BYDUREON 2 mg powder and solvent for prolonged-release suspension for injection

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

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Active ingredient:
EXENATIDE
Available from:
ASTRAZENECA SDN. BHD.
INN (International Name):
EXENATIDE
Units in package:
4units Units; 4units Units; 4units Units; 4units Units
Manufactured by:
Amylin Ohio LLC
Authorization number:
MAL14015009AZ

Documents in other languages

Patient Information leaflet Patient Information leaflet - Malay

16-06-2020

BYDUREON

®

Powder and solvent for prolonged-release suspension for injection

Exenatide 2 mg

Consumer Medication Information

Leaflet (RiMUP)

What is in this leaflet

What BYDUREON is used

How BYDUREON works

Before you use BYDUREON

How to use BYDUREON

While you are using it

Side effects

Storage and disposal of

BYDUREON

Product description

Manufacturer

Product Registration Holder

Date of revision

Serial number

What BYDUREON is used for

BYDUREON contains the active

substance exenatide. It is an

injectable medicine used to

improve blood sugar control in

adults with type 2

diabetes

mellitus.

This medicine is used in

combination with the following

diabetes medicines: metformin,

sulphonylureas, thiazolidinediones

and SGLT2 inhibitors. Your doctor

is now prescribing this medicine as

an additional

medicine to help

control your blood sugar. Continue

to follow your food and exercise

plan.

How BYDUREON works

You have diabetes because your

body does not make enough insulin

to control the level of sugar in

your

blood or your body is not able to

use the insulin properly. The active

substance in this medicine helps

your body to

increase the

production of insulin when your

blood sugar is high.

Before you use BYDUREON

When you must not use it

Do not use BYDUREON

If you are allergic

(hypersensitive) to exenatide or

any of the other ingredients of

this medicine (listed in section

“Product description”).

Before you start to use it

Talk to your doctor, pharmacist,

or diabetes nurse before using

BYDUREON about the following:

Using this medicine in

combination with a

sulphonylurea, as low blood

sugar (hypoglycaemia) can

occur. Test your blood glucose

levels regularly. Ask your

doctor, pharmacist or diabetes

nurse if you are not

sure if any

of your other medicines contain

a sulphonylurea.

If you have type 1 diabetes or

diabetic ketoacidosis, as this

medicine should not be used.

If you have severe problems

with your stomach emptying

(including gastroparesis) or

food

digestion, as the use of this

medicine is not recommended.

The active substance in this

medicine slows stomach

emptying

so food passes more

slowly through your stomach.

If you have ever had

inflammation of the pancreas

(pancreatitis) (see section “Side

effects”).

If you lose weight too quickly

(more than 1.5 kg per week) talk

to your doctor about it since this

may cause problems such as

gallstones.

If you have severe kidney

disease or you are on dialysis, as

the use of this medicine is not

recommended. There is little

experience with this medicine

in patients with kidney

problems.

Children and adolescents

Do not give this medicine to

children and adolescents less than

18 years, as there is no experience

with this medicine in this age

group.

Pregnancy and breast-feeding

It is

not known if this medicine

may harm your unborn child,

therefore you should not use it

during pregnancy and for at least 3

months before a planned

pregnancy. It is not known if

exenatide passes into your milk. You

should not use this medicine while

breast feeding. If you are pregnant

or breast-feeding, think you

be pregnant, or are planning to

have a baby, ask your doctor or

pharmacist for advice before

taking this medicine. You should

use contraception if you could

potentially become pregnant

during treatment with this

medicine.

Driving and using machines

If you use this medicine in

combination with a sulphonylurea,

low blood sugar (hypoglycaemia)

occur. Hypoglycaemia may

reduce your ability to concentrate.

Please keep this possible problem

mind in all situations where

you might put yourself and others

at risk (e.g. driving a car or using

machines).

Important information about

some of the ingredients of

BYDUREON

This medicine contains less than 1

mmol sodium (23 mg) per dose, i.e.

essentially “sodium-free”.

Taking other medicines

Tell your doctor or pharmacist if

you are taking, have recently

taken, or might take any other

medicines,

particularly:

other medicines that are used to

treat type 2 diabetes, such as

insulins and other medicines that

work like Bydureon (for

example: liraglutide and Byetta

[immediate release exenatide]),

as taking these medicines with

Bydureon is not recommended.

medicines used to thin the blood

(anticoagulants) e.g. warfarin, as

you will require additional

Consumer Medication Information Leaflet (RiMUP)

monitoring of changes in INR

(measurement of blood thinning)

during initiation of therapy with

this medicine.

How to use BYDUREON

How much to use

Always use this medicine exactly

as your doctor, pharmacist or

diabetes nurse has told you.

