Wegovy

Package leaflet: Information for the patient

Wegovy 0.25 mg injectable solution in pre-filled pen, 0.5 mg injectable solution in pre-filled pen, 1 mg injectable solution in pre-filled pen, 1.7 mg injectable solution in pre-filled pen, 2.4 mg injectable solution in pre-filled pen

semaglutide
This medicinal product is subject to additional monitoring. This will allow rapid identification of new safety information. You can help by reporting any side effects you experience while taking this medicine. See the end of section 4 for information on how to report side effects.
Please read this leaflet carefully before using this medicine, as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, consult your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

1. What Wegovy is and what it is used for
2. What you need to know before using Wegovy
3. How to use Wegovy
4. Possible side effects
5. How to store Wegovy
6. Contents of the pack and other information

1. What is Wegovy and what is it used for

What is Wegovy
Wegovy is a medicine for weight loss and weight maintenance, containing 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. It acts on targets (receptors) in the brain that control appetite, inducing a feeling of fullness and reduced appetite, as well as decreased food cravings. In this way, it helps you eat less and reduce body weight. Wegovy may also help prevent heart disease.

What is Wegovy used for
Wegovy is used together with diet and physical activity for weight loss and to help maintain weight control. It is used in adults who have:

• a body mass index (BMI) of 30 kg/m² or higher (obesity), or
• a body mass index (BMI) of at least 27 kg/m² but below 30 kg/m² (overweight) who have weight-related health problems (such as diabetes, high blood pressure, abnormal blood fat levels, breathing problems during sleep called "obstructive sleep apnoea", or a history of heart attack, stroke, or blood vessel problems).

BMI is a measure of weight relative to height.
Wegovy is used for weight loss in addition to diet and physical activity in adolescents aged 12 years and older who have:

• obesity and
• body weight > 60 kg.

As an adolescent patient, continue using Wegovy only if you have lost at least 5% of your BMI after 12 weeks on a dose of 2.4 mg or the maximum tolerated dose (see section 3). Consult your doctor before continuing.

2. What you need to know before using Wegovy

Do not use Wegovy

• if you are allergic to semaglutide or to 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,
• have type 1 diabetes,
• have severely reduced kidney function,
• have severely reduced liver function,
• suffer from severe heart failure,
• have diabetic eye disease (retinopathy).

Experience with the use of Wegovy is limited in patients:

• aged 85 years or older,
• with liver problems.

Consult your doctor if any of the above conditions apply to you.
If you are scheduled for surgery under anesthesia, inform your doctor that you are taking Wegovy.

• Dehydration During treatment with Wegovy, you may experience nausea, vomiting, or diarrhea. These side effects can lead to dehydration (loss of fluids). It is important to drink plenty of fluids to prevent dehydration. This is particularly important if you have kidney problems. Speak to your doctor if you have any questions or concerns.
• Inflammation of the pancreas If you have severe and persistent pain in the stomach area (see section 4), contact a doctor immediately, as it may be a sign of inflammation of the pancreas (acute pancreatitis).
• People with type 2 diabetes Wegovy must not be used as a substitute for insulin. Do not use Wegovy in combination with other medicines containing GLP-1 receptor agonists (such as liraglutide, dulaglutide, exenatide, or lixisenatide).
• Low blood sugar levels (hypoglycaemia) Taking a sulfonylurea or insulin together with Wegovy may increase the risk of low blood sugar levels (hypoglycaemia). See section 4 for information on signs indicating low blood sugar levels. Your doctor may ask you to monitor your blood sugar levels. This will help your doctor decide whether the dose of sulfonylurea or insulin should be adjusted to reduce the risk of low blood sugar levels.
• Diabetic retinopathy (a diabetes complication affecting the eyes) If you have diabetic retinopathy and are using insulin, this medicine may lead to worsening of vision that may require treatment. Rapid improvement in blood glucose control may cause a temporary worsening of eye disorders. Inform your doctor if you have diabetic retinopathy or if you develop eye problems during treatment with this medicine.
• Sudden changes in vision If you notice sudden loss of vision or a rapid worsening of vision during treatment with this medicine, contact your doctor immediately for advice. This could be caused by a very rare side effect called non-arteritic anterior ischemic optic neuropathy (NAION) (see section 4: Serious side effects). Your doctor may recommend an eye examination and may need to discontinue treatment with this medicine.
• Patients with delayed gastric emptying (gastroparesis) If you suffer from slow (delayed) gastric emptying (called gastroparesis), using Wegovy may cause serious or severe gastrointestinal adverse events. Consult your doctor before using Wegovy.

Children and adolescents
The safety and efficacy of Wegovy have not been studied in children under 12 years of age, and its use is not recommended in this population.
Other medicines and Wegovy
Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines.
In particular, inform your doctor, pharmacist, or nurse if you are taking a medicine containing:

• Warfarin or other similar oral medicines used to reduce blood clotting (oral anticoagulants). When starting treatment with, for example, warfarin or similar medicines, you may be asked to have frequent blood tests to monitor your blood's clotting ability.

