Patient leaflet - Wegovy 2.4 mg solution for injection in Pre-filled pen
1. What wegovy® is and what it is used for
What wegovy® is
wegovy® is a medicine for weight loss and weight maintenance that contains the active substance semaglutide. It is similar to a natural hormone called glucagon-like peptide-1 (GLP-1) that is released from the intestine after a meal. wegovy® works by acting on receptors in the brain that control your appetite, causing you to feel fuller and less hungry and experience less craving for food. This will help you eat less food and reduce your body weight. wegovy® should be used with a reduced calorie meal plan and increased physical activity.
What wegovy® is used for
wegovy® is used for weight loss and weight maintenance in addition to diet and physical activity in adults, who have
- a BMI of 30 kg/m² or greater (with obesity) or
- a BMI of 27 kg/m² and less than 30 kg/m² (overweight) and weight-related health problems.
BMI (Body Mass Index) is a measure of your weight in relation to your height.
2. What you need to know before you use wegovy®
Do not use wegovy®
- if you are allergic to semaglutide or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor, pharmacist or nurse before using wegovy® or during treatment if you have:
Effects on the digestive system
During treatment with wegovy®, you may feel sick (nausea) or be sick (vomiting), or have diarrhoea. These side effects can cause dehydration (loss of fluids). It is important that you drink enough fluids to prevent dehydration. This is especially important if you have kidney problems. Talk to your doctor if you have any questions or concerns.
Inflammation of the pancreas
If you have severe and on-going pain in the stomach area – see a doctor straight away as this could be a sign of inflamed pancreas (acute pancreatitis).
Diabetes
Do not use wegovy® as a substitute for insulin.
Low blood sugar (hypoglycaemia)
Taking a sulfonylurea or an insulin with wegovy® might increase the risk of getting low blood sugar levels (hypoglycaemia). Please see section 4 for the warning signs of low blood sugar levels. Your doctor may ask you to test your blood sugar levels. This will help your doctor decide if the dose of the sulfonylurea or insulin needs to be changed to reduce the risk of low blood sugar.
Diabetic eye disease (retinopathy)
Fast improvements in blood sugar control may lead to a temporary worsening of diabetic eye disease. If you have diabetic eye disease and experience eye problems while taking this medicine, talk to your doctor.
Children and adolescents
This medicine is not recommended in children and adolescents under 18 years as the safety and efficacy in this age group have not been established.
Other medicines and wegovy®
Tell your doctor, pharmacist or nurse if you are using, have recently used or might use any other medicines.
Pregnancy and breast-feeding
This medicine should not be used during pregnancy, as it is not known if it may affect your unborn child. Therefore, it is recommended to use contraception while using this medicine. If you wish to become pregnant, you should stop using this medicine at least two months in advance. If you become or are pregnant, think you may be pregnant or are planning to have a baby when using this medicine, talk to your doctor straight away, as your treatment will need to be stopped. Do not use this medicine if you are breast-feeding, as it is unknown if it passes into breast milk.
Driving and using machines
wegovy® is unlikely to affect your ability to drive and use machines. Some patients may feel dizzy when taking wegovy® mainly during the first 3 months of treatment (see section 4). If you feel dizzy be extra careful while driving or using machines. If you need any further information, talk to your doctor, pharmacist or nurse.
People with diabetes
If you use this medicine in combination with a sulfonylurea or insulin, low blood sugar (hypoglycaemia) may occur which may reduce your ability to concentrate. Avoid driving or using machines if you get any signs of low blood sugar. See section 2, ‘Warning and precautions’ for information on increased risk of low blood sugar and section 4 for the warning signs of low blood sugar. Talk to your doctor for further information.
Sodium content
This medicine contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium-free’.
3. How to use wegovy®
Always use this medicine wegovy® exactly as your doctor has told you. Check with your doctor, pharmacist or nurse if you are not sure.
How much to use
The recommended dose is 2.4 mg once weekly. Your treatment will start at a low dose which will be gradually increased over 16 weeks of treatment.
- When you first start using wegovy®, the starting dose is 0.25 mg once weekly.
- Your doctor will instruct you to gradually increase your dose every 4 weeks until you reach the recommended dose of 2.4 mg once weekly.
Once you reach the recommended dose of 2.4 mg, do not increase this dose further.
You will be told to follow the table below.
Dose escalation Weekly dose
Week 1–4 0.25 mg
Week 5–8 0.5 mg
Week 9–12 1 mg
Week 13–16 1.7 mg
From week 17 2.4 mg
Your doctor will assess your treatment on a regular basis.
How wegovy® is given
wegovy® is given as an injection under the skin (subcutaneous injection). Do not inject it into a vein or muscle.
- The best places to give the injection are the front of your waist (abdomen), your thigh, or your upper arm.
- Before you use the pen for the first time, ask your doctor or nurse how to use it.
Detailed instructions for use are on the other side 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 wegovy® up with other medicines that you inject (e.g. insulins).
