Liraglutide
Consumer Medicine Information
What is in this leaflet
This leaflet answers some common questions about Victoza®.
It does not contain all the available information. It does not take the place of talking
to your doctor, diabetes education nurse or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the risks of you using
Victoza® against the benefits they expect it will have for you.
If you have any concerns about using this medicine, ask your doctor or pharmacist.
Keep this leaflet with the medicine. You may need to read it again.
What Victoza® is used for
Victoza® contains the active ingredient liraglutide. This belongs to a group of medicines
called ‘GLP-1 receptor agonists’. Victoza® is an injection that is used once a day.
Victoza® is used to treat type 2 diabetes mellitus.
Diabetes mellitus is a condition where your pancreas does not produce enough insulin
to control your blood sugar (glucose) level.
If you have type 2 diabetes mellitus your body is also not able to use insulin properly.
Victoza® helps your body to produce more insulin when your blood sugar level is high.
Victoza® is used on its own if your blood sugar is not properly controlled by diet and exercise
alone and you cannot use metformin (another diabetes medicine). Victoza® is also able to be used with other medicines for diabetes when they are not enough
to control your blood sugar levels.
Victoza® is used in addition to standard of care therapy to reduce the risk of a heart disease
related event if you are at an increased risk for heart disease and have elevated
blood sugar levels.
Victoza® has not been studied in children and should not be used in children or adolescents
under 18 years.
Victoza® is not addictive.
Victoza® is available only with a doctor’s prescription.
Ask your doctor, diabetes education nurse or pharmacist if you have any questions
about why Victoza® has been prescribed for you.
Before you use Victoza®
When you must not use it
Do not use Victoza® if you are allergic (hypersensitive) to liraglutide or to any
of the ingredients listed in the “Ingredients” section at the end of this leaflet.
Some of the symptoms of an allergic reaction may include:
redness, swelling, rash and itching at the injection site
rash, itching or hives on the skin
shortness of breath
wheezing or difficulty breathing
swelling of the face, lips, tongue or other parts of the body.
If you are not sure whether you should start using this medicine, talk to your doctor.
Do not use this medicine after the expiry date printed on the pack or if the packaging
is torn or shows signs of tampering.
If it has expired or is damaged, return it to your pharmacist for disposal.
Before you start to use it
Tell your doctor if:
you are also taking medicines for your diabetes that contain sulfonylurea (such as
glimepiride or glibenclamide) or insulin. Your doctor may tell you to test your blood
sugar levels. This will help your doctor to decide if the dose of the sulfonylurea
or insulin needs to be changed to avoid you getting hypoglycaemia (low blood sugar).
you have severe heart failure (disease of the heart with shortness of breath and swelling
of the feet or legs due to fluid build-up).
you have inflammatory bowel disease, such as Crohn's disease.
you have diabetic gastroparesis (a condition in which your stomach has difficulty
in emptying food properly).
you currently have or have had thyroid disease.
you have or have had a disease of the pancreas.
you have kidney problems.
you are on dialysis.
Drink plenty of fluids to avoid dehydration if you experience vomiting or diarrhoea
when beginning treatment with Victoza®.
Dehydration can lead to kidney problems, particularly in patients who have pre-existing
kidney disease.
If you notice your urine changes appearance or you produce urine less frequently,
see your doctor. Contact your doctor if you have any questions or concerns.
Victoza® should not be used if you have type 1 diabetes or diabetic ketoacidosis (a complication
of diabetes with high blood sugar and an increase in the effort required to breathe).
Victoza® is not an insulin.
If you experience symptoms of acute pancreatitis, like persistent, severe stomach
ache, you should consult your doctor.
Tell your doctor if you have allergies to any other medicines, foods, preservatives
or dyes.
Tell your doctor if you are pregnant or plan to become pregnant.
Use of this medicine in pregnancy has not been studied. Victoza® should not be used during pregnancy. It is not known if Victoza® may harm your unborn child.
Tell your doctor if you are breast-feeding or plan to breast-feed.
It is not known if Victoza® passes into breast milk. Do not use Victoza® if you are breast-feeding.
