Patient Information Leaflet

Wegovy 0.25 mg FlexTouch pre-filled pen injectable solution

Wegovy 0.5 mg FlexTouch pre-filled pen injectable solution

Wegovy 1 mg FlexTouch pre-filled pen injectable solution

Wegovy 1.7 mg FlexTouch pre-filled pen injectable solution

Wegovy 2.4 mg FlexTouch pre-filled pen injectable solution

semaglutide

This medicine is subject to additional monitoring, which will speed up the detection of new information about its safety. You can contribute by reporting any adverse effects you may experience. The final part of section 4 includes information on how to report these adverse effects.

Read this leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you are unsure, consult your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only; do not give it to others even if they have similar symptoms, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

What is Wegovy

Wegovy is a weight loss and maintenance medication that contains the active ingredient semaglutide. It is similar to a naturally occurring hormone called glucagon-like peptide-1 (GLP-1) that is released from the intestines after eating. It works by acting on regions (receptors) in the brain that control appetite, causing you to feel fuller and less hungry, and to experience less food cravings. This will help you eat fewer foods and reduce your body weight. Wegovy may also help prevent heart disease.

How is Wegovy used

Wegovy is used in combination with diet and physical activity to lose weight and 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 BMI of at least 27 kg/m², but less than 30 kg/m² (overweight) who have health problems related to weight (such as diabetes, high blood pressure, abnormal levels of fats in the blood, sleep apnea, or a history of heart attack, stroke, or vascular problems).

The BMI (Body Mass Index) is a measure of weight in relation to height.

Wegovy is used in combination with diet and physical activity for weight control in adolescents aged 12 years and older with

• obesity and
• a body weight > 60 kg.

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

No use Wegovy

• if you are allergic to semaglutide or any of the other components of this medication (listed in section6).

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to use Wegovy.

This medication is not recommended for use if:

• you are using other weight loss products,
• you have type1 diabetes,
• you have severely reduced kidney function,
• you have severely reduced liver function,
• you have severe heart failure,
• you have diabetic eye disease (retinopathy).

There is limited experience with Wegovy in patients:

• 85years of age or older,
• with liver problems,
• with severe stomach or intestinal problems that cause delayed stomach emptying (gastroparesia) or any inflammatory intestinal disease.

Consult your doctor if you fall into any of the above cases.

If you are planning to undergo surgery under anesthesia (sleep state), inform your doctor that you are taking Wegovy.

• Dehydration

During treatment with Wegovy, you may experience nausea, vomiting, or diarrhea. These side effects can cause dehydration (loss of fluids). It is essential to drink enough liquids to prevent dehydration. This is especially important if you have kidney problems. If you have any doubts or concerns, consult your doctor.

• Pancreatitis

If you experience severe and persistent pain in the stomach area (see section 4), seek medical attention immediately, as it could be a symptom of acute pancreatitis.

• Patients with type2 diabetes

Wegovy cannot be used as a substitute for insulin. Do not use Wegovy in combination with other medications containing GLP-1 receptor agonists (such as liraglutide, dulaglutide, exenatide, or lixisenatide).

• Hypoglycemia

Combining Wegovy with sulfonylurea or insulin may increase the risk of experiencing low blood sugar (hypoglycemia). To know the warning signs of low blood sugar, see section 4. Your doctor may ask you to measure your blood sugar levels. This will help your doctor decide if you need to adjust the dose of sulfonylurea or insulin to reduce the risk of low blood sugar.

• Diabetic eye disease (retinopathy)

If you have diabetic eye disease and are using insulin, this medication may worsen your vision and may require treatment. Sudden improvements in blood sugar control may temporarily worsen diabetic eye disease. Inform your doctor if you have diabetic eye disease and experience eye problems while taking this medication.

Children and adolescents

Wegovy has not been studied in children under 12years of age, and its use is not recommended in this population.

Other medications and Wegovy

Inform your doctor, pharmacist, or nurse if you are using, have used recently, or may need to use any other medication.

Particularly, inform your doctor, pharmacist, or nurse if you are using medications containing the following:

• Warfarin or other oral anticoagulants taken to reduce blood clotting. When starting treatment with warfarin or similar medications, you may need to have frequent blood tests to determine your blood clotting ability.