Check

with your doctor,

pharmacist, or diabetes nurse if you

are not sure.

When to use it

You should inject this medicine

once a week, at any time of day,

with or without meals.

How long to use it

If you feel you should stop using

this medicine, please consult your

doctor first. If you stop using

this

medicine this can affect your blood

sugar levels.

If you have any further questions

on the use of this medicine, ask

your doctor, pharmacist, or

diabetes

nurse.

If you forget to use it

You might like to choose a day that

you always plan to make your

BYDUREON injection. If you

miss

a dose it should be taken as

soon as it is possible to do so. For

your next injection

you can return

to your chosen injection day.

However, only one injection

should be taken in 24-hours

period. You can also change your

chosen injection day. Do not take

two injections on the same day.

If you use too much (overdose)

If you use more of this medicine

than you should, you may need

medical treatment. Using too much

of this medicine can

cause nausea,

vomiting, dizziness, or symptoms

of low blood sugar (see section

“Side effects”).

While you are using it

Things you must do

You should inject this medicine

into the skin (subcutaneous

injection) of your stomach area

(abdomen), upper leg (thigh), or

the back of your upper arm.

Each week you can use the same

area of your body. Be sure to

choose a different injection site in

that area.

Test your blood glucose levels

regularly, it is particularly

important to do this if you are also

using a

sulphonylurea.

Follow the “Instructions for the

User” provided in the carton to

inject BYDUREON.

Your doctor or diabetes nurse

should teach you how to inject

this medicine before you use it for

first time.

Check that the liquid in the pen is

clear and free of particles before

you begin. After mixing the liquid

with the powder, use the

suspension only if the mixture is

white to off white and cloudy. If

you see clumps of dry powder on

the sides of the pen, the medicine is

NOT mixed well. Tap vigorously

again until well

mixed.

You should inject this medicine

immediately after mixing the

powder and the solvent.

Use a new pen for each injection.

You should dispose of the pen

safely, with the needle still attached,

after use, as instructed by your

doctor or diabetes nurse.

Things you must not do

This medicine should be injected

into the skin and not into a vein or

into the muscle.

Things to be careful of

If you are not sure if you have

taken all your dose, do not inject

another dose of this medicine, just

take it next week as planned.

Side effects

Like all medicines, this medicine

can cause side effects, although not

everybody gets them.

Severe allergic reactions

(anaphylaxis) have been reported

rarely (may affect up to 1 in 1000

people). You should see your

doctor immediately if you

experience symptoms such as:

Swelling of the face, tongue or

throat (angioedema)

Hypersensitivity (rashes, itching

and rapid swelling of the tissues

of the neck, face, mouth or

throat)

Difficulty with swallowing

Hives and difficulty with

breathing

Cases of inflammation of the

pancreas

(pancreatitis) have been

reported (frequency not known) in

patients receiving

this medicine.

Pancreatitis can be a serious,

potentially life-threatening medical

condition.

Tell your doctor if you have had

pancreatitis, gallstones,

alcoholism or very high

triglycerides. These medical

conditions can increase your

chance of getting pancreatitis, or

getting it again,

whether or not

you are taking this medicine.

STOP taking this medicine and

contact your doctor immediately

if you experience

severe and

persistent

stomach pain, with or

without

vomiting, because you

could have an inflamed pancreas

(pancreatitis).

Very common side effects of

BYDUREON

(may affect more

than 1 in 10 people):

nausea (nausea is most common

when first starting this medicine,

but decreases over time in

most

patients)

diarrhoea

hypoglycaemia

When this medicine is used with

a medicine that contains a

sulphonylurea

, episodes of low

Consumer Medication Information Leaflet (RiMUP)

blood

sugar (hypoglycaemia,

generally mild to moderate) can

occur. The dose of your

sulphonylurea

medicine may

need to be reduced while you use

this medicine. The signs and

symptoms of low blood

sugar

may include headache,

drowsiness, weakness, dizziness,

confusion, irritability, hunger,

fast

heartbeat, sweating, and

feeling jittery. Your doctor

should tell you how to treat low

blood sugar.

Common side effects of

BYDUREON

(may affect up to 1

in 10 people):

dizziness

headache

vomiting

loss of energy and strength

tiredness (fatigue)

constipation

pain in the stomach area

bloating

indigestion

flatulence (passing gas)

heartburn

reduced appetite

This medicine may reduce your

appetite, the amount of food you

eat, and your weight. If you lose

weight too quickly (more than

1.5 kg per week) talk to your

doctor about it since this may

cause problems such as

gallstones.

injection site reaction

If you have an injection site

reaction (redness, rash, or

itching) you may like to ask

your doctor for something to

help relieve any signs or

symptoms. You may see or feel

a small bump under the skin

after your injection; it should go

away after 4 to 8 weeks. You

should not need to stop your

treatment.

