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

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Saxenda 6 mg/ml injection solution in a pre-filled pen

liraglutide

Read the entire leaflet carefully before you start using this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse reactions, consult your doctor, pharmacist, or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents

1. What Saxenda is and what it is used for
2. What you need to know before using Saxenda
3. How to use Saxenda
4. Possible side effects
5. How to store Saxenda
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 containing the active substance liraglutide. It is similar to a naturally occurring hormone called glucagon-like peptide-1 (GLP-1), which is released in the intestine after eating. Saxenda acts on receptors in the brain that control appetite, 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 for weight loss in combination with a proper diet and exercise in adults over 18 years of age who have:

• a BMI of 30 kg/m² or higher (obesity), or
• a BMI of 27 kg/m² up to less than 30 kg/m² (overweight) and weight-related health problems (such as diabetes, high blood pressure, abnormal blood fat levels, or sleep-related breathing disorders known as "obstructive sleep apnoea").

BMI (body mass index) is a measure of weight relative to height.

You should only continue using 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 healthy nutrition and increased physical activity for weight management in adolescents aged 12 years and older who have:

• obesity (diagnosed by their 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 of treatment with a dose of 3.0 mg/day or the highest tolerated dose (see section 3). Consult your doctor before continuing.

Saxenda is indicated in combination with healthy nutrition and increased physical activity for weight management in patients aged 6 to less than 12 years with:

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

You should only continue using 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 highest tolerated dose (see section 3). Consult your doctor before continuing.

Diet and exercise

Your doctor will prescribe a diet and recommend an exercise program, which you must follow while being treated with Saxenda.

2. What you need to know before using Saxenda

Do not use Saxenda

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

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting to use 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 years and older. It is not recommended for patients aged 75 years 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 disease, consult your doctor.

This medicine is not recommended if you have a severe stomach or intestinal problem causing delayed stomach emptying (called gastroparesis), or if you have inflammatory bowel disease.

If you know you are going to undergo surgery under anesthesia (a state of sleep), inform your doctor that you are taking Saxenda.

Patients with diabetes

If you have diabetes, 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 weight rapidly, you may be at risk of developing gallstones and, as a result, 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, under the ribs. The pain may radiate to your back or right shoulder. See section 4.

Thyroid disease

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

Heart rate

Consult your doctor if you experience palpitations (awareness of your heartbeat) or a sensation of increased pulse rate 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 nausea, vomiting, and diarrhea. It is important to prevent 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 taking, have recently taken, or might need to take any other medicines.

Specifically, inform your doctor, pharmacist, or nurse if:

• you are taking diabetes medications called "sulfonylureas" (such as glimepiride or glyburide) or if you are receiving insulin. Your blood sugar level may drop (hypoglycemia) if you use these medicines with Saxenda. Your doctor may adjust the dose of your diabetes medication to prevent episodes of hypoglycemia. See section 4 for symptoms indicating low blood sugar. If you adjust your insulin dose, your doctor may recommend more frequent monitoring of your blood sugar levels.
• you take warfarin or other oral anticoagulant medicines that reduce blood clotting. More frequent blood tests may be needed to monitor your blood's clotting ability.

Pregnancy and breastfeeding

Do not use Saxenda if you are pregnant, think you might be pregnant, or are planning to become pregnant, as it is unknown whether Saxenda may affect the fetus.

If you are using Saxenda, you should avoid breastfeeding, as it is unknown whether Saxenda is excreted in human breast milk.

Driving and using machines

It is unlikely that Saxenda will affect your ability to drive or operate machinery.

Some patients may experience dizziness when taking Saxenda, particularly during the first 3 months of treatment (see section "Possible side effects"). If you feel dizzy, exercise caution when driving or operating machinery. If you need further information, consult your doctor.

Important information about certain ingredients of Saxenda

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

3. How to use Saxenda

Follow exactly the administration instructions for this medicine given by your doctor. If in doubt, consult your doctor, pharmacist, or nurse again.

Your doctor will put you on a diet and recommend an exercise program, which you must follow while receiving Saxenda treatment.

How much to inject

Adults

Treatment will start at a low dose, which will be gradually increased over the first five weeks of treatment.

• When you start using Saxenda, the initial dose is 0.6 mg once daily for at least one week.
• Your doctor will instruct you to gradually increase the dose, usually by 0.6 mg each week, until reaching the recommended dose of 3.0 mg once daily.

Your doctor will tell you how much Saxenda to use each week. Typically, you will be instructed to follow the following table.

Week	Injected dose
Week 1	0.6 mg once daily
Week 2	1.2 mg once daily
Week 3	1.8 mg once daily
Week 4	2.4 mg once daily
Week 5 onwards	3.0 mg once daily

Once the recommended dose of 3.0 mg has been reached in week 5 of treatment, continue using this dose until the end of the treatment period. Do not increase the dose further.

