Consumer Medicine Information (CMI) summary
The
full CMI on the next page has more details. If you are worried about using this medicine,
speak to your doctor or pharmacist.
1. Why am I using Saxenda®?
Saxenda
® contains the active ingredient liraglutide.
Saxenda
® is used in weight loss, in addition to diet and exercise in adults aged 18 years
or older.
For more information, see Section
1. Why am I using Saxenda®? in the full CMI.
2. What should I know before I use Saxenda®?
Do not use if you have ever had an allergic reaction to liraglutide or any of the
ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines,
or are pregnant or plan to become pregnant or are breastfeeding.
For more information, see Section
2. What should I know before I use Saxenda®? in the full CMI.
3. What if I am taking other medicines?
4. How do I use Saxenda®?
Your doctor or pharmacist will have given you advice on how to use your medicine.
The usual starting dose of Saxenda® is 0.6 mg once per day, which will be increased step wise until reaching the recommended
dose of 3.0 mg once a day.
5. What should I know while using Saxenda®?
|
Things you should do
|
Remind any doctor, dentist or pharmacist or health professional you visit that you
are using Saxenda®.
Tell your doctor if you have diabetes, or a racing heartbeat when at rest.
Do not use Saxenda® in combination with other medicines that contain GLP-1 receptor agonists.
|
|
Things you should not do
|
Do not stop using this medicine unless your doctor tells you to.
|
|
Driving or using machines
|
Be careful driving or operating machinery until you know how Saxenda® affects you.
|
|
Drinking alcohol
|
n/a
|
|
Looking after your medicine
|
Before opening, store Saxenda® pens in a refrigerator (2°C to 8°C). Do not freeze.
During use, Saxenda® pens can be stored for 1 month either at room temperature (below 30°C) or in a refrigerator
(2°C to 8°C). Store the pen without a needle attached.
|
6. Are there any side effects?
The most common side effects are feeling sick (nausea), being sick (vomiting), diarrhoea,
constipation, headache, changed sense of taste, dizziness, indigestion (dyspepsia),
feeling bloated, burping, wind (flatulence) or dry mouth, heartburn, painful or swollen
abdomen, low blood sugar (a hypo), injection site reactions, fast heartbeat, feeling
weak or tired, difficulty sleeping (insomnia), increase of pancreatic enzymes and
rash. More serious side effects include severe and persistent pain in the abdomen,
lump or swelling in the neck, hoarseness, trouble swallowing or shortness of breath,
signs of reduced kidney function, signs of gallbladder problems and depression.
Active ingredient(s):
Liraglutide
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using Saxenda®. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about using Saxenda
®
.
Where to find information in this leaflet:
1. Why am I using Saxenda®?
Saxenda
®
contain the active ingredient liraglutide, similar to a naturally occurring hormone
called GLP-1 that is released from the intestine after a meal.
Saxenda
®
is used for weight loss, in addition to diet and exercise, in adults aged 18 years
and above who have:
a BMI of 30 or more (obese), or
a BMI of 27 or more and less than 30 (overweight) and weight related health problems
(such as diabetes, high blood pressure, abnormal levels of fats in the blood or breathing
problems during sleep, called 'obstructive sleep apnoea').
Saxenda® should be used with a reduced calorie diet and increased physical activity.
BMI (Body Mass Index) is a simple measure of your weight in relation to your height.
It is calculated by dividing your weight in kg by your height in metres squared.
Saxenda® works by acting on receptors in the brain that control your appetite, causing you
to feel fuller and less hungry. This may help you eat less food and reduce your body
weight.
Weight loss normally starts within 2 weeks and continues for 9 to 12 months on Saxenda® treatment. Saxenda® may then help you to maintain this new lower weight and help to prevent weight being
regained.
Saxenda® is not addictive.
2. What should I know before I use Saxenda®?
Warnings
Do not use Saxenda
®
if:
You are allergic to liraglutide, or any of the ingredients listed 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.
Always check the ingredients to make sure you can use this medicine
Tell your doctor if you have allergies to any other medicines, foods, preservatives
or dyes
It is after the expiry date printed on the pack or if the packaging is torn or shows
signs of tampering
It has expired or is damaged, return it to your pharmacist for disposal. The expiry
date refers to the last day of that month.
