Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Diavic 6 mg/1 ml Solution for injection in pre-filled pen
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Liraglutide may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
for
Diavic 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. Diavic 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). Diavic 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.
What you need to know before you take it
e Diavic Do not use Diavic
- 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:
- If you have ever had pancreatitis (inflammation of the pancreas) which may cause severe pain in the stomach and back which does not go away (see section 4). If you know that you are due to have surgery where you will be under anaesthesia (sleeping), please tell your doctor that you are taking Diavic. V006
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 Diavic is not recommended if you are on dialysis. The use of Diavic is not recommended if you have severe liver disease. The use of Diavic 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 thyroid disease including thyroid nodules and enlargement of the thyroid gland, consult your doctor. When initiating treatment with Diavic, 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 Diavic 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 Diavic 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 Diavic 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. Diavic should not be used during pregnancy because it is not known if it may harm your unborn child. It is not known if Diavic 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. V006
Important information about some of the ingredients of Diavic This medicine contains less than 1 mmol sodium (23 mg) per dose. This means that it is essentially 'sodium free'. 3.
How to take it
Diavic 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.
Diavic 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. Change the place where you inject each day to reduce the risk of developing lumps. 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 Diavic 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 Diavic than you should If you use more Diavic 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 Diavic If you forget a dose, use Diavic as soon as you remember. However, if it is more than 12 hours since you should have used Diavic, 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 Diavic Do not stop using Diavic 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, V006
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 Diavic. 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 • Inflamed pancreas (acute pancreatitis) which could cause severe pain in the stomach and back which does not go away. This is a serious, potentially life-threatening condition. You should see a doctor immediately if you experience such symptoms. • Stop taking Diavic and contact a doctor immediately if you notice any of the following serious
Possible side effects
: Severe and persistent pain in the abdomen (stomach area) which might reach through to your back, with or without nausea and vomiting. This could be a sign of an inflamed pancreas (acute pancreatitis), which is serious and potentially life-threatening. 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 Diavic, 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. • • • • • • • • • • • • • • • • •
V006
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. 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). 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 the Yellow Card Scheme at: 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 it
Diavic
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. Store 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 ̊C- 8 ̊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 Diavic 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 disodium phosphate dihydrate, propylene glycol, phenol, water for injections, hydrochloric acid (for pH adjustment) and sodium hydroxide (for pH adjustment). What Diavic looks like and contents of the pack Diavic is supplied as a pre-filled pen, with a light blue body and a dose button, and a yellow dose selector with grey pen cap. 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. V006
Diavic 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 and Manufacturer Marketing Authorisation Holder: SUN PHARMA UK LIMITED 6-9 The Square, Stockley Park, Uxbridge, UB11 1FW United Kingdom Manufacturers: Terapia S.A. 124 Fabricii Street 400632 Cluj-Napoca Cluj Romania Sun Pharmaceutical Industries Europe BV Polarisavenue 87 2132 JH Hoofddorp The Netherlands This leaflet was last revised in July 2025.
V006
INSTRUCTIONS FOR USING THE DIAVIC PEN 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 or1.8 mg. The pen is designed to be used with disposable injection needles up to a length of 8 mm and as thin as 32G (0.25/0.23 mm) such as outer needle cap, inner needle cap, needle, paper tab.
Prepare your pen A Check the name and coloured label of your pen to make sure that it contains liraglutide. Using the wrong medicine could cause severe harm. Pull off the pen cap. B Pull off the paper tab from a new disposable needle. Screw the needle straight and tightly onto your pen.
C Pull off the outer needle cap and keep it for later.
D Pull off the inner needle cap and dispose of it.
Always use a new needle for each injection. This reduces the risk of contamination, infection, leakage of liraglutide, blocked needles and inaccurate dosing. 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. V006
Caring for 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 • Do not share your pen or needles with anyone else. • Keep your pen out of the reach of others, especially children. • Change the place where you inject each day to reduce the risk of developing lumps. 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. E Turn the dose selector until the flow check symbol lines up with the pointer.
F 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.
G 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 four 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. 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.
V006
Select your dose Always check that the pointer lines up with 0 mg. H 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 lliraglutide to inject – it is not accurate enough. Inject your dose I Insert the needle into your skin using the injection technique shown by your doctor or nurse. 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.
V006
J 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.
K Guide the needle tip into the outer needle cap without touching the needle or the outer needle cap.
L 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. 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. Caregivers must be very careful when handling used needles – to prevent needle injury and cross-infection
V006
Frequently asked questions about Diavic 6 mg/1 ml Solution for injection in pre-filled pen
How do I take Diavic 6 mg/1 ml Solution for injection in pre-filled pen?