Pregnancy and breastfeeding

This medication should not be used during pregnancy because its effects on the fetus are unknown. Therefore, it is recommended to use contraceptive methods during treatment with this medication. If you become pregnant or are planning to become pregnant, you should discontinue use of this medication at least two months in advance. If you become pregnant or are pregnant, inform your doctor immediately, as you will need to discontinue treatment.

This medication should not be used during breastfeeding, as its excretion in breast milk is unknown.

Driving and operating machinery

It is unlikely that Wegovy will affect your ability to drive and operate machinery. Some patients may feel dizzy when using Wegovy, mainly during the first 4months of treatment (see section4). If you feel dizzy, exercise extra caution when driving or operating machinery. If you need more information, consult your doctor, pharmacist, or nurse.

Patients with type2 diabetes

If you are using this medication in combination with sulfonylurea or insulin, you may experience low blood sugar (hypoglycemia), which may reduce your ability to concentrate. Avoid driving or operating machinery if you experience any symptoms of low blood sugar. See section2, “Warnings and precautions” for information on the increased risk of low blood sugar and section4 to know the warning signs of low blood sugar. For additional information, consult your doctor.

Wegovy contains sodium

This medication contains less than 1mmol of sodium (23mg) per dose; it is essentially “sodium-free.”

Follow the exact administration instructions indicated by your doctor. If in doubt, consult your doctor, pharmacist, or nurse again.

How much to use

Adults

The recommended dose is 2.4mg once a week.

Treatment will begin with a low dose that will be gradually increased over 16weeks of treatment.

• When starting to use Wegovy, the initial dose is 0.25mg once a week.
• Your doctor will instruct you to gradually increase the dose every 4weeks until reaching the recommended dose of 2.4mg once a week.
• Once you reach the recommended dose of 2.4mg, do not increase this dose further.
• If you feel very uncomfortable due to nausea or vomiting, talk to your doctor about the possibility of delaying the dose escalation or reducing the dose to the previous one until the symptoms have improved.

Normally, you will be instructed to follow the following table.

Your doctor will regularly evaluate your treatment.

Adolescents (over 12years old)

For adolescents, the same dose escalation schedule as for adults (see above) should be applied. The dose should be increased to 2.4mg (maintenance dose) or until the maximum tolerated dose is reached. Weekly doses above 2.4mg are not recommended.

How to administer Wegovy

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

• The best areas for administering the injection are the frontal area of the upper arm, the upper part of the legs, or the abdomen.
• Before using the pen for the first time, your doctor, pharmacist, or nurse will teach you how to use it.

You will find detailed instructions on how to use the pen on the other side of this leaflet.

People with type2 diabetes

Inform your doctor if you have type2 diabetes. Your doctor may adjust your diabetes medication dose to avoid a decrease in blood sugar levels.

When to use Wegovy

• You should use this medication once a week and, if possible, on the same day of the week.
• You can administer the injection at any time of the day, regardless of meals.

If necessary, you can change the day of the weekly injection of this medication, provided at least 3days have passed since the last injection. Once the new administration day has been selected, you should continue with the weekly dosing schedule.

If you use more Wegovy than you should

Talk to your doctor immediately. You may experience side effects such as nausea, vomiting, or diarrhea, which can cause dehydration (loss of fluids).

If you forget to use Wegovy

If you forget to administer a dose and:

• 5days or less have passed since you should have used Wegovy, use it as soon as you remember. Then, administer the next dose as usual, on the scheduled day.
• More than 5days have passed since you should have used Wegovy, skip the missed dose. Then, administer the next dose as usual, on the scheduled day.

Do not administer a double dose to compensate for the missed doses.

If you interrupt treatment with Wegovy

Do not stop treatment with this medication without consulting your doctor.

If you have any other questions about using this medication, ask your doctor, pharmacist, or nurse.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Severe side effects

Common(may affect up to 1 in 10people)

• 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 100people)

• Acute pancreatitis (inflammation of the pancreas). Symptoms of a pancreas inflamed may include severe and prolonged stomach pain, the pain may radiate to the back. If you experience such symptoms, seek immediate medical attention.