Check with your doctor if:
you have palpitations (you feel aware of your heartbeat) or if you have feelings of
a racing heartbeat while at rest during Saxenda® treatment.
you have diabetes. Do not use Saxenda® as a replacement for insulin. Saxenda® and insulin should not be used together.
you have heart failure (disease of the heart with shortness of breath, and swelling
of the feet or legs due to fluid build-up). The use of Saxenda® is not recommended if you have severe heart failure.
you are taking any other weight loss medications, including prescription, over the
counter or herbal medicines.
you have inflammatory bowel disease, such as Crohn's disease.
you have gastroparesis (a condition in which your stomach has difficulty in emptying
food properly).
you currently have or have had thyroid disease, including thyroid nodules and enlargement
of the thyroid gland.
you have kidney disease or are on dialysis (a treatment where your blood is filtered
and purified using a machine).
you have liver problems
you have or have had a disease of the pancreas.
you have or have had depression, suicidal thoughts or any other major mental illness.
you have other medical conditions or have taken other medicines that may have caused
you to gain weight.
During treatment, you may be at risk of developing certain side effects. It is important
you understand these risks and how to monitor for them. See additional information
under Section
6. Are there any side effects?
Pregnancy and breastfeeding
Check with your doctor if you are pregnant or intend to become pregnant.
Use of this medicine in pregnancy has not been studied. Saxenda® should not be used during pregnancy. It is not known if Saxenda® may harm your unborn child.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
It is not known if Saxenda® passes into breast milk. Do not use Saxenda® if you are breast-feeding.
Effects on the digestive system
Drink plenty of fluids to avoid dehydration, particularly if you experience vomiting
or diarrhoea when beginning treatment with Saxenda®. Dehydration can cause kidney problems that sometimes require dialysis.
Inflammation of the pancreas
Stop taking Saxenda® and contact a doctor immediately if you experience severe pain in your upper abdomen,
usually worse on the right side under the ribs.
The pain may be felt through to your back or right shoulder. If you lose substantial
weight, you are at risk of gallstones and thereby inflamed gallbladder.
Children and adolescents
Saxenda® should not be used in children and adolescents under 18 years. This is because the
effects of this medicine have not been studied in this age group.
Use in the elderly
There is little experience with Saxenda® in patients ≥ 75 years old. It is not recommended if you are 75 years or older.
3. What if I am taking other medicines?
Tell your doctor or pharmacist if you are taking any other medicines, including any
medicines, vitamins or supplements that you buy without a prescription from your pharmacy,
supermarket or health food shop.
Some medicines may interfere with Saxenda
®
and affect how it works.
In particular, tell your doctor or pharmacist if you are using the following medicines:
for the treatment of type 2 diabetes, such as a sulfonylurea (including glimepiride
or glibenclamide). You may get low blood sugar (hypoglycaemia) when you use these
medicines with Saxenda®. Your doctor may adjust the dose of your diabetes medicine to prevent you from getting
low blood sugar.
to thin your blood (anticoagulants), such as warfarin or other types of medicines
called 'coumarin derivatives'. Your doctor may need to monitor you more closely.
for high blood pressure, such as amlodipine, atenolol or bisoprolol or for heart disease,
such as digoxin.
for HIV, such as atazanavir or ritonavir.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect Saxenda
®
.
4. How do I use Saxenda®?
Your doctor 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, nurse or pharmacist for
help.
Your doctor will start you on a diet and exercise programme. Stay on this programme
while you are using Saxenda®.
How much to use
Your doctor will tell you how much of this medicine you need to use each day.
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 by 0.6 mg each week until you reach the recommended
dose of 3.0 mg once a day.
Your doctor will tell you how much Saxenda® to use each week. Usually, you will be told to follow the table below:
|
Week
|
Dose to inject
|
|
Week 1
|
0.6 mg once a day
|
|
Week 2
|
1.2 mg once a day
|
|
Week 3
|
1.8 mg once a day
|
|
Week 4
|
2.4 mg once a day
|
|
Week 5 onwards
|
3.0 mg once a day
|
Once you reach the recommended dose of 3.0 mg in Week 5 of treatment, keep using this
dose until your treatment period ends. Do not increase your dose further.
