.

Immediately telephone your doctor

or the Poisons Information Centre

(telephone Australia 13 11 26 or

New Zealand 0800 POISON or

0800 764766), or go to Accident

and Emergency at your nearest

hospital, if you think you or anyone

else may have used too much

Lixisenatide Winthrop.

Do this even if there are no signs of

discomfort or poisoning.

While You Are Using

Lixisenatide

Winthrop

Things you must do

Tell all the doctors, dentists and

pharmacists who are treating you

that you are using Lixisenatide

Winthrop

Make sure all friends, relatives

workmates or carers know that

you have diabetes

If you are about to be started on

any new medicine, tell your

doctor and pharmacist that you

are using Lixisenatide Winthrop.

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If you plan to travel overseas ask

your doctor, diabetes educator/nurse

for a letter explaining why you are

taking injectable devices with you .

You may not be able to get

Lixisenatide Winthrop in the

country that you are visiting.

If you become pregnant while you

are taking this medicine, stop

taking it and tell your doctor or

pharmacist immediately.

Things you must not do

Do not use Lixisenatide Winthrop

more often than recommended by

your doctor.

Do not use this medicine to treat

any other complaints unless your

doctor tells you to.

Do not stop using Lixisenatide

Winthrop without checking with

your doctor.

If you stop using Lixisenatide

Winthrop, your blood sugar levels

can increase.

Do not give this medicine to

anyone else, even if they have the

same condition as you.

Things to be careful of

Tell your doctor if you drink

alcohol.

Alcohol may mask the symptoms of

low blood sugar levels

(hypoglycaemia) or make it worse.

Be careful driving or operating

machinery

If you use Lixisenatide Winthrop in

combination with a sulfonylurea

and a basal insulin, you may get low

blood sugar (hypoglycaemia). This

may cause dizziness or reduce your

ability to concentrate.

Side Effects

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 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 as

soon as possible if you do not feel

well while you are using

Lixisenatide Winthrop.

Lixisenatide Winthrop helps most

people with type 2 diabetes to reduce

their blood glucose levels, but it may

have unwanted side effects in a few

people.

When Lixisenatide Winthrop is used

in combination with a sulfonylurea

and a basal insulin, your risk of low

blood sugar levels (hypoglycaemia)

can increase.

Your doctor may reduce the dose of

these medicines if this happens.

The first symptoms of mild to

moderate hypoglycaemia can come on

suddenly. They may include:

cold sweat, cool pale skin

fatigue, drowsiness, unusual

tiredness and weakness

nervousness, anxious feeling

tremor, rapid heart beat

confusion, difficulty concentrating

excessive hunger

vision changes

headache, nausea

If you are experiencing any of these

symptoms of hypoglycaemia,

immediately eat some sugary food or

have a drink, e.g. lollies, biscuits or

fruit juice.

Then immediately go to Accident

and Emergency at your nearest

hospital, and tell them that you

think you are having a “hypo”.

Tell your doctor if you have

trouble recognising the symptoms

of hypoglycaemia.

Under certain conditions, the early

warning signs of hypoglycaemia

can be different or less obvious.

Tell your doctor or pharmacist if

you notice any of the following

and they worry you:

nausea (feeling sick)

vomiting (being sick)

diarrhoea

dizziness or light headedness

redness, swelling or itching at

the site of the injection site

These are the more common side

effects of Lixisenatide Winthrop.

These side effects are mostly mild

and usually go away over time.

If any of the following happen,

stop taking this medicine and tell

your doctor immediately, or go to

Accident and Emergency at your

nearest hospital:

swelling of the face, lips,

mouth or throat, which may

cause difficulty in swallowing

or breathing

hives or itchy pinkish swellings

on the skin

feeling faint

passing of little or no urine

drowsiness

any severe skin reaction

severe abdominal pain which

may also be accompanied by

diarrhoea and/or nausea and/or

vomiting

These are very serious side effects.