Pregnancy and breastfeeding
This medicine must not be used during pregnancy because it is not known whether it could harm the unborn baby. Therefore, you are advised to use a contraceptive method while using this medicine. If you plan to become pregnant, you should stop using this medicine at least two months before. If you become pregnant, suspect you are pregnant, or are planning a pregnancy while using this medicine, consult your doctor immediately, as treatment will need to be stopped.
Do not use this medicine if you are breastfeeding, as it is not known whether Wegovy passes into breast milk.
Driving and using machines
It is unlikely that Wegovy will affect your ability to drive or operate machinery. Some patients may experience dizziness when taking Wegovy, especially during the first 4 months of treatment (see section 4). If you feel dizzy, exercise caution when driving or operating machinery. If you need further information, speak to your doctor, pharmacist, or nurse.
People with type 2 diabetes
If you are using this medicine in combination with a sulfonylurea or insulin, low blood sugar levels (hypoglycaemia) may occur, which could impair your concentration. Avoid driving or operating machinery if you experience signs of low blood sugar levels. Refer to section 2 “Warnings and precautions” for information on the increased risk of low blood sugar levels and section 4 for signs indicating low blood sugar levels. Consult your doctor for further information.
Wegovy contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per dose, i.e., it is essentially “sodium-free”.

3. How to use Wegovy

Use this medicine exactly as instructed by your doctor. If you have any doubts, consult your
doctor, pharmacist, or nurse.
How much medicine to take
Adults
The recommended dose is 2.4 mg once a week.
Treatment will start at a low dose, which will be gradually increased over 16 weeks of treatment.

• When you start using Wegovy, the initial dose will be 0.25 mg once a week.
• Your doctor will instruct you to gradually increase the dose every 4 weeks until reaching the recommended dose of 2.4 mg once a week.
• Once the recommended dose of 2.4 mg has been reached, do not increase this dose further.
• If you experience significant nausea or vomiting, talk to your doctor about the possibility of delaying the dose increase or reducing the dose to the previous level until symptoms improve.

You will generally be asked to follow the table below.

Your doctor will periodically evaluate your treatment.
Adolescents (over 12 years of age)
Adolescents should follow the same dose-escalation schedule as adults (see above). The dose should be increased until reaching 2.4 mg (maintenance dose) or the maximum tolerated dose. Weekly doses of Wegovy higher than 2.4 mg are not recommended.

How Wegovy is administered
Wegovy is administered as an injection under the skin (subcutaneous injection). Do not inject it into a vein or muscle.

• The best sites for injection are the front of the upper arm, the upper legs, 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 provided on the back of this leaflet.

People with type 2 diabetes
Inform your doctor if you have type 2 diabetes. Your doctor may adjust the dose of your diabetes medications to prevent low blood sugar levels.

When to use Wegovy

• You should use this medicine once a week, preferably on the same day each week.
• You may administer the injection at any time of day, regardless of meals.

If necessary, you may change the day of your weekly injection, provided at least 3 days have passed since your last dose. Once you have chosen a new day for administration, continue taking the medicine once weekly on that day.

If you use more Wegovy than you should
Contact your doctor immediately. You may experience side effects such as nausea, vomiting, or diarrhea, which could lead to dehydration (loss of fluids).

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

• 5 days or fewer have passed since you were supposed to use Wegovy, inject it as soon as you remember. Then take your next dose as usual on your scheduled day.
• more than 5 days have passed since you were supposed to use Wegovy, skip the missed dose. Then inject your next dose as usual on your next scheduled day. Do not use a double dose to make up for the missed dose.

If you stop treatment with Wegovy
Do not stop treatment with this medicine without first talking to your doctor.
If you have any questions about how to use this medicine, speak with your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Serious side effects
Common (may affect up to 1 in 10 people)

• Retinopathy complications. If you have diabetes and experience eye problems such as changes in vision during treatment with this medicine, inform your doctor.

Uncommon (may affect up to 1 in 100 people)

• Inflammation of the pancreas (acute pancreatitis). Signs of pancreas inflammation may include severe, persistent stomach pain that may spread to the back. You must consult 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 must seek immediate medical assistance and inform your doctor right away if you experience symptoms such as difficulty breathing, swelling, mild confusion, rapid heartbeat, sweating, loss of consciousness, or sudden swelling under the skin in areas such as the face, throat, arms, and legs, which can be life-threatening if swelling in the throat blocks the airways.

Very rare (may affect up to 1 in 10,000 people)

• A medical condition affecting the eye called non-arteritic anterior ischemic optic neuropathy (NAION), which can cause painless vision loss in one eye. You must contact your doctor immediately if you notice sudden vision loss or gradual worsening of vision (see section 2: "Sudden changes in vision").

