Pharmacy Guide

Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.

Pharmacy Guide

Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.

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Wegovy 1.7 mg, FlexTouch solution for injection in pre-filled pen

⚠ This medicine appears to have been discontinued

The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.

If you were prescribed this medicine, other products containing Semaglutide may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.

Active substance: Semaglutide
Source: electronic medicines compendium (emc)
Official leaflet: Read the PIL on emc

What it is and what it is used for

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 • a BMI of 27 kg/m2 and less than 30 kg/m2 (overweight) and weight-related health problems. BMI (Body Mass Index) is a measure of your weight in relation to your height. 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 take it

e 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 worsening eyesight during treatment with semaglutide, 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.

•

Patients with delayed stomach emptying (gastroparesis) 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®. 2

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: • 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, frequent blood testing to determine the ability of your blood to clot may be required. 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. 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 mg) per dose, i.e. essentially 'sodium-free'. 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: • When you first start using wegovy®, the starting dose is 0.25 mg once weekly. • Your doctor will instruct you to gradually increase your dose every 4 weeks until you reach the dose of 2.4 mg once weekly.

3

For weight management in patients with obesity • If needed, a dose increase to the next maintenance 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. •

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 mg Week 5-8 0.5 mg Week 9-12 1 mg Week 13-16 1.7 mg From week 17 2.4 mg From week 21 – for 7.2 mg adult patients with obesity, if needed For risk reduction of serious heart issues in adults and MASH Dose escalation Weekly dose Week 1-4 0.25 mg Week 5-8 0.5 mg Week 9-12 1 mg Week 13-16 1.7 mg From week 17 2.4 mg Your doctor will assess your treatment on a regular basis. Adolescents (above 12 years of age) 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 tolerated dose has been reached. Weekly doses higher than 2.4 mg are not recommended.

How to take it

wegovy® is given as an injection under the skin (subcutaneous injection). Do not inject it into a vein or muscle. • The best places to give the injection are the upper arms, stomach or upper legs. • Before you use the pen for the first time, ask your doctor or nurse how to use it. For the wegovy 7.2 mg weight management dose

  • you will need to inject three doses of 2.4 mg, one after each other on the same day.
  • the injections can be given in the same body area but should be at least 5 cm apart.
  • you must change the needle between each dose.
  • you may need to use multiple pens. Do not discard the pen until it is empty. Partially used pens must be stored in the fridge with the needle removed.
  • make sure you have a sufficient supply of pens to complete your dose before you start injecting. Detailed instructions for use are on the other side of this leaflet. People with diabetes Tell your doctor if you have diabetes. Your doctor may adjust the dose of your diabetes medicines to prevent you from getting low blood sugar. • Do not mix wegovy® up with other medicines that you inject (e.g. insulins). • Do not use wegovy® in combination with other medicines that contain GLP-1 receptor agonists (such as liraglutide, dulaglutide, exenatide or lixisenatide). 4

When to use wegovy® • You should use this medicine once a week and if possible, on the same day each week. • You can give yourself the injection at any time of the day – regardless of meals. If necessary, you can change the day of your weekly injection of this medicine as long as it has been at least 3 days since your last injection. After selecting a new dosing day, continue with once a week dosing. If you use more wegovy® than you should Talk to your doctor straight away. You may get side effects such as feeling sick (nausea). If you forget to use wegovy® If you forgot to inject a dose and: • it is 5 days or less since you should have used wegovy®, use it as soon as you remember. Then inject your next dose as usual on your scheduled day. • it is more than 5 days since you should have used wegovy®, skip the missed dose. Then inject your next dose as usual on your next scheduled day. Do not take a double dose to make up for a forgotten dose. If you stop using wegovy® Do not stop using this medicine without talking to your doctor. If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse. 4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Serious side effects Common: may affect up to 1 in 10 people • Complications of diabetic eye disease (diabetic retinopathy). If you have diabetes you should inform your doctor if you experience eye problems, such as changes in vision, during treatment with this medicine. Uncommon: may affect up to 1 in 100 people • Inflamed pancreas (acute pancreatitis) which could 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. 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. • Kidney or bladder stones. Signs may include back or lower abdomen pain, difficulty in urination or change in colour of your urine. Rare: may affect up to 1 in 1,000 people • Severe allergic reactions (anaphylactic reactions, angioedema). You should seek immediate medical help and inform your doctor straight away if you get symptoms such as breathing problems, swelling of face, lips, tongue, and/or throat with difficulty swallowing, wheezing, fast heartbeat, pale and cold skin, feeling dizzy or weak • Hip fractures. •

Very rare: may affect up to 1 in 10,000 people A medical condition of the eye called non-arteritic 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"). 5

Not known (frequency cannot be estimated from the available data) • Bowel obstruction. A severe form of constipation with additional symptoms such as stomach ache, bloating, vomiting etc. Other side effects Very common: may affect more than 1 in 10 people • headache • feeling sick (nausea) • being sick (vomiting) • diarrhoea • constipation • stomach pain • feeling weak or tired. These usually go away over time. Common: may affect up to 1 in 10 people