If you have not told your doctor about any of the above, tell them before you use
Victoza®.
Taking other medicines
Tell your doctor, pharmacist or diabetes education nurse if you are taking any other
medicines, including any that you buy without a prescription from your pharmacy, supermarket,
naturopath or health food shop.
In particular, tell your doctor if you are using medicines containing any of the following
active ingredients:
A sulfonylurea (such as glimepiride or glibenclamide), and/or insulin for your diabetes.
This is because using Victoza® 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 or insulin.
If you are also taking a sulfonylurea and/or insulin together with Victoza®, 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 and/or insulin needs to
be changed.
Warfarin or other anticoagulants (medicines that thin your blood) called ‘coumarin
derivatives’. Your doctor may need to monitor you more closely.
Tell your doctor about any other medicines that you are taking.
This is very important. Your doctor will advise you if it is all right to keep taking
them or if you should stop taking them.
Your doctor and pharmacist have more information on medicines to be careful with or
avoid while using this medicine.
How to use Victoza®
Your doctor, diabetes education nurse or pharmacist will have given you advice on
how to use your medicine.
Carefully follow all the directions.
They may differ from the information contained in this leaflet.
If you do not understand the instructions, ask your doctor, diabetes education nurse
or pharmacist for help.
Victoza® is supplied as a pre-filled pen containing liraglutide. The Victoza® pen can give 15 doses of 1.2 mg or 10 doses of 1.8 mg. The Victoza® pen can also give starting doses of 0.6 mg.
How much to use
Your doctor or diabetes education nurse will tell you how much of this medicine you
need to use.
The usual starting dose is 0.6 mg once a day.
Your doctor will tell you how long to keep taking this dose. It will be for at least
one week.
Your dose may then be increased to 1.2 mg once a day.
If your blood sugar level is not controlled with a dose of 1.2 mg, your doctor may
increase the dose to 1.8 mg once a day.
Do not change your dose unless your doctor has told you to.
Any change in dose should be made cautiously and only under medical supervision.
When to use it
You can inject Victoza® at any time of day. It is preferable to inject Victoza® at about the same time each day, at a time that is most convenient for you.
Victoza® does not need to be injected at mealtimes.
How to use it
Inject Victoza® under the skin (subcutaneous injection) as shown to you by your doctor or diabetes
education nurse.
Never inject Victoza® into a vein or muscle.
Victoza® may be injected into the front of your waist (abdomen), the front of your thigh,
or your upper arm.
Change the place within the area where you inject each day to reduce the risk of developing
lumps under the skin. See ‘Side effects’.
Victoza® pen is designed to be used with NovoFine® needles, up to a length of 8 mm and as thin as 32G. Needles are not included with
the pen.
Ask your doctor or diabetes education nurse which needle width (gauge) and length
is best for you.
Use a new needle for each injection and dispose of it after use.
Checking your Victoza® pen:
Victoza® should be clear and colourless, or almost colourless.
Do not use this medicine if it is thickened, coloured, or has solid bits in it.
Victoza® should not be used if it has been frozen.
Follow the detailed instructions on how to inject Victoza® in the instructions for use supplied with the product.
These instructions are also available via the following hyperlinks:
How long to use it
Do not stop using Victoza® unless your doctor tells you to.
If you use too much (overdose)
If you use more Victoza® than you should, talk to your doctor straight away. You may need medical treatment.
Overdose may cause nausea, vomiting, diarrhoea or low blood sugar (hypoglycaemia).
See ‘Side effects’ for the early warning signs of hypos.
If you forget to use it
If you forget a dose, use Victoza® as soon as you remember.
However, if it is more than 12 hours since you should have used Victoza®, skip the missed dose. Then take your next dose as usual the following day.
Do not take an extra dose or increase the dose on the following day to make up for
the missed dose.
If you are not sure what to do, talk to your doctor, diabetes education nurse or pharmacist.
While you are using Victoza®
Things you must do
Make sure all your friends, relatives, workmates or carers know that you have diabetes.
Tell your doctor if you often have hypos (low blood sugar levels). When Victoza® is used with a sulfonylurea or with insulin (other medicines for diabetes), hypos
can occur. The dose of your sulfonylurea or insulin may need to be reduced while you
take Victoza®.