Diavic 6 mg/1 ml Solution for injection in pre-filled pen comes as injection containing 6mg / 1ml. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Diavic 6 mg/1 ml Solution for injection in pre-filled pen?
The active substance in Diavic 6 mg/1 ml Solution for injection in pre-filled pen is liraglutide.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Diavic 6 mg/1 ml Solution for injection in pre-filled pen, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Diavic 6 mg/1 ml Solution for injection in pre-filled pen without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: liraglutide
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
Liraglutide is indicated for the treatment of adults, adolescents and children aged 10 years and above with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise
• as monotherapy when metformin is considered inappropriate due to intolerance or contraindications
• in addition to other medicinal products for the treatment of diabetes.
For study results with respect to combinations, effects on glycaemic control and cardiovascular events, and the populations studied, see sections 4.4, 4.5 and 5.1.
4.2. Posology and method of administration
Posology
To improve gastro-intestinal tolerability, the starting dose is 0.6 mg liraglutide daily. After at least one week, the dose should be increased to 1.2 mg. Some patients are expected to benefit from an increase in dose from 1.2 mg to 1.8 mg and based on clinical response, after at least one week, the dose can be increased to 1.8 mg to further improve glycaemic control. Daily doses higher than 1.8 mg are not recommended.
When Liraglutide is added to a sulfonylurea or insulin, a reduction in the dose of sulfonylurea or insulin should be considered to reduce the risk of hypoglycaemia (see section 4.4). Combination therapy with sulfonylurea is only valid for adult patients.
Self-monitoring of blood glucose is not needed in order to adjust the dose of liraglutide. Blood glucose self-monitoring is necessary to adjust the dose of sulfonylurea and insulin, particularly when liraglutide therapy is started and insulin is reduced. A stepwise approach to insulin dose reduction is recommended.
Special populations
Elderly patients (>65 years old)
No dose adjustment is required based on age (see section 5.2).
Renal impairment
No dose adjustment is required for patients with mild, moderate or severe renal impairment. There is no therapeutic experience in patients with end-stage renal disease, and liraglutide is therefore not recommended for use in these patients (see sections 5.1 and 5.2).
Hepatic impairment
No dose adjustment is recommended for patients with mild or moderate hepatic impairment. Liraglutide is not recommended for use in patients with severe hepatic impairment (see section 5.2).
Paediatric population
No dose adjustment is required for adolescents and children aged 10 years and above. No data are available for children below 10 years of age (see sections 5.1 and 5.2).
Method of administration
Liraglutide must not be administered intravenously or intramuscularly.
Liraglutide is administered once daily at any time, independent of meals, and can be injected subcutaneously in the abdomen, in the thigh or in the upper arm. The injection site and timing can be changed without dose adjustment. However, it is preferable that liraglutide is injected around the same time of the day, when the most convenient time of the day has been chosen. Injection sites should always be rotated in order to reduce the risk of injection site amyloid deposits (see section and 4.8). For further instructions on administration, see section 6.6.
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
4.4. Special warnings and precautions for use
Liraglutide should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.
Liraglutide is not a substitute for insulin. Diabetic ketoacidosis has been reported in insulin-dependent patients after rapid discontinuation or dose reduction of insulin (see section 4.2).
There is no therapeutic experience in patients with congestive heart failure New York Heart
Association (NYHA) class IV, and liraglutide is therefore not recommended for use in these patients.
There is limited experience in patients with inflammatory bowel disease and diabetic gastroparesis. Use of liraglutide is not recommended in these patients since it is associated with transient gastrointestinal adverse reactions, including nausea, vomiting and diarrhoea.
Aspiration in association with general anaesthesia or deep sedation
Cases of pulmonary aspiration have been reported in patients receiving GLP-1 receptor agonists undergoing general anaesthesia or deep sedation. Therefore, the increased risk of residual gastric content due to delayed gastric emptying (see section 4.8) should be considered prior to performing procedures with general anaesthesia or deep sedation.
Acute pancreatitis
Liraglutide has not been studied in patients with a history of pancreatitis, and should be used with caution in these patients.
Acute pancreatitis has been reported in patients treated with GLP-1 receptor agonists. This includes post-marketing reports of necrotising pancreatitis and reports with a fatal outcome. Patients should be informed of the symptoms of acute pancreatitis, including persistent, severe abdominal pain. Patients should be advised to seek immediate medical attention if they occur. If pancreatitis is suspected, liraglutide should be discontinued. If the diagnosis of pancreatitis is confirmed, liraglutide should not be restarted.