  • feeling dizzy
  • upset stomach or indigestion
  • burping
  • gas (flatulence)
  • bloating of the stomach
  • inflamed stomach ('gastritis') – the signs include stomach ache, feeling sick (nausea) or being sick (vomiting)
  • reflux or heartburn – also called 'gastro-oesophageal reflux disease'
  • gallstones
  • hair loss – may occur more frequently with semaglutide 7.2 mg
  • injection site reactions
  • change in the way food or drink tastes
  • changed skin sensation – this usually goes away over time and may happen more frequently with semaglutide 7.2 mg
  • low blood sugar (hypoglycaemia) in patients with diabetes. The warning signs of low blood sugar may come on suddenly. They can include: cold sweat, cool pale skin, headache, fast heartbeat, feeling sick (nausea) or very hungry, changes in vision, feeling sleepy or weak, feeling nervous, anxious or confused, difficulty concentrating or shaking. Your doctor will tell you how to treat low blood sugar and what to do if you notice these warning signs. Low blood sugar is more likely to happen if you also take a sulfonylurea or insulin. Your doctor may reduce your dose of these medicines before you start using this medicine. Uncommon: may affect up to 1 in 100 people • low blood pressure • feeling dizzy or lightheaded on standing or sitting up because of a drop in blood pressure • fast heartbeat • increase of pancreatic enzymes (such as lipase and amylase) shown in blood tests • a delay in the emptying of the stomach • low blood sugar (hypoglycaemia) in patients without diabetes • increased levels of bilirubin in your blood. Signs include jaundice which is yellowing of the skin or the whites of your eyes. 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. 6

5.

How to store it

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 – The active substance is semaglutide. – The other ingredients are disodium phosphate dihydrate, propylene glycol, phenol, sodium hydroxide/hydrochloric acid (for pH adjustment), water for injection. wegovy® 0.25 mg FlexTouch® solution for injection One mL of solution contains 0.68 mg of semaglutide. One pre-filled pen contains 1.0 mg semaglutide in 1.5 mL solution wegovy® 0.5 mg FlexTouch® solution for injection 1.5 mL: One mL of solution contains 1.34 mg of semaglutide. One pre-filled pen contains 2.0 mg semaglutide in 1.5 mL solution 3 mL: One mL of solution contains 0.68 mg of semaglutide. One pre-filled pen contains 2.0 mg semaglutide in 3 mL solution wegovy® 1 mg FlexTouch® solution for injection One mL of solution contains 1.34 mg of semaglutide. One pre-filled pen contains 4.0 mg semaglutide in 3 mL solution wegovy® 1.7 mg FlexTouch® solution for injection One mL of solution contains 2.27 mg of semaglutide. One pre-filled pen contains 6.8 mg semaglutide in 3 mL solution wegovy® 2.4 mg FlexTouch® solution for injection One mL of solution contains 3.2 mg of semaglutide. One pre-filled pen contains 9.6 mg of semaglutide in 3 mL solution. What wegovy® looks like and contents of the pack wegovy® is a clear and colourless solution for injection in a pre-filled disposable pen. 7

Each FlexTouch® pen contains four doses. After having injected the 4 doses, there might still be solution left in the pen despite having administered correctly. Any solution left is insufficient for a dose and the pen should be disposed of. The pack size of each strength of wegovy® contains 1 pre-filled pen and 4 disposable NovoFine® Plus needles. Your pen is designed to be used with NovoFine® Plus, NovoFine® or NovoTwist® disposable needles up to a length of 8 mm Marketing Authorisation 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 This leaflet was last revised in 06/2026 wegovy®, FlexTouch®, NovoFine® and NovoTwist® are trademarks owned by Novo Nordisk A/S, Denmark © 2026 Novo Nordisk A/S The product's authorisation has been changed to 'conditional marketing authorisation' because further evidence on efficacy [and/or safety] is required with respect to the MASH indication. The MHRA will review new information on this medicine at least every year and the leaflet will be updated, as necessary.

8

Instructions on how to use wegovy® FlexTouch® Before you begin using your once-weekly wegovy® FlexTouch® pen, always read these instructions carefully, and talk to your doctor, nurse or pharmacist about how to inject wegovy® correctly. wegovy® FlexTouch® pen is a dial-a-dose pen that contains four of your doses of wegovy®. Please use the table inside the lid of the carton to keep track of how many injections you have taken and how many doses remain in your pen. wegovy® FlexTouch® comes in five different pen variants, each containing one of the following prescribed doses of semaglutide:

Always start by checking your pen label to make sure that it contains your prescribed dose of wegovy®. Your pen is designed to be used with NovoFine® Plus, NovoFine® or NovoTwist® disposable needles up to a length of 8 mm. The pack contains: •

wegovy® FlexTouch® pen

•

4 NovoFine® Plus needles

•

Leaflet

wegovy® FlexTouch® pen (example) Please note: Your pen may differ in size from the pen shown in the pictures.

wegovy® FlexTouch® pen Please Note: Your pen may differ in size from the pen shown in the pictures. (example) These instructions apply to all wegovy® pens.

EXP: BATCH:

Pen window

Pen cap

NovoFine® Plus needle (example) NovoFine® Plus needle (example) Outer needle cap

Inner needle cap Needle

Paper tab

9

Expiry date (EXP) on back of pen label

Dose counter Dose pointer

Dose selector Dose button

1 Prepare your pen with a new needle Check the name and dose of your pen to make sure it contains your prescribed dose of wegovy®. Pull off the pen cap.

Check that the wegovy® in your pen is clear and colourless. Look through the pen window. If wegovy® looks cloudy or coloured, do not use the pen.

Always use a new needle for each injection, including between the injections for the 3 x 2.4 mg (7.2 mg) dose. Take a needle when you are ready to take your injection. Check the paper tab and the outer needle cap for damages. If you see any damage, this could affect sterility. Dispose of it and use a new needle. Tear off the paper tab.

