6 mg/ml solution for injection in a pre-filled pen
What Saxenda is and what it is used for
What Saxenda is
Saxenda is a weight control drug that contains the active substance liraglutide. It is similar to a naturally occurring hormone called glucagon-like peptide -1 (GLP-1) which is released from the gut after a meal. Saxenda works by acting on the receptor in your brain that controls your appetite, which makes you feel fuller and less hungry. It can help you eat less and reduce your body weight.
What Saxenda is used for
Saxenda is used for weight loss in combination with an adapted diet and exercise in adults 18 years and older who have
- a BMI of 30 kg / m² or higher ( 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 apnea”).
BMI ( Body Mass Index ) is a measure of your weight about your height.
You should only continue to use Saxenda if you have lost at least 5% of your initial body weight after 12 weeks of dosing at 3.0 mg/day (see section 3). Consult a physician before proceeding.
Saxenda can be used as a supplement to a healthy diet and increased physical activity for weight control in adolescents from the age of 12 who have:
• obesity (diagnosed by your doctor).
• body weight over 60 kg.
You should only continue to use Saxenda if your BMI has decreased by at least 4% after 12 weeks with a dose of 3.0 mg/day or the maximum tolerated dose (see section 3). Consult your doctor before proceeding.
Diet and exercise
Your doctor will compile a diet and exercise program for you. Follow this program while using Saxenda.
What you need to know before using 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 cautions
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 aged 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 a doctor.
There is little experience with this medicine in patients with liver problems. If you have liver problems, consult a doctor.
This medicine is not recommended if you have severe stomach or intestinal problems that cause slow gastric emptying (so-called gastroparesis) or if you have an inflammatory bowel disease.
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 gallbladder and gallstones
If you lose a lot of weight, there is a risk that gallstones will form and that your gallbladder will become inflamed. Stop taking Saxenda and contact a doctor immediately if you experience severe pain in the upper abdomen, usually worst on the right side below the ribs. The pain can be felt in the back or right shoulder. See section 4.
Thyroid disease
If you have thyroid disease with thyroid nodules and enlargement of the thyroid gland, consult a doctor.
Heart rate
See a doctor if you experience palpitations during Saxenda treatment (you feel your heart beating extra or beating hard) or if it feels like your heart is racing while you are resting.
Fluid loss and dehydration
When you start treatment with Saxenda, you may lose body fluid and become dehydrated. This can happen if you get nausea, vomiting, or get diarrhea. It is important to avoid dehydration by drinking enough fluids. Contact your doctor, pharmacist, or nurse if you have any questions or concerns. See section 4.
Children and young people
The safety and efficacy of Saxenda in children under 12 years of age have not been studied.
Other medicines and Saxenda
Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines.
It is especially important to talk to your doctor, pharmacist, or nurse about:
- you are taking a medicine for diabetes called ‘sulphonylurea’ (for example glimepiride or glibenclamide) or if you are taking insulin, as you may have low blood sugar (hypoglycemia) while taking these medicines at the same time as Saxenda. Your doctor may adjust the dose of one of your diabetes medicines to prevent you from getting low blood sugar. See section 4 for information on low blood sugar warning signals. If your insulin dose changes, your doctor may recommend that you check your blood sugar more often.
- you take warfarin or other medicines by mouth that reduce blood clotting (anticoagulant). You may be required to perform more frequent checks on your blood’s ability to coagulate.
Pregnancy and breastfeeding
Do not use Saxenda if you are pregnant, think you may be pregnant, or are planning to have a baby. It is not known if Saxenda affects the baby during pregnancy.
You should not breastfeed if you are using Saxenda. It is not known if Saxenda passes into breast milk.
Driving and using machines
Saxenda is unlikely to affect your ability to drive and use machines. Some patients may feel dizzy when taking Saxenda, especially during the first 3 months of treatment (see section “Possible side effects” ). If you become dizzy, be extra careful when driving or using machines. For more information, talk to your doctor.
Important information about some of the ingredients of Saxenda
This medicine contains less than 1 mmol sodium (23 mg) per dose, ie essentially ‘sodium-free’. is next to “sodium-free”.
How to use Saxenda
Always use this medicine exactly as your doctor has told you. If you are not sure, talk to your doctor, pharmacist, or nurse.
Your doctor will compile a diet and exercise program for you. Follow this program while using Saxenda.
How much to inject
Adults
Your treatment will start with a low dose that will be gradually increased during the first five weeks of treatment.
- When you 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 weekly until you reach the recommended dose of 3.0 mg once daily.
Your doctor will tell you how much Saxenda to take each week. You will probably follow the table below.
| 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 and onwards | 3.0 mg once daily |
Once you have reached the recommended dose of 3.0 mg in week 5 of treatment, you should continue with this dose until the end of the treatment period. Do not increase your dose further.
Your doctor will regularly evaluate your treatment.
Adolescents (≥12 years)
For adolescents aged 12 to 18 years, a similar dose-escalation schedule should be used as for adults (see table above for adults). Dose one should be increased to 3.0 mg (maintenance dose) or until the maximum tolerated dose has been reached. Daily doses above 3.0 mg are not recommended.
