SAXENDA 6 mg/ml injectable solution in a pre-filled pen

Introduction

Package Leaflet: Information for the Patient

Saxenda 6mg/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.

• 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.

Contents of the pack

1. What is Saxenda and what is it used for
2. What you need to know before you use Saxenda
3. How to use Saxenda
4. Possible side effects
5. Storing Saxenda
6. Package contents and further information

1. What is Saxenda and what is it used for

What is Saxenda

Saxenda is a weight-loss medicine that contains the active substance liraglutide. It is similar to a naturally occurring hormone called glucagon-like peptide-1 (GLP-1) that is released from the intestine after eating. Saxenda works on the brain's appetite control centers, making you feel fuller and less hungry. This can help you eat less and reduce your body weight.

What Saxenda is used for

Saxenda is used to help with weight loss in combination with a reduced-calorie diet and increased physical activity in adults aged 18 and over with:

• a Body Mass Index (BMI) of 30 kg/m2 or more (obese) or
• a BMI of 27 kg/m2 to less than 30 kg/m2 (overweight) and weight-related health conditions such as type 2 diabetes, high blood pressure, abnormal blood fats, or breathing difficulties during sleep (called obstructive sleep apnoea).

BMI is a measure of body weight relative to height.

You should only continue to use Saxenda if you have lost at least 5% of your initial body weight after 12 weeks of treatment with a daily dose of 3.0 mg (see section 3). Consult your doctor before continuing.

Saxenda can be used in combination with a healthy diet and increased physical activity to help control weight in adolescents from 12 years of age and older with:

• obesity (diagnosed by your doctor)
• body weight over 60 kg

You should only continue to use Saxenda if you have lost at least 4% of your BMI after 12 weeks of treatment with a dose of 3.0 mg/day or the maximum tolerated dose (see section 3). Consult your doctor before continuing.

Saxenda is indicated in combination with a healthy diet and increased physical activity to help control weight in patients from 6 to less than 12 years of age with

• obesity (diagnosed by your doctor)
• body weight ≥45 kg

You should only continue to use Saxenda if you have lost at least 4% of your BMI after 12 weeks of treatment with a dose of 3.0 mg/day or the maximum tolerated dose (see section 3). Consult your doctor before continuing.

Diet and exercise

Your doctor will put you on a diet and indicate an exercise program for you to follow while you are being treated with Saxenda.

2. What you need to know before you use 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

Consult your doctor, pharmacist, or nurse before starting treatment with Saxenda.

The use of Saxenda is not recommended if you have severe heart failure.

There is limited experience with this medicine in patients aged 75 and over. It is not recommended if you are 75 or older.

There is limited experience with this medicine in patients with kidney problems. If you have kidney disease or are on dialysis, consult your doctor.

There is limited 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 intestinal problem that causes delayed emptying of the stomach (called gastroparesis), or if you have an inflammatory bowel disease.

If you know you are going to have surgery that requires you to be under anesthesia (put to sleep), inform your doctor that you are taking Saxenda.

People with diabetes

If you are diabetic, do not use Saxenda as a substitute for insulin.

Pancreatitis

Consult your doctor if you have or have had a pancreatic disease.

Gallbladder inflammation and gallstones

If you lose a lot of weight, you are at risk of developing gallstones and consequently gallbladder inflammation. Stop using Saxenda and contact your doctor immediately if you experience severe pain in the upper abdomen, usually worse on the right side, below the ribs. The pain can radiate to the back or right shoulder. See section 4.

Thyroid disease

Consult your doctor if you have thyroid disease, including thyroid nodules and thyroid gland enlargement.

Heart rate

Consult your doctor if you have palpitations (you are aware of your heartbeat) or if you have a feeling of rapid heartbeat at rest during treatment with Saxenda.

Fluid loss and dehydration

When starting treatment with Saxenda, you may lose fluids or become dehydrated. This may be due to the occurrence of nausea, vomiting, and diarrhea. It is essential to avoid dehydration by drinking plenty of fluids. If you have any doubts or questions, consult your doctor, pharmacist, or nurse. See section 4.