Push the needle straight onto the pen. Turn until it is on tight.

10

A

B

C

D

The needle is covered by two caps. You must remove both caps. If you forget to remove both caps you will not inject any wegovy®. Pull off the outer needle cap and keep it for later. You will need it to safely remove the needle from the pen after the injection. Pull off the inner needle cap and dispose of it. A drop of wegovy® may appear at the needle tip. You must still check the wegovy® flow if you use a new pen for the first time. See 'Check the flow with each new pen'. Never use a bent or damaged needle. For more information about needle handling, see 'About your needles' below these instructions.

E

Check the flow with each new pen Only check the wegovy® flow before your first injection with each new pen. If your wegovy® pen is already in use, go to '2 Set your dose'. Turn the dose selector until you see the flow check symbol (

Make sure the flow check symbol lines up with the dose pointer.

11

F

).

G

Check the flow Hold the pen with the needle pointing up. Press and hold in the dose button until the dose counter returns to . The must line up with the dose pointer. A drop of wegovy® should appear at the needle tip. This drop indicates that your pen is ready for use. If a drop does not appear, check the flow again. This should only be done twice. If there is still no drop, change the needle and check the flow once more. Do not use the pen if a drop of wegovy® still does not appear.

H

2 Set your dose Turn the dose selector until the dose counter stops, and it shows your prescribed dose.

12

I

The dashed line ( ) in the dose counter will guide you to your dose. The dose selector clicks differently when turned forward, backwards or past your dose. You will hear a 'click' every time you turn the dose selector. Do not set the dose by counting the number of clicks you hear.

J

Dashed line

When your prescribed dose lines up with the dose pointer, you have selected your dose. In this picture, the dose is shown as an example. If the dose counter stops before you reach your prescribed dose, see the section 'Do you have enough wegovy®?' below these instructions.

K

Example: 0.25 mg selected

Choose your injection site Choose upper arms, stomach or upper legs (keep a 5 cm distance from your belly button). You may inject in the same body area, but make sure it is not in the same spot as used the last time. If you are injecting 3 x 2.4 mg (7.2 mg) injections on the same day, you may inject in the same body area but make sure each injection is at least 5cm apart.

Upper arms

Stomach

Upper legs

13

3 Inject your dose Insert the needle into your skin. Make sure you can see the dose counter. Do not cover it with your fingers. This could interrupt the injection.

Press and hold down the dose button until the dose counter shows . Keep pressing the dose button with the needle in your skin and slowly count to 6. The must line up with the dose pointer. You may hear or feel a click when the dose counter returns to .

L

M

N

Count slowly 1-2-3-4-5-6

14

Remove the needle from your skin. If the needle is removed earlier, a stream of wegovy® may come from the needle tip and the full dose will not be delivered. If blood appears at the injection site, press lightly on the area to stop the bleeding. You may see a drop of wegovy® at the needle tip after injecting. This is normal and does not affect your dose.

O

4 After your injection Lead the needle tip into the outer needle cap on a flat surface without touching the needle or the outer needle cap. Once the needle is covered, carefully push the outer needle cap completely on.

P

Unscrew the needle and dispose of it carefully as instructed by your doctor, nurse, pharmacist or local authorities. Never try to put the inner needle cap back on the needle. You may stick yourself with the needle. Always dispose of the needle immediately after each injection to prevent blocked needles, contamination, infection and inaccurate dosing. Never store your pen with the needle attached.

Q

If you are injecting 3 x 2.4 mg (7.2 mg) injections on the same day, place a new needle on the pen as described in step 1 (pictures A to E) and perform the second and third injections as per step 2 and 3 above.

15

Put the pen cap on your pen after each use to protect wegovy® from light.

R

When the pen is empty, dispose of the pen without a needle on as instructed by your doctor, nurse, pharmacist or local authorities. The pen cap and the empty carton can be disposed of in your household waste. About your needles Needles are medical devices. How to identify a blocked or damaged needle • If does not appear in the dose counter after continuously pressing the dose button, you may have used a blocked or damaged needle. • In this case, you have not received any wegovy® – even though the dose counter has moved from the original dose that you have set. How to handle a blocked needle • Change the needle as instructed in '1 Prepare your pen with a new needle' and go to '2 Set your dose'. Caring for your pen Treat your pen with care. Rough handling or misuse may cause inaccurate dosing. If this happens, you might not get the intended effect of wegovy®. • See the back of this leaflet to read the storage conditions for your pen. • Do not inject wegovy® that has been exposed to direct sunlight. • Do not subject wegovy® to frost and never inject wegovy® that has been frozen. Dispose of the pen. • Do not drop your pen or knock it against hard surfaces. • Do not try to refill your pen. Once empty, it must be disposed of. • Do not try to repair your pen or pull it apart. • Do not expose your pen to dust, dirt or liquid. • Do not wash, soak or lubricate your pen. If necessary, clean it with a mild detergent on a moistened cloth.

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Do you have enough wegovy®? If the dose counter stops before you reach your prescribed dose, there is not enough wegovy® left for a full dose. Dispose of the pen and use a new wegovy® FlexTouch® pen. If you are injecting 3 x 2.4 mg (7.2 mg) injections on the same day, make sure you have enough supply of pens to complete your dose before you start injecting.

