Patient leaflet - Liraglutide Adalvo 6 mg/ml solution for injection in Pre-filled pen
1. What Liraglutide Adalvo is and what it is used for
Liraglutide Adalvo contains the active substance liraglutide. It helps your body reduce your blood sugar level only when blood sugar is too high. It also slows food passage through your stomach and can help prevent heart disease.
Liraglutide Adalvo 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).
Liraglutide Adalvo is used with other medicines for diabetes when they are not enough to control your blood sugar levels. These may include oral antidiabetics (such as metformin, pioglitazone, sulfonylurea, sodium-glucose cotransporter 2 inhibitor (SGLT2i)) and/or insulin.
2. What you need to know before you use Liraglutide Adalvo
Do not use Liraglutide Adalvo
if you are allergic to liraglutide or any of the other ingredients of this
medicine (listed in section 6).
Warnings and precautions
Talk to your doctor, pharmacist or nurse:
- before using Liraglutide Adalvo.
- if you have or have had a disease of the pancreas.
This medicine should not be used if you have type 1 diabetes (your body does not produce any insulin) or diabetic ketoacidosis (a complication of diabetes with high blood sugar and increase in effort to breathe). It is not an insulin and should therefore not be used as a substitute for insulin.
The use of Liraglutide Adalvo is not recommended if you are on dialysis. The use of Liraglutide Adalvo is not recommended if you have severe liver disease.
The use of Liraglutide Adalvo is not recommended if you have severe heart failure.
This medicine is not recommended if you have a severe stomach or gut problem which results in delayed stomach emptying (called gastroparesis), or inflammatory bowel disease.
If you have symptoms of acute pancreatitis, such as persistent, severe stomach ache, you should consult your doctor immediately (see section 4).
If you have thyroid disease including thyroid nodules and enlargement of the thyroid gland, consult your doctor.
When initiating treatment with Liraglutide Adalvo, you may in some cases experience loss of fluids/dehydration, e.g. in case of vomiting, nausea and diarrhoea. It is important to avoid dehydration by drinking plenty of fluids. Contact your doctor if you have any questions or concerns.
Children and adolescents
Liraglutide Adalvo can be used in adolescents and children aged 10 years and above. No data are available in children below 10 years of age.
Other medicines and Liraglutide Adalvo
Please tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines.
In particular, tell your doctor, pharmacist or nurse if you are using medicines containing any of the following active substances:
Sulfonylurea (such as glimepiride or glibenclamide) or insulin. You may get
hypoglycaemia (low blood sugar) when using Liraglutide Adalvo together with a sulfonylurea or insulin, as sulfonylureas and insulin increase the risk of hypoglycaemia. When you first start using these medicines together, your doctor may tell you to lower the dose of the sulfonylurea or insulin. Please see section 4 for the warning signs of low blood sugar. If you are also taking a 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.
If you are using insulin, your doctor will tell you how to reduce the dose
of insulin and will recommend you to monitor your blood sugar more frequently, in order to avoid hyperglycaemia (high blood sugar) and diabetic ketoacidosis (a complication of diabetes that occurs when the body is unable to break down glucose because there is not enough insulin).
Warfarin or other oral anti-coagulation medicines. More frequent blood
testing to determine the ability of your blood to clot may be required.
Pregnancy and breast-feeding
Tell your doctor if you are, you think you might be, or are planning to become pregnant. Liraglutide Adalvo should not be used during pregnancy because it is not known if it may harm your unborn child.
It is not known if liraglutide passes into breast milk, therefore do not use this
medicine if you are breastfeeding.
Driving and using machines
Low blood sugar (hypoglycaemia) may reduce your ability to concentrate. Avoid driving or using machines if you experience signs of hypoglycaemia. Please see section 4 for the warning signs of low blood sugar. Please consult your doctor for further information on this topic.
Liraglutide Adalvo contains potassium and sodium
This medicine contains potassium, less than 1 mmol (39 mg) per dose. This means it is essentially ‘potassium-free’.