Not known (frequency cannot be estimated from available data)

• Intestinal obstruction. A severe form of 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
• fatigue or weakness
  • these side effects are mainly observed during dose escalation and usually resolve over time.

Common (may affect up to 1 in 10 people)

• dizziness
• stomach pain or indigestion
• belching
• intestinal gas (flatulence)
• stomach bloating
• inflammation of the stomach (gastritis): signs include stomach pain, nausea, and vomiting
• reflux or heartburn, also known as "gastroesophageal reflux disease"
• gallstones
• hair loss
• injection site reactions
• altered taste of food or drink
• altered skin sensation
• low blood sugar levels (hypoglycaemia) in patients with type 2 diabetes.

Signs indicating low blood sugar levels may occur suddenly. They may include: cold sweating, paleness and cold skin, headache, rapid heartbeat, nausea or feeling very hungry, changes in vision, drowsiness or feeling weak, nervousness, anxiety or confusion, difficulty concentrating or tremor.
Your doctor will advise you on how to manage low blood sugar levels and what to do if you notice these signs.
Low blood sugar levels are more likely to occur if you are also taking a sulphonylurea or insulin. Before you start using Wegovy, your doctor may reduce the dose of these medicines.
Uncommon (may affect up to 1 in 100 people)

• low blood pressure
• feeling dizzy or lightheaded when standing up or sitting down due to a drop in blood pressure
• rapid heartbeat
• increased levels of pancreatic enzymes (such as lipase and amylase) found in blood tests
• delayed stomach emptying.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly through the national reporting system listed in Annex V. 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 stated on the pen label and on the carton after "Exp.". The expiry date refers to the last day of that month.
Store in the refrigerator (2 °C – 8 °C). Do not freeze. Keep away from refrigerating elements.
Always store the pen in its original packaging to protect the medicine from light.
Wegovy may be stored unrefrigerated for up to 28 days at a temperature not exceeding 30 °C.
Dispose of the pen if it has been exposed to light or temperatures above 30 °C, has been kept outside the refrigerator for more than 28 days, or has been frozen.
Do not use this medicine if you notice that the solution is not clear and colourless.
After use: the pen is for single use only and contains a single dose. Dispose of the pen after use.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Wegovy contains

• The active substance is semaglutide.
  Wegovy 0.25 mg injectable solution
  Each pre-filled pen contains 0.25 mg of semaglutide in 0.5 mL (0.5 mg/mL).
  Wegovy 0.5 mg injectable solution
  Each pre-filled pen contains 0.5 mg of semaglutide in 0.5 mL (1 mg/mL).
  Wegovy 1 mg injectable solution
  Each pre-filled pen contains 1.0 mg of semaglutide in 0.5 mL (2 mg/mL).
  Wegovy 1.7 mg injectable solution
  Each pre-filled pen contains 1.7 mg of semaglutide in 0.75 mL (2.27 mg/mL).
  Wegovy 2.4 mg injectable solution
  Each pre-filled pen contains 2.4 mg of semaglutide in 0.75 mL (3.2 mg/mL).

• The other components are: disodium phosphate dihydrate, sodium chloride, hydrochloric acid/sodium hydroxide (for pH adjustment), water for injections. See also section 2 "Wegovy contains sodium" for information on sodium.

Description of the appearance of Wegovy and contents of the pack
Wegovy is a clear, colourless injectable solution in a single-use pre-filled pen.
Each pen contains a single dose.
Pack containing 4 pre-filled pens.
Marketing Authorisation Holder and Manufacturer
Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd
Denmark
Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu .

Package leaflet: Information for the patient Foglio illustrativo: informazioni per il paziente

Wegovy

0.25 mg 0.25 mg 0.5 mg 0.5 mg 1 mg 1 mg 1.7 mg 1.7 mg 2.4 mg 2.4 mg
Wegovy 0.25 mg solution for injection in pre-filled pen
Wegovy 0.5 mg solution for injection in pre-filled pen
Wegovy 1 mg solution for injection in pre-filled pen
Wegovy 1.7 mg solution for injection in pre-filled pen
Wegovy 2.4 mg solution for injection in pre-filled pen
semaglutide semaglutide
Pull out to get started Pull out to get started
Use Wegovy one time each week Use Wegovy one time each week
Instructions on how to use the Wegovy pen
Important information before starting
The package contains a package leaflet and four pre-filled Wegovy pens.
This section of the package leaflet provides instructions on how to use the pen. For further
information about the medicine, please refer to the back of this leaflet.
Each pen must be used only once.
It comes with:

• a pre-set dose.
• a needle cover cap that conceals the integrated needle before, during, and after use.
• an automatic delivery mechanism that starts when the needle cover cap is pressed against the skin, as instructed by your doctor or nurse.