- Do not use wegovy® in combination with other medicines that contain GLP-1 receptor agonists (such as liraglutide, dulaglutide, exenatide or lixisenatide).
When to use wegovy®
- You should use this medicine once a week and if possible, on the same day each week.
- You can give yourself the injection at any time of the day – regardless of meals.
If necessary, you can change the day of your weekly injection of this medicine as long as it has been at least 3 days since your last injection. After selecting a new dosing day, continue with once a week dosing.
If you use more wegovy® than you should
Talk to your doctor straight away. You may get side effects such as feeling sick (nausea).
If you forget to use wegovy®
If you forgot to inject a dose and:
- it is 5 days or less since you should have used wegovy®, use it as soon as you remember. Then inject your next dose as usual on your scheduled day.
- it is more than 5 days since you should have used wegovy®, skip the missed dose. Then inject your next dose as usual on your next scheduled day. Do not take a double dose to make up for a forgotten dose.
If you stop using wegovy®
Do not stop using this medicine without talking to 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
Common: may affect up to 1 in 10 people
- Complications of diabetic eye disease (diabetic retinopathy). If you have diabetes you should inform your doctor if you experience eye problems, such as changes in vision, during treatment with this medicine.
Uncommon: may affect up to 1 in 100 people
- Inflamed pancreas (acute pancreatitis). Signs of inflamed pancreas may include severe and long-lasting pain in your stomach, the pain may move to your back. You should see your doctor immediately if you experience such symptoms. Rare: may affect up to 1 in 1,000 people
Severe allergic reactions (anaphylactic reactions, angioedema). You should seek immediate medical help and inform your doctor straight away if you get symptoms such as breathing problems, swelling of face, lips, tongue, and/or throat with difficulty swallowing, wheezing, fast heartbeat, pale and cold skin, feeling dizzy or weak.
Other side effects
Very common: may affect more than 1 in 10 people
- headache
- feeling sick (nausea)
- being sick (vomiting)
- diarrhoea
- constipation
- stomach pain.
- feeling weak or tired
- these usually go away over time.
Common: may affect up to 1 in 10 people
- feeling dizzy
- upset stomach or indigestion
- burping
- gas (flatulence)
- bloating of the stomach
- inflamed stomach (‘gastritis’) – the signs include stomach ache, feeling sick (nausea) or being sick (vomiting)
- reflux or heartburn – also called ‘gastro-oesophageal reflux disease’
- gallstones
- hair loss
- injection site reactions
- low blood sugar (hypoglycaemia) in patients with diabetes.
The warning signs of low blood sugar may come on suddenly. They can include: cold sweat, cool pale skin, headache, fast heartbeat, feeling sick (nausea) or very hungry, changes in vision, feeling sleepy or weak, feeling nervous, anxious or confused, difficulty concentrating or shaking. Your doctor will tell you how to treat low blood sugar and what to do if you notice these warning signs.
Low blood sugar is more likely to happen if you also take a sulfonylurea or insulin. Your doctor may reduce your dose of these medicines before you start using this medicine.
Uncommon: may affect up to 1 in 100 people
- fast heartbeat
increase of pancreatic enzymes (such as lipase and amylase) shown in blood tests.
Reporting of side effects
If you get 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 Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store wegovy®
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 label and carton after ‘EXP’. The expiry date refers to the last day of that month.
Always store the pen in the original carton in order to protect from light.
Store in a refrigerator (2°C – 8°C). Do not freeze. Keep away from the cooling element.
wegovy® can be stored out of the refrigerator for up to 21 days at a temperature not above 25°C. The product must not be returned to the refrigerator.
Do not use this medicine if you notice that the solution is not clear and colourless.
After use: Discard after use.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What wegovy® contains
- The active substance is semaglutide.
- The other ingredients are disodium phosphate dihydrate, sodium chloride, sodium hydroxide/ hydrochloric acid (for pH adjustment), water for injection.
wegovy® 0.25 mg solution for injection Each pre-filled pen contains 0.25 mg semaglutide in 0.5 mL wegovy® 0.5 mg solution for injection
Each pre-filled pen contains 0.5 mg semaglutide in 0.5 mL wegovy® 1 mg solution for injection
Each pre-filled pen contains 1.0 mg semaglutide in 0.5 mL wegovy® 1.7 mg solution for injection
Each pre-filled pen contains 1.7 mg semaglutide in 0.75 mL wegovy® 2.4 mg solution for injection
Each pre-filled pen contains 2.4 mg of semaglutide in 0.75 mL
What wegovy® looks like and contents of the pack wegovy® is a clear and colourless solution for injection in a pre-filled disposable pen. Each pen contains one dose only. The pack size of each strength of wegovy® contains 4 pre-filled single use pens.
Marketing Authorisation Holder and Manufacturer
Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd
Denmark
This leaflet was last revised in 09/2021 Other sources of information wegovy® is a trademark owned by Novo Nordisk A/S, Denmark
© 2021
Novo Nordisk A/S