Wegovy 1 mg/dose. 4 doses

1. What Wegovy is and what it is used for
What Wegovy is
Wegovy is a medicine for weight loss and maintenance that contains the active substance semaglutide. It is similar to a natural hormone called glucagon-like peptide-1 (GLP-1), which is released from the gut after meals. It works by affecting targets (receptors) in the brain that control your appetite, making you feel fuller and less hungry and having fewer food cravings. This will help you eat less food and reduce your weight. Wegovy may also help prevent heart disease.

What Wegovy is used for
Wegovy is used together with diet and exercise to reduce weight and to help keep your weight under control. It is used in adults who have a BMI of 30 kg/m2 or more (obese) or a BMI of at least 27 kg/m2 but less than 30 kg/m2 (overweight) who have health problems related to their weight (such as diabetes, high blood pressure, abnormal levels of fat in the blood, a problem with breathing during sleep called ‘obstructive sleep apnoea’, or have ever had a heart attack, stroke or problems with blood vessels). BMI (body mass index) is a measure of your weight in relation to your height. Wegovy is used together with diet and exercise to control weight in adolescents aged 12 years and over who are obese and weigh >60 kg. As an adolescent, you should only continue using Wegovy if you have reduced your BMI by at least 5% after 12 weeks on 2.4 mg or the maximum tolerated dose (see section 3). Talk to your doctor before continuing.

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.

The use of Wegovy is not recommended if:

you are using other weight loss products,
you have type 1 diabetes,
you have severely reduced kidney function,
you have severely reduced liver function,
you have severe heart failure,
you have an eye disease related to diabetes (retinopathy).
There is limited experience with Wegovy in patients:

85 years of age and older,
with liver problems,
with a serious stomach or intestinal problem that causes delayed emptying of the stomach (called gastroparesis), or if you have inflammatory bowel disease.

Please consult your doctor if any of the above apply to you.

If you know that you are going to have an operation where you will be under anesthesia (sleeping), you should tell your doctor that you are being treated with Wegovy.

Dehydration
You may experience nausea, vomiting or diarrhea during treatment with Wegovy. These side effects can lead to dehydration (loss of fluids). It is important to 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 persistent pain in your stomach area (see section 4), see a doctor immediately, as this may be a sign of inflammation of the pancreas (acute pancreatitis).

People with type 2 diabetes
Wegovy cannot be used as a substitute for insulin. Do not use Wegovy in combination with other medicines that contain GLP-1 receptor agonists (such as liraglutide, dulaglutide, exenatide or lixisenatide).

Low blood sugar (hypoglycaemia)
Combining sulphonylureas or insulin with this medicine may increase the risk of low blood sugar (hypoglycaemia). Please see section 4 for warning signs of low blood sugar. Your doctor may want you to test your blood sugar levels. This will help your doctor
determine whether the dose of your sulphonylurea or insulin needs to be changed to reduce the risk of low blood sugar.

Diabetic eye disease (retinopathy)
If you have diabetic eye disease and are using insulin, this medicine may cause your vision to get worse and may require treatment. Rapid improvement in blood sugar control may cause temporary worsening of your eye disease. If you have diabetic eye disease and experience eye problems while taking this medicine, talk to your doctor.

Children and adolescents
The safety and efficacy of Wegovy in children under 12 years of age have not been studied and its use in this population is not recommended.

Other medicines and Wegovy
You should tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines.

In particular, you should tell your doctor if you
Tell your pharmacist or nurse if you are using medicines containing the following:

Warfarin or other similar medicines taken by mouth to reduce blood clotting (oral anticoagulants). When you start treatment with e.g. warfarin or similar medicines, you may need frequent blood tests to determine your blood's ability to clot.

Pregnancy and breast-feeding
This medicine should not be used during pregnancy, as it is not known whether it may affect the unborn baby. It is therefore advisable to use contraception while using this medicine. If you want to become pregnant, you should stop using this medicine at least two months in advance. If you become pregnant, are pregnant, think you may be pregnant, or are planning to become pregnant while using this medicine, talk to your doctor immediately, as your treatment will need to be stopped.