Children

The safety and efficacy of Saxenda have not been studied in children under 6 years of age.

Other medicines and Saxenda

Inform your doctor, pharmacist, or nurse if you are using, have recently used, or might use any other medicines.

In particular, inform your doctor, pharmacist, or nurse if:

• you are taking diabetes medicines called sulfonylureas (such as glimepiride or glibenclamide) or if you are taking insulin. Your blood sugar level may drop (hypoglycemia) if you use these medicines with Saxenda. Your doctor may adjust the dose of your diabetes medicine to prevent episodes of hypoglycemia. See section 4 for symptoms of low blood sugar. If you adjust your insulin dose, your doctor may recommend checking your blood sugar level more frequently.
• you are taking warfarin or other oral medicines that reduce blood clotting (anticoagulants). More frequent blood tests may be needed to determine your blood's clotting ability.

Pregnancy and breastfeeding

Do not use Saxenda if you are pregnant, think you may be pregnant, or plan to become pregnant, as it is not known whether Saxenda can affect the fetus.

If you are using Saxenda, you should avoid breastfeeding, as it is not known whether Saxenda is excreted in breast milk.

Driving and using machines

Saxenda is unlikely to affect your ability to drive or use machines.

Some patients may feel dizzy when taking Saxenda, mainly during the first 3 months of treatment (see section "Possible side effects"). If you feel dizzy, be very careful when driving or using machines. If you need more information, consult your doctor.

Important information about some of the ingredients of Saxenda

This medicine contains less than 1 mmol of sodium (23 mg) per dose; this is essentially "sodium-free".

3. How to use Saxenda

Follow the instructions for administration of this medicine exactly as told by your doctor. If you are unsure, consult your doctor, pharmacist, or nurse.

Your doctor will put you on a diet and indicate an exercise program for you to follow while you are being treated with Saxenda.

How much to inject

Adults

Treatment will start with a low dose that will be gradually increased over the first 5 weeks of treatment.

• When you start using Saxenda, the initial dose is 0.6 mg once a day, for at least one week.
• Your doctor will tell you to gradually increase the dose, usually by 0.6 mg 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. You will usually be told to follow the following table.

Once you have reached the recommended dose of 3.0 mg in week 5 of treatment, continue to use this dose until the end of the treatment period. Do not increase the dose further.

Your doctor will assess your treatment periodically.

Children and adolescents (6 to 18 years)

For children and adolescents from 6 years to less than 18 years, the dose should be increased gradually as in adults (see the table for adults above). The dose should be increased to 3.0 mg (maintenance dose) or to the maximum tolerated dose. Daily doses above 3.0 mg are not recommended.

How and when to use Saxenda

• Before using the pen for the first time, your doctor or nurse will show you how to use it.
• You can use Saxenda at any time of day, with or without food and drink.
• Use Saxenda at approximately the same time every day: choose a time that suits you best.

Where to inject

Saxenda is given as an injection under the skin (subcutaneous injection).

• The best injection sites are the abdomen, the front of the thigh, or the upper arm.
• Change the injection site each day to reduce the risk of developing lumps under the skin.
• Do not inject into a vein or muscle.

On the other side of this leaflet, you will find detailed instructions on how to use the pen.

People with diabetes

Inform your doctor if you have diabetes. Your doctor may adjust the dose of your diabetes medicine to prevent episodes of hypoglycemia.

• Do not mix Saxenda with other injectable medicines (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 immediately. Take the medicine pack with you. You may need medical treatment. The following effects may happen:

• nausea
• vomiting
• low blood sugar (hypoglycemia). See "Common side effects" for symptoms of low blood sugar.

If you forget to use Saxenda

• If you forget a dose and remember within 12 hours of when you normally inject 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 the next dose the following day at the usual time.
• Do not use a double dose or increase the dose the next day to make up for the missed dose.

If you stop using Saxenda

Do not stop using Saxenda without consulting 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

Rarely, serious allergic reactions (anaphylaxis) have been reported in patients using Saxenda. See a doctor immediately if you have symptoms such as breathing difficulties, swelling of the face and throat, and palpitations.