If you experience any of the symptoms of a hypo, immediately eat some sugary food
or have a sugary drink, e.g. lollies, biscuits or fruit juice.
Tell your doctor, diabetes education nurse or pharmacist if you are travelling.
Ask them for a letter explaining why you are taking injecting devices with you. Each
country you visit will need to see this letter, so you should take several copies.
You may not be able to get Victoza® in the country you are visiting.
Your doctor, diabetes education nurse or pharmacist can provide you with some helpful
information.
If you are about to be started on any new medicine, remind your doctor and pharmacist
that you are using Victoza®.
Things you must not do
Do not stop using your medicine unless your doctor tells you to. If you stop using
it, your blood sugar levels may increase.
Do not use Victoza® in combination with other medicines that work in the same way (also contain ‘GLP-1
receptor agonists’). Ask your doctor, pharmacist or diabetes education nurse if you
are not sure what to do.
Do not use this medicine if you think it has been frozen or exposed to excessive heat.
It will not work as well.
Do not use this medicine to treat any other complaints unless your doctor tells you
to.
Do not give your medicine to anyone else, even if they have the same condition as
you.
Do not share your pen or needles with anyone else.
Things to be careful of
While you are driving or using tools or machines, you should avoid getting low blood
sugar (hypoglycaemia), because this may reduce your ability to concentrate. Your doctor
will tell you how to do this.
Side effects
Tell your doctor, diabetes education nurse or pharmacist as soon as possible if you
do not feel well while you are using Victoza®.
All medicines can have side effects. Sometimes they are serious, most of the time
they are not. You may need medical treatment if you get some of the side effects.
Do not be alarmed by the following lists of side effects. You may not experience any
of them.
Ask your doctor, diabetes education nurse or pharmacist to answer any questions you
may have.
The most common side effects when using Victoza® are diarrhoea and nausea (feeling sick). These side effects are usually mild and normally
decrease with continued use.
Tell your doctor if you notice any of the following and they worry you:
low blood sugar (a hypo).
Hypos are more likely to occur if you are also taking a sulfonylurea or insulin for
your diabetes. A hypo may come on suddenly. The warning signs of a hypo can include:
cold sweat, cool pale skin
headache
feeling dizzy
feeling sick
feeling very hungry
changes in vision
feeling sleepy, feeling weak
feeling nervous or anxious, shaking (tremor), fast heart beat
feeling confused, difficulty concentrating.
Your doctor can provide you with further information about how to treat low blood
sugar levels and what to do if you notice these warning signs. If you are already
taking a sulfonylurea or insulin, your doctor may reduce the dose of these medicines
before you start using Victoza®.
anorexia (no appetite)
decreased appetite
headache
vomiting (being sick)
indigestion (dyspepsia)
burping, wind (flatulence) or constipation
heartburn
painful or swollen stomach (abdomen)
blocked or runny nose, sneezing, cough and/or sore throat (upper respiratory tract
infection)
infection of the urinary tract
injection site reactions (such as bruising, pain, irritation, itching and rash)
fast heart beat
feeling tired
increase of pancreatic enzymes (such as lipase and amylase). This can only be detected
with a blood test.
increase in liver blood test results.
The above list includes side effects of your medicine that are usually mild and short-lived.
Tell your doctor if you experience:
rash or urticaria (a type of skin rash)
itching
malaise (feeling unwell)
dehydration, sometimes with a decrease in kidney function
change in how things taste (dysgeusia)
delay in the emptying of the stomach.
When initiating treatment with Victoza®, you may in some cases experience dehydration as a result of vomiting, nausea or
diarrhoea. It is important to avoid dehydration by drinking plenty of fluids.
Lumps under the skin may be caused by build-up of a protein called amyloid (cutaneous
amyloidosis; how often this occurs is not known). Victoza® may not work very well if you inject into a lumpy area. Change the injection site
with each injection to help prevent this skin change.