This medicine contains less than 1 mmol sodium (23 mg) per dose. This means that it is essentially `sodium free’.
3. How to use Liraglutide Adalvo
Always use this medicine exactly as your doctor has told you. Check with your doctor, pharmacist or nurse if you are not sure.
- The starting dose is 0.6 mg once a day, for at least one week.
- Your doctor will tell you when to increase it to 1.2 mg once a day.
Your doctor may tell you to further increase the dose to 1.8 mg once a day,
if your blood glucose is not adequately controlled with a dose of 1.2 mg.
Do not change your dose unless your doctor has told you to.
Liraglutide Adalvo is given as an injection under the skin (subcutaneous). Do not inject it into a vein or muscle. The best places to give yourself the injection are the front of your thighs, the front of your waist (abdomen), or your upper arm.
You can give yourself the injection at any time of the day, regardless of meals. When you have found the most convenient time of the day it is preferred that you inject Liraglutide Adalvo around the same time of the day.
Before you use the pen for the first time, your doctor or nurse will show you how to use it.
Detailed instructions for use are provided on the other side of this leaflet.
If you use more Liraglutide Adalvo than you should
If you use more Liraglutide Adalvo than you should, talk to your doctor straight away. You may need medical treatment. You may experience nausea, vomiting, diarrhoea or low blood sugar (hypoglycaemia). Please refer to section 4 for warning signs of low blood sugar.
If you forget to use Liraglutide Adalvo
If you forget a dose, use Liraglutide Adalvo as soon as you remember. However, if it is more than 12 hours since you should have used Liraglutide Adalvo, 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 stop using Liraglutide Adalvo
Do not stop using Liraglutide Adalvo without talking to your doctor. If you stop using it, your blood sugar levels may increase.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects
Common: may affect up to 1 in 10 people
Hypoglycaemia (low blood sugar). The warning signs of low blood
sugar may come on suddenly and can include: cold sweat, cool pale skin, headache, fast heartbeat, feeling sick, feeling very hungry, changes in vision, feeling sleepy, feeling weak, nervous, anxious, confused, difficulty concentrating, shaking (tremor). Your doctor will tell you how to treat low blood sugar and what to do if you notice these warning signs. This is more likely to happen if you also take a sulfonylurea or insulin. Your doctor may reduce your dose of these medicines before you start using Liraglutide Adalvo.
Rare: may affect up to 1 in 1,000 people
A severe form of allergic reaction (anaphylactic reaction) with additional
symptoms such as breathing problems, swelling of throat and face, fast heartbeat, etc. If you experience these symptoms you should seek immediate medical help and inform your doctor as soon as possible.
Bowel obstruction. A severe form of constipation with additional
symptoms such as stomach ache, bloating, vomiting etc.
Very rare: may affect up to 1 in 10,000 people
Cases of inflammation of the pancreas (pancreatitis). Pancreatitis can
be a serious, potentially life-threatening medical condition. Stop taking Liraglutide Adalvo and contact a doctor immediately if you notice any of the following serious side effects:
Severe and persistent pain in the abdomen (stomach area) which might
reach through to your back, as well as nausea and vomiting, as it could be a sign of an inflamed pancreas (pancreatitis).
Other side effects
Very common: may affect more than 1 in 10 people
- Nausea (feeling sick). This usually goes away over time.
- Diarrhoea. This usually goes away over time.
Common
- Vomiting.
When initiating treatment with Liraglutide Adalvo, you may in some cases experience loss of fluids/dehydration, e.g. in case of vomiting, nausea and diarrhoea. It is important to avoid dehydration by drinking plenty of fluids.
- Headache
- Indigestion
- Inflamed stomach (gastritis). The signs include stomach ache, nausea and vomiting.
- Gastro-oesophageal reflux disease (GORD). The signs include heartburn.
- Painful or swollen tummy (abdomen)
- Abdominal discomfort
- Constipation
- Wind (flatulence)
- Decreased appetite
- Bronchitis
- Common cold
- Dizziness
- Increased pulse
- Tiredness
- Toothache
- Injection site reactions (such as bruising, pain, irritation, itching and rash)
- Increase of pancreatic enzymes (such as lipase and amylase).