In the absence of other signs and symptoms of acute pancreatitis, elevations in pancreatic enzymes alone are not predictive of acute pancreatitis (see sections 4.8 and 5.1).
Thyroid disease
Thyroid adverse events, such as goitre, have been reported in clinical trials and in particular in patients with pre-existing thyroid disease. Liraglutide should therefore be used with caution in these patients.
Hypoglycaemia
Patients receiving liraglutide in combination with a sulfonylurea or insulin may have an increased risk of hypoglycaemia (see section 4.8). The risk of hypoglycaemia can be lowered by a reduction in the dose of sulfonylurea or insulin.
Dehydration
Signs and symptoms of dehydration, including renal impairment and acute renal failure, have been reported in patients treated with liraglutide. Patients treated with liraglutide should be advised of the potential risk of dehydration in relation to gastrointestinal side effects and take precautions to avoid fluid depletion.
Excipients
Liraglutide contains less than 1 mmol sodium (23 mg) per dose, therefore the medicinal product is essentially 'sodium-free'.
Traceability
In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
4.5. Interaction with other medicinal products and other forms of interaction
In vitro, liraglutide has shown very low potential to be involved in pharmacokinetic interactions with other active substances related to cytochrome P450 and plasma protein binding.
The small delay of gastric emptying with liraglutide may influence absorption of concomitantly administered oral medicinal products. Interaction studies did not show any clinically relevant delay of absorption and therefore no dose adjustment is required. Few patients treated with liraglutide reported at least one episode of severe diarrhoea. Diarrhoea may affect the absorption of concomitant oral medicinal products.
Warfarin and other coumarin derivatives
No interaction study has been performed. A clinically relevant interaction with active substances with poor solubility or with narrow therapeutic index such as warfarin cannot be excluded. Upon initiation of liraglutide treatment in patients on warfarin or other coumarin derivatives, more frequent monitoring of INR (International Normalised Ratio) is recommended.
Paracetamol
Liraglutide did not change the overall exposure of paracetamol following a single dose of 1000 mg. Paracetamol Cmax was decreased by 31% and median tmax was delayed up to 15 min. No dose adjustment for concomitant use of paracetamol is required.
Atorvastatin
Liraglutide did not change the overall exposure of atorvastatin to a clinically relevant degree following single dose administration of atorvastatin 40 mg. Therefore, no dose adjustment of atorvastatin is required when given with liraglutide. Atorvastatin Cmax was decreased by 38% and median tmax was delayed from 1 h to 3 h with liraglutide.
Griseofulvin
Liraglutide did not change the overall exposure of griseofulvin following administration of a single dose of griseofulvin 500 mg. Griseofulvin Cmax increased by 37% while median tmax did not change. Dose adjustments of griseofulvin and other compounds with low solubility and high permeability are not required.
Digoxin
A single dose administration of digoxin 1 mg with liraglutide resulted in a reduction of digoxin AUC by 16%; Cmax decreased by 31%. Digoxin median tmax was delayed from 1 h to 1.5 h. No adjustment of digoxin dose is required based on these results.
Lisinopril
A single dose administration of lisinopril 20 mg with liraglutide resulted in a reduction of lisinopril AUC by 15%; Cmax decreased by 27%. Lisinopril median tmax was delayed from 6 h to 8 h with liraglutide. No dose adjustment of lisinopril is required based on these results.
Oral contraceptives
Liraglutide lowered ethinyloestradiol and levonorgestrel Cmax by 12 and 13%, respectively, following administration of a single dose of an oral contraceptive product. Tmax was delayed by 1.5 h with liraglutide for both compounds. There was no clinically relevant effect on the overall exposure of either ethinyloestradiol or levonorgestrel. The contraceptive effect is therefore anticipated to be unaffected when co-administered with liraglutide.
Insulin
No pharmacokinetic or pharmacodynamic interactions were observed between liraglutide and insulin detemir when administering a single dose of insulin detemir 0.5 U/kg with liraglutide 1.8 mg at steady state in patients with type 2 diabetes.
Paediatric Population
Interaction studies have only been performed in adults.
4.6. Fertility, pregnancy and lactation
Pregnancy
There are no adequate data from the use of liraglutide in pregnant women. Studies in animals have shown reproductive toxicity (see section 5.3). The potential risk for humans is unknown.
Liraglutide should not be used during pregnancy, and the use of insulin is recommended instead. If a patient wishes to become pregnant, or pregnancy occurs, treatment with liraglutide should be discontinued.
