Saxenda

• Weight-loss medicine
• Self-injectable treatment
• Reduces appetite
• BMI of 27 kg/m² or greater

Saxenda is a self-injectable weight-loss treatment. It contains the active ingredient liraglutide which is very similar to a hormone in your body called GLP-1 that is naturally released from your intestines 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 between 27 kg/m² and 30 kg/m² (overweight) and weight-related health problems (such as diabetes, high blood pressure, high cholesterol or obstructive sleep apnoea).
  

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. Consult your doctor before you continue.

Always use this medicine exactly as your doctor or pharmacist has told you. When in doubt, ask your doctor, pharmacist or nurse.

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

How much should you inject? Saxenda weight-loss treatment dosages start small and are gradually increased in the first five weeks as your body gets used to the treatment.

• When you first start using Saxenda weight-loss treatment, you will need a dose of 0.6 mg per day for at least one week.
• Then you should increase by 0.6 mg each week until you reach a total of 3.0 mg per day.

It is important to increase the dose each week in line with your doctor’s recommendation. As a general rule, the table below applies.

As soon as you have reached the recommended dosage of 3.0 mg in week 5, you should continue using this dose until the end of your treatment. Do not increase the dose any further.

Your doctor will monitor the treatment regularly.

Frequency of use It is important to follow the instructions given by your doctor or nurse when using the pen.

• Saxenda can be taken at any time of the day, with or without food or drink.
• You should inject yourself at the same time each day.

Where to inject Saxenda Saxenda is a self-administered subcutaneous injection that you inject under your skin.

• The best sites for injecting are the front of your waist (abdomen), the front of your thigh or the upper arm.
• You must take extra care not to inject into a vein or muscle.

Please read the instructions on the package leaflet carefully before injecting yourself.

Diabetes If you are taking any medication for diabetes it is important to tell your doctor. Your doctor may adjust your diabetes medicine to prevent you from getting low blood sugar.

• Saxenda should not be mixed with other medicines that are administered by injection, such as insulin.
• Do not use Saxenda in combination with other medicines that contain GLP-1 receptor agonists (such as exenatide or lixisenatide).

Used more Saxenda than you should?

If you have used more Saxenda than you should have, talk to a doctor or go to a hospital straight away. Take the medicine pack with you. You may need medical treatment. The following side effects may occur:

• Nausea and vomiting.

Missed a dose?

• 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 take a double dose or increase the dose to make up for the missed dose.

Do not discontinue the use of Saxenda without consulting your doctor first.

Use of Saxenda

Use this medicine exactly as directed by your doctor. If, for whatever reason, you have temporarily stopped taking Saxenda, then go back two steps from where you left off in the dosing schedule.

For example, if you stopped in week 4 of the treatment period, then start with the week 2 dose when you resume taking Saxenda. This will allow your body to adjust to the medicine and reduce the chance of side effects.

One pre-filled pen contains 18 mg liraglutide, and you can select doses of 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg and 3 mg.

The starting dose is 0.6 mg once a day. Your doctor will instruct you to gradually increase your dose by 0.6 mg each week until you reach the recommended dose of 3 mg once a day (maintenance dose).
Each pen will last for six days when using the 3-mg dose.

When not to use this medicine

• Do not use Saxenda if you are allergic to any of the ingredients in this medicine (see section ‘What Saxenda contains’).
• Saxenda is not suitable for children under the age of 18.

When should this medicine be used with caution?

• There is little experience with this medicine in patients with congestive heart failure, liver or kidney disease and in patients of 75 years and older. It is not recommended if you have heart failure and are 74 years or older. Consult a doctor before using this medicine if you have a liver or renal impairment and in end-stage renal disease requiring dialysis.
• This medicine should be avoided if you have an inflammatory bowel disease or a serious stomach or intestinal disorder causing delayed gastric emptying.
• If you have diabetes, do not use Saxenda as a replacement for insulin.
• Talk to your doctor if you have or have had a disease of the pancreas.
• 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 symptoms associated with gallstones or inflamed gall bladder.
• If you have thyroid disease, consult your doctor.
• Talk to your doctor if you have palpitations or if you have feelings of a racing heartbeat while at rest during Saxenda treatment.
• When starting treatment with Saxenda, you may lose body fluid or become dehydrated. This may be due to nausea, vomiting or diarrhoea. It is important to avoid dehydration by drinking plenty of fluids.

Other medicines and SAXENDA

Saxenda may interact with certain medicines. Consult a doctor, nurse or pharmacist if:

• You are taking medicines for diabetes called ‘sulfonylurea’ (such as glimepiride orglibenclamide) or if you are taking insulin –
  you may get low blood sugar (hypoglycaemia) when you use these medicines with Saxenda. Your doctor may adjust your diabetes medicine to prevent you from getting low blood sugar.
• You are taking warfarin or other medicines that reduce your blood clotting (anticoagulants). More frequent blood testing to determine the ability of your blood to clot may be required.

Pregnancy and breastfeeding

Saxenda should not be used during pregnancy and while breastfeeding.

Before starting treatment with Saxenda, a pregnancy test can be taken to rule out the chance of pregnancy.

To prevent pregnancy, you must use at least one reliable method of contraception.

If you wish to become pregnant, you should stop using this medicine at least two months in advance of the planned pregnancy. If you become pregnant while using Saxenda, talk to your doctor straight away as your treatment will need to be stopped.

Saxenda may cause side effects. The most common side effects are:

• Nausea, vomiting, diarrhoea, constipation – these side effects usually go away after a few days or weeks.
• Problems affecting the stomach and intestines.
• Feeling weak or tired.
• Changed sense of taste.
• Dizziness.
• Difficulty sleeping (insomnia).
• Gallstones.
• Injection site reactions (such as skin irritation or rash).

For a complete list of side effects, see the package leaflet. Consult a doctor if you experience side effects, also if the side effects are not listed on the package leaflet.

Saxenda contains the active ingredient liraglutide. One 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.

The manufacturer of Saxenda is:

Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd
Denmark

Read the package leaflet before use.