Your doctor will periodically evaluate your treatment.

Children and adolescents (6 to 18 years)

For children and adolescents from 6 years up to but less than 18 years, a gradual dose escalation should be followed as in adults (see the table above for adults). The dose should be increased up to 3.0 mg (maintenance dose) or until the maximum tolerated dose is reached. Daily doses higher than 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 may use Saxenda at any time of day, with or without food and drink.
• Use Saxenda at approximately the same time each day: choose the time that best suits you.

Where to inject

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

• The best areas for injection are the abdominal area, 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 into a muscle.

Detailed instructions on how to use the pen can be found on the other side of this leaflet.

People with diabetes

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

• Do not mix Saxenda with other injectable medications (e.g., insulins).
• Do not use Saxenda in combination with other medications containing 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, speak to a doctor or go immediately to a hospital. Take the medicine pack with you. You may require medical treatment. The following effects may occur:

• nausea
• vomiting
• low blood sugar (hypoglycaemia). See the warning symptoms of low blood sugar under “Frequent adverse effects”.

If you forget to use Saxenda

• If you forget a dose and remember within 12 hours of your usual injection time, inject the missed dose 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 your usual time.
• Do not use a double dose or increase the next day’s dose 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 about the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Serious adverse effects

Serious allergic reactions (anaphylaxis) have rarely been reported in patients using Saxenda. Seek immediate medical attention if you experience symptoms such as breathing difficulties, swelling of the face and throat, or palpitations.

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

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

• Severe and persistent abdominal pain (stomach area) that may extend to the back, along with nausea and vomiting, as this could be a sign of inflammation of the pancreas (pancreatitis).

Other adverse effects

Very common: may affect more than 1 in 10 people

• Nausea, vomiting, diarrhea, constipation, headache; these 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, upper abdominal pain, heartburn, bloating, gas (flatulence), burping, and dry mouth
• Feeling of weakness or fatigue
• Changes in taste sensation
• 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 (hypoglycemia). Warning signs of low blood sugar may appear suddenly and include: cold sweat, cold and pale skin, headache, palpitations, feeling unwell, excessive hunger, visual disturbances, drowsiness, weakness, nervousness, anxiety, confusion, difficulty concentrating, and tremors. Your doctor will advise you on how to treat low blood sugar and what to do if you experience these warning signs
• Increased levels of 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 beginning of treatment and may be due to vomiting, nausea, and diarrhea
• Delayed gastric emptying
• Inflamed gallbladder
• Allergic reactions including skin rashes
• General feeling of malaise
• Faster heartbeat.

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

• Reduced kidney function
• Acute kidney failure. Symptoms may include reduced urine volume, metallic taste in the mouth, and increased tendency to bruise easily.

Frequency not known: cannot be estimated from available data

• Intestinal obstruction. A severe form of constipation with additional symptoms such as stomach pain, bloating, vomiting, etc.
• Lumps under the skin may occur due to the accumulation of a protein called amyloid (cutaneous amyloidosis; frequency of occurrence is unknown).

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the national reporting system listed in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Saxenda

Keep this medicine out of the sight and reach of children.

Do not use Saxenda after the expiry date stated on the label of the pen and on the outer packaging, following "EXP". The expiry date refers to the last day of the month indicated.

Before first use:

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

After starting use:

The pen may be stored for up to one month either below 30 °C or in a refrigerator (between 2 °C and 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 colourless or almost colourless.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and containers that you no longer need. This will help protect the environment.

6. Package 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 injections.

Appearance of the product and contents of the pack

Saxenda is supplied as a clear, colourless or almost colourless 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. Only certain pack sizes may be marketed.

Needles are not included.

Marketing Authorisation 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 the most recent revision of this leaflet:

Other sources of information

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

Instructions for use of Saxenda 6 mg/ml injectable solution in pre-filled pen

Read these instructions carefully before using your pre-filled Saxenda pen.

Do not use the pen without having received proper training from your doctor or nurse.

Start by checking the pen to ensure it contains Saxenda 6 mg/ml, then review the illustrations to become familiar with the different parts of the pen and the needle.

If you are blind or have reduced vision and cannot read the dose counter on the pen, do not use this pen without assistance. Seek help from someone with good eyesight who has been trained in the use of the Saxenda pre-filled 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 fine as 32 G gauge.

Needles are not included in the pack.

Important information

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

1 Preparing the pen with a new needle

• Check the name and colour of the label on your pen to ensure it contains Saxenda. This is especially important if you use more than one type of injectable medicine. Using the wrong medicine may be harmful to your health.
• Remove the pen cap.

• Check that the solution in the pen appears clear and colourless. Look through the pen window. Do not use the pen if the solution appears cloudy.

