Patient leaflet - Wegovy 1 mg FlexTouch, 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 as well as treating metabolic dysfunction-associated steatohepatitis (MASH) 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. In the liver it works by reducing liver damage, such as build-up of fat, inflammation and scar tissue.

What wegovy® is used for

Weight management

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

•

and weight-related health problems.

a BMI of 27 kg/m² and less than 30 kg/m² (overweight)

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

wegovy® is used together with diet and physical activity for weight management in adolescents ages 12 years and above, who have

•

obesity

•

body weight >60kg

As an adolescent patient, you should only continue using wegovy® if you have lost at least 5% of your

BMI after 12 weeks on the 2.4 mg dose or maximum tolerated dose (see section 3). Consult your doctor

before you continue.

Risk reduction of serious heart issues in adults

wegovy® is used in addition to diet and physical activity to reduce the risk of serious heart issues (heart-related death, heart attacks, strokes) in adults with a history of heart disease (like a heart attack, stroke or poor blood flow to the limbs) and either obesity or overweight (BMI ≥27 kg/m²).

Treatment of metabolic dysfunction-associated steatohepatitis (MASH)

wegovy® is used in addition to diet and physical activity to treat MASH in adults with moderate to advanced liver scarring (fibrosis) without cirrhosis.

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 ever had pancreatitis (inflammation of the

pancreas) which may cause severe pain in the stomach and back which does not go away; see section 4.

• Diabetes

wegovy® must not be used as a substitute for insulin.

• Low blood sugar (hypoglycaemia)

wegovy® can cause low blood sugar. Please see section

4 for the warning signs of low blood sugar levels.

If you have diabetes and are taking a sulfonylurea or an

insulin with wegovy® the risk of getting low blood sugar levels (hypoglycaemia) might increase.

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.

• Sudden changes to your eyesight

If you notice a sudden loss of vision or rapidly

urgently contact your doctor. This may be caused by a very rare side effect called non-arteritic anterior ischaemic optic neuropathy (NAION) (See section 4: Serious side effects). Your doctor will refer you for an eye examination by an ophthalmologist and you may have to stop treatment with semaglutide.

worsening eyesight during treatment with semaglutide,

• (gastroparesis)

Patients with delayed stomach emptying

If you have slow (delayed) stomach emptying (called

gastroparesis), use of wegovy® may lead to serious or severe gastrointestinal adverse events. Talk to your doctor before using wegovy®.

If you know that you are due to have surgery where you will be under anaesthesia (sleeping), please tell your doctor that you are taking wegovy®.

Children and adolescents

The safety and efficacy of wegovy® in children with overweight or obesity below 12 years of age have not been studied and are not recommended for use in this population.

The safety and efficacy of wegovy® in children and adolescents with MASH have not been studied and wegovy® is not recommended for use in this population.

Other medicines and wegovy®

Tell your doctor, pharmacist or nurse if you are using, have recently used or might use any other medicines.

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

•

reduce blood clotting (oral anti-coagulants). When you start treatment with e.g. warfarin or similar medicines, frequent blood testing to determine the ability of your blood to clot may be required.

Warfarin or other similar medicines taken by mouth to

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.

If you become pregnant, you are encouraged to ask your doctor to register your pregnancy in an official registry.

You can also report this information on your own at https://novonordiskpregnancyregistry.co.uk/. Your information will remain anonymous – nobody will know it is information about you. Sharing your information may help women in the future understand the safety or risks of wegovy® during a pregnancy.

You should 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 you should not drive or operate machines until you feel better. If you need any further information, talk to your doctor, pharmacist or nurse.

For diabetics using this medicine in combination with a sulfonylurea or insulin, low blood sugar (hypoglycaemia) may occur which may reduce your ability to concentrate. Do not drive or use 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

per dose, i.e. essentially ‘sodium-free’.

mg)

3. How to use wegovy®

Always use this medicine exactly as your doctor has told you. Check with your doctor, pharmacist or nurse if you are not sure.

How much to use

Adults

For weight management, risk reduction of serious heart issues and MASH

Your treatment will start at a low dose which will be gradually increased over 16 weeks of treatment as follows:

•

0.25 mg once weekly.

When you first start using wegovy®, the starting dose is

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dose every 4 weeks until you reach the dose of 2.4 mg once weekly.

Your doctor will instruct you to gradually increase your

For weight management in patients with obesity

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dose 7.2 mg once weekly (3 injections of 2.4 mg) can be made after a minimum of 4 weeks on 2.4 mg.

If needed, a dose increase to the next maintenance

•

The maximum dose is 7.2 mg once weekly.

You will be told to follow the relevant table below.

For weight management

Dose escalation	Weekly dose
Week 1–4	0.25

Week 5–8

0.5

Week 9–12

Week 13–16

1.7

From week 17

2.4

From week 21 – for adult patients with obesity, if needed

7.2 mg

For risk reduction of serious heart issues in adults and MASH

Dose escalation	Weekly dose
Week 1–4	0.25

Week 5–8

0.5

Week 9–12

Week 13–16

1.7

From week 17

2.4

Your doctor will assess your treatment on a regular basis.

