Saxenda ® 6 mg Solution

Liraglutide is similar to a natural occurring hormone called GLP-1 that is released from the intestine after a meal. SAXENDA ® is used for chronic weight management in addition to reduced calorie-diet and increased physical activity in adults aged 18 and above who have:

• a Body Mass Index (BMI) of 30 or greater (obesity) or
• a Body Mass Index (BMI) of 27 and less than 30 (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 simple measure of your weight in relation to your height. SAXENDA ® can be used in adolescents from the age of 12 to below 18 with obesity as diagnosed by your doctor. Consult with your doctor for the use of SAXENDA ® in adolescents aged 12 to below 18 years.

Do not administer SAXENDA ®:

• If you are allergic to liraglutide or any of the other ingredients of SAXENDA ®
• If you are pregnant or you are breastfeeding your baby

Warnings and precautions

Tell your doctor or healthcare professional before using SAXENDA ® if:

• you have severe heart failure, it is not recommended to use SAXENDA ®.
• you have kidney disease or are on dialysis, consult your doctor.
• you have liver problems, consult your doctor.
• you have a severe stomach or gut problem which results in delayed stomach emptying (called gastroparesis), or if you have an inflammatory bowel disease.
• Some patients taking medicines like Saxenda ® have had problems with food or liquid from their stomach getting into their lungs while under general anaesthesia or deep sedation.

Tell your healthcare professional that you are taking Saxenda ® before you have a procedure that requires general anaesthesia or deep sedation.

People with diabetes

If you have diabetes, do not use SAXENDA ® as a replacement for insulin.

Inflammation of the pancreas

Tell your doctor if you have or have had a disease of the pancreas.

Inflamed gall bladder and gall stones

If you lose substantial weight, you are at a risk of gall stones and thereby inflamed gall bladder. Stop taking SAXENDA ® and consult your 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.

Thyroid disease

If you have thyroid disease including thyroid nodules and enlargement of the thyroid gland, consult your doctor.

Heart rate

Tell 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

With SAXENDA ®, you may have loss of fluids or dehydration. This may be due to feeling sick (nausea), being sick (vomiting) or diarrhoea. It is important to try to stop this dehydration by drinking plenty of fluids. Tell your doctor or your healthcare professional if you have any questions or concerns.

Children and adolescents

SAXENDA ® should not be used in children under 12 years of age or in adolescents with a body weight below or equal to 60 kg. This is because the effects of SAXENDA ® have not been studied in these sub groups.

Using SAXENDA ® with food and drink:

You can inject SAXENDA ® at any time of day, independent of meals.

Other medicines and SAXENDA

Always tell your healthcare professional if you are taking any other medicine. (This includes complementary or traditional medicines.) Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines. This includes medicines obtained without a prescription, and herbal medicines.

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

• You are taking medicines for diabetes called ‘sulphonylurea’ (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 for the warnings 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 share SAXENDA ® prescribed to you with any other person. Always use SAXENDA ® exactly as your doctor has instructed you. You should check with your doctor or healthcare professional if you are unsure. Your doctor will start you on a diet and exercise programme. Stay on this programme while you are using SAXENDA ®.

How much to inject

Your treatment will start at a lower dose which will gradually increase 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 should increase your dose 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. Usually, you will be told to follow the table below.

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. You should only continue using SAXENDA ®, if you have lost at least 5 % of your initial body weight after 12 weeks on the 3 mg/day dose. Consult your doctor before you continue. Your doctor will assess your treatment on a regular basis.

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 drinks.
• Use SAXENDA ® at about the same time each day – find the time of the day that works best for you.

Where to inject

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

• The best places to inject are the front of your waist (abdomen), the front of your thighs or your upper arm.
• Change the place within the area where you inject each day to reduce the risk of developing lumps under the skin (see section 4 ‘Possible side effects’).
• Do not inject into a vein or muscle.

Detailed instructions for use are provided at the end 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, lixisenatide).

If you inject more SAXENDA ® than you should:

If you inject more SAXENDA ® than you should, tell your doctor or go to a hospital straight away. Take the SAXENDA ® 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 ‘Frequent side effects’ for early warning signs of low blood sugar.

If you forget to inject SAXENDA ®

If you forget a dose and remember it within 12 hours from when you usually take the dose, inject it as soon as you remember.

• However, if more than 12 hours has 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.

Effects when treatment with SAXENDA ® is stopped:

Do not stop using SAXENDA ® without telling your doctor or healthcare professional. If you have any further questions on the use of SAXENDA ® ask your doctor or healthcare professional.

SAXENDA ® can have side effects. Not all side effects reported for SAXENDA ® are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking this medicine, please consult your doctor, pharmacist or other healthcare professional for advice.

Serious side effects

• Some severe allergic reactions (anaphylaxis) have been reported in patients using SAXENDA ®. You should tell your doctor immediately or go to the casualty department at your nearest hospital 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 in patients using SAXENDA ®. Pancreatitis is a serious, potentially life-threatening medical condition. Stop administering SAXENDA ® and consult your 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 frequent:

• Feeling sick (nausea), being sick (vomiting), diarrhoea, constipation, headache - these usually go away after a few days or weeks

Frequent:

• Problems affecting the stomach and intestines such as: indigestion (dyspepsia), inflammation in the lining of the stomach (gastritis), stomach discomfort, upper stomach pain, heart burn, feeling bloated, wind (flatulence), belching, dry mouth.
• Feeling weak or tired
• Changed sense of taste
• Dizziness
• Difficulty sleeping (insomnia). This usually occurs the first 3 months of treatment
• Gall stones
• 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, 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.
• Rash
• increase of pancreatic enzymes, such as lipase and amylase

Less frequent:

• 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
• Inflamed gall bladder
• Allergic reactions including skin rash
• Feeling generally unwell
• Faster pulse.
• Reduced kidney function
• Acute kidney failure. Signs may include reduction in urine volume, metallic taste in mouth and easily bruising.
• Lumps under the skin may be caused by build-up of a protein called amyloid (cutaneous amyloidosis; how often this occurs is not known). Saxenda may not work very well if you inject into a lumpy area. Change the injection site with each injection to help prevent this skin change.
• Delay in the emptying of the stomach.
• Bowel obstruction. A severe form of constipation with additional symptoms such as stomachache, bloating, vomiting etc

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects

If you get side effects, talk to your doctor, pharmacist or nurse. You can also report side effects to SAHPRA via the Med Safety APP (Medsafety X SAHPRA) and eReporting platform (who-umc.org) found on SAHPRA website. By reporting side effects, you can help provide more information on the safety of SAXENDA ®.

Keep SAXENDA ® out of 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 or 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 SAXENDA ® if the solution is not clear and colourless. Return all unused medicine to your pharmacist. Do not dispose of unused medicines in drains or sewerage systems (e.g. toilets).