Very rarely, cases of pancreatitis (inflammation of the pancreas) have been reported in patients using Saxenda. Pancreatitis is a serious and potentially life-threatening disease.

Stop using Saxenda and contact your doctor immediately if you notice any of the following serious side effects:

• Severe and persistent abdominal pain (stomach area) that may radiate to the back, as well as nausea and vomiting, as it may be a sign of pancreatitis.

Other side effects

Very common:may affect more than 1 in 10 people

• nausea, vomiting, diarrhea, constipation, headache; usually disappear after a few days or weeks.

Common:may affect up to 1 in 10 people

• stomach and intestinal problems such as indigestion (dyspepsia), inflammation of the stomach lining (gastritis), stomach discomfort, pain in the upper stomach, heartburn, feeling bloated, gas (flatulence), belching, and dry mouth
• feeling weak or tired
• changes in taste
• dizziness
• difficulty sleeping (insomnia). Usually occurs during the first 3 months of treatment
• gallstones
• rash
• reactions at the injection site (such as bruising, pain, irritation, itching, and rash)
• low blood sugar (hypoglycemia). Symptoms of low blood sugar can appear suddenly and include: cold sweat, cool pale skin, headache, palpitations, feeling unwell, excessive hunger, vision disturbances, drowsiness, feeling weak, nervousness, anxiety, confusion, difficulty concentrating, and shakiness. Your doctor will tell you how to treat low blood sugar and what to do if you notice these symptoms
• increased pancreatic enzymes, such as lipase and amylase.

Uncommon:may affect up to 1 in 100 people

• fluid loss (dehydration). This is more likely to occur at the start of treatment and may be due to vomiting, nausea, and diarrhea
• delayed emptying of the stomach
• inflamed gallbladder
• allergic reactions including skin rashes
• feeling unwell
• rapid heartbeat.

Rare:may affect up to 1 in 1,000 people

• reduced kidney function
• acute kidney failure. Symptoms may include reduced urine output, metallic taste in the mouth, and easy bruising (bleeding).

Frequency not known:cannot be estimated from the available data

• intestinal obstruction. A severe form of constipation with additional symptoms such as stomach pain, bloating, vomiting, etc.
• Lumps under the skin can occur due to the accumulation of a protein called amyloid (cutaneous amyloidosis; the frequency of this is not known).

Reporting of side effects

If you experience 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 Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing 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 label of the pen and on the carton after "EXP". The expiry date is the last day of the month shown.

Before first use:

Store in a refrigerator (2°C to 8°C). Do not freeze. Keep away from the freezer.

When you start using the pen:

You can store the pen for a month if you keep it below 30°C or in a refrigerator (2°C to 8°C). Do not freeze. Keep away from the freezer.

When not in use, store the pen with the cap on to protect it from light.

Do not use this medicine if you notice that the solution is not clear and colorless or almost colorless.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Container Contents and Additional Information

Composition of Saxenda

• The active substance is liraglutide. 1 ml of injectable solution contains 6 mg of liraglutide. A pre-filled pen contains 18 mg of liraglutide.
• The other components are disodium phosphate dihydrate, propylene glycol, phenol, hydrochloric acid, and sodium hydroxide (for pH adjustment) and water for injectable preparations.

Appearance and Container Contents of the Product

Saxenda is supplied as a clear and colorless or almost colorless injectable solution in a pre-filled pen. Each pen contains 3 ml of solution and can deliver doses of 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg, and 3.0 mg.

Saxenda is available in packs of 1, 3, or 5 pens. Not all pack sizes may be marketed.

Needles are not included.

Marketing Authorization Holder

Novo Nordisk A/S

Novo Alle 1

DK-2880 Bagsværd

Denmark

Manufacturer

Novo Nordisk A/S

Novo Alle 1

DK-2880 Bagsværd

Denmark

Novo Nordisk Production SAS

45 Avenue D Orleans

28000 Chartres

France

Date of Last Revision of this Leaflet:

Other Sources of Information

Detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu.