When the dose is being injected, a yellow bar will appear in the pen window. Before lifting the
pen, you must wait until the yellow bar stops moving. Otherwise, the automatic delivery will continue,
but you may not receive the full dose.
The needle cover cap locks when the pen is removed from the skin. You cannot stop the injection and resume it later.
People who are blind or have visual impairments must not use the Wegovy pen without the assistance of someone trained in using Wegovy.
Always remember to follow these instructions for use, as well as any instructions provided by your doctor or nurse.

Before use After use
Expiry date
(on the back)
Check that Wegovy
has not expired
Window of the pen
Always check that you
have the correct medicine
and dose. O:
Check that the
yellow bar has
Window of the pen
stopped moving to
Check that Wegovy is
ensure you have
clear and colourless.
received the full dose
Air bubbles are normal.
They do not affect the dose.
Cap
Cap
needle cover
needle cover
Locks after use
The needle is hidden
inside after use
Pen cap
Remove shortly
before injecting
EXP/ XX/XXXX
Batch: AB1234
0.25 mg 0.5 mg 1 mg 1.7 mg 2.4 mg

How to use Wegovy

1. Prepare to inject. 2. Remove the cap

from the pen.
Check the Wegovy pen carefully and do not use it if:
Pull the pen cap

1. it is past the expiry date
2. it appears to have been used or damaged (e.g. if it has been dropped or stored incorrectly)
3. the medicine appears cloudy.

straight off the pen.

Choose the injection site
Choose an injection site in one of the body areas
indicated below. You may choose the upper arms,
thighs, or abdomen (keep a distance of 5 cm from the
navel). You may inject in the same body area each
week, but make sure it is not the exact same spot used
the previous time.

Upper arms
Abdomen
Upper thighs

3. Injecting Wegovy

The injection
takes about 5–10
Press the pen firmly against the
seconds
skin until the yellow bar has
stopped moving.
If the yellow bar does not start moving, press the pen more
Click 1
firmly against the skin
The injection
starts.
Click 2
Keep pressing for
a few seconds until
the yellow bar
stops
moving.
The yellow bar has
stopped moving.
The injection is
complete.
Remove the pen
slowly and dispose
of it safely.

How can I handle the pen safely?
For information about the medicine, please see the back of this leaflet.

• The pen is for one single subcutaneous injection of Wegovy, once weekly, and must be used by only one person.
• Always follow the instructions provided on the back of this leaflet and make sure your doctor or nurse has shown you how to use these pens.
• Keep Wegovy out of sight and reach of children at all times. Also, keep the pen cap out of reach of children to prevent accidental swallowing.
• Handle the pen carefully and do not expose it to any liquids. Rough handling or improper use may cause the pen to deliver less than the full dose or no dose at all.
• Do not remove the pen cap until you are ready to inject. The pen will no longer be sterile if stored unused without the cap, if the cap is removed and then replaced, or if the cap is missing. This could lead to infection.
• Be careful when handling the pen before use and do not touch the needle or the needle cover. The hidden needle may cause needle-stick injuries.
• Each pen contains one weekly dose and cannot be reused. Dispose of the pen after use.

How should I store unused pens?
For storage information, please refer to section 5 on the back of this leaflet.
How should I dispose of the pens?
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

Patient information leaflet

Wegovy 0.25 mg FlexTouch injectable solution in pre-filled pen, 0.5 mg FlexTouch injectable solution in pre-filled pen, 1 mg FlexTouch injectable solution in pre-filled pen, 1.7 mg FlexTouch injectable solution in pre-filled pen, 2.4 mg FlexTouch injectable solution in pre-filled pen

semaglutide
This medicinal product is subject to additional monitoring. This will allow for rapid identification of new safety information. You can help by reporting any side effects you experience while taking this medicinal product. See the end of section 4 for information on how to report side effects.
Please read this leaflet carefully before using this medicine, as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

1. What Wegovy is and what it is used for
2. What you need to know before using Wegovy
3. How to use Wegovy
4. Possible side effects
5. How to store Wegovy
6. Contents of the pack and other information

1. What is Wegovy and what is it used for

What is Wegovy
Wegovy is a medicine for weight loss and weight maintenance, containing 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. It acts on targets (receptors) in the brain that regulate appetite, inducing a feeling of fullness and reduced appetite, as well as decreased food cravings. In this way, it helps you eat less and reduce body weight. Wegovy may also help prevent heart disease.
What Wegovy is used for
Wegovy is used together with diet and physical activity for weight loss and to help maintain weight control. It is used in adults who have:

• a body mass index (BMI) of 30 kg/m² or higher (obesity), or
• a body mass index (BMI) of at least 27 kg/m² but below 30 kg/m² (overweight) who have weight-related health problems (such as diabetes, high blood pressure, abnormal blood fat levels, breathing problems during sleep called "obstructive sleep apnoea", or a history of heart attack, stroke, or blood vessel problems).

BMI is a measure of weight in relation to height.
Wegovy is used for weight management in addition to diet and exercise in adolescents aged 12 years and older who have:

• obesity and
• body weight > 60 kg.

