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.
Saxenda 6 mg/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
What Saxenda is Saxenda is a weight loss medicine that contains the active substance liraglutide. It is similar to a natural occurring hormone called glucagon-like peptide-1 (GLP-1) that is released from the intestine after a meal. 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. What Saxenda is used for Saxenda is used for weight loss in addition to diet and exercise in adults aged 18 and above who have
- a BMI of 30 kg/m2 or greater (obesity) or
- a BMI of 27 kg/m2 and less than 30 kg/m2 (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'). BMI (Body Mass Index) is a measure of your weight in relation to your height. You should 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 (see section 3). Consult your doctor before you continue. Saxenda can be used as an adjunct to a healthy nutrition and increased physical activity for weight management in adolescents from the age of 12 years and above who have: • •
obesity (diagnosed by your doctor) body weight above 60 kg
You should only continue using Saxenda if you have lost at least 4% of your BMI after 12 weeks on the 3.0 mg/day dose or maximum tolerated dose (see section 3). Consult your doctor before you continue. Diet and exercise Your doctor will start you on a diet and exercise programme. Stay on this programme while you are using Saxenda.
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2.
What you need to know before you take it
e Saxenda
Do not use Saxenda – 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. The use of Saxenda is not recommended if you have severe heart failure. There is little experience with this medicine in patients of 75 years and older. It is not recommended if you are 75 years or older. There is little experience with this medicine in patients with kidney problems. If you have kidney disease or are on dialysis, consult your doctor. There is little experience with this medicine in patients with liver problems. If you have liver problems, consult your doctor. This medicine is not recommended if you have a severe stomach or gut problem which results in delayed stomach emptying (called gastroparesis), or if you have an inflammatory bowel disease. 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 Saxenda. 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. People with diabetes If you have diabetes, do not use Saxenda as a replacement for insulin. Inflamed gall bladder and gallstones If you lose substantial weight, you are at a risk of gallstones and thereby inflamed gall bladder. Stop taking Saxenda and contact a doctor immediately if you experience severe pain in your upper abdomen, usually worst on the right side under the ribs. The pain may be felt through to your back or right shoulder. See section 4. Thyroid disease If you have thyroid disease, including thyroid nodules and enlargement of the thyroid gland, consult your doctor. Heart rate Talk to 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. Loss of fluid and dehydration When starting treatment with Saxenda, you may lose body fluid or become dehydrated. This may be due to feeling sick (nausea), being sick (vomiting) and diarrhoea. It is important to avoid dehydration by drinking plenty of fluids. Talk to your doctor, pharmacist or nurse if you have any questions or concerns. See section 4.
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Children and adolescents The safety and efficacy of Saxenda in children below 12 years of age has not been studied. Other medicines and Saxenda 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 taking medicines for diabetes called 'sulfonylurea' (such as glimepiride or glibenclamide) or if you are taking insulin – 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. See section 4 for the warning signs of low blood sugar. If you adjust your insulin dose your doctor may recommend you to monitor your blood sugar more frequently.
- you are taking warfarin or other medicines by mouth that reduce your blood clotting (anticoagulants). More frequent blood testing to determine the ability of your blood to clot may be required. Pregnancy and breast-feeding Do not use Saxenda if you are pregnant, think that you might be pregnant or are planning to have a baby. This is because it is not known if Saxenda may affect the baby. Do not breast-feed if you are using Saxenda. This is because it is not known if Saxenda passes into breast milk. Driving and using machines Saxenda is unlikely to affect your ability to drive and use machines. Some patients may feel dizziness when taking Saxenda mainly during the first 3 months of treatment (see section 'Possible side effects'). If you feel dizziness be extra careful while driving or using machines. If you need any further information, talk to your doctor. Important information about some of the ingredients of Saxenda This medicine contains less than 1 mmol sodium (23 mg) per dose, i.e., essentially 'sodium-free'. 3.
How to take it
Saxenda
Always use this medicine exactly as your doctor has told you. Check with your doctor, pharmacist or nurse if you are not sure. Your doctor will start you on a diet and exercise programme. Stay on this programme while you are using Saxenda. How much to inject Adults Your treatment will start at a low dose which will be gradually increased over the first five weeks of treatment.
- When you first start using Saxenda, the starting dose is 0.6 mg once a day, for at least one week.
- Your doctor will instruct you to gradually increase your dose by 0.6 mg usually 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.