Visit your doctor on a regular basis to assess your need for continued treatment with
Saxenda®.
Do not change your dose unless your doctor has told you to.
Follow the instructions provided and use Saxenda® until your doctor tells you to stop.
When to use Saxenda®
You can use Saxenda® at any time of day, with or without food and drinks. It is preferable to use Saxenda® at about the same time each day, at a time that is most convenient for you.
Only continue using Saxenda® if you have lost at least 5% of your initial body weight after 12 weeks on the 3.0
mg/day dose. Consult your doctor before you continue.
How to use Saxenda®
Before you use the pen for the first time, your doctor or nurse will show you how
to use the pen.
Saxenda® pre-filled pen is designed to be used with NovoFine® needles, up to a length of 8 mm. Needles are not included with the pen.
Ask your doctor or nurse which needle width (gauge) and length is best for you.
Use a new needle for each injection and dispose of it after use.
Saxenda® is given as an injection under the skin (subcutaneous injection) as shown to you
by your doctor or nurse. Never inject Saxenda
®
into a vein or muscle.
Saxenda® 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 Section
6. Are there any side effects?
Checking your Saxenda® pen:
Saxenda® should be clear and colourless.
Do not use this medicine if it is thickened, coloured, or has solid bits in it.
Follow the detailed instructions on how to inject Saxenda
®
in the instructions for use supplied with the product. These instructions are also available via the following hyperlinks:
If you forget to use Saxenda®
If you forget a dose and remember it within 12 hours from when you usually take the
dose, inject Saxenda® as soon as you remember.
However, if more than 12 hours have passed since you should have used Saxenda®, skip the missed dose and inject your next dose the following day at the usual time.
Do not use 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, nurse or pharmacist.
If you use too much Saxenda® (overdose)
You should immediately:
phone the Poisons Information Centre
(by calling 13 11 26 in Australia; 0800 764 766 in New Zealand), or
contact your doctor, or
go to the Accident and Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning.
Take the medicine pack with you. You may need medical treatment. Using too much Saxenda
® may cause nausea (feeling sick), vomiting (being sick), or low blood sugar (hypoglycaemia),
see Section
6. Are there any side effects? for the early warning signs of hypos.
5. What should I know while using Saxenda®?
Things you should do
Tell your doctor if you have diabetes.
They may adjust the dose of your diabetes medicine to prevent you getting ‘hypos’
(low blood sugar levels).
Do not mix Saxenda® with other medicines that you inject (e.g. insulins).
Do not use Saxenda® in combination with other medicines that contain GLP-1 receptor agonists (e.g. exenatide,
dulaglutide, semaglutide or lixisenatide).
Tell your doctor, 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 Saxenda® in the country you are visiting.
Your doctor, nurse or pharmacist can provide you with some helpful information.
Remind any doctor, dentist or pharmacist or other health professional you visit that
you are using Saxenda®.
Things you should not do
Do not stop using your medicine unless your doctor tells you to.
Do not use the medicine if you think it has been frozen or exposed to excessive heat.
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 needles or pens.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how the Saxenda
®
affects you.
For further information talk to your doctor or pharmacist.
Looking after your medicine
Store Saxenda® pens that are not being used between 2°C and 8°C in a refrigerator (not in or too
near the freezer section or cooling element). Do not freeze.
When Saxenda® is being used, you can keep the pen for 1 month either at room temperature (below
30°C) or in a refrigerator (2°C to 8°C), away from the cooling element. Store the
pen without a needle attached.
The medicine in Saxenda® 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 it from light.
Follow the instructions in the carton on how to take care of your medicine properly.
Keep it where young children cannot reach it.
When to discard your medicine
Discard Saxenda
®
after 1 month even if there is still some medicine left in it.
Do not use Saxenda
®
after the expiry date printed on the pen label and carton. The expiry date refers
to the last day of that month.
Do not use Saxenda
®
if the solution is not clear and colourless.
Getting rid of any unwanted medicine
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.
6. Are there any side effects?
All medicines can have side effects. If you do experience any side effects, most of
them are minor and temporary. However, some side effects may need medical attention.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects.