Uncommon: may affect up to 1 in 100 people
- Allergic reactions like pruritus (itching) and urticaria (a type of skin rash)
- Dehydration, sometimes with a decrease in kidney function
- Malaise (feeling unwell)
- Gallstones
- Inflamed gallbladder
- Change in how things taste
- A delay in the emptying of the stomach.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme Website: www.mhra.gov.uk/ yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Liraglutide Adalvo
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 pen label and carton after ‘EXP’. The expiry date refers to the last day of that month.
Before opening:
Store in a refrigerator (2˚C–8˚C). Do not freeze. Keep away from the freezer compartment.
During use:
You can keep the pen for 1 month when stored at a temperature below 30˚C or in a refrigerator (2˚C8˚C), away from the freezer compartment. Do not freeze. When you are not using the pen, keep the pen cap on in order to protect from light.
Do not use this medicine if the solution is not clear and colourless or almost colourless.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Liraglutide Adalvo contains
- The active substance is liraglutide. 1 ml solution for injection contains 6 mg liraglutide. One pre-filled pen contains 18 mg liraglutide.
The other ingredients are: potassium phosphate dibasic (anhydrous) (E
340), propylene glycol (E 1520), phenol, sodium hydroxide, hydrochloric acid and water for injections.
What Liraglutide Adalvo looks like and contents of the pack
Liraglutide Adalvo is a clear, and colourless or almost colourless, solution for injection and is supplied in glass cartridge (with cartridge holder and a blue dose button) with a combi-seal cap with a grey plunger and a protective cover. 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.
Liraglutide Adalvo is available in packs containing 1, 2, 3, 5 or 10 pens. Not all pack sizes may be marketed. Needles are not included.
Marketing Authorisation Holder
Adalvo Limited
Malta Life Sciences Park,
Building 1, Level 4,
Sir Temi Zammit Buildings,
San Gwann, SGN 3000, Malta
Manufacturer
Eurofins PROXY Laboratories B.V.
Archimedesweg 25 2333 CM Leiden
The Netherlands
Pharmadox Healthcare Ltd.
KW20A Kordin Industrial Park,
Paola PLA 3000, Malta
KeVaRo GROUP Ltd
9 Tzaritza Elenora Str. Office 23
Sofia 1618 Bulgaria
This leaflet was last revised in 08/2024
Liraglutide Adalvo 6 mg/ml solution for injection in pre-filled pen liraglutide
Package leaflet: Information for the user
Please read these instructions carefully before using your pen.
Your pen comes with 18 mg of liraglutide. You can select doses of 0.6 mg, 1.2 mg and 1.8 mg.
The pen is designed to be used with Clickfine, Penfine classic, Clickfine AutoProtect, Microfine Ultra, NovoFine or NovoFine Plus disposable injection needles to a length of 4 mm to 12.7 mm, and as thin as 29G, 31G or 32G.
Caring and cleaning your pen
- Do not try to repair your pen or pull it apart.
- Keep your pen away from dust, dirt and all kinds of liquids.
- Clean the pen with a cloth moistened with a mild detergent.
- Do not try to wash, soak or lubricate it – this can harm the pen.
Important information
- Keep your pen out of the reach of others, especially children.
- Do not share your pen or needles with anyone else.
Always use a new needle for each injection. This reduces the risk of
contamination, infection, leakage of liraglutide, blocked needles and inaccurate dosing.
Prepare your pen
Wash your hands with soap and water before and after handling your pen. Check the name and coloured label of your pen to make sure that it contains liraglutide. Using the wrong medicine could cause severe harm. Inspect your pen and make sure it is not damaged.
Pull off the pen cap.
Make sure the solution is clear
and colourless.
Pull off the paper tab from a
new disposable needle.
Screw the needle straight and
tightly onto your pen.
Pull off the outer needle cap
and keep it for later.