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Dose injected
Week 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. Your doctor will assess your treatment on a regular basis. Adolescents (≥ 12 years) For adolescents from the age of 12 to below 18 years old a similar dose escalation schedule as for adults should be applied (see above table for adults). The dose should be increased until 3.0 mg (maintenance dose) or maximum tolerated dose has been reached. Daily doses higher than 3.0 mg are not recommended. How and when to use Saxenda
- Before you use the pen for the first time, your doctor or nurse will show you how to use the pen.
- You can use Saxenda at any time of the day, with or without food and drink.
- Use Saxenda at about the same time each day – choose a time of the day that works best for you. Where to inject Saxenda is given as an injection under the skin (subcutaneous injection).
- The best places to inject are the front of your waist (abdomen), the front of your thighs or your upper arm.
- Change the place where you inject each day to reduce the risk of developing lumps.
- Do not inject into a vein or muscle. Detailed instructions for use are provided on the other side of this leaflet. People with diabetes Tell your doctor if you have diabetes. Your doctor may adjust the dose of your diabetes medicines to prevent you from getting low blood sugar.
- Do not mix Saxenda up with other medicines that you inject (e.g. insulins).
- Do not use Saxenda in combination with other medicines that contain GLP-1 receptor agonists (such as exenatide or lixisenatide). If you use more Saxenda than you should If you use more Saxenda than you should, talk to a doctor or go to a hospital straight away. Take the medicine pack with you. You may need medical treatment. The following effects may happen:
- feeling sick (nausea)
- being sick (vomiting)
- low blood sugar (hypoglycaemia). Please refer to 'Common side effects' for warning signs of low blood sugar. If you forget to use Saxenda
- If you forget a dose and remember it within 12 hours from when you usually use the dose, inject it as soon as you remember. 4
• •
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 a double dose or increase the dose on the following day to make up for the missed dose.
If you stop using Saxenda Do not stop using Saxenda without talking to your doctor. 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 Some severe allergic reactions (anaphylaxis) have been reported rarely in patients using Saxenda. You should see your doctor straight away if you get symptoms such as breathing problems, swelling of face and throat and a fast heartbeat. •
•
Inflamed pancreas (acute pancreatitis), which could cause severe pain in the stomach and back which does not go away. Cases of pancreatitis have been reported uncommonly in patients using Saxenda. This is a serious, potentially life-threatening condition. You should see a doctor immediately if you experience such symptoms Stop taking Saxenda and contact a doctor immediately if you notice any of the following serious
Possible side effects
: o 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 acute pancreatitis which is serious and potentially life-threatening.
Other side effects 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
- Problems affecting the stomach and intestines, such as indigestion (dyspepsia), inflammation in the lining of the stomach (gastritis), stomach discomfort, upper stomach pain, heartburn, feeling bloated, wind (flatulence), belching and dry mouth
- Feeling weak or tired
- Changed sense of taste
- Dizziness
- Difficulty sleeping (insomnia). This usually occurs during the first 3 months of treatment
- Gallstones
- Rash
- Injection site reactions (such as bruising, pain, irritation, itching and rash)
- Low blood sugar (hypoglycaemia). 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, being nervous, being anxious, confusion, difficulty concentrating and shaking (tremor). Your doctor will tell you how to treat low blood sugar and what to do if you notice these warning signs
- increase of pancreatic enzymes, such as lipase and amylase.
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Uncommon: may affect up to 1 in 100 people
- Loss of fluids (dehydration). This is more likely to occur at the start of treatment and may be due to being sick (vomiting), feeling sick (nausea) and diarrhoea
- Delay in the emptying of the stomach
- Inflamed gall bladder
- Allergic reactions including skin rash
- Feeling generally unwell
- Faster pulse. Rare: may affect up to 1 in 1 000 people
- Reduced kidney function
- Acute kidney failure. Signs may include reduction in urine volume, metallic taste in mouth and easily bruising. Not Known: frequency cannot be estimated from the available data
- Bowel obstruction. A severe form of constipation with additional symptoms such as stomach ache, bloating, vomiting etc.