• • • • • • •

Important information Only use wegovy® once weekly as prescribed. If you do not take your wegovy® as prescribed, you may not get the intended effect of this medicine. If you take more than one type of injectable medicine, it is very important to check the name and dose of your pen label before use. Do not use this pen without help if you have poor eyesight and cannot follow these instructions. Get help from a person with good eyesight who is trained to use the wegovy® FlexTouch® pen. Always keep pen and needles out of sight and reach of others, especially children. Never share your pen or your needles with other people. Needles are for single use only. Never reuse your needles as it may lead to blocked needles, contamination, infection and inaccurate dosing. Caregivers must be very careful when handling used needles to prevent accidental needle stick injuries and infection.

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Frequently asked questions about Wegovy 1.7 mg, FlexTouch solution for injection in pre-filled pen

How do I take Wegovy 1.7 mg, FlexTouch solution for injection in pre-filled pen?

Wegovy 1.7 mg, FlexTouch solution for injection in pre-filled pen comes as injection containing 1.7mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.

What is the active substance in Wegovy 1.7 mg, FlexTouch solution for injection in pre-filled pen?

The active substance in Wegovy 1.7 mg, FlexTouch solution for injection in pre-filled pen is semaglutide.

Where does this information come from?

This leaflet reproduces the patient information leaflet approved for Wegovy 1.7 mg, FlexTouch solution for injection in pre-filled pen, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.

Can I get Wegovy 1.7 mg, FlexTouch solution for injection in pre-filled pen without a prescription?

Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.

About this leaflet

The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.

Medical disclaimer: This page is for information only and does not replace advice from your doctor or pharmacist. Always read the leaflet supplied with your medicine. If you are unwell, call NHS 111; in an emergency, call 999.

Medicines with the same active substance: Semaglutide (20 medicines)
See every medicine containing this substance, or browse the full A–Z of active substances.
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
Technical information intended for healthcare professionals (doctors and pharmacists). The Summary of Product Characteristics (SmPC) is the official document approved by the MHRA/EMA. It does not replace the patient leaflet or a doctor’s advice.

4.1. Therapeutic indications

Weight management

Adults

Wegovy is indicated as an adjunct to a reduced-calorie diet and increased physical activity for weight management, including weight loss and weight maintenance, in adults with an initial Body Mass Index (BMI) of

• ≥30 kg/m2 (obesity), or

• ≥27 kg/m2 to <30 kg/m2 (overweight) in the presence of at least one weight-related comorbidity.

Adolescents (≥12 years)

Wegovy is indicated as an adjunct to a reduced-calorie diet and increased physical activity for weight management in adolescents ages 12 years and above with

• obesity* and

• body weight above 60 kg.

Treatment with Wegovy should be discontinued and re-evaluated if adolescent patients have not reduced their BMI by at least 5% after 12 weeks on the 2.4 mg or maximum tolerated dose.

*Obesity (BMI ≥95th percentile) as defined on sex- and age-specific BMI growth charts (CDC.gov) (see Table 1).

Table 1 BMI cut-off points for obesity (≥95th percentile) by sex and age for paediatric patients aged 12 and older (CDC criteria)

Age (years)

BMI (kg/m2) at 95th Percentile

Males

Females

12

24.2

25.2

12.5

24.7

25.7

13

25.1

26.3

13.5

25.6

26.8

14

26.0

27.2

14.5

26.4

27.7

15

26.8

28.1

15.5

27.2

28.5

16

27.5

28.9

16.5

27.9

29.3

17

28.2

29.6

17.5

28.6

30.0

Cardiovascular Risk Reduction

Wegovy is indicated as an adjunct to a reduced-calorie diet and increased physical activity to reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke) in adults with established cardiovascular disease and either obesity or overweight (BMI ≥27 kg/m2).

Metabolic dysfunction-associated steatohepatitis (MASH)

Wegovy is indicated in conjunction with diet and exercise for the treatment of non-cirrhotic metabolic dysfunction-associated steatohepatitis (MASH) in adults with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis).

For trial results with respect to the effect on cardiovascular events, obesity-related heart failure, populations studied and background therapies see section 5.1.

4.2. Posology and method of administration

Posology

Adults

The maintenance dose of semaglutide 2.4 mg once-weekly is reached by starting with a dose of 0.25 mg. To reduce the likelihood of gastrointestinal symptoms, the dose should be escalated over a 16-week period to a maintenance dose of 2.4 mg once weekly (see Table 2).

If needed, for weight management in patients with obesity (see section 4.1), the dose can be increased to 7.2 mg once weekly after a minimum of 4 weeks on the 2.4 mg dose.

In case of significant gastrointestinal symptoms, consider delaying dose escalation or lowering to the previous dose until symptoms have improved.

Table 2 Dose escalation schedule

Dose escalation

Weekly dose

Week 1–4

0.25 mg

Week 5–8

0.5 mg

Week 9–12

1 mg

Week 13–16

1.7 mg

Maintenance dose (all indications)

2.4 mg

Maintenance dose (weight management in adult patients with obesity, if needed)

7.2 mg

Weight management

If patients have been unable to lose at least 5% of their initial body weight after 6 months on treatment, a decision is required on whether to continue treatment, taking into account the benefit/risk profile in the individual patient (see section 5.1).

Adolescents

For adolescents ages 12 years and above, the same dose escalation schedule as for adults should be applied (see Table 2). The dose should be increased until 2.4 mg (maintenance dose) or maximum tolerated dose has been reached. Weekly doses higher than 2.4 mg are not recommended.

Missed dose

If a dose is missed, it should be administered as soon as possible and within 5 days after the missed dose. If more than 5 days have passed, the missed dose should be skipped, and the next dose should be administered on the regularly scheduled day. In each case, patients can then resume their regular once weekly dosing schedule. If more doses are missed, reducing the starting dose for re-initiation should be considered.