As an adolescent patient, continue using Wegovy only if you have lost at least 5% of your initial body weight after 12 weeks on a 2.4 mg dose or the maximum tolerated dose (see section 3). Consult your doctor before continuing.

2. What you need to know before using Wegovy

Do not use Wegovy

• if you are allergic to semaglutide or to 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,
• have type 1 diabetes,
• have severely reduced kidney function,
• have severely reduced liver function,
• suffer from severe heart failure,
• have diabetic eye disease (retinopathy).

Experience with the use of Wegovy is limited in patients:

• aged 85 years or older,
• with liver problems.

Consult your doctor if any of the above conditions apply to you.
If you are scheduled for surgery under anesthesia, inform your doctor that you are taking
Wegovy.

• Dehydration During treatment with Wegovy, you may experience nausea, vomiting, or diarrhea. These side effects may cause dehydration (loss of fluids). It is important to drink plenty of fluids to prevent dehydration. This is particularly 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 the stomach area (see section 4), contact a doctor immediately, as it may be a sign of inflammation of the pancreas (acute pancreatitis).

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

• Low blood sugar levels (hypoglycaemia) Taking a sulphonylurea or insulin together with Wegovy may increase the risk of low blood sugar levels (hypoglycaemia). See section 4 for information on signs indicating low blood sugar levels. Your doctor may ask you to monitor your blood sugar levels. This will help your doctor decide whether the dose of sulphonylurea or insulin should be adjusted to reduce the risk of low blood sugar levels.

• Diabetic retinopathy (a diabetes complication affecting the eyes) If you have diabetic retinopathy and are using insulin, this medicine may lead to worsening of vision that may require treatment. Rapid improvement in blood glucose control may temporarily worsen eye disorders. Inform your doctor if you have diabetic retinopathy or if you develop eye problems during treatment with this medicine.

• Sudden changes in vision If you notice sudden loss of vision or a rapid worsening of vision during treatment with this medicine, contact your doctor immediately for advice. This could be caused by a very rare side effect called non-arteritic anterior ischemic optic neuropathy (NAION) (see section 4: Serious side effects). Your doctor may recommend an eye examination and may need to discontinue treatment with this medicine.

• Patients with delayed gastric emptying (gastroparesis) If you suffer from slow (delayed) gastric emptying (called gastroparesis), using Wegovy may cause severe or serious gastrointestinal adverse events. Consult your doctor before using Wegovy.

Children and adolescents
The safety and efficacy of Wegovy has not been studied in children under 12 years of age, and its use is not recommended in this population.
Other medicines and Wegovy
Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines.
In particular, inform your doctor, pharmacist, or nurse if you are taking a medicine containing:

• Warfarin or similar oral medicines used to reduce blood clotting (oral anticoagulants). When starting treatment with, for example, warfarin or similar medicines, you may be asked to have frequent blood tests to monitor your blood's ability to clot.

Pregnancy and breastfeeding
This medicine must not be used during pregnancy because it is not known whether it could harm the unborn child. Therefore, you are advised to use a contraceptive method while using this medicine. If you plan to become pregnant, you must stop using this medicine at least two months before. If you become pregnant, suspect you are pregnant, or are planning a pregnancy while using this medicine, consult your doctor immediately, as treatment will need to be stopped.
Do not use this medicine if you are breastfeeding, as it is not known whether Wegovy passes into breast milk.
Driving and using machines
It is unlikely that Wegovy will affect your ability to drive or use machines. Some patients may experience dizziness when taking Wegovy, especially during the first 4 months of treatment (see section 4). If you experience dizziness, be very careful when driving or using machines. If you need further information, talk to your doctor, pharmacist, or nurse.
People with type 2 diabetes
If you use this medicine in combination with a sulphonylurea or insulin, low blood sugar levels (hypoglycaemia) may occur, which can impair your concentration. Avoid driving or using machines if you experience signs of low blood sugar levels. See section 2 “Warnings and precautions” for information on the increased risk of low blood sugar levels and section 4 for signs indicating low blood sugar levels. Consult your doctor for further information.
Wegovy contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per dose, i.e., it is essentially “sodium-free”.

3. How to use Wegovy

Use this medicine exactly as instructed by your doctor. If you have any doubts, consult your
doctor, pharmacist, or nurse.
How much medicine to take
Adults
Treatment will start with a low dose, which will be gradually increased over 16 weeks of treatment.

• When you start using Wegovy, the initial dose will be 0.25 mg once a week.
• Your doctor will instruct you to gradually increase the dose every 4 weeks until you reach the dose of 2.4 mg once a week.
• If necessary, the dose may be increased to the next maintenance dose of 7.2 mg once weekly (3 injections of 2.4 mg) after at least 4 weeks at 2.4 mg.
• The maximum dose is 7.2 mg once a week.
• If you experience significant nausea or vomiting, talk to your doctor about the possibility of delaying the dose increase or reducing the dose to the previous level until symptoms improve.