- 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 Yellow Card Scheme Website: https://yellowcard.mhra.gov.uk/ 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
Saxenda
Keep this medicine out of the sight and reach of children. Do not use Saxenda 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 first use: Store in a refrigerator (2 °C – 8 °C). Do not freeze. Keep away from the freezer compartment. Once you start using the pen: You can keep the pen for 1 month when stored at a temperature below 30 °C or in a refrigerator (2 °C – 8 °C). Do not freeze. Keep away from the freezer compartment. When you are not using the pen, keep the pen cap on in order to protect it 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 Saxenda 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, hydrochloric acid and sodium hydroxide (for pH adjustment) and water for injections. 6
What Saxenda looks like and contents of the pack Saxenda is supplied as a clear and colourless or almost colourless solution for injection in a pre-filled pen. Each pen contains 3 ml solution and is able to deliver doses of 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg and 3.0 mg. Saxenda is available in pack sizes containing 1, 3 or 5 pens. Not all pack sizes may be marketed. Needles are not included. Marketing Authorisation Holder and Manufacturer Novo Nordisk A/S Novo Allé DK-2880 Bagsværd Denmark This leaflet was last revised in 08/2025 Saxenda®, NovoFine® and NovoTwist® are trademarks owned by Novo Nordisk A/S, Denmark © 2025 Novo Nordisk A/S
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Instructions on how to use Saxenda 6 mg/ml solution for injection in prefilled pen Please read these instructions carefully before using your Saxenda pre-filled pen. Do not use the pen without proper training from your doctor or nurse. Start by checking your pen to make sure that it contains Saxenda 6 mg/ml, then look at the illustrations below to get to know the different parts of your pen and needle. If you are blind or have poor eyesight and cannot read the dose counter on the pen, do not use this pen without help. Get help from a person with good eyesight who is trained to use the Saxenda pre-filled pen. Your pen is a pre-filled dial-a-dose pen. It contains 18 mg of liraglutide and delivers doses of 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg and 3.0 mg. Your pen is designed to be used with NovoFine or NovoTwist disposable needles up to a length of 8 mm and as thin as 32 G. Needles are not included in the pack. Important information Pay special attention to these notes as they are important for safe use of the pen.
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Saxenda® pre-filled pen and needle (example)
Pen cap
Outer needle cap
Inner needle cap
Needle
Paper tab Pen scale Pen window
Saxenda
Pen label
Dose counter
Dose pointer
Flow check symbol
Dose selector Dose button
1 Prepare your pen with a new needle •
•
A
Check the name and coloured label of your pen, to make sure that it contains Saxenda. This is especially important if you take more than one type of injectable medicine. Using the wrong medicine could be harmful to your health. Pull off the pen cap.
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•
Check that the solution in your pen is clear and colourless. Look through the pen window. If the solution looks cloudy, do not use the pen.
B
•
Take a new needle and tear off the paper tab.
C
•
Make sure to attach the needle correctly.
D
• •
Push the needle straight onto the pen. Turn until it is on tight.
•
The needle is covered by two caps. You must remove both caps. If you forget to remove both caps, you will not inject any solution.
•
Pull off the outer needle cap and keep it for later. You will need it after the injection, to safely remove the needle from the pen.
•
Pull off the inner needle cap and throw it away. If you try to put it back on, you may accidentally stick yourself with the needle. A drop of solution may appear at the needle tip. This is normal, but you must still check the flow if you use a new pen for the first time. Do not attach a new needle to your pen until you are ready to take your injection.
Always use a new needle for each injection. This may prevent blocked needles, contamination, infection and inaccurate dosing. Never use a bent or damaged needle. 2 Check the flow with each new pen • •
E
F
A
If your pen is already in use, go to step 3 'Select your dose'. Only check the flow before your first injection with each new pen. Turn the dose selector to the flow check symbol ( ) right past 0. Make sure the flow check symbol lines up with the pointer. Flow check symbol selected
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•
Hold the pen with the needle pointing up. Press and hold in the dose button until the dose counter returns to 0. The 0 must line up with the dose pointer. A drop of solution should appear at the needle tip.
B
A small drop may remain at the needle tip, but it will not be injected. If no drop appears, repeat step 2 'Check the flow with each new pen' up to 6 times. If there is still no drop, change the needle and repeat step 2 'Check the flow with each new pen' once more. If a drop still does not appear, dispose of the pen and use a new one. Always make sure that a drop appears at the needle tip before you use a new pen for the first time. This makes sure that the solution flows. If no drop appears, you will not inject any medicine, even though the dose counter may move. This may indicate a blocked or damaged needle. If you do not check the flow before your first injection with each new pen, you may not get the prescribed dose and the intended effect of Saxenda. 3 Select your dose •
A
Turn the dose selector until the dose counter shows your dose (0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg or 3.0 mg). If you select the wrong dose, you can turn the dose selector forward or backwards to the correct dose. The pen can dial up to a maximum of 3.0 mg.