Do not use this medicine if you are breast-feeding, as it is not known whether it passes into breast milk.

Driving and using machines
Wegovy is unlikely to affect your ability to drive or use machines. Some patients may feel dizzy when taking Wegovy, mainly during the first 4 months of treatment (see section 4). If you feel dizzy, be very careful when driving or using machines. If you need more information, talk to your doctor, pharmacist or nurse.

People with type 2 diabetes
If you use this medicine in combination with sulphonylureas or insulin, your blood sugar may become very low (hypoglycaemia), which may impair your ability to concentrate. Avoid driving or using machines if you get any signs of low blood sugar. See section 2, “Warnings and precautions” for information on the increased risk of low blood sugar, and section 4 for the warning signs of low blood sugar. Talk to your doctor for more information.

Wegovy contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially sodium-free.

3. How to use Wegovy
Always use this medicine exactly as your doctor has told you. If you are not sure, ask your doctor, pharmacist or nurse.

How much to use
Adults
The recommended dose is 2.4 mg once a week.
Your treatment will start with a low dose that will be gradually increased over 16 weeks of treatment.

When you first start using Wegovy, the starting dose is 0.25 mg once a week.
Your doctor will instruct you to gradually increase your dose every 4 weeks until you reach the recommended dose of 2.4 mg once a week.
Once you have reached the recommended dose of 2.4 mg, do not increase this dose any further.
If you have a lot of trouble tolerating nausea or vomiting, talk to your doctor about delaying the dose increase or reducing it to the previous dose until your symptoms improve.
You will usually be told to follow the table below.

Dose increase
Weekly dose
Weeks 1-4 0.25 mg
Weeks 5-8 0.5 mg
Weeks 9-12 1 mg
Weeks 13-16 1.7 mg
From week 17 2.4 mg
Your doctor will regularly review your treatment.

Adolescents (over 12 years of age)
The same dose increase schedule as for adults should be used in adolescents (see above). The dose should be increased until 2.4 mg (maintenance dose) or the maximum tolerated dose is reached.

How Wegovy is given
Wegovy is given by injection under the skin (subcutaneous injection). Do not inject into a vein or muscle.

The best places to inject are the front of the upper arm, the upper leg or the abdomen.
Before you use the pen for the first time, your doctor, pharmacist or nurse will show you how to use it.
Detailed instructions on how to use the pen are given on the other side of this leaflet.
Tell your doctor if you have type 2 diabetes. Your doctor may adjust the dose of your diabetes medicine to prevent your blood sugar from getting too low.

When to use Wegovy
You should use this medicine once a week and preferably on the same day each week.
You can inject yourself 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 at least 3 days have passed since your last injection. After choosing a new day for administration, continue injecting once a week.

If you use more Wegovy than you should
Tell your doctor straight away. You may experience side effects such as nausea, vomiting or diarrhoea, which can cause dehydration (loss of fluids).

If you forget to use Wegovy
If you forget to inject a dose and:

it is 5 days or less since you were supposed to use Wegovy, inject it as soon as you remember. Then inject your next dose as usual on the scheduled day.

it is more than 5 days since you were supposed to use Wegovy, skip the missed dose. Then inject your next dose as usual on the next scheduled day.

Do not use a double dose to make up for a forgotten dose.

If you stop using Wegovy
Do not stop using this medicine without telling 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 eye disease due to diabetes (diabetic retinopathy). If you have diabetes, you should tell your doctor if you have any eye problems during treatment with this medicine, such as if you have changes in your vision.
Uncommon (may affect up to 1 in 100 people)
Inflammation of the pancreas (acute pancreatitis). Signs of inflammation of the pancreas may include severe and persistent stomach pain, which may move to your back. You should see a doctor immediately if you experience these symptoms.
Rare (may affect up to 1 in 1,000 people)
Severe allergic reactions (anaphylactic reactions, angioedema). You should seek immediate medical attention and inform your doctor immediately if you experience symptoms such as difficulty breathing, swelling, dizziness, rapid heartbeat, sweating and loss of consciousness or rapid swelling under the skin in areas such as the face, throat, arms and legs, which can be life-threatening if the swelling of the throat blocks the airways.
Not known (frequency cannot be estimated from the available data)
Intestinal obstruction. Severe constipation with additional symptoms such as stomach pain, bloating, vomiting, etc.
Other side effects
Very common (may affect more than 1 in 10 people)
Headache
Nausea
Vomiting
Diarrhoea
Constipation
Stomach pain
Feeling weak or tired
These mainly occur when the dose is increased and usually disappear over time.