You will generally be asked to follow the table below.

Your doctor will periodically review your treatment.
Adolescents (over 12 years of age)
Adolescents should follow the same dose-escalation regimen as adults (see above). The dose should be increased until reaching 2.4 mg (maintenance dose) or the maximum tolerated dose. Weekly doses of Wegovy higher than 2.4 mg are not recommended.
How Wegovy is administered
Wegovy is administered by subcutaneous injection (injection under the skin). Do not inject it into a vein or muscle.

• The best sites for injection are the front of the upper arm, the upper thighs, or the abdomen.
• Before you use the pen for the first time, your doctor, pharmacist, or nurse will show you how to use it. For Wegovy 7.2 mg, inject three doses of 2.4 mg one after the other. Injections may be given in the same body area, but must be at least 5 cm apart. Detailed instructions on how to use the pen are provided on the back of this leaflet.

People with type 2 diabetes
Inform your doctor if you have type 2 diabetes. Your doctor may adjust the dose of your diabetes medications to prevent low blood sugar levels.
When to use Wegovy

• You should use this medicine once a week, preferably on the same day each week.
• You may administer the injection at any time of day, regardless of meals.

If necessary, you may change the day of your weekly injection, provided at least 3 days have passed since your last dose. Once you have chosen a new administration day, continue taking the medicine once weekly.
If you use more Wegovy than you should
Contact your doctor immediately. You may experience side effects such as nausea, vomiting, or diarrhea, which can lead to dehydration (loss of fluids).
If you forget to use Wegovy
If you forget to inject a dose and:

• 5 days or fewer have passed since you were supposed to use Wegovy, inject the missed dose as soon as you remember. Then take the next dose on your regularly scheduled day.
• more than 5 days have passed since you were supposed to use Wegovy, skip the missed dose. Then inject the next dose on your next scheduled day. Do not use a double dose to make up for the missed dose.

If you stop using Wegovy
Do not stop treatment with this medicine without discussing it with your doctor.
If you have any questions about how to use this medicine, speak with your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

Serious side effects

Common (may affect up to 1 in 10 people)

• Complications of retinopathy. If you have diabetes, tell 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)

• Inflammation of the pancreas (acute pancreatitis). Signs of pancreas inflammation may include persistent, severe stomach pain that may spread to the back. You must consult your doctor immediately if you experience these symptoms.

Rare (may affect up to 1 in 1,000 people)

• Serious allergic reactions (anaphylactic reactions, angioedema). You must seek immediate medical attention and inform your doctor right away if you experience symptoms such as difficulty breathing, swelling, mild confusion, rapid heartbeat, sweating, loss of consciousness, or sudden swelling under the skin in areas such as the face, throat, arms, and legs. Swelling in the throat can be life-threatening if it blocks the airways.

Very rare (may affect up to 1 in 10,000 people)

• A medical condition of the eye called non-arteritic anterior ischemic optic neuropathy (NAION), which can cause painless vision loss in one eye. You must contact your doctor immediately if you notice sudden vision loss or gradual worsening of vision (see section 2: "Sudden vision changes").

Not known (frequency cannot be estimated from available data)

• Intestinal obstruction. A severe form of 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

• tiredness or weakness

  • these side effects are mainly observed during dose escalation and usually resolve over time.

Common (may affect up to 1 in 10 people)

• dizziness
• stomach pain or indigestion
• belching
• intestinal gas (flatulence)
• stomach bloating
• inflammation of the stomach (gastritis): signs include stomach pain, nausea, and vomiting
• reflux or heartburn, also known as "gastroesophageal reflux disease"
• gallstones
• hair loss – may occur more frequently with semaglutide 7.2 mg
• injection site reactions
• altered taste of food or drink
• changes in skin sensitivity – this usually resolves over time and may occur more frequently with semaglutide 7.2 mg
• low blood sugar levels (hypoglycaemia) in patients with type 2 diabetes.

Signs indicating low blood sugar levels may occur suddenly. They may include: cold, clammy skin, paleness, headache, rapid heartbeat, nausea or feeling very hungry, changes in vision, drowsiness or feeling weak, nervousness, anxiety or confusion, difficulty concentrating, or tremor.

Your doctor will advise you on how to manage low blood sugar levels and what to do if you notice these signs.

Low blood sugar levels are more likely if you are also taking a sulfonylurea or insulin. Before you start using Wegovy, your doctor may reduce the dose of these medicines.

Uncommon (may affect up to 1 in 100 people)

• low blood pressure
• feeling dizzy or lightheaded when standing up or sitting down due to a drop in blood pressure
• rapid heartbeat
• increased levels of pancreatic enzymes (such as lipase and amylase) found in blood tests
• delayed stomach emptying

Reporting of side effects

If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly through the national reporting system listed in Annex V. 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 stated on the pen label and on the carton after "Exp.". The expiry date refers to the last day of that month.
Before first use
Store in a refrigerator (2 °C – 8 °C). Do not freeze. Store away from refrigerating elements.
Protect the medicine from light.
During use

• The pen may be stored for up to 6 weeks, either at a temperature below 30 °C or in a refrigerator (2 °C – 8 °C), away from refrigerating elements. 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 it from light.