Example 0.6 mg selected
The dose selector changes the dose. Only the dose counter and dose pointer will show how many mg you select per dose. You can select up to 3.0 mg per dose. When your pen contains less than 3.0 mg the dose counter stops before 3.0 is shown. The dose selector clicks differently when turned forward, backwards or past the number of mg left. Do not count the pen clicks. Always use the dose counter and the dose pointer to see how many mg you have selected before injecting this medicine. Do not count the pen clicks. Do not use the pen scale. It only shows approximately how much solution is left in your pen. Only doses of 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg or 3.0 mg must be selected with the dose selector. The selected dose must line up precisely with the dose pointer to ensure that you get a correct dose. How much solution is left? •
The pen scale shows you approximately how much solution is left in your pen.
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A
Approx. how much solution is left
•
To see precisely how much solution is left, use the dose counter: Turn the dose selector until the dose counter stops. If it shows 3.0, at least 3.0 mg are left in your pen. If the dose counter stops before 3.0 mg, there is not enough solution left for a full dose of 3.0 mg.
If you need more medicine than what is left in your pen Only if trained or advised by your doctor or nurse, you may split your dose between your current pen and a new pen. Use a calculator to plan the doses as instructed by your doctor or nurse. Be very careful to calculate correctly. If you are not sure how to split your dose using two pens, then select and inject the dose you need with a new pen. 4 Inject your dose
B
Example Dose counter stopped: 2.4 mg left
A
• •
Insert the needle into your skin as your doctor or nurse has shown you. Make sure you can see the dose counter. Do not cover it with your fingers. This could interrupt the injection.
•
Press and hold down the dose button. Watch as the dose counter returns to 0. The 0 must line up with the dose pointer. You may then hear or feel a click. Continue pressing the dose button while keeping the needle in your skin.
B
Count slowly to 6 while keeping the dose button pressed. If the needle is removed earlier, you may see a stream of solution coming from the needle tip. If so, the full dose will not be delivered.
C
Remove the needle from your skin. You can then release the dose button. If blood appears at the injection site, press lightly.
D
•
• •
•
You may see a drop of solution at the needle tip after injecting. This is normal and does not affect your dose. Always watch the dose counter to know how many mg you inject. Hold the dose button down until the dose counter shows 0. How to identify a blocked or damaged needle?
- If 0 does not appear in the dose counter after continuously pressing the dose button, you may have used a blocked or damaged needle.
- In this case – you have not received any medicine – even though the dose counter has moved from the original dose that you have set. How to handle a blocked needle? 12
Count slowly: 1-2-3-4-5-6
Change the needle as described in step 5 'After your injection' and repeat all steps starting with step 1 'Prepare your pen with a new needle'. Make sure you select the full dose you need. Never touch the dose counter when you inject. This can interrupt the injection. 5 After your injection • • • •
•
Always dispose of the needle after each injection to ensure convenient injection and prevent blocked needles. If the needle is blocked, you will not inject any medicine. Lead the needle tip into the outer needle cap on a flat surface without touching the needle or the outer needle cap. Once the needle is covered, carefully push the outer needle cap completely on. Unscrew the needle and dispose of it carefully, as instructed by your doctor, nurse, pharmacist or local authorities.
Put the pen cap on your pen after each use to protect the solution from light. When the pen is empty, throw it away without a needle on as instructed by your doctor, nurse, pharmacist or local authorities. Never try to put the inner needle cap back on the needle. You may stick yourself with the needle. Always remove the needle from your pen after each injection. This may prevent blocked needles, contamination, infection, leakage of solution and inaccurate dosing. Further important information
•
Always keep your pen and needles out of sight and reach of others, especially children.
- Never share your pen or your needles with other people.
- Caregivers must be very careful when handling used needles – to prevent needle injury and cross-infection.