Instructions for Use of Saxenda 6 mg/ml Solution for Injection in Pre-filled Pen

Read these Instructions Carefullybefore using your pre-filled Saxenda pen.

Do not use the Pen without Proper Trainingfrom your doctor or nurse.

Start by checking the pen to make sure it contains Saxenda 6 mg/mland then look at the illustrations to familiarize yourself with the different parts of the pen and needle.

If you are Blind or have Low Vision and cannot Read the Dose Counter on the Pen, do not use this Pen without Help.Ask for help from a person who can see well and is trained in the use of the pre-filled Saxenda pen.

Your pen is a pre-filled dosing 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. The pen is designed to be used with NovoFine or NovoTwist disposable needles up to 8 mm in length and as thin as 32 G.

Needles are not included in the pack.

Important Information

Pay special attention to these notes because they are important for the safe use of the pen.

1 Preparing the Pen with a New Needle

• Check the Name and Color of the Labelon your pen to make sure it contains Saxenda. This is especially important if you use more than one type of injectable medication. Using the wrong medication can be harmful to your health.
• Remove the Cap from the Pen.

• Check that the Solution in the Pen has a Clear and Colorless Appearance.Look through the pen window. If the solution appears cloudy, do not use the pen.

• Take a New Needleand remove the paper tab.

Make sure to Insert the Needle Correctly.

• Place the Needle Straight onto the Pen.
• Screw it on until it is Tight.

The Needle is Covered by Two Caps. You must Remove both Caps.If you forget to remove both caps, you may notinject any solution.

• Remove the Outer Cap from the Needle and Set it aside.You will need it later to safely remove the needle from the pen.

• Remove the Inner Cap from the Needle and Dispose of it.If you try to put it back on, you may accidentally prick yourself with the needle.

A drop of solution may appear at the tip of the needle. This is normal, but you must still check the flow if you are using a new pen for the first time.

Do not Put a New Needle on the Penuntil you are ready to take your injection.

Always use a New Needle for each Injection.

This way, you can avoid clogged needles, contamination, infection, and inaccurate dosing.

• Never use Bent or Damaged Needles.

2 Checking the Flow with each New Pen

• If your pen is already in use, go to step 3 “Selecting the Dose”. Only check the flow before the first injection with each new pen.
• Turn the dose selector to the flow check symbol ()just past 0. Make sure the flow check symbol is aligned with the dose marker.

• Hold the pen with the needle pointing upwards.

Press and Hold the Dose Buttonuntil the dose counter returns to 0. The 0 must be aligned with the dose marker.

A drop of solution should appear at the tip of the needle.

A small drop may remain at the tip of the needle, but it will not be injected.

If no Drop appears, repeat step 2 “Checking the flow with each new pen” up to 6 times. If still no drop appears, change the needle and repeat step 2 “Checking the flow with each new pen” one more time.

If, despite this, no Drop appears,discard the pen and use a new one.

Always make sure a Drop appearsat the tip of the needle before using a new pen for the first time. This ensures that the solution flows.

If no drop appears, nomedication will be injected, even though the dose counter moves. This may indicate that the needle is blocked or damaged.

If you do not check the flow before the first injection with each new pen, you may not receive the prescribed dose, and Saxenda may not have the intended effect.

3 Selecting the Dose

• Turn the Dose Selector until the Dose appears in the Dose Counter (0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg, or 3.0 mg).

If you have selected the wrong dose, you can turn the dose selector forward or backward to select the correct dose.

The pen can select up to a maximum of 3.0 mg.

The dose selector changes the dose. Only the dose counter and dose marker show how many mg you have selected for each administration.

You can select up to 3.0 mg per dose. When the pen contains less than 3.0 mg, the dose counter stops before 3.0 mg appears.

The dose selector clicks differently when turned forward, backward, or when passing the number of mg remaining. Do not count the pen's clicks.

Always use the Dose Counter and Dose Marker to see how many mg you have selected.

Do not count the pen's clicks.

Do not use the pen's scale, as it only shows the approximate amount of solution remaining in the pen.