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

• Severe allergic reactions (anaphylactic reactions, angioedema). You should seek medical help 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 potentially fatal if the swelling of the throat blocks the airways.

Frequency not known(cannot be estimated from available data)

• Intestinal obstruction. A severe form of constipation with other symptoms such as stomach pain, abdominal swelling, vomiting, etc.

Other side effects

Very common(may affect more than 1 in 10people)

• headache
• nausea
• vomiting
• diarrhea
• constipation
• stomach pain
• sensation of weakness or fatigue

• These are mainly observed during dose escalation and generally disappear over time.

Common(may affect up to 1 in 10people)

• sensation of dizziness
• stomach upset or indigestion
• belching
• gas (flatulence)
• stomach swelling
• inflamed stomach (gastritis); symptoms include stomach pain, nausea, or vomiting
• reflux or heartburn; also known as "gastroesophageal reflux disease"
• bile stones
• hair loss
• reactions at the injection site
• change in the taste of food or drink
• change in skin sensation
• low blood sugar (hypoglycemia) in patients with type 2 diabetes.

The warning signs of low blood sugar may appear suddenly. They may include cold sweat, pale and cold skin, headache, rapid heartbeat, nausea, or excessive appetite, changes in vision, drowsiness, or feeling weak, nervousness, anxiety, or confusion, difficulty concentrating, or tremors.

Your doctor will instruct you on how to treat low blood sugar and what to do if you observe these warning signs.

It is more likely that your blood sugar will drop if you also use a sulfonylurea or insulin. Your doctor may reduce the dose of these medicines before you start using this medicine.

Uncommon(may affect up to 1 in 100people)

• low blood pressure
• sensation of dizziness or drowsiness when standing up or sitting down due to a drop in blood pressure
• rapid heartbeat
• increase in pancreatic enzymes (such as lipase and amylase) in blood tests
• delayed emptying of the stomach.

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through thenational reporting system included in theAppendix V. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the pen label and on the packaging after “CAD”. The expiration date is the last day of the month indicated.

Before opening

Store in the refrigerator (between 2°C and 8°C). Do not freeze. Keep away from the refrigerator's cooling component.

During use

• The pen can be stored for 6 weeks if stored at a temperature not exceeding 30°C or in the refrigerator (between 2°C and 8°C) away from the cooling component. Do not freeze Wegovy and do not use if it has frozen.
• When not using the pen, keep the cap on to protect it from light.

Do not use this medication if you observe that the solution is not transparent and colorless.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. This will help protect the environment.

Composition of Wegovy

• The active ingredient is semaglutide.

Wegovy 0.25mg FlexTouch injectable solution

Each pre-filled pen contains 1mg of semaglutide in 1.5ml (0.68mg/ml).

Wegovy 0.5mg FlexTouch injectable solution

1.5ml: each pre-filled pen contains 2mg of semaglutide in 1.5ml (1.34mg/ml).

3ml: each pre-filled pen contains 2mg of semaglutide in 3ml (0.68mg/ml).

Wegovy 1mg FlexTouch injectable solution

Each pre-filled pen contains 4mg of semaglutide in 3ml (1.34mg/ml).

Wegovy 1.7mg FlexTouch injectable solution

Each pre-filled pen contains 6.8mg of semaglutide in 3ml (2.27mg/ml).

Wegovy 2.4mg FlexTouch injectable solution

Each pre-filled pen contains 9.6mg of semaglutide in 3ml (3.2mg/ml).

• The other components are disodium phosphate dihydrate, propylene glycol, phenol, hydrochloric acid/sodium hydroxide (for pH adjustment), and water for injection. See also the section2 “Wegovy contains sodium” for more information on sodium.

Appearance of Wegovy and packaging contents

Wegovy is a transparent and colorless injectable solution in a pre-filled pen.

Each pre-filled pen contains 4doses.

Wegovy 0.25, 0.5, 1, and 1.7mg FlexTouch injectable solution is available in the following packaging size:

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

Wegovy 2.4mg FlexTouch injectable solution is available in the following packaging sizes:

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

3pre-filled pens and 12disposable NovoFine Plus needles

Only some packaging 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

Last update of this leaflet:

Other sources of information

The detailed information on this medicine is available on the website of the European Medicines Agency:http://www.ema.europa.eu.