Do not use this medicine if you notice that the solution is not clear and colourless.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Wegovy contains

• The active substance is semaglutide.
  Wegovy 0.25 mg FlexTouch injectable solution: Each pre-filled pen contains 1 mg of semaglutide in 1.5 mL (0.68 mg/mL).

Wegovy 0.5 mg FlexTouch injectable solution
1.5 mL: Each pre-filled pen contains 2 mg of semaglutide in 1.5 mL (1.34 mg/mL).
3 mL: Each pre-filled pen contains 2 mg of semaglutide in 3 mL (0.68 mg/mL).
Wegovy 0.5 mg FlexTouch injectable solution
Each pre-filled pen contains 2 mg of semaglutide in 3 mL (0.68 mg/mL).
Wegovy 1 mg FlexTouch injectable solution
Each pre-filled pen contains 4 mg of semaglutide in 3 mL (1.34 mg/mL).
Wegovy 1.7 mg FlexTouch injectable solution
Each pre-filled pen contains 6.8 mg of semaglutide in 3 mL (2.27 mg/mL).
Wegovy 2.4 mg FlexTouch injectable solution
Each pre-filled pen contains 9.6 mg of 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.

Description of the appearance of Wegovy and package contents
Wegovy is a clear, colourless injectable solution in a pre-filled pen.
Each pre-filled pen contains 4 doses. After injecting the 4 doses, some solution may still remain in the pen, even though administration has been performed correctly. The remaining solution is not sufficient for a full dose, and the pen must be discarded.
Wegovy 0.25 mg FlexTouch, 0.5 mg FlexTouch, 1 mg FlexTouch and 1.7 mg FlexTouch injectable solution are available in the following pack:
1 pre-filled pen and 4 NovoFine Plus disposable needles.
Wegovy 2.4 mg FlexTouch injectable solution is available in the following packs:
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.

Marketing Authorization Holder
Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd
Denmark

Manufacturer
Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd
Denmark
Novo Nordisk Production SAS
45, Avenue d’Orléans
28000 Chartres
France

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu.

Instructions for the use of Wegovy

Before starting to use the Wegovy FlexTouch pen once weekly, always read
carefully these instructions and speak with your doctor, nurse, or pharmacist about how to correctly
administer the Wegovy injection.
The Wegovy pen is a dosing pen that contains four doses of Wegovy.
Use the table inside the package lid to keep track of the injections you have administered and
the remaining doses in the pen.
Wegovy is available in five different pen variants, each containing one of the following doses of
semaglutide:

0.25 mg 0.5 mg 1 mg 1.7 mg 2.4 mg
Before starting, always check the label on the pen to ensure it contains the dose of Wegovy
prescribed for you.
The pen is designed to be used with disposable 30G, 31G, and 32G needles up to 8 mm in length.
The package contains:

• Wegovy pen
• 4 NovoFine Plus needles
• Instruction leaflet

Wegovy FlexTouch Pen

NovoFine Plus needle (example)
1 Preparing the pen with a new needle
Check the name and dose of the pen to ensure it contains

the dose of Wegovy prescribed for you.
Remove the pen cap.
(See figure A).
Check that the Wegovy solution inside the pen is
clear and colorless.
Look through the pen window. If Wegovy appears cloudy
or colored, do not use the pen.
(See figure B)
Always use a new needle for each injection.

Take a new needle when you are ready to administer the injection.
Check that the protective seal and the outer needle cap are undamaged, as damage could
compromise sterility. If you notice any damage, use a new needle.
Remove the protective seal.
(See figure C).
Push the needle straight onto the pen. Rotate it until
it is securely attached.
(See figure D).
The needle is covered by two caps. You must remove
both.
If you forget to remove both caps, the dose of Wegovy
will not be injected.
Remove the outer needle cap and keep it for later. You
will need it to safely remove the needle from the pen after
the injection.
Remove the inner needle cap and discard it. A
drop of Wegovy may appear at the tip of the needle. You must
still check the flow of Wegovy if using a new pen for the first time. See section “Checking flow
with each new pen”.
Never use a bent or damaged needle. For further information
on handling needles, see section “Needle information” below these instructions.
(See figure E).
Checking flow with each new pen
If your Wegovy pen is already in use, go to section

“ 2 Setting the dose ”.
Check the flow of Wegovy only before the first injection with
each new pen.
Rotate the dose selector until you see the flow check symbol ( ).

(See figure F).
Ensure that the flow check symbol is aligned with

the dose indicator.
(See figure G).
Flow check
Hold the pen with the needle pointing upward.