With the Dose Selector, only select doses of 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg, or 3.0 mg.The selected dose must be exactly aligned with the dose marker to ensure that the injected dose is correct.

How much Solution is Left?

• The pen's scaleshows the approximateamount of solution left in the pen.

• To know exactly how much Solution is Left,use the dose counter:

Turn the dose selector until the dose counter stops.

If it shows 3.0, it means there are at least 3.0 mgleft in the pen. If the dose counter stops before 3.0 mg, it means there is not enough solution for a full 3.0 mg dose.

If you need more Medication than is Left in the Pen

If your doctor or nurse advises you to do so and has taught you how, you can split the dose between the pen in use and a new one. Use a calculator to plan the dose as your doctor or nurse has instructed.

Be very Careful to Calculate Correctly.

If you are unsure how to split the dose using two pens, select and inject the dose you need with a new pen.

4 Injecting the Dose

• Insert the Needle under the Skinas your doctor or nurse has taught you.
• Make sure you can see the Dose Counter.Do not cover it with your fingers. This could interrupt the injection.

• Press and Hold the Dose Button. Watch the Dose Counter return to 0.The 0 must be aligned with the dose marker. You may hear or feel a click.
• Continue to Press the Dose Button while keeping the Needle in your Skin.

• Count Slowly to 6 while keeping the Dose Button Pressed.
• If you remove the needle too soon, you may see solution leaking from the tip of the needle. This means you have not received the full dose.

• Remove the Needle from the Skin.You can release the dose button.

If blood appears at the injection site, press lightly.

A drop of solution may appear at the tip of the needle after injection. This is normal and does not affect the dose.

Always check the Dose Counter to know how many mg you are Injecting.Press and hold the dose button until the dose counter shows 0.

How to Tell if the Needle is Blocked or Damaged?

• If the 0 does not appear on the dose counter after continuously pressing the dose button, the needle may be blocked or damaged.
• In this case, you will nothave received anymedication, even though the dose counter has moved from the original dose you selected.

What to do if the Needle is Blocked?

Change the needle as described in step 5 “After the Injection” and repeat all steps from step 1 “Preparing the Pen with a New Needle”. Make sure to select the full dose you need.

Never Touch the Dose Counter while Injecting.This can interrupt the injection.

5 After the Injection

• Always Dispose of the Needle after each Injectionto ensure that injections are administered correctly and to avoid clogged needles. If the needle is clogged, nomedication will be injected.
• Place the Tip of the Needle into its Outer Cap,lying on a flat surface, without touching the needle or the outer cap.

• When the Needle is Covered, Carefully Press the Outer Cap Fully On.
• Unscrew the Needleand dispose of it carefully, following the instructions of your doctor, nurse, pharmacist, or local authorities.

• Put the Cap Back onthe pen after each use to protect the solution from light.

When the pen is empty, discard it withoutthe needle attached, following the instructions of your doctor, nurse, pharmacist, or local authorities.

Never try to Put the Inner Cap of the Needle Back On.You could prick yourself with it.

Always Remove the Needle from the Pen after each Injection.

This way, you can avoid clogged needles, contamination, infection, solution loss, and inaccurate dosing.

More Important Information

• Always keep the Pen and Needles out of Sight and Reach of other People, especially children.
• Never Sharethe pen or needles with other people.
• People caring for patients should be very Careful when Handling Used Needlesto avoid accidental pricks and infections.
• Change the injection site each day to reduce the risk of developing lumps under the skin.

Care of the Pen

• Do not Leave the Pen in the Caror any other place where it can become too hot or too cold.
• Do not Inject Saxenda if it has been Frozen.If you do, you will not achieve the intended effect of this medication.
• Do not Expose the Pen to Dust, Dirt, or Liquids.
• Do not Wash, Soak, or Lubricate the Pen. It can be Cleanedwith a damp cloth and a mild detergent.
• Make sure the Pen does not Fallor hit hard surfaces. If you drop the pen or suspect it may have a problem, put a new needle on and check the flow before injecting.
• Do not try to Refill the Pen.Once empty, it must be discarded.
• Do not try to Repair the Penor disassemble it.