Special populations

Patients with type 2 diabetes

Semaglutide should not be used in combination with other GLP-1 receptor agonist products.

When initiating semaglutide, consider reducing the dose of concomitantly administered insulin or insulin secretagogues (such as sulfonylureas) to reduce the risk of hypoglycaemia.

Elderly patients (≥65 years old)

No dose adjustment is required based on age. Therapeutic experience in patients ≥85 years of age is limited.

Patients with renal impairment

No dose adjustment is required for patients with mild, moderate or severe renal impairment. Experience with the use of semaglutide in patients with severe renal impairment is limited. Semaglutide is not recommended for use in patients with end-stage renal disease (see section 5.2).

Patients with hepatic impairment (Child-Pugh A, B or C)

No dose adjustment is required for patients with hepatic impairment. Experience with the use of semaglutide in patients with severe hepatic impairment (Child-Pugh C) is limited. Caution should be exercised when treating these patients with semaglutide (see section 5.2). In a trial in adult patients with MASH and F4c, no safety signals were identified.

Patients with MASH

If a patient becomes underweight (BMI <18.5) during treatment, a decision is required on whether to continue treatment, considering the benefit/risk profile in the individual patient.

Paediatric population

Weight management

No dose adjustment is required for adolescents ages 12 years and above. Doses above 2.4 mg are not recommended.

The safety and efficacy of semaglutide in children below 12 years of age have not been established.

MASH

The safety and efficacy of semaglutide in children and adolescents with MASH below 18 years have not been established. No data are available.

Method of administration

Wegovy is administered once weekly at any time of the day, with or without meals.

It is to be injected subcutaneously in the abdomen, in the thigh or in the upper arm. The injection site can be changed. It should not be administered intravenously or intramuscularly.

For the 7.2 mg dose, administer either 1 injection of 7.2 mg or 3 injections of 2.4 mg one after each other, depending on the device.

When administering wegovy 7.2 mg solution for injection in pre-filled pen for single use, the pen should be pressed firmly against the skin until the yellow bar has stopped moving. The injection takes about 5-10 seconds.

For 3 injections of 2.4 mg, the injections can be given in the same body area but should be at least 5 cm apart - doses from more than one pen may need to be used and the needle should be changed between each dose.

The day of weekly administration can be changed, if necessary, as long as the time between doses is at least 3 days (>72 hours). After selecting a new dosing day, once-weekly dosing should be continued.

Patients should be advised to read the instruction for use included in the package leaflet carefully before administering the medicinal product.

For further information on administration see section 6.6.

4.3. Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

4.4. Special warnings and precautions for use

Gastrointestinal effects and Dehydration

Use of GLP-1 receptor agonists may be associated with gastrointestinal adverse reactions. This should be considered when treating patients with impaired renal function, as nausea, vomiting, and diarrhoea may cause dehydration, which in rare cases can lead to a deterioration of renal function (see section 4.8). Patients treated with semaglutide should be advised of the potential risk of dehydration in relation to gastrointestinal side effects and take precautions to avoid fluid depletion.

Aspiration in association with general anaesthesia or deep sedation

Cases of pulmonary aspiration have been reported in patients receiving GLP-1 receptor agonists undergoing general anaesthesia or deep sedation. Therefore, the increased risk of residual gastric content due to delayed gastric emptying (see section 4.8) should be considered prior to performing procedures with general anaesthesia or deep sedation.

Acute pancreatitis

Semaglutide has not been studied in patients with a history of pancreatitis, and should be used with caution in these patients.

Acute pancreatitis has been reported in patients treated with GLP-1 receptor agonists. This includes post-marketing reports of necrotising pancreatitis and reports with a fatal outcome. Patients should be informed of the symptoms of acute pancreatitis, including persistent, severe abdominal pain. Patients should be advised to seek immediate medical attention if they occur. If pancreatitis is suspected, semaglutide should be discontinued. If the diagnosis of pancreatitis is confirmed, semaglutide should not be restarted.

In the absence of other signs and symptoms of acute pancreatitis, elevations in pancreatic enzymes alone are not predictive of acute pancreatitis.

Non-arteritic anterior ischaemic optic neuropathy (NAION)

Data from epidemiological studies may indicate an increased risk of non-arteritic anterior ischaemic optic neuropathy (NAION) during treatment with semaglutide. There is no identified time interval for when NAION may develop following treatment start. Patients reporting a sudden loss of vision (including partial loss) should be urgently referred for ophthalmological examination and treatment with semaglutide should be discontinued if NAION is confirmed (see section 4.8).

For patients with diabetes

Semaglutide must not be used as a substitute for insulin in patients with diabetes.

Hypoglycaemia

Semaglutide lowers blood glucose and can cause hypoglycaemia. Patients should be aware of the risk of hypoglycaemia and be educated on the signs and symptoms of hypoglycaemia.

In patients with diabetes, insulin and sulfonylurea are known to cause hypoglycaemia. Patients treated with semaglutide in combination with a sulfonylurea or insulin may have an increased risk of hypoglycaemia. The risk of hypoglycaemia can be lowered by reducing the dose of sulfonylurea or insulin when initiating treatment with a GLP-1 receptor agonist.