- Change the place where you inject each day to reduce the risk of developing lumps. Caring for your pen • • • • • • •
Do not leave the pen in a car or other place where it can get too hot or too cold. Do not inject Saxenda which has been frozen. If you do that, you may not get the intended effect of this medicine. Do not expose your pen to dust, dirt or liquid. Do not wash, soak or lubricate your pen. It may be cleaned with a mild detergent on a moistened cloth. Do not drop your pen or knock it against hard surfaces. If you drop it or suspect a problem, attach a new needle and check the flow before you inject. Do not try to refill your pen. Once empty, it must be disposed of. Do not try to repair your pen or pull it apart.
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A
B
C
Annex IV Scientific conclusions and grounds for the variation to the terms of the marketing authorisation(s)
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Scientific conclusions Taking into account the PRAC Assessment Report on the PSUR(s) for liraglutide, the scientific conclusions of PRAC are as follows: In view of available data on cutaneous amyloidosis from literature, spontaneous reports including in some cases a close temporal relationship, a positive biopsy and in view of a plausible mechanism of action, the PRAC considers a causal relationship between liraglutide and cutaneous amyloidosis is at least a reasonable possibility. The PRAC concluded that the product information of products containing liraglutide should be amended accordingly. Having reviewed the PRAC recommendation, the CHMP agrees with the PRAC overall conclusions and grounds for recommendation. Grounds for the variation to the terms of the marketing authorisation(s) On the basis of the scientific conclusions for liraglutide the CHMP is of the opinion that the benefitrisk balance of the medicinal product(s) containing liraglutide is unchanged subject to the proposed changes to the product information The CHMP recommends that the terms of the marketing authorisation(s) should be varied.
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Frequently asked questions about Saxenda 6 mg/mL solution for injection in pre-filled pen
How do I take Saxenda 6 mg/mL solution for injection in pre-filled pen?
Saxenda 6 mg/mL solution for injection in pre-filled pen comes as injection containing 6mg/ml. 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 Saxenda 6 mg/mL solution for injection in pre-filled pen?
The active substance in Saxenda 6 mg/mL solution for injection in pre-filled pen is liraglutide.
Are there equivalent medicines to Saxenda 6 mg/mL solution for injection in pre-filled pen?
Medicines with the same active substance, strength and form include: Nevolat 6 mg/ml solution for injection in pre-filled pen, Plaobes 6 mg/ml solution for injection in pre-filled pen, Zegluxen 6 mg/ml solution for injection in pre-filled pen. They are interchangeable only if your prescriber or pharmacist says so.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Saxenda 6 mg/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 Saxenda 6 mg/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
Adults
Saxenda is indicated as an adjunct to a reduced-calorie diet and increased physical activity for weight management in adult patients with an initial Body Mass Index (BMI) of:
• ≥ 30 kg/m2 (obesity), or
• ≥ 27 kg/m2 to < 30 kg/m2 (overweight) in the presence of at least one weight-related comorbidity such as dysglycaemia (prediabetes or type 2 diabetes mellitus), hypertension, dyslipidaemia or obstructive sleep apnoea.
Treatment with Saxenda should be discontinued after 12 weeks on the 3.0 mg/day dose if patients have not lost at least 5% of their initial body weight.
Adolescents (≥ 12 years)
Saxenda can be used as an adjunct to a healthy nutrition and increased physical activity for weight management in adolescent patients from the age of 12 years and above with:
• obesity (BMI corresponding to ≥ 30 kg/m2 for adults by international cut-off points)* and
• body weight above 60 kg.
Treatment with Saxenda should be discontinued and re-evaluated if patients have not lost at least 4% of their BMI or BMI z score after 12 weeks on the 3.0 mg/day or maximum tolerated dose.
*IOTF BMI cut-off points for obesity by sex between 12-18 years (see table 1):
Table 1 IOTF BMI cut-off points for obesity by sex between 12-18 years
Age
(years)
BMI corresponding to 30 kg/m2 for adults by international cut-off points.
Males
Females
12
26.02
26.67
12.5
26.43
27.24
13
26.84
27.76
13.5
27.25
28.20
14
27.63
28.57
14.5
27.98
28.87
15
28.30
29.11
15.5
28.60
29.29
16
28.88
29.43
16.5
29.14
29.56
17
29.41
29.69
17.5
29.70
29.84
18
30.00
30.00
4.2. Posology and method of administration
Posology
Adults
The starting dose is 0.6 mg once daily. The dose should be increased to 3.0 mg once daily in increments of 0.6 mg with at least one-week intervals to improve gastro-intestinal tolerability (see table 2). If escalation to the next dose step is not tolerated for two consecutive weeks, consider discontinuing treatment. Daily doses higher than 3.0 mg are not recommended.