Uncommon side effects of

BYDUREON

(may affect up to 1

in 100 people):

decrease in kidney function

dehydration, sometimes with a

decrease in kidney function

intestinal obstruction (blockage

in intestine)

burping

unusual taste in the mouth

increased sweating

hair loss

sleepiness

Rare side effects of BYDUREON

(may affect up to 1 in 1,000

people):

feeling jittery

In addition some

other side effects

have been reported (frequency not

known, cannot be estimated from

the available data):

bleeding or bruising more easily

than normal due to low level of

blood platelets

changes in INR (measurement of

blood thinning) have been

reported when used together

with warfarin

skin reactions at the injection

site following injection of

exenatide. These include: cavity

containing pus (abscess) and

swollen, or red area of skin that

feels hot and tender (cellulitis).

You may report any side effects or

adverse reactions directly to the

National Centre for Adverse Drug

Reaction Monitoring by calling

Tel: 03-78835490, or visiting the

website npra.moh.gov.my

[Consumers

Reporting Side

Effects to Medicines (ConSERF)

or Vaccines (AEFI)].

Storage and disposal of

BYDUREON

Storage

Keep this medicine out of the sight

and reach of children.

Do not use this medicine after the

expiry date, which is stated on the

label and the carton after EXP.

expiry date refers to the last day of

that month

Store in a refrigerator (2 °C to 8

°C). Do not freeze. The pen may be

kept for up to 4 weeks below 30ºC

prior to use.

Store in the original

package in order to protect from

light. Throw away any

BYDUREON pen that has been

frozen.

Disposal

Do not throw away any medicines

wastewater

household

waste. Ask your pharmacist how to

throw

away

medicines

longer

use.

These

measures

will

help protect the environment.

Product description

What it looks like

This medicine is provided as a

powder and solvent (liquid) for

suspension for injection in pre-

filled pen. The powder (2 mg) in

one chamber, is white to off-white

and the solvent (0.65 ml) in the

other chamber, is a clear, colourless

to pale yellow to pale brown

solution. Each single-dose pre-

filled pen is provided with one

custom needle. Each carton also

contains one spare needle.

This medicine is available in pack

of 4 single-dose pre-filled pens.

Ingredients

Active ingredients:

The active substance is exenatide.

Each pre-filled pen contains 2 mg of

exenatide. After suspension, the

delivered dose is 2 mg/0.65 mL.

Inactive ingredients:

In the powder: poly (D,L-lactide-

co-glycolide) and sucrose.

In the solvent: carmellose

sodium, sodium chloride,

polysorbate 20, sodium

dihydrogen phosphate

monohydrate, disodium

phosphate heptahydrate, water

for injection and sodium

hydroxide (for pH adjustment).

MAL number

MAL14015009AZ

Manufacturer

Amylin Ohio LLC

8814 Trade Port Drive

West Chester, Ohio 45071

USA.

Consumer Medication Information Leaflet (RiMUP)

Product Registration Holder

AstraZeneca Sdn. Bhd.

Level 11 & 12, Nucleus Tower

No. 10 Jalan PJU 7/6

Mutiara Damansara

47800 Petaling Jaya

Malaysia

Date of revision

18/05/2020

Doc ID-002467286 Version 4.0

(based on PI: Doc ID-002466156

Version 7.0)

Serial number

NPRA(R1/2) 15062020/102

INSTRUCTIONS FOR THE USER

Read these instructions carefully before use

Bydureon 2 mg powder and solvent for prolonged-release suspension for injection in

pre-filled pen

How to use Bydureon pre-filled pen

Cover

Knob

Orange Label

Striped Label

Needle

Top of pen

Mixing window

Inspection window

Green label

Prior to use of the pen, it is recommended that you should be trained by a doctor or diabetes

nurse on its proper use.

Unless a trained person can help to inject this medicine it is not recommended for people who

are blind or cannot see well.

Step 1: Prepare your pen

Let your pen warm up. Remove one pen from the

refrigerator and let it stand at room temperature for at

least 15 minutes. DO NOT use a pen past its

expiration date.

WAIT

15

Minutes

Wash your hands while the pen is warming up.

Open the tray by pulling on the corner tab. Then

remove the pen and needle. DO NOT use your pen or

needle if any parts are broken or missing.

Check the liquid inside the inspection window. It

should be clear and free of particles. It’s normal if you

see air bubbles in the liquid.

Peel off the paper tab from the needle cover.

Attach the needle to the pen by pushing and

screwing it onto the top of the pen until it is tight. DO

NOT remove the needle cover yet.