• Take a new needle and remove the paper tab.

Ensure the needle is inserted correctly.

• Place the needle straight onto the pen.
• Screw it on tightly.

The needle is covered by two caps. You must remove both caps. If you forget to remove both caps, no solution may be injected.

• Remove the outer needle cap and keep it for later. You will need it after the injection to safely remove the needle from the pen.

• Remove the inner needle cap and discard it. If you try to reattach it, 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 should still perform a flow check if this is the first time you are using a new pen.

Do not attach a new needle to the pen until you are ready to administer your injection.

Always use a new needle for each injection.

This helps prevent needle clogging, contamination, infections and inaccurate dosing.

• Never use bent or damaged needles.

2 Flow check with each new pen

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

• Hold the pen with the needle pointing upwards.

Press and hold the dose button until the dose counter returns to 0. The 0 must align with the dose marker.

A drop of solution should appear at the needle tip.

There may be a small drop remaining at the needle tip, but no solution will be injected.

If no drop appears, repeat step 2 “Flow check with each new pen” up to 6 times. If still no drop appears, change the needle and repeat step 2 “Flow check with each new pen” once more.

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

Always ensure a drop appears at the needle tip before using a new pen for the first time. This confirms that the solution is flowing.

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

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

3 Dose selection

• Turn the dose selector until the desired dose appears in the dose counter (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 forwards or backwards 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 have been 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 will stop before 3.0 appears.

The dose selector clicks differently when turned forwards, backwards or when passing the remaining mg amount. Do not count the pen clicks.

Before injecting the medicine, always use the dose counter and dose marker to verify how many mg you have selected.

Do not count the pen clicks.

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

Only doses of 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg or 3.0 mg should be selected using the dose selector. The selected dose must be exactly aligned with the dose marker to ensure the correct dose is injected.

How much solution is left?

• The pen scale shows the approximate amount of solution remaining in the pen.

• To determine the exact amount of solution remaining, use the dose counter:

Turn the dose selector until the dose counter stops.

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

If you need more medicine than remains in the pen

If your doctor or nurse advises and has trained you to do so, you may split the dose between the current pen and a new one. Use a calculator to plan your dose as instructed by your doctor or nurse.

Be very careful to calculate correctly.

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

4 Administering the dose

• Insert the needle under the skin as instructed by your doctor or nurse.
• Ensure 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 as the dose counter returns to 0. The 0 must align with the dose marker. You may hear or feel a click at this point.
• Continue holding 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 early, you may see solution leaking from the needle tip. This means the full dose was not administered.

• Remove the needle from the skin. You may now release the dose button.

If blood appears at the injection site, apply light pressure.

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

Always watch the dose counter to confirm how many mg are injected. Press and hold the dose button until the dose counter shows 0.

How to detect if the needle is blocked or damaged?

• 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, no medicine will have been delivered, even if the dose counter moved from the original dose selected.

What to do if the needle is blocked?

Change the needle as described in step 5 “After injection” and repeat all steps from step 1 “Preparing the pen with a new needle”. Ensure you select the full dose required.

Never touch the dose counter during injection. This may interrupt the injection.

5 After injection

• Always discard the needle after each injection to ensure injections are administered correctly and to prevent needle clogging. If the needle is clogged, no medicine will be injected.
• Place the needle tip into its outer cap, placed on a flat surface, without touching the needle or the outer needle cap.

• When the needle is covered, press the outer cap fully and carefully.
• Unscrew the needle and dispose of it carefully, following instructions from your doctor, nurse, pharmacist or local authorities.

• Replace the pen cap after each use to protect the solution from light.

When the pen is empty, discard it without the needle attached, following instructions from your doctor, nurse, pharmacist or local authorities.

Never attempt to reattach the inner needle cap. You may prick yourself.

Always remove the needle from the pen after each injection.

This helps prevent needle clogging, contamination, infections, solution leakage and inaccurate dosing.

Additional important information

• Always keep the pen and needles out of sight and reach of others, especially children.
• Never share the pen or needles with other people.
• Caregivers handling used needles must exercise extreme caution to avoid accidental needlestick injuries and infections.
• Change your injection site daily to reduce the risk of developing lumps under the skin.

Pen care

• Do not leave the pen in a car or any other place where it could become too hot or too cold.
• Do not inject Saxenda if it has been frozen. If you do, the medicine will not have the intended effect.
• Do not expose the pen to dust, dirt or liquids.
• Do not wash, soak or lubricate the pen. It may be cleaned with a cloth dampened with mild detergent.
• Avoid dropping the pen or letting it hit hard surfaces. If the pen is dropped or you suspect it may be damaged, attach a new needle and perform a flow check before injecting.
• Do not attempt to refill the pen. Once empty, it must be discarded.
• Do not attempt to repair or disassemble the pen.