Pull off the inner needle cap
and dispose of it.
- Be careful not to bend or damage the needle.
Never try to put the inner needle cap back on the needle. You may
stick yourself with the needle.
With each new pen, check the flow
Check the flow before your first injection with each new pen. If your pen is already in use, go to ‘Select your dose’, step H.
If you have dropped your pen against a hard surface or suspect that something is wrong with it, always put on a new disposable needle and check the flow before you inject.
Turn the dose selector until the flow check symbol lines up with the pointer.
Hold the pen with the needle pointing up. Tap the cartridge gently with your finger a few times. This will make any air bubbles collect at the top of the cartridge.
Keep the needle pointing up and press the dose button until 0 mg lines up with the pointer.
A drop of liraglutide should appear at the needle tip. If no drop appears, repeat steps E to G up to 4 times. If there is still no drop of liraglutide, change the needle and repeat steps E to G once more.
Do not use the pen if a drop of liraglutide still does not appear. This indicates the pen is defective and you must use a new one.
Select your dose
Always check that the pointer lines up with 0 mg.
Turn the dose selector until your needed dose lines up with the pointer (0.6 mg, 1.2 mg or 1.8 mg).
If you selected a wrong dose by mistake, simply change it by turning the dose selector backwards or forwards until the right dose lines up with the pointer.
Be careful not to press the dose button when turning the dose selector backwards, as liraglutide may come out.
If the dose selector stops before your needed dose lines up with the pointer, there is not enough liraglutide left for a full dose.
Then you can either:
Split your dose into two injections:
Turn the dose selector in either direction until 0.6 mg or 1.2 mg lines up with the pointer. Inject the dose. Then prepare a new pen for injection and inject the remaining number of mg to complete your dose.
You may only split your dose between your current pen and a new pen if trained or advised by your healthcare professional. Use a calculator to plan the doses. If you split the dose wrong, you may inject too much or too little liraglutide.
Inject the full dose with a new pen:
If the dose selector stops before 0.6 mg lines up with the pointer, prepare a new pen and inject the full dose with the new pen.
Do not try to select other doses than 0.6 mg, 1.2 mg or 1.8 mg. The numbers in the display must line up precisely with the pointer to ensure that you get the correct dose. The dose selector clicks when you turn it. Do not use these clicks to select your dose. Do not use the cartridge scale to measure how much liraglutide to inject – it is not accurate enough.
Inject your dose
Insert the needle into your skin using the injection technique shown by your
doctor or nurse.
The best places to give
yourself the injection are the
front of your thighs, the front
of your waist (abdomen),
or your upper arm.
Then follow the instructions below:
Press the dose button to inject
until 0 mg lines up with the
pointer. Be careful not to
touch the display with your
other fingers or press the
dose selector sideways when
you inject. This is because it
may block the injection.
Keep the dose button pressed
down and leave the needle
under the skin for at least
6 seconds.
This is to make sure that you
get your full dose.
Pull out the needle.
After that, you may see a
drop liraglutide at the needle
tip.
This is normal and does not
affect your dose.
Guide the needle tip into the
outer needle cap without
touching the needle or the
outer needle cap.
When the needle is covered,
carefully push the outer
needle cap completely on.
Then unscrew the needle.
Dispose of it carefully and
put the pen cap back on.
Store the pen injector in a
refrigerator (2°C to 8°C),
away from the freezer
compartment. After first use
the pen injector can be stored
below 30°C or in a refrigerator.
When the pen is empty, carefully dispose of it without a needle attached. Please dispose of the pen and needle in accordance with local requirements.
- Always remove the needle after each injection, and store your pen without a needle attached. This reduces the risk of contamination, infection, leakage of liraglutide, blocked needles and inaccurate dosing.
- Carefully dispose of your pen 1 month after the first use, when it is expired or when it is empty.
- Caregivers must be very careful when handling used needles – to prevent needle injury and cross-infection.
ARTDB027827P
Other sources of information
INSTRUCTIONS FOR USING THE Liraglutide Adalvo PEN