Diabetic retinopathy in patients with type 2 diabetes

In patients with diabetic retinopathy treated with insulin and semaglutide, an increased risk of developing diabetic retinopathy complications has been observed. Rapid improvement in glucose control has been associated with a temporary worsening of diabetic retinopathy, but other mechanisms cannot be excluded. Patients with diabetic retinopathy using semaglutide should be monitored closely and treated according to clinical guidelines. There is no experience with semaglutide 2.4 mg in patients with type 2 diabetes with uncontrolled or potentially unstable diabetic retinopathy.

Patients with gastroparesis

Semaglutide treated patients with gastroparesis may experience more serious or severe gastrointestinal adverse events. Semaglutide should be used with caution in these patients, and semaglutide is not recommended if gastroparesis is severe (see section 4.8).

Populations not studied

There is no experience in patients with congestive heart failure New York Heart Association (NYHA) class IV. There is limited experience in patients aged 85 years or more. The efficacy and safety data in patients with lean MASH BMI <25 kg/m2 or BMI<23 kg/m2 for Asian population is limited (see section 5.1). There is no experience in MASH patients with HIV.

Sodium content

This medicine contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially 'sodium-free'.

Traceability

In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.

4.5. Interaction with other medicinal products and other forms of interaction

As with other GLP-1 receptor agonists, semaglutide may delay gastric emptying and could potentially influence the absorption of concomitantly administered oral medicinal products. No clinically relevant effect on the rate of gastric emptying was observed with semaglutide 2.4 mg. In clinical pharmacology trials assessing the effect of semaglutide 1.0 mg on the absorption of co-administered oral medications at steady state, no clinically relevant drug-drug interactions with semaglutide was observed based on the evaluated medications. Therefore, no dose adjustment is required when co-administered with semaglutide.

Coadministration with other semaglutide-containing products or with any other GLP-1 receptor agonist is not recommended.

Oral contraceptives

Semaglutide is not anticipated to decrease the effectiveness of oral contraceptives as semaglutide did not change the overall exposure of ethinylestradiol and levonorgestrel to a clinically relevant degree, when an oral contraceptive combination medicinal product (0.03 mg ethinylestradiol/0.15 mg levonorgestrel) was co-administered with semaglutide. Exposure of ethinylestradiol was not affected; an increase of 20% was observed for levonorgestrel exposure at steady state. Cmax was not affected for any of the compounds.

Atorvastatin

Semaglutide did not change the overall exposure of atorvastatin following a single dose administration of atorvastatin (40 mg). Atorvastatin Cmax was decreased by 38%. This was assessed not to be clinically relevant.

Digoxin

Semaglutide did not change the overall exposure or Cmax of digoxin following a single dose of digoxin (0.5 mg).

Metformin

Semaglutide did not change the overall exposure or Cmax of metformin following dosing of 500 mg twice daily over 3.5 days.

Warfarin and other coumarin derivatives

Semaglutide did not change overall exposure or Cmax of R- and S-warfarin following a single dose of warfarin (25 mg), and the pharmacodynamic effects of warfarin as measured by the international normalised ratio (INR) were not affected in a clinically relevant manner. However, cases of decreased INR have been reported during concomitant use of acenocoumarol and semaglutide. Upon initiation of semaglutide treatment in patients on warfarin or other coumarin derivatives, frequent monitoring of INR is recommended.

Paediatric population

Interaction studies have only been performed in adults.

4.6. Fertility, pregnancy and lactation

Women of childbearing potential

Women of childbearing potential are recommended to use contraception when treated with semaglutide.

Pregnancy

Studies in animals have shown reproductive toxicity (see section 5.3). There are limited data from the use of semaglutide in pregnant women. Therefore, semaglutide should not be used during pregnancy. If a patient wishes to become pregnant, or pregnancy occurs, semaglutide should be discontinued. Semaglutide should be discontinued at least 2 months before a planned pregnancy due to the long half-life (see section 5.2).

Breast-feeding

In lactating rats, semaglutide was excreted in milk. A risk to a breast-fed child cannot be excluded. Semaglutide should not be used during breast-feeding.

Fertility

The effect of semaglutide on fertility in humans is unknown. Semaglutide did not affect male fertility in rats. In female rats, an increase in oestrous length and a small reduction in number of ovulations were observed at doses associated with maternal body weight loss.

4.7. Effects on ability to drive and use machines

Semaglutide has no or negligible influence on the ability to drive or use machines. However, dizziness can be experienced mainly during the dose escalation period. Driving or use of machines should be done cautiously if dizziness occurs.

Patients with type 2 diabetes

If semaglutide is used in combination with a sulfonylurea or insulin, patients should be advised to take precautions to avoid hypoglycaemia while driving and using machines (see section 4.4).

4.8. Undesirable effects

Summary of safety profile

In four phase 3a trials, 2,650 adult patients were exposed to semaglutide 2.4 mg. The duration of the trials was 68 weeks. Similar to other GLP-1 receptor agonists, the most frequently reported adverse reactions were gastrointestinal disorders including nausea, diarrhoea, constipation and vomiting.

Tabulated list of adverse reactions

Table 3 lists adverse reactions identified in clinical trials in adults, the SELECT trial and post-marketing reports. The frequencies are based on a pool of the phase 3a trials.

Adverse reactions associated with semaglutide 2.4 mg are listed by system organ class and frequency. Frequency categories are defined as: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000) and not known (cannot be estimated from the available data).

