Saxenda 6 mg/mL solution for injection in pre-filled pen

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• 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.

1. What Saxenda is and what it is used for
2. What you need to know before you use Saxenda
3. How to use Saxenda
4. Possible side effects
5. How to store Saxenda
6. Contents of the pack and other information

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.

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.

Your doctor will start you on a diet and exercise programme. Stay on this programme while you are using Saxenda.

• if you are allergic to liraglutide or any of the other ingredients of this medicine (listed in section 6).

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.

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.

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.

The safety and efficacy of Saxenda in children below 12 years of age has not been studied.

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.

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.

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.

This medicine contains less than 1 mmol sodium (23 mg) per dose, i.e., essentially ‘sodium-free’.

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.

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.

• 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.

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.

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, 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 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.

Do not stop using Saxenda without talking to your doctor.

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).

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.

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).

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.

• 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.

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.

• 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.

• 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.

• Take a new needle and tear off the paper tab.

• Make sure to attach the needle correctly.
• 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.

• 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.

• 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.

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.

• 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.

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.

• 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.

• 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.

• 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.

• Remove the needle from your skin. You can then release the dose button.

If blood appears at the injection site, press lightly.

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?

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.

• 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.