Table 2 Dose escalation schedule
Dose
Weeks
Dose escalation
4 weeks
0.6 mg
1
1.2 mg
1
1.8 mg
1
2.4 mg
1
Maintenance dose
3.0 mg
Adolescents (≥ 12 years)
For adolescents from the age of 12 to below 18 years old a similar dose escalation schedule as for adults should be applied (see table 2). The dose should be increased until 3.0 mg (maintenance dose) or maximum tolerated dose has been reached. Daily doses higher than 3.0 mg are not recommended.
Missed doses
If a dose is missed within 12 hours from when it is usually taken, the patient should take the dose as soon as possible. If there is less than 12 hours to the next dose, the patient should not take the missed dose and resume the once-daily regimen with the next scheduled dose. An extra dose or increase in dose should not be taken to make up for the missed dose.
Patients with type 2 diabetes mellitus
Saxenda should not be used in combination with another GLP-1 receptor agonist.
When initiating Saxenda, it should be considered to reduce the dose of concomitantly administered insulin or insulin secretagogues (such as sulfonylureas) to reduce the risk of hypoglycaemia. Blood glucose self-monitoring is necessary to adjust the dose of insulin or insulin-secretagogues (see section 4.4).
Special populations
Elderly (≥ 65 years old)
No dose adjustment is required based on age. Therapeutic experience in patients ≥ 75 years of age is limited and use in these patients is not recommended (see sections 4.4 and 5.2).
Renal impairment
No dose adjustment is required for patients with mild or moderate renal impairment (creatinine clearance ≥ 30 ml/min). Saxenda is not recommended for use in patients with severe renal impairment (creatinine clearance < 30 ml/min) including patients with end-stage renal disease (see sections 4.4, 4.8 and 5.2).
Hepatic impairment
No dose adjustment is recommended for patients with mild or moderate hepatic impairment. Saxenda is not recommended for use in patients with severe hepatic impairment and should be used cautiously in patients with mild or moderate hepatic impairment (see sections 4.4 and 5.2).
Paediatric population
No dose adjustment is required for adolescents from the age of 12 years and above.
The safety and efficacy of Saxenda in children below 12 years of age has not been established (see section 5.1).
Method of administration
Saxenda is for subcutaneous use only. It must not be administered intravenously or intramuscularly.
Saxenda is administered once daily at any time, independent of meals. It should be injected in the abdomen, thigh or upper arm. The injection site and timing can be changed without dose adjustment. However, it is preferable that Saxenda 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 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 liraglutide or to any of the excipients listed in section 6.1.
4.4. Special warnings and precautions for use
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.
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.
Patients with heart failure
There is no clinical 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.
Special populations
The safety and efficacy of liraglutide for weight management have not been established in patients:
– aged 75 years or more,
– treated with other products for weight management,
– with obesity secondary to endocrinological or eating disorders or to treatment with medicinal products that may cause weight gain,
– with severe renal impairment,
– with severe hepatic impairment.
Use in these patients is not recommended (see section 4.2).
As liraglutide for weight management was not investigated in subjects with mild or moderate hepatic impairment, it should be used with caution in these patients (see sections 4.2 and 5.2).
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.
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 section 4.8).
Cholelithiasis and cholecystitis
In clinical trials for weight management, a higher rate of cholelithiasis and cholecystitis was observed in patients treated with liraglutide than in patients on placebo. The fact that substantial weight loss can increase the risk of cholelithiasis and thereby cholecystitis only partially explained the higher rate with liraglutide. Cholelithiasis and cholecystitis may lead to hospitalisation and cholecystectomy. Patients should be informed of the characteristic symptoms of cholelithiasis and cholecystitis.
Thyroid disease
In clinical trials in type 2 diabetes, thyroid adverse events, such as goitre, have been reported in particular in patients with pre-existing thyroid disease. Liraglutide should therefore be used with caution in patients with thyroid disease.
Heart rate
An increase in heart rate was observed with liraglutide in clinical trials (see section 5.1). Heart rate should be monitored at regular intervals consistent with usual clinical practice. Patients should be informed of the symptoms of increased heart rate (palpitations or feelings of a racing heartbeat while at rest). For patients who experience a clinically relevant sustained increase in resting heart rate, treatment with liraglutide should be discontinued.