Adolescents (above 12 years of age)

tolerated dose has been reached. Weekly doses higher than 2.4 mg are not recommended.

For adolescents, the same dose escalation schedule as for adults should be applied (see above). The dose should be increased until 2.4 mg (maintenance dose) or maximum

How wegovy® is given

wegovy® is given as an injection under the skin (subcutaneous injection). Do not inject it into a vein or muscle.

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arms, stomach or upper legs.

The best places to give the injection are the upper

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doctor or nurse how to use it.

Before you use the pen for the first time, ask your

For the wegovy® 7.2 mg weight management dose

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each other on the same day.

you will need to inject three doses of 2.4 mg, one after

•

should be at least 5 cm apart.

the injections can be given in the same body area but

•

you must change the needle between each dose.

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pen until it is empty. Partially used pens must be stored in the fridge with the needle removed.

you may need to use multiple pens. Do not discard the

•

complete your dose before you start injecting.

make sure you have a sufficient supply of pens to

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.

•

inject (e.g. insulins).

Do not mix wegovy® up with other medicines that you

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medicines that contain GLP-1 receptor agonists (such as liraglutide, dulaglutide, exenatide or lixisenatide).

Do not use wegovy® in combination with other

When to use wegovy®

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possible, on the same day each week.

You should use this medicine once a week and if

•

day – regardless of meals.

You can give yourself the injection at any time of the

If necessary, you can change the day of your weekly injection of this medicine as long as it has been at least 3

dosing day, continue with once a week dosing.

days since your last injection. After selecting a new

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:

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use it as soon as you remember. Then inject your next dose as usual on your scheduled day.

it is 5 days or less since you should have used wegovy®,

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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.

it is more than 5 days since you should have used

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

•

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.

Complications of diabetic eye disease (diabetic

Uncommon: may affect up to 1 in 100 people

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cause severe pain in the stomach and back which does not go away. This is a serious, potentially life-threatening condition. You should see a doctor immediately if you experience such symptoms.

Inflamed pancreas (acute pancreatitis) which could

Stop using this medicine and seek urgent medical help

if you experience: Severe, persistent pain in the stomach area (abdomen), with or without nausea and vomiting. This could be a sign of acute pancreatitis, which is serious and potentially life-threatening.

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lower abdomen pain, difficulty in urination or change in colour of your urine.

Kidney or bladder stones. Signs may include back or

Rare: may affect up to 1 in 1,000 people

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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

Severe allergic reactions (anaphylactic reactions,

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Hip fractures.

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

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anterior ischaemic optic neuropathy (NAION), which may cause loss of vision without any pain. You should urgently contact your doctor if you notice sudden or gradually worsening eyesight (see section 2: “Sudden changes to your eyesight”).

A medical condition of the eye called non-arteritic

Not known (frequency cannot be estimated from the available data)

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additional symptoms such as stomach ache, bloating, vomiting etc.

Bowel obstruction. A severe form of constipation with

Other side effects

Very common: may affect more than 1 in 10 people

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headache

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feeling sick (nausea)

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being sick (vomiting)

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diarrhoea

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constipation

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stomach pain

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feeling weak or tired.

These usually go away over time.

Common: may affect up to 1 in 10 people

•

feeling dizzy

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upset stomach or indigestion

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burping

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gas (flatulence)

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bloating of the stomach

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stomach ache, feeling sick (nausea) or being sick (vomiting)

inflamed stomach (‘gastritis’) – the signs include

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reflux disease’

reflux or heartburn – also called ‘gastro-oesophageal

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gallstones

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7.2 mg

hair loss – may occur more frequently with semaglutide

•

injection site reactions

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change in the way food or drink tastes

•

time and may happen more frequently with semaglutide 7.2 mg

changed skin sensation - this usually goes away over

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diabetes.

low blood sugar (hypoglycaemia) in patients with

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

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low blood pressure

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because of a drop in blood pressure

feeling dizzy or lightheaded on standing or sitting up

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fast heartbeat

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amylase) shown in blood tests

increase of pancreatic enzymes (such as lipase and

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a delay in the emptying of the stomach

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diabetes

low blood sugar (hypoglycaemia) in patients without

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jaundice which is yellowing of the skin or the whites of your eyes.

increased levels of bilirubin in your blood. Signs include

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: https://yellowcard.mhra.gov.uk/ 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.

Do not freeze wegovy® and do not use it if it has been frozen.

Keep the pen cap on in order to protect from light.

Before opening:

Store in a refrigerator (2°C to 8°C). Keep away from the cooling element.

During use:

You can keep the pen for 6 weeks when stored at a temperature below 30°C or in a refrigerator (2°C to 8°C) away from cooling element.

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

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The active substance is semaglutide.

–

dihydrate, propylene glycol, phenol, sodium hydroxide/hydrochloric acid (for pH adjustment), water for injection.

The other ingredients are disodium phosphate

wegovy® 0.25