Breast-feeding
It is not known whether liraglutide is excreted in human milk. Animal studies have shown that the transfer of liraglutide and metabolites of close structural relationship into milk is low. Non-clinical studies have shown a treatment-related reduction of neonatal growth in suckling rat pups (see section 5.3). Because of lack of experience, liraglutide should not be used during breast-feeding.
Fertility
Apart from a slight decrease in the number of live implants, animal studies did not indicate harmful effects with respect to fertility.
4.7. Effects on ability to drive and use machines
Liraglutide has no or negligible influence on the ability to drive and use machines.
Patients should be advised to take precautions to avoid hypoglycaemia while driving and using machines, in particular when liraglutide is used in combination with a sulfonylurea or insulin.
4.8. Undesirable effects
Summary of the safety profile
In five large long-term clinical phase 3a trials over 2,500 adult patients have received treatment with liraglutide alone or in combination with metformin, a sulfonylurea (with or without metformin) or metformin plus rosiglitazone.
The most frequently reported adverse reactions during clinical trials were gastrointestinal disorders: nausea and diarrhoea were very common, whereas vomiting, constipation, abdominal pain, and dyspepsia were common. At the beginning of the therapy, these gastrointestinal adverse reactions may occur more frequently. These reactions usually diminish within a few days or weeks on continued treatment. Headache and nasopharyngitis were also common. Furthermore, hypoglycaemia was common, and very common when liraglutide is used in combination with a sulfonylurea. Severe hypoglycaemia has primarily been observed when combined with a sulfonylurea.
Tabulated list of adverse reactions
Table 1 lists adverse reactions reported in long-term phase 3a controlled trials, the LEADER trial (a long-term cardiovascular outcome trial) and spontaneous (post-marketing) reports. Frequencies for all events have been calculated based on their incidence in phase 3a clinical trials.
Frequencies are defined as: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
MedDRA system organ classes
Very common
Common
Uncommon
Rare
Very rare
Not known
Infections and infestations
Nasopharyngitis
Bronchitis
Immune system disorders
Anaphylactic reactions
Metabolism and nutrition disorders
Hypoglycaemia
Anorexia
Appetite decreased
Dehydration
Nervous system disorders
Headache
Dizziness
Dysgeusia
Cardiac disorders
Increased heart rate
Gastrointestinal disorders
Nausea
Diarrhoea
Vomiting
Dyspepsia
Abdominal pain upper
Constipation
Gastritis
Flatulence
Abdominal distension
Gastroesophageal reflux disease
Delayed gastric emptying
Intestinal obstruction
Pancreatitis (including necrotising pancreatitis)
Abdominal discomfort
Toothache
Hepatobiliary disorders
Cholelithiasis
Cholecystitis
Skin and subcutaneous tissue disorder
Rash
Urticaria
Pruritus
Cutaneous
amyloidosis
Renal and urinary disorders
Renal impairment
Renal failure acute
General disorders and administration site conditions
Fatigue
Injection site reactions
Malaise
Investigations
Increased lipase*
Increased amylase*
Table 1 Adverse reactions from long-term controlled phase 3a trials, the long-term cardiovascular outcome trial (LEADER) and spontaneous (post-marketing) reports
* From controlled phase 3b and 4 clinical trials only where they were measured.
Description of selected adverse reactions
In a clinical trial with liraglutide as monotherapy, rates of hypoglycaemia reported with liraglutide were lower than rates reported for patients treated with active comparator (glimepiride). The most frequently reported adverse reactions were gastrointestinal disorders, infections and infestations.
Hypoglycaemia
Most episodes of confirmed hypoglycaemia in clinical trials were minor. No episodes of severe hypoglycaemia were observed in the trial with liraglutide used as monotherapy. Severe hypoglycaemia may occur uncommonly and has primarily been observed when liraglutide is combined with a sulfonylurea (0.02 events/patient year). Very few episodes (0.001 events/patient year) were observed with administration of liraglutide in combination with oral antidiabetics other than sulfonylureas. The risk of hypoglycaemia is low with combined use of basal insulin and liraglutide (1.0 events per patient year, see section 5.1). In the LEADER trial, severe hypoglycaemic episodes were reported at a lower rate with liraglutide vs placebo (1.0 vs 1.5 events per 100 patient years; estimated rate ratio 0.69 [0.51 to 0.93]) (see section 5.1). For patients treated with premix insulin at baseline and at least for the following 26 weeks, the rate of severe hypoglycaemia for both liraglutide and placebo was 2.2 events per 100 patient years.