Step 2: Mix your dose

Combine the medicine. While holding the pen

upright with the needle cover uppermost, slowly turn

the knob anticlockwise. STOP when you hear the

click and the green label disappears.

Hold Upright

Firmly tap the pen to mix. Hold the pen by the end

with the orange label and tap the pen firmly against

the palm of your hand. WITHOUT twisting the knob,

ROTATE the pen every few taps. Tap the prefilled

pen firmly until a uniformly cloudy suspension with no

clumps is obtained. You may need to tap 80 times or

more.

Check the suspension. Hold the pen up to the light and look through both sides of

the mixing window. The solution should have NO CLUMPS and be uniformly cloudy.

Not Mixed

Well

Clumps,

uniform solution

Mixed Well

NO Clumps, uniformly cloudy solution

To get your full dose the medicine must be mixed well.

If it’s not mixed well, tap longer and more firmly.

DO NOT proceed unless your medicine is mixed well

To get your full dose the medicine must be mixed well. If it’s not mixed well, tap longer and

more firmly. It’s normal if you see air bubbles in the liquid, and they will cause no harm.

80 times or more

STOP

Compare both sides of the mixing window to the photos below by holding the pen

against the page. Pay attention to the bottom surface. If you don’t see clumps you are

ready to inject.

Step 3: Inject your dose

IMPORTANT Once the medicine is mixed well, you must inject the dose immediately.

You cannot save it for later use.

Choose your injection site in either your stomach,

thigh, or back of the arm. Each week you can use the

same area of your body but choose a different

injection site in that area. Gently clean the area with

soap and water or an alcohol swab.

Twist knob to release injection button. While

holding the pen upright with the needle cover

uppermost, twist the knob anticlockwise until the

orange label disappears and the injection button is

released. DO NOT push the injection button yet.

Remove the needle cover by pulling straight off. DO

NOT twist. You may see a few drops of liquid on the

needle or in the cover.

Inject the medicine. Insert the needle into your skin

(subcutaneously). Press the injection button with your

thumb until you hear a click. Hold for 10 seconds to

make sure you get the full dose.

Properly dispose of your pen, with the needle

attached, in a puncture-resistant container. DO NOT

try to recap or reuse the needle.

Keep Tapping

View your pen here

Ready to inject

Hold

Upright

Injection

Button

PULL

PRESS & HOLD

10

Seconds

Common Questions and Answers

1.

How do I know that the medicine is mixed well?

The medicine is mixed well when the liquid looks cloudy from both sides of the window.

You should not see any clumps in the liquid. It may help to hold the pen up to the light to

see in the window. If you see clumps of any size keep tapping the pen firmly against the

palm of your hand until mixed.

2.

I am having trouble mixing my dose. What should I do?

Remember, before preparing your dose, leave the pen out of the refrigerator for at least

15 minutes. This will let the pen warm up to room temperature. It will be easier to mix the

medicine if the pen is at room temperature.

Be sure you are holding the pen at the end with the knob and the orange label. This will

help you grip the pen better and tap it more firmly against your palm.

It may also help to tap the mixing window on both sides against your palm. If you see

any clumps, keep tapping.

3.

After I mix the medicine, how long can I wait before taking the injection?

You must inject your dose right after mixing it. If you do not inject your dose right away,

small clumps of medicine may form in the pen and you may not get your full dose.

4.

I’m ready to inject my dose. What should I do if I see air bubbles in the pen?

It is normal for air bubbles to be in the pen. The medicine is injected into your skin

(subcutaneously). Air bubbles will not harm you or affect your dose with this type of

injection.

5.

What should I do if I cannot push the injection button all the way in when trying to

inject my dose?

Check that you have fully screwed on the pen needle. Also be sure you twisted the knob

until it stopped, the orange label disappeared, and the injection button appears.

If you still cannot push the button in, this may mean that the needle is clogged. Remove

the needle from your skin and replace it with the spare needle from the carton. Review

how to attach the needle. Then choose a different injection site and finish taking the

injection.

If you still cannot push the button all the way in, remove the needle from your skin. Use a

puncture-resistant container to throw away the pen with the needle still attached.

6.

How do I know if I injected my full dose?

To be sure you get your full dose, press the injection button with your thumb until you

hear a click. After the click, continue to hold the needle in your skin for 10 seconds. This

will allow enough time for all the medicine to go from the pen to under your skin.

7.

How do I dispose of my Bydureon pen?

You will need a puncture-resistant container that is large enough to hold the entire pen

with a used needle attached. Be sure the container has a lid. You may use a biohazard

container, another hard plastic container, or a metal container. A container is not

included in the carton.

Ask your pharmacist how to safely throw away the container with used pens and

needles. Do not throw the container in your household waste.

Instructions for the User was last updated in November 2017.

Doc ID-002467277 version 5.0

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