How and when to use Saxenda
- Before using the pen for the first time, a doctor or nurse will show you how to use the pen.
- You can take Saxenda at any time during the day, with or without food and drink.
- Take Saxenda at about the same time each day – choose the time of day that suits you best.
Where to inject
Saxenda is given as an injection under the skin ( subcutaneous injection ).
- The best places to inject are the front of the waist (abdomen), and the front of the thighs, or upper arms.
- Do not inject directly into a blood vessel or muscle.
There is a detailed instruction manual on the back of this leaflet.
People with diabetes
Tell your doctor if you have diabetes. Your doctor may adjust the dose of one of your diabetes medicines to prevent you from getting low blood sugar.
- Do not mix Saxenda with other medicines you inject (eg insulin ).
- Do not use Saxenda with other medicines that contain GLP-1 receptor agonists (such as exenatide or lixisenatide).
If you use more Saxenda than you should
Contact a doctor or go to a hospital immediately if you have used too much Saxenda. Take the medicine pack with you. You may need medical attention. The following side effects may occur:
- nausea
- vomiting
- low blood sugar (hypoglycemia). See section “Common side effects” for information on warning signs of low blood sugar.
If you forget to use Saxenda
- If you miss a dose and remember it within 12 hours of when you usually take a dose, take it as soon as you remember.
- However, if more than 12 hours have passed since you used Saxenda, skip the missed dose and inject the next dose the following day at the usual time.
- Do not take a double or increased dose the following day to compensate for the missed dose.
If you stop using Saxenda
Do not stop using Saxenda without talking to a doctor first.
If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects are
Severe allergic reactions ( anaphylaxis ) have been reported rarely in patients using Saxenda. You should see a doctor immediately if you experience symptoms such as difficulty breathing, swelling of the face and throat, and palpitations.
Inflammation of the pancreas ( pancreatitis ) is a less common side effect reported in patients using Saxenda. Pancreatitis is a serious and potentially life-threatening condition.
Stop taking Saxenda and contact your doctor immediately if you get any of the following serious side effects:
- Severe and persistent pain in the abdomen (stomach) that may radiate to the back as well as nausea and vomiting, as it may be a sign of an inflamed pancreas ( pancreatitis ).
Other side effects are
Very common: may affect more than 1 user in 10
- Nausea, vomiting, diarrhea, constipation, headache – these usually disappear after a few days or weeks.
Common: may affect up to 1 in 10 users
- Problems affecting the stomach and intestines, such as indigestion ( dyspepsia ), gastritis ( gastritis ), stomach upset, pain in the upper abdomen, heartburn, feeling of bloating, gas in the stomach ( flatulence ), belching, and dry mouth
- Feeling weak and tired
- Changed taste
- Dizziness
- Hard to sleep. This usually occurs during the first 3 months of treatment
- Gallstone
- Injection site reactions (bruising, pain, irritation, itching, and rash)
- Low blood sugar (hypoglycemia). Warning signals for low blood sugar can come suddenly and manifest themselves as cold sweat, cold and pale skin, headache, palpitations, nausea, strong hunger, vision changes, drowsiness, weakness, nervousness, anxiety, confusion, difficulty concentrating, and tremors ( tremor ). Your doctor will tell you how to treat low blood sugar and what to do if you notice any the warning signs
- Increase in pancreatic enzymes, such as lipase and amylase.
Uncommon: may affect up to 1 in 100 people
- Fluid loss (dehydration). This is likely to occur at the beginning of treatment and may be caused by vomiting, nausea, and diarrhea
- Delay of gastric emptying
- Inflamed gallbladder
- Allergic reactions including rash
- General malaise
- Faster pulse.
Rare: may affect up to 1 in 1,000 users
- Impaired renal function
- Acute renal failure. Symptoms may include decreased urine volume, metallic taste in the mouth, and easy bruising.
How to store Saxenda
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pen and label after EXP. The expiration date is the last day of the specified month.
Before first use:
Store in a refrigerator (2 ° C to 8 ° C). Do not freeze. Do not store near the freezer compartment.
After you start using the pen:
The pen can be stored for 1 month at a maximum of 30 ° C or in a refrigerator (2 ° C to
8 ° C). Do not freeze. Do not store near the freezer compartment.
When the pen is not in use, store it with the pen cap on. Sensitive to light.
May only be used if the solution is 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. These measures will help to protect the environment.
Contents of the packaging and other information
Content declaration
- The active substance is liraglutide. 1 ml of solution for injection contains 6 mg liraglutide. One pre-filled pen contains 18 mg of liraglutide.
- The other ingredients are disodium phosphate dihydrate, propylene glycol, phenol, hydrochloric acid, and sodium hydroxide (for pH adjustment), and water for injections.
What the medicine looks like and the contents of the pack
Saxenda is delivered as a clear and colorless or almost colorless, solution for injection in a pre-filled pen. Each pen contains 3 ml of solution and can give doses of 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg, and 3.0 mg.
Scissors are available in pack sizes of 1, 3, or 5 pens. Not all pack sizes may be marketed.
Injection needles are not included.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder and Manufacturer
Novo Nordisk A / S
Novo Allé
DK-2880 Bagsværd
Denmark