Tell your doctor immediately or go to Accident and Emergency at your nearest hospital
if you notice any of the following:
severe and persistent pain in the abdomen (stomach area) which might reach through
to your back, as well as nausea and vomiting. These can be symptoms of acute inflammation
of the pancreas (pancreatitis). Pancreatitis can be a serious, potentially life-threatening
medical condition.
These can also be symptoms of an inflamed gallbladder or gallstones, which can be
serious.
a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath.
These can be symptoms of a condition called ‘goitre’.
a severe allergic reaction. Some symptoms may include:
skin rashes over a large part of the body
shortness of breath, wheezing
swelling of the face, lips or tongue
fast pulse
sweating.
bowel obstruction. A severe form of constipation with additional symptoms such as
stomach ache, bloating, vomiting etc.
This list includes very serious side effects. You may need urgent medical attention
or hospitalisation. These side effects are uncommon, rare or very rare.
Tell your doctor if you notice anything else that is making you feel unwell.
Other side effects not listed above may also occur in some people.
Ask your doctor, diabetes education nurse or pharmacist to answer any questions you
have.
After using Victoza®
Storage
Before opening:
Keep your unopened Victoza® pens in a refrigerator (2°C to 8°C). Keep away from the cooling element. Do not freeze.
During use:
While you are using your Victoza® pen you can keep it for 1 month either at room temperature (not above 30°C), or in
a refrigerator (2°C to 8°C), away from the cooling element. Do not freeze. Store the
pen without a needle attached.
Discard the Victoza® pen you are using after 1 month even if there is still some medicine left in it.
The medicine in Victoza® must not be frozen, or exposed to heat or direct sunlight. When you are not using
the pen, keep the pen cap on in order to protect from light. Never use Victoza® after the expiry date printed on the pen label and carton. Expiry is the last day
of the month.
Never use Victoza® if the solution is not clear and colourless, or almost colourless.
Keep out of the reach of children.
Disposal
Dispose of used needles safely into a yellow plastic sharps container.
If your doctor tells you to stop using this medicine or the expiry date has passed,
ask your pharmacist what to do with any medicine that is left over.
Product description
What it looks like
Victoza® is supplied as a clear and colourless, or almost colourless solution for injection
in a pre-filled pen. One mL solution for injection contains 6 mg liraglutide. One
pre-filled pen contains 18 mg liraglutide.
Each pen contains 3 mL of solution, delivering 30 doses of 0.6 mg, 15 doses of 1.2
mg or 10 doses of 1.8 mg.
Victoza® is available in packs containing 1, 2 or 3 pens. Not all pack sizes may be marketed.
Ingredients
Victoza® contains liraglutide (rys) 6 mg/mL as the active ingredient. The abbreviation “rys”
indicates the method of genetic engineering used to manufacture liraglutide.
Victoza® also contains the following inactive ingredients:
dibasic sodium phosphate dihydrate
propylene glycol
phenol
hydrochloric acid
sodium hydroxide
water for injections.
Sponsor
Victoza® is supplied in Australia by:
Novo Nordisk Pharmaceuticals Pty. Ltd.
Level 10
118 Mount Street
North Sydney NSW 2060
Australian Registration Number:
AUST R 153980
Victoza® is supplied in New Zealand by:
Novo Nordisk Pharmaceuticals Ltd.
11-19 Customs Street West,
Commercial Bay Tower,
Level 18, Office 1834
Auckland 1010
New Zealand
Victoza® and NovoFine® are trademarks owned by Novo Nordisk A/S.
© 2024
Novo Nordisk A/S
Further information
For further information call Novo Nordisk Customer Care on 1800 668 626 (AU) or 0800
733 737 (NZ).
You can also get more information about diabetes from:
Diabetes Australia
freecall helpline 1300 136 588
www.diabetesaustralia.com.au
Diabetes New Zealand
Freecall helpline 0800 342 238
www.diabetes.org.nz
Always check the following websites to ensure you are reading the most recent version
of the Victoza® consumer medicine information:
Australia
www.novonordisk.com.au
https://www.ebs.tga.gov.au/
New Zealand
www.novonordisk.co.nz
www.medsafe.govt.nz/
This leaflet was prepared in June 2024