Table 3 Frequency of adverse reactions of semaglutide

MedDRA system organ class

Very common

Common

Uncommon

Rare

Very rare

Not known

Immune system disorders

Anaphylactic reaction

Metabolism and nutrition disorders

Hypoglycaemia in patients with type 2 diabetesa

Hypoglycaemia in patients without type 2 diabetesa

Nervous system disorders

Headacheb

Dizzinessb

Dysaesthesiaa,c,f

Dysgeusiab,c

Eye disorders

Diabetic retinopathy in patients with type 2 diabetesa

Non- arteritic anterior ischaemic optic neuropathy (NAION)

Cardiac disorders

Increased heart ratea,c

Vascular disorders

Hypotension

Orthostatic hypotension

Gastrointestinal disorders

Vomitinga,b

Diarrhoeaa,b

Constipationa,b

Nauseaa,b

Abdominal painb, c

Gastritisb, c

Gastrooesophageal reflux diseaseb

Dyspepsiab

Eructationb

Flatulenceb

Abdominal distensionb

Acute pancreatitisa

Delayed gastric emptying

Intestinal obstruction,c,d,e

Hepatobiliary disorders

Cholelithiasisa

Renal and urinary disorders

Urolithiasis

Skin and subcutaneous tissue disorders

Hair lossa

Angioedema

General disorders and administration site conditions

Fatigueb,c

Injection site reactionsc

Investigations

Increased amylasec

Increased lipasec

Increased Bilirubina

Injury

Hip Fracturea

a) See description of selected adverse reactions below

b) Mainly seen in the dose-escalation period

c) Grouped preferred terms

d) From post-marketing reports

e) Grouped term covering PTs Intestinal obstruction, Ileus, small intestinal obstruction

f) Frequency is based on the 3a program. An increased frequency has been observed with the 7.2 mg dose. Please refer to dysaesthesia subheading below for more information.

In a cardiovascular outcomes trial (SELECT), 8,803 patients were exposed to Wegovy for a median of 37.3 months and 8,801 patients were exposed to placebo for a median of 38.6 months (See section 5.1). Safety data collection was limited to serious adverse events (including death), adverse events leading to discontinuation, and adverse events of special interest. Sixteen percent (16%) of Wegovy-treated patients and 8% of placebo-treated patients, respectively, discontinued study drug due to an adverse event. Additional information from this trial is included in subsequent sections below when relevant.

In the HFpEF trials, in adults with obesity related heart failure with preserved ejection fraction (HFpEF), the adverse reaction profile was similar to that seen in the weight management phase 3a trials.

In the ESSENCE trial, in adults with MASH, the adverse reaction profile was similar to that seen in the weight management phase 3a trials.

Description of selected adverse reactions

Gastrointestinal adverse reactions

The events were most frequently reported during dose escalation. Over 68 weeks, nausea occurred in 43.9% of patients when treated with semaglutide 2.4 mg (16.1% for placebo), diarrhoea in 29.7% (15.9% for placebo) and vomiting in 24.5% (6.3% for placebo). Most events were mild to moderate in severity and of short duration. Constipation occurred in 24.2% of patients treated with semaglutide 2.4 mg (11.1% for placebo) and was mild to moderate in severity and of longer duration.

The gastrointestinal events led to permanent treatment discontinuation in 4.3% of patients.

In STEP UP trials gastrointestinal events were most frequently reported during dose escalation (during the initial 20 weeks of treatment). Over 72 weeks, nausea occurred in 38.9% of patients when treated with semaglutide 7.2 mg (12.6% for placebo), diarrhoea in 24.2% (11.6% for placebo) and vomiting in 22.1% (5.7% for placebo). Most events were mild to moderate in severity and of short duration. Constipation occurred in 20.4% of patients when treated with semaglutide 7.2 mg (7.6% for placebo) and was mild to moderate in severity and of longer duration. The gastrointestinal events led to permanent discontinuation in 3.2% of patients.

Patients with gastroparesis may experience more serious or severe gastrointestinal effects when treated with semaglutide.

Acute pancreatitis

The frequency of adjudication-confirmed acute pancreatitis reported in phase 3a clinical trials was 0.2% for semaglutide 2.4 mg and <0.1% for placebo, respectively.

Acute gallstone disease/Cholelithiasis

Cholelithiasis was reported in 1.6% and led to cholecystitis in 0.6% of patients treated with semaglutide 2.4 mg.

Hair loss

Hair loss was reported in 2.5% of patients treated with semaglutide 2.4 mg and in 1.0% of patients treated with placebo. In STEP UP trials, hair loss was reported in 5.3% of patients treated with semaglutide 7.2 mg and in 1.0% of patients on placebo. The events were mainly of mild severity and most patients recovered while on continued treatment. Hair loss was reported more frequently in patients with a greater weight loss (≥20%).

Increased heart rate

In the phase 3a trials, a mean increase of 3 beats per minute (bpm) from a baseline mean of 72 bpm was observed in patients treated with semaglutide 2.4 mg. The proportions of patients with a maximum increase from baseline ≥20 bpm/min at any timepoint during the on-treatment period were 26.0% in the semaglutide 2.4 mg group vs 15.6% in the placebo group.

Immunogenicity

Consistent with the potentially immunogenic properties of medicinal products containing proteins or peptides, patients may develop antibodies following treatment with semaglutide. The proportion of patients testing positive for anti-semaglutide antibodies at any time post-baseline was 2.9 – 10.9% for semaglutide 2.4 mg and 15.3% for semaglutide 7.2 mg. No patients had anti-semaglutide neutralising antibodies or anti-semaglutide antibodies with endogenous GLP-1 neutralising effect.