Gastrointestinal adverse reactions
When combining liraglutide with metformin, 20.7% of patients reported at least one episode of nausea, and 12.6% of patients reported at least one episode of diarrhoea. When combining liraglutide with a sulfonylurea, 9.1% of patients reported at least one episode of nausea and 7.9% of patients reported at least one episode of diarrhoea. Most episodes were mild to moderate and occurred in a dose-dependent fashion. With continued therapy, the frequency and severity decreased in most patients who initially experienced nausea.
Patients >70 years may experience more gastrointestinal effects when treated with liraglutide.
Patients with mild and moderate renal impairment (creatinine clearance 60–90 ml/min and 30– 59 ml/min, respectively) may experience more gastrointestinal effects when treated with liraglutide.
Cholelithiasis and cholecystitis
Few cases of cholelithiasis (0.4%) and cholecystitis (0.1%) have been reported during long-term, controlled phase 3a clinical trials with liraglutide. In the LEADER trial, the frequency of cholelithiasis and cholecystitis was 1.5% and 1.1% for liraglutide and 1.1% and 0.7% for placebo, respectively (see section 5.1).
Cutaneous amyloidosis
Cutaneous amyloidosis may occur at the injection site (See section 4.2)"
Withdrawal
The incidence of withdrawal due to adverse reactions was 7.8% for liraglutide-treated patients and 3.4% for comparator-treated patients in the long-term controlled trials (26 weeks or longer). The most frequent adverse reactions leading to withdrawal for liraglutide-treated patients were nausea (2.8% of patients) and vomiting (1.5%).
Injection site reactions
Injection site reactions have been reported in approximately 2% of patients receiving liraglutide in long- term (26 weeks or longer) controlled trials. These reactions have usually been mild.
Pancreatitis
Few cases of acute pancreatitis (<0.2%) have been reported during long-term, controlled phase 3 clinical trials with liraglutide. Pancreatitis was also reported from marketed use. In the LEADER trial, the frequency of acute pancreatitis confirmed by adjudication was 0.4% for liraglutide and 0.5% for placebo, respectively (see sections 4.4 and 5.1).
Allergic reactions
Allergic reactions including urticaria, rash and pruritus have been reported from marketed use of Liraglutide.
Few cases of anaphylactic reactions with additional symptoms such as hypotension, palpitations, dyspnoea and oedema have been reported with marketed use of liraglutide. Few cases (0.05%) of angioedema have been reported during all long-term clinical trials with liraglutide.
Paediatric population
Overall, frequency, type and severity of adverse reactions in adolescents and children aged 10 years and above were comparable to that observed in the adult population. Rate of confirmed hypoglycaemic episodes was higher with liraglutide (0.58 events/patient year) compared to placebo (0.29 events/patient year). In patients treated with insulin prior to a confirmed hypoglycaemic episode the rate was higher with liraglutide (1.82 events/patient year) compared to placebo (0.91 events/patient years). No severe hypoglycaemic episodes occurred in the liraglutide treatment group.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9. Overdose
From clinical trials and marketed use, overdoses have been reported of up to 40 times (72 mg) the recommended maintenance dose. Events reported included severe nausea, vomiting, diarrhoea and severe hypoglycaemia.
In the event of overdose, appropriate supportive treatment should be initiated according to the patient's clinical signs and symptoms. The patient should be observed for clinical signs of dehydration and blood glucose should be monitored.
🇷🇴 Known in Romania as
Medicines sold in Romania with the same active substance: Cunoscut în România ca
- DIAVIC 6 mg/ml prescriptionLIRAGLUTIDUM · injection / infusion
- ZEGLUXEN 6 mg/ml prescriptionLIRAGLUTIDUM · injection / infusion
- LIRAGLUTID CIPLA 6 mg/ml prescriptionLIRAGLUTIDUM · injection / infusion
- EJULIR 6 mg/ml prescriptionLIRAGLUTIDUM · injection / infusion
- SAXENDA 6 mg/ml prescriptionLIRAGLUTIDUM · injection / infusion
- VICTOZA 6 mg/ml prescriptionLIRAGLUTIDUM · injection / infusion
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Romanian medicines in the UK →
🇵🇱 Known in Poland as
Medicines sold in Poland with the same active substance: W Polsce znany jako
- VictozaLiraglutidum · injection / infusion
- SaxendaLiraglutidum · injection / infusion
- PlyzariLiraglutidum · injection / infusion
- ZEGLUXENLiraglutidum · injection / infusion
- DIAVICLiraglutidum · injection / infusion
- TriglyvaLiraglutidum · injection / infusion
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Polish medicines in the UK →
💬 Ask about this leaflet
Ask anything about Diavic 6 mg/1 ml Solution for injection in pre-filled pen. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.