Dehydration
Signs and symptoms of dehydration, including renal impairment and acute renal failure, have been reported in patients treated with GLP-1 receptor agonists. 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.
Hypoglycaemia in patients with type 2 diabetes mellitus
Patients with type 2 diabetes mellitus receiving liraglutide in combination with insulin and/or sulfonylurea may have an increased risk of hypoglycaemia. The risk of hypoglycaemia may be lowered by a reduction in the dose of insulin and/or sulfonylurea.
Paediatric population
Episodes of clinically significant hypoglycaemia have been reported in adolescents (≥ 12 years) treated with liraglutide. Patients should be informed about the characteristic symptoms of hypoglycaemia and the appropriate actions.
Hyperglycaemia in insulin treated patients with diabetes mellitus
In patients with diabetes mellitus Saxenda must not be used as 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).
Excipients
Saxenda contains less than 1 mmol sodium (23 mg) per dose, therefore the medicinal product is essentially 'sodium-free'.
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 (CYP) 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.
Interaction studies have been performed with 1.8 mg liraglutide. The effect on rate of gastric emptying was equivalent between liraglutide 1.8 mg and 3.0 mg, (paracetamol AUC0-300 min). 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 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 International Normalised Ratio (INR) is recommended.
Paracetamol (Acetaminophen)
Liraglutide did not change the overall exposure of paracetamol following a single dose of 1 000 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 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 dose adjustment of digoxin 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 ethinylestradiol 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 ethinylestradiol or levonorgestrel. The contraceptive effect is therefore anticipated to be unaffected when co-administered with liraglutide.
Paediatric population
Interaction studies have only been performed in adults.
4.6. Fertility, pregnancy and lactation
Pregnancy
There are limited 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. 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, Saxenda 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 (see section 5.3).
4.7. Effects on ability to drive and use machines
Saxenda has no or negligible influence on the ability to drive and use machines. However, dizziness can be experienced mainly during the first 3 months of treatment with Saxenda. Driving or use of machines should be exercised with caution if dizziness occurs.
4.8. Undesirable effects
Summary of the safety profile:
Saxenda was evaluated for safety in 5 double-blind, placebo-controlled trials that enrolled 5 813 adult patients with overweight or obesity with at least one weight-related comorbidity. Overall, gastrointestinal reactions were the most frequently reported adverse reactions during treatment (67.9%) (see section 'Description of selected adverse reactions').
Tabulated list of adverse reactions
Table 3 lists adverse reactions reported in adults. Adverse reactions are listed by system organ class and frequency. Frequency categories 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) and not known (cannot be estimated from the available data). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Table 3 Adverse reactions reported in adults
MedDRA system organ classes
Very common
Common
Uncommon
Rare
Not known
Immune system disorders
Anaphylactic reaction
Metabolism and nutrition disorders
Hypoglycaemia*
Dehydration
Psychiatric disorders
Insomnia**
Nervous system disorders
Headache
Dizziness
Dysgeusia
Cardiac disorders
Tachycardia
Gastrointestinal disorders
Nausea
Vomiting
Diarrhoea
Constipation
Dry mouth
Dyspepsia
Gastritis
Gastro-oesophageal reflux disease
Abdominal pain upper
Flatulence
Eructation
Abdominal distension
Pancreatitis***
Delayed gastric emptying****
Intestinal obstruction†
Hepatobiliary disorders
Cholelithiasis***
Cholecystitis***
Skin and subcutaneous tissue disorders
Rash
Urticaria
Cutaneous amyloidosis
Renal and urinary disorders
Acute renal failure
Renal impairment
General disorders and administration site conditions
Injection site reactions
Asthenia
Fatigue
Malaise
Investigations
Increased lipase
Increased amylase
*Hypoglycaemia (based on self-reported symptoms by patients and not confirmed by blood glucose measurements) reported in patients without type 2 diabetes mellitus treated with Saxenda in combination with diet and exercise. Please see section 'Description of selected adverse reactions' for further information.
**Insomnia was mainly seen during the first 3 months of treatment.
***See section 4.4.
****From controlled phase 2, 3a and 3b clinical trials.
†ADR from post marketing sources.