Hypoglycaemia in patients with overweight or obesity, MASH and type 2 diabetes

In STEP 2, clinically significant hypoglycaemia was observed in 6.2% (0.1 events/patient year) of patients treated with semaglutide 2.4 mg compared with 2.5% (0.03 events/patient year) of patients treated with placebo. One episode (0.2% of subjects, 0.002 events/patient year) was reported as severe. The risk of hypoglycaemia was increased when semaglutide 2.4 mg was used with a sulfonylurea.

In STEP-HFpEF-DM, clinically significant hypoglycaemia was observed in 4.2% of subjects in both the semaglutide and placebo groups when used in combination with sulfonylurea and/or insulin (0.065 events/patient year with semaglutide and 0.098 events/patient year with placebo).

In ESSENCE severe hypoglycaemia was reported in 2.2% of patients (0.015 events/patient year) treated with Wegovy.

Hypoglycaemia in patients without type 2 diabetes

In a cardiovascular outcomes trial (SELECT) in adult patients without type 2 diabetes, 3 episodes of serious hypoglycaemia were reported in Wegovy-treated patients versus 1 episode in placebo. Patients with a history of bariatric surgery (a risk factor for hypoglycaemia) had more events of serious hypoglycaemia while taking Wegovy (2.3%, 2/87) than placebo (0%, 0/97).

Diabetic retinopathy in patients with type 2 diabetes

New onset or worsening of diabetic retinopathy (4.0% vs 2.7% of patients treated with semaglutide 2.4 mg vs placebo, respectively) was observed in STEP 2.

Fractures

In the cardiovascular outcomes trial (SELECT) in adults, more fractures of the hip and pelvis were reported on Wegovy than on placebo in female patients: 1.0% (24/2448) vs. 0.2% (5/2424), and in patients ages 75 years and older: 2.4% (17/703) vs. 0.6% (4/663), respectively.

Urolithiasis

In a cardiovascular outcomes trial (SELECT), 1.2% of Wegovy-treated patients and 0.8% of patients receiving placebo reported urolithiasis, including serious reactions that were reported more frequently among patients receiving Wegovy (0.6%) than placebo (0.4%).

Bilirubin

In the cardiovascular outcomes trial in adults (SELECT), increases in total bilirubin greater than or equal to 3 times the upper limit of normal were observed in 0.3% (30/8585) of Wegovy-treated patients versus 0.2% (14/8579) of placebo-treated patients.

Dysaesthesia

Events related to a clinical picture of altered skin sensation such as dysaesthesia, paraesthesia, hyperaesthesia, burning sensation, allodynia and sensitive skin were reported in 2.1% of patients treated with Wegovy injection and 1.2% of patients treated with placebo. The events were mild to moderate in severity and most patients recovered while on continued treatment.

In STEP-UP, dysaesthesia events were reported by 21.6% of patients treated with semaglutide 7.2 mg and 0.3% of patients on placebo. Most events were mild to moderate and recovered while on treatment.

Non-arteritic anterior ischaemic optic neuropathy (NAION)

Results from several large epidemiological studies suggest that exposure to semaglutide in adults with type 2 diabetes may be associated with an approximately two-fold increase in the relative risk of developing NAION, corresponding to approximately one additional case per 10 000 person-years of treatment.

Paediatric population

In a clinical trial conducted in adolescents of 12 years to below 18 years with obesity or overweight with at least one weight-related comorbidity, 133 patients were exposed to Wegovy. The trial duration was 68 weeks.

Overall, the frequency, type and severity of adverse reactions in the adolescents were comparable to that observed in the adult population. Cholelithiasis was reported in 3.8% of patients treated with Wegovy compared to 0% of patients treated with placebo.

No effects on growth or pubertal development were found after 68 weeks of treatment.

Wegovy has not been studied in children and adolescents below 18 years with MASH.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via Yellow Card Scheme Website: https://yellowcard.mhra.gov.uk/ or search for MHRA Yellow Card in the Google Play or Apple App Store.

4.9. Overdose

Overdose with semaglutide may be associated with gastrointestinal disorders which could lead to dehydration. In the event of overdose, the patient should be observed for clinical signs and appropriate supportive treatment initiated.

🇷🇴 Known in Romania as

Medicines sold in Romania with the same active substance: Cunoscut în România ca

  • WEGOVY 0,25 mg prescriptionSEMAGLUTIDUM · injection / infusion
  • WEGOVY 0,25 mg FLEXTOUCH prescriptionSEMAGLUTIDUM · injection / infusion
  • WEGOVY 0,5 mg prescriptionSEMAGLUTIDUM · injection / infusion
  • WEGOVY 0,5 mg FLEXTOUCH prescriptionSEMAGLUTIDUM · injection / infusion
  • WEGOVY 1 mg prescriptionSEMAGLUTIDUM · injection / infusion
  • WEGOVY 1 mg FLEXTOUCH prescriptionSEMAGLUTIDUM · injection / infusion

Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Romanian medicines in the UK →

🇵🇱 Known in Poland as

Medicines sold in Poland with the same active substance: W Polsce znany jako

  • OzempicSemaglutidum · injection / infusion
  • WegovySemaglutidum · injection / infusion
  • Wegovy 0,25 mg FlexTouchSemaglutide · injection / infusion
  • Wegovy 0,5 mg FlexTouchSemaglutide · injection / infusion
  • Wegovy 1 mg FlexTouchSemaglutide · injection / infusion
  • Wegovy 1,7 mg FlexTouchSemaglutide · injection / infusion

Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Polish medicines in the UK →

💬 Ask about this leaflet

Ask anything about Wegovy 1.7 mg, FlexTouch solution for injection in pre-filled pen. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.

Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.

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