Patient leaflet - Saxenda
B. PACKAGE LEAFLET
Package leaflet: Information for the patient
Saxenda 6 mg/ml solution for injection in pre-filled pen liraglutide
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
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– Keep this leaflet. You may need to read it again.
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– If you have any further questions, ask your doctor, pharmacist or nurse.
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– This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,
even if their signs of illness are the same as yours.
- If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet
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1. What Saxenda is and what it is used for
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2. What you need to know before you use Saxenda
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3. How to use Saxenda
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4. Possible side effects
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5. How to store Saxenda
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6. Contents of the pack and other information
1. What Saxenda is and what it is used 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.
2. What you need to know before you use Saxenda
Do not use Saxenda
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– 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 Saxenda.
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.
People with diabetes
If you have diabetes, do not use Saxenda as a replacement for insulin.
Inflammation of the pancreas
Talk to your doctor if you have or have had a disease of the pancreas.
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.
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, that it is to say essentially ‘sodium-free’.
3. How to use 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.
- You 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.
| Week | Dose injected |
| 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.
- 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.
- 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.
Cases of inflammation of the pancreas (pancreatitis) have been reported uncommonly in patients using Saxenda. Pancreatitis is a serious, potentially life-threatening medical condition.
Stop taking Saxenda and contact a doctor immediately if you notice any of the following serious side effects:
- Severe and persistent pain in the abdomen (stomach area) which might reach through to your back, as well as nausea and vomiting, as it could be a sign of an inflamed pancreas (pancreatitis).
Other side effects
Very common: may affect more than 1 in 10 people
- 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
- 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.
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.
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 national reporting system listed in By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store 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 to 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 to 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
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– The active substance is liraglutide. 1 ml solution for injection contains 6 mg liraglutide. One pre-filled pen contains 18 mg liraglutide.
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– The other ingredients are disodium phosphate dihydrate, propylene glycol, phenol, hydrochloric acid and sodium hydroxide (for pH adjustment) and water for injections.
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
Other sources of information
Detailed information on this medicine is available on the European Medicines Agency website:
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.
Y our 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.
A Important information
Pay special attention to these notes as they are important for safe use of the pen.
Saxenda pre-filled pen and needle (example)
Pen cap
Pen scale
Pen window
Pen label
Dose pointer
Dose selector
Dose button
Needle
Paper tab
Outer needle cap
Inner needle cap
Dose counter
Flow check symbol
1 Prepare your pen with a new needle
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.
through the pen window. If the solution looks cloudy, do not use the pen. | o | ||
| Q X~ | ||
| B \\\ | ||
after the injection, to safely remove the needle from the pen. | IE | ||
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. A Always use a new needle for each injection. This may prevent blocked needles, contamination, infection and inaccurate dosing. A Never use a bent or damaged needle. | 'O | ||
| 2 Check the flow
pen is already in use, go to step 3 ‘Select your dose’.
symbol (*'"“). | O J\ £ _ Flow check symbol selected | ||
| | 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. | o | 2™ ™ |
| 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’ up to 6 times. If there is still no drop, change the needle and repeat step 2 ‘Check the flow’ once | |||
| more. If a drop still does not appear, dispose of the pen and use a new one. | |||
| A | 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 | o | ||
| | 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. The dose selector changes the dose. Only the dose counter and dose pointer will show how many mg you select per dose. | i 1 Example < 0.6 mg selected | |
| 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. | |||
| A | 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. | 'Dl | ■ Approx. I how much ■LU solution is left |
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. A 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. | » Al Example Dose counter 2.4 stopped: 2.4 mg left | ||||
| 4 Inject your dose
fingers. This could interrupt the injection. | 'o | ||||
The 0 must line up with the dose pointer. You may then hear or feel a click. | 0 cn 0' Jj _ | ||||
and count slowly to 6.
from the needle tip. If so, the full dose will not be delivered. | FC Count slowly: _ (f-2–3–4–5465 | ||||
| k lCJ | |||||
If blood appears at the injection site, press lightly. Do not rub the area. You may see a drop of solution at the needle tip after injecting. This is normal and does not affect your dose. A 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?
How to handle a blocked needle? | ° n t [J | ||||
| 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
touching the needle or the outer needle cap. | 0 + | ||
completely on.
| «B\ | ||
light. Always dispose the needle after each injection to ensure convenient injections and prevent blocked needles. If the needle is blocked, you will not inject any medicine. When the pen is empty, throw it away without a needle on as instructed by your doctor, nurse, pharmacist or local authorities. A Never try to put the inner needle cap back on the needle. You may stick yourself with the needle. A Always remove the needle from your pen after each injection. This may prevent blocked needles, contamination, infection, leakage of solution and inaccurate dosing. | 0 / lx s | ||
| A Further important information
especially children.
prevent needle injury and cross-infection. | |||
| Caring for your pen
too cold.
not get the intended effect of this medicine.
mild detergent on a moistened cloth.
suspect a problem, attach a new needle and check the flow before you inject.
|
Annex IV
Scientific conclusions and grounds for the variation to the terms of the marketing authorisation(s)
Scientific conclusions
Taking into account the PRAC Assessment Report on the PSUR(s) for liraglutide, the scientific conclusions of CHMP are as follows:
In view of available data on headache from clinical trial, the literature, spontaneous reports including in 12 cases a close temporal relationship, a positive de-challenge and in at least one case a re-challenge and in view of a plausible mechanism of action, the PRAC considers a causal relationship between liraglutide in weight management and headache is at least a reasonable possibility. The PRAC concluded that the product information of products containing liraglutide for weight management should be amended accordingly.
Update of section 4.8 of the SmPC to add the adverse reaction ‘headache’ with a frequency very common.
The Package leaflet is to be updated accordingly.
The CHMP agrees with the scientific conclusions made by the PRAC.
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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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.
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