Description of selected adverse reactions
Hypoglycaemia in patients without type 2 diabetes mellitus
In clinical trials in overweight or obese patients without type 2 diabetes mellitus treated with Saxenda in combination with diet and exercise, no severe hypoglycaemic events (requiring third party assistance) were reported. Symptoms of hypoglycaemic events were reported by 1.6% of patients treated with Saxenda and 1.1% of patients treated with placebo; however, these events were not confirmed by blood glucose measurements. The majority of events were mild.
Hypoglycaemia in patients with type 2 diabetes mellitus
In a clinical trial in overweight or obese patients with type 2 diabetes mellitus treated with Saxenda in combination with diet and exercise, severe hypoglycaemia (requiring third party assistance) was reported by 0.7% of patients treated with Saxenda and only in patients concomitantly treated with sulfonylurea. Also, in these patients documented symptomatic hypoglycaemia was reported by 43.6% of patients treated with Saxenda and in 27.3% of patients treated with placebo. Among patients not concomitantly treated with sulfonylurea, 15.7% of patients treated with Saxenda and 7.6% of patients treated with placebo reported documented symptomatic hypoglycaemic events (defined as plasma glucose ≤ 3.9 mmol/L accompanied by symptoms).
Hypoglycaemia in patients with type 2 diabetes mellitus treated with insulin
In a clinical trial in overweight or obese patients with type 2 diabetes mellitus treated with insulin and liraglutide 3.0 mg/day in combination with diet and exercise and up to 2 OADs, severe hypoglycaemia (requiring third party assistance) was reported by 1.5% of patients treated with liraglutide 3.0 mg/day. In this trial, documented symptomatic hypoglycaemia (defined as plasma glucose ≤ 3.9 mmol/L accompanied by symptoms) was reported by 47.2% of patients treated with liraglutide 3.0 mg/day and by 51.8% of patients treated with placebo. Among patients concomitantly treated with sulfonylurea, 60.9% of patients treated with liraglutide 3.0 mg/day and 60.0% of patients treated with placebo reported documented symptomatic hypoglycaemic events.
Gastrointestinal adverse reactions
Most episodes of gastrointestinal events were mild to moderate, transient and the majority did not lead to discontinuation of therapy. The reactions usually occurred during the first weeks of treatment and diminished within a few days or weeks on continued treatment.
Patients ≥ 65 years of age may experience more gastrointestinal effects when treated with Saxenda.
Patients with mild or moderate renal impairment (creatinine clearance ≥ 30 ml/min) may experience more gastrointestinal effects when treated with Saxenda.
Acute renal failure
In patients treated with GLP-1 receptor agonists, there have been reports of acute renal failure. A majority of the reported events occurred in patients who had experienced nausea, vomiting or diarrhoea leading to volume depletion (see section 4.4).
Allergic reactions
Few cases of anaphylactic reactions with symptoms such as hypotension, palpitations, dyspnoea and oedema have been reported with marketed use of liraglutide. Anaphylactic reactions may potentially be life threatening. If an anaphylactic reaction is suspected, liraglutide should be discontinued and treatment should not be restarted (see section 4.3).
Injection site reactions
Injection site reactions have been reported in patients treated with Saxenda. These reactions were usually mild and transitory and the majority disappeared during continued treatment.
Tachycardia
In clinical trials, tachycardia was reported in 0.6% of patients treated with Saxenda and in 0.1% of patients treated with placebo. The majority of events were mild or moderate. Events were isolated and the majority resolved during continued treatment with Saxenda.
Cutaneous amyloidosis
Cutaneous amyloidosis may occur at the injection site (see section 4.2).
Paediatric population
In a clinical trial conducted in adolescents of 12 years to less than 18 years with obesity, 125 patients were exposed to Saxenda for 56 weeks.
Overall, the frequency, type and severity of adverse reactions in the adolescents with obesity were comparable to that observed in the adult population. Vomiting occurred with a 2-fold higher frequency in adolescents compared to adults.
The percentage of patients reporting at least one episode of clinically significant hypoglycaemia was higher with liraglutide (1.6%) compared to placebo (0.8%). No severe hypoglycaemic episodes occurred in the trial.
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 Yellow Card Scheme
Website: https://yellowcard.mhra.gov.uk/ or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9. Overdose
From clinical trials and post-marketing use of liraglutide overdoses have been reported up to 72 mg (24 times the recommended dose for weight management). Events reported included severe nausea, severe vomiting 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.
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