Press and hold the injection button until the dose counter returns to . The symbol should be aligned with

the dose indicator.
A drop of Wegovy should appear at the tip of the needle. This
drop indicates that the pen is ready for use.
If no drop appears, repeat the flow check. This procedure must be performed only twice.
If no drop still appears, replace the needle and check the flow again.
Do not use the pen if no drop of Wegovy appears.
(See figure H),
2 Setting the dose
Rotate the dose selector until the dose counter

stops and displays the prescribed dose.
(See figure I).

The dashed line ( ) in the dose counter will guide you to your
prescribed dose.
The dose selector makes a distinct click when rotated forward, backward, or when the dose is exceeded. You will hear a
“click” each time the dose selector rotates. Do not set the dose by counting the number of clicks you hear.
(See figure J).
When the prescribed dose is aligned with the dose indicator,

this means you have selected your dose. In the adjacent figure,
the dose is shown as an example.
If the dose counter stops before reaching the prescribed dose, refer to the section “Is the amount of Wegovy sufficient?” in these instructions.
(See figure K).
Choosing the injection site

Choose the upper arms, upper thighs, or abdomen (keeping a distance of 5 cm
from the navel).
You may administer the injection in the same body area, but ensure it is not at the exact spot used last time.
3 Injecting the dose
Insert the needle into the skin.

Ensure that the dose counter is visible. Do not cover it with
your fingers, as the injection may be interrupted.
(See figure L).
Press and hold the injection button until the

dose counter shows the symbol .

(See figure M).
Continue holding the injection button with the needle in the skin and
count slowly to 6. The symbol must be aligned with
the dose indicator. You will hear a click when the dose counter returns to .

(See figure N).

Count slowly
1-2-3-4-5-6
Remove the needle from the skin. If the needle is removed prematurely,
Wegovy may leak from the needle tip and the full dose will not be delivered.
If bleeding occurs at the injection site, apply light pressure to stop the bleeding.
After injection, a drop of Wegovy may be visible at the needle tip. This is normal and does not affect the dose.
(See figure O).
4 After the injection
Place the needle tip into the outer needle cap

placed on a flat surface without touching the needle or the
outer needle cap.
Once the needle is covered, carefully press the outer needle cap fully into place.
(See figure P).
Unscrew the needle and dispose of it carefully according to instructions from your doctor,
nurse, pharmacist, or local authorities.
Never try to reinsert the inner needle cap
onto the needle. You may prick yourself with the needle.
Always dispose of the needle immediately after each injection to prevent needle blockage, contamination, infection, and incorrect dosing. Never store the pen with the needle attached.
(See figure Q).
Replace the pen cap after each use to protect

Wegovy from light.
(See figure R).
When the pen is empty, dispose of it without the needle as instructed by your doctor, nurse, pharmacist, or local authorities.
The pen cap and empty packaging can be discarded in household waste.
Needle information
How to identify a blocked or damaged needle

• If the symbol does not appear on the dose counter after
  continuously pressing the injection button, a blocked or damaged needle may have been used.

• In this case, no dose of Wegovy has been administered, even if the dose counter has moved from the originally set dose.

How to handle a blocked needle

• Replace the needle as described in section “1 Preparing the pen with a new needle” and proceed to section “2 Setting the dose”.

Pen maintenance
Handle the pen with care. Improper or careless use may result in incorrect administration. In such cases, you may not achieve the desired effect from Wegovy.

• Refer to the back of this instruction leaflet for storage conditions of the pen.
• Do not inject Wegovy if it has been exposed to direct sunlight.
• Do not freeze Wegovy and never inject Wegovy if it has been frozen. Dispose of the pen.
• Do not drop the pen or allow it to hit hard surfaces.
• Do not attempt to refill the pen. Once empty, it must be discarded.
• Do not attempt to repair or disassemble the pen.
• Do not expose the pen to dust, dirt, or liquids.
• Do not wash, immerse in liquid, or lubricate the pen. If necessary, clean it with a neutral detergent on a damp cloth.

Is the amount of Wegovy sufficient?
If the dose counter stops before reaching the prescribed

dose, this means there is not enough Wegovy left for a complete dose. Dispose of the Wegovy pen and
use a new pen.

Important information

• Use Wegovy only once a week as prescribed. If you do not take Wegovy as prescribed, you may not achieve the desired effect of this medicine.
• If you use more than one type of injectable medicine, it is very important to check the name and dose on the pen label before use.
• If you have vision problems and cannot follow these instructions, do not use this pen without assistance. Ask someone with good vision who has been properly trained to use the Wegovy pen to help you.
• Always keep the pen and needles out of sight and reach of others, especially children.
• Never share the pen or needles with other people.
• Needles are for single use only. Never reuse needles, as this prevents needle blockage, contamination, infections, and incorrect dosing.
• Caregivers must be very careful when handling used needles to avoid accidental needlestick injuries and infections.