If you have them, you may have had

a serious reaction to Lixisenatide

Winthrop. You may need urgent

medical attention or hospitalisation.

These side effects are very rare.

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Tell your doctor or pharmacist if

you notice anything else that is

making you feel unwell.

Other side effects not listed above

may occur in some patients.

Do not be alarmed by this list of

possible side effects.

You may not experience any of

them.

Ask your doctor or pharmacist to

answer any questions you may

have.

After Using

Lixisenatide

Winthrop

Storage

Keep your Lixisenatide Winthrop

pen in the carton until it is time to

use it.

Keep the cap on your Lixisenatide

Winthrop pen until you need to

use it.

The ingredients in Lixisenatide

Winthrop may not work as well if

exposed to light for long periods.

Before first Use

Lixisenatide Winthrop must be

stored refrigerated between 2°C

and 8°C in the outer packaging in

order to protect it from light.

Keep it away from the freezer

compartment.

During use of the pen

The pen can be used for 14 days.

Lixisenatide Winthrop can be

kept out of the refrigerator at a

temperature not exceeding 30°C.

Do not refrigerate or freeze it

after first use. The pen cap should

be replaced on the pen after each

use to protect it from light. The

pen should not be stored with a

needle attached.

Do not use if frozen.

Keep the medicine in a cool dry

place where the temperature stays

below 30°C.

Do not store it or any other

medicine in the bathroom or near a

sink.

Do not leave it in the car on hot days

or on window sills.

Heat and dampness and light can

destroy some medicines.

Keep it where children cannot reach

it.

Disposal

If your doctor or pharmacist tells

you to stop using Lixisenatide

Winthrop or the medicine has

passed its expiry date, ask your

pharmacist what to do with any that

are left over.

Return any unused medicine to your

pharmacist.

Product Description

What it looks like

Lixisenatide Winthrop is a clear and

colourless solution for injection filled

in a glass cartridge that is inserted in a

pre-filled pen.

Lixisenatide Winthrop comes in two

strengths 10 microgram and 20

micrograms.

Each

green

coloured Lixisenatide

Winthrop pen contains 3 ml of

solution, delivering 14 doses of 10

micrograms for Lixisenatide Winthrop

10 mcg.

Each

purple

coloured Lixisenatide

Winthrop pen contains 3 ml of

solution, delivering 14 doses of 20

micrograms for Lixisenatide Winthrop

20 mcg.

Lixisenatide Winthrop is available in

packs containing 1 pen for

Lixisenatide Winthrop 10 micrograms

and in packs containing 1, 2 or 6 pens

for Lixisenatide Winthrop 20

micrograms.

For treatment initiation,

Lixisenatide Winthrop is available

in a pack containing one pen for

Lixisenatide Winthrop 10

micrograms and one pen for

Lixisenatide Winthrop 20

micrograms.

Not all pack sizes may be marketed.

Ingredients

Active Ingredient:

Each 0.2 mL dose contains either 10

micrograms or 20 micrograms of

the active ingredient, lixisenatide

Inactive Ingredients:

glycerol (85%)

sodium acetate

methionine

meta-cresol

hydrochloric acid

sodium hydroxide

water for injections

Lixisenatide Winthrop does not

contain sucrose, gluten, tartrazine or

any other azo dyes.

Lixisenatide Winthrop contains less

than 1 mmol sodium (23mg) per

dose i.e essentially “sodium free”

Manufacturer/Sponsor

Lixisenatide Winthrop is supplied

in Australia by:

sanofi-aventis australia pty ltd

12-24 Talavera Road

Macquarie Park NSW 2113

Australian Registration Number(s):

Lixisenatide Winthrop 10

microgram – AUST R 192716

Lixisenatide Winthrop 20

microgram – Aust R 192717

Lixisenatide Winthrop Treatment

Initiation Pack - Aust R 192724

This leaflet was prepared in

February 2013