Less serious side effects
|
Less serious side effects
|
What to do
|
|
Very common: may affect more than 1 in 10 people:
feeling sick (nausea)
being sick (vomiting)
diarrhoea
constipation
headache
these usually go away after a few days or weeks.
Common: may affect up to 1 in 10 people:
changed sense of taste
dizziness
indigestion (dyspepsia)
inflammation in the lining of the stomach (gastritis)
feeling bloated, burping, wind (flatulence), or dry mouth
heartburn
stomach discomfort
upper stomach pain
gall stones
low blood sugar (a ‘hypo’)
injection site reactions (such as bruising, pain, irritation, itching and rash)
feeling weak or tired
difficulty sleeping (insomnia) This usually occurs during the first 3 months of treatment
increase of pancreatic enzymes (such as lipase and amylase)
rash.
Uncommon: may affect up to 1 in 100 people:
fast heartbeat
feeling generally unwell
inflamed gall bladder
allergic reactions including skin rash
delay in the emptying of the stomach
loss of fluids (dehydration)
This is more likely to occur at the start of treatment and may be due to you being
sick (vomiting), feeling sick (nausea), and diarrhoea.
Not known: frequency cannot be estimated from the available data
Lumps under the skin may be caused by build-up of a protein called amyloid (cutaneous
amyloidosis; how often this occurs is not known).
Saxenda® 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.
|
Speak to your doctor if you have any of these less serious side effects and they worry
you.
|
Hypoglycaemia
Hypos are more likely to occur if you have diabetes and are also taking a sulfonylurea.
A hypo may come on suddenly. The warning signs of a hypo can include:
cold sweat, cool pale skin
headache
fast heartbeat
feeling sick
feeling very hungry
changes in vision
feeling sleepy
feeling weak, nervous, anxious, or confused
difficulty concentrating
shaking (tremor)
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 when you start using Saxenda® your doctor may tell you to reduce the dose of the sulfonylurea.
Serious side effects
Tell your doctor or pharmacist if you notice anything else that may be making you
feel unwell.
Other side effects not listed here may occur in some people.
Reporting side effects
After you have received medical advice for any side effects you experience, you can
report side effects to the Therapeutic Goods Administration online at
www.tga.gov.au/reporting-problems . By reporting side effects, you can help provide more information on the safety of
this medicine.
Always make sure you speak to your doctor or pharmacist before you decide to stop
taking any of your medicines.
7. Product details
This medicine is only available with a doctor's prescription.
What Saxenda® contains
|
Active ingredient
(main ingredient)
|
liraglutide 6 mg/mL
|
|
Other ingredients
(inactive ingredients)
|
phenol
dibasic sodium phosphate dihydrate
Propylene glycol
sodium hydroxide
hydrochloric acid
water for injections.
|
Do not take this medicine if you are allergic to any of these ingredients.
What Saxenda® looks like
Saxenda® is supplied as a clear and colourless solution for injection in a pre-filled pen.
Each pen contains 3 mL of solution, and is able to deliver doses of 0.6 mg, 1.2 mg,
1.8 mg, 2.4 mg or 3.0 mg.
Saxenda® is available in packs containing 1, 3 or 5 pens. Not all pack sizes may be marketed.
Needles are not included.
AUST R 225804
Who distributes Saxenda®
Australia
Novo Nordisk Pharmaceuticals Pty. Ltd.
Level 10
118 Mount Street
North Sydney NSW 2060
New Zealand
Novo Nordisk Pharmaceuticals Ltd.
11-19 Customs Street West,
Commercial Bay Tower,
Level 18, Office 1834
Auckland 1010
New Zealand
Saxenda® and NovoFine® are trademarks owned by Novo Nordisk A/S.
© 2024
Novo Nordisk A/S
Further information
Always check the following websites to ensure you are reading the most recent version
of
the Saxenda® consumer medicine information:
Australia
www.novonordisk.com.au
New Zealand
For further information call Novo Nordisk Customer Care on 1800 668 626 (AU) or 0800
733 737 (NZ).
For further dietary advice, refer to the dietary guidelines on the NH&MRC website
at
www.nhmrc.gov.au (Australia), or the current food and nutrition guidelines on the Ministry of Health
website at
www.health.govt.nz (New Zealand).
This leaflet was prepared in February 2024.