Common (may affect up to 1 in 10 people)
dizziness
upset stomach or indigestion
belching
flatulence
inflammation of the stomach (gastritis) - signs include stomach pain, nausea or vomiting
reflux or heartburn - also called gastroesophageal reflux disease
gallstones
hair loss
injection site reactions
change in the way food or drink tastes
change in the way your skin feels
low blood sugar (hypoglycaemia) in patients with type 2 diabetes.
Warning signs of low blood sugar can come on suddenly. These may include: cold sweat, cool pale skin, headache, fast heartbeat, feeling sick or very hungry, changes in vision, feeling sleepy or weak; feeling nervous, anxious or confused, having 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.
Your blood sugar level is more likely to fall if you are taking sulphonylureas or insulin. Your doctor may reduce the dose of these medicines before you start using this medicine.

Uncommon (may affect up to 1 in 100 people)
low blood pressure
dizziness or lightheadedness when standing up or sitting up from a lying position due to a sudden drop in blood pressure
rapid heartbeat
increased pancreatic enzymes (such as lipase and amylase) in blood tests
delayed emptying of the stomach.
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.
5. How to store Wegovy
Keep out of the reach and sight 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.

Before opening

Store in a refrigerator (2°C - 8°C). Do not freeze. Store away from the cooling element.

During use
You can use the pen for 6 weeks if stored below 30°C or in a refrigerator (2°C - 8°C) away from the cooling element. Do not freeze Wegovy and do not use it if it has been frozen.
When not in use, keep the pen cap on to protect from light.
Do not use this medicine if you notice that the solution is not clear and colourless.

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.

Wegovy 0.25 mg FlexTouch solution for injection
Each pre-filled pen contains 1 mg semaglutide in 1.5 ml (0.68 mg/ml).

Wegovy 0.5 mg FlexTouch solution for injection
1.5 ml: Each pre-filled pen contains 2 mg semaglutide in 1.5 ml (1.34 mg/ml). 3 ml: Each pre-filled pen contains 2 mg semaglutide in 3 ml (0.68 mg/ml).

Wegovy 1 mg FlexTouch solution for injection
Each pre-filled pen contains 4 mg semaglutide in 3 ml (1.34 mg/ml).

Wegovy 1.7 mg FlexTouch solution for injection
Each pre-filled pen contains 6.8 mg semaglutide in 3 ml (2.27 mg/ml).

Wegovy 2.4 mg FlexTouch solution for injection
Each pre-filled pen contains 9.6 mg semaglutide in 3 ml (3.2 mg/ml).

The other ingredients are disodium phosphate dihydrate, propylene glycol, phenol, hydrochloric acid/sodium hydroxide (for pH adjustment), water for injections. See also section 2 “Wegovy contains sodium” for information on sodium.
What Wegovy looks like and contents of the pack
Wegovy is a clear and colourless solution for injection in a pre-filled pen. Each pre-filled pen contains 4 doses.

Wegovy 0.25; 0.5; 1 and 1.7 mg FlexTouch solution for injection is available in the following pack sizes:

1 pre-filled pen and 4 NovoFine Plus disposable needles.

Wegovy 2.4 mg FlexTouch solution for injection is available in the following pack sizes:

1 pre-filled pen and 4 NovoFine Plus disposable needles.

3 pre-filled pens and 12 NovoFine Plus disposable needles.

Not all pack sizes may be marketed.

 

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