Wegovy 7.2 mg Solution for injection in pre-filled pen

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

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

wegovy^® is a medicine for weight loss and weight maintenance 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.

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.

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^®.

The safety and efficacy of wegovy^® 7.2 mg has not been studied in children (below 12 years of age) or adolescents (above 12 years of age).

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 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.

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.

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, ‘Warnings 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.

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

Adults

For weight management

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.

For weight management in patients with obesity

• If needed, a dose increase to the next maintenance dose 7.2 mg once weekly can be made after a minimum of 4 weeks on 2.4 mg.
• The maximum dose is 7.2 mg once weekly.

Usually, you will be told to follow the 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 adult patients with obesity, if needed 7.2 mg

Your doctor will assess your treatment on a regular basis.

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.

Detailed instructions for use are on the other side of this leaflet.

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).

• 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.

Talk to your doctor straight away. You may get side effects such as feeling sick (nausea).

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.

Do not stop using this medicine without talking to your doctor.

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”).

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.

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.

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.

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

wegovy^® may be stored unrefrigerated for up to 28 days at a temperature not above 30°C. Discard the pen if it has been exposed to light or temperatures above 30°C, has been out of the refrigerator for more than 28 days, or has been frozen.

Do not use this medicine if you notice that the solution is not clear and colourless.

The pen is for single use and contains one dose only. Discard pen after use.

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.

• The active substance is semaglutide.
• The other ingredients are disodium phosphate dihydrate, sodium chloride, hydrochloric acid/sodium hydroxide (for pH adjustment), water for injections. See also section 2 ‘wegovy^® contains sodium’ for information on sodium.

wegovy^® 7.2 mg solution for injection

Each pre-filled pen contains 7.2 mg of semaglutide in 0.75 mL (9.6 mg/mL)

wegovy^® is a clear and colourless solution for injection in a pre-filled disposable pen.

Each pen contains one dose only.

Pack size of 4 pre-filled pens

The package contains one package leaflet and four wegovy^® pre-filled pens.

This part of the package leaflet instructs on how to use the pen. For further information regarding your medicine please refer to the other side of this package leaflet.

Each pen is only to be used once.

It comes with:

• one pre-set dose.
• a needle cover that hides the built-in needle before, during and after use.
• an automatic dosing mechanism that starts when the needle cover is pressed against your skin as described by your doctor or nurse.

When injecting the dose, a yellow bar will appear in the pen window. Do not lift the pen before the yellow bar has stopped moving. If you do, the automatic dosing will continue, but you may not receive your full dose.

The needle cover will lock when the pen is removed from your skin. You cannot pause the injection and restart it later.

People who are blind or have vision problems should not use wegovy^® pen without help from a person trained to use wegovy^®.

Always follow these user instructions and any directions given by your doctor or nurse.

1. Prepare for your injection.

Check your wegovy pen and be careful not to use your pen if:

1. it has expired
2. it appears to have been used or damaged, e.g. if it has been dropped or stored incorrectly
3. the medicine looks cloudy.

Choose your injection site

Choose an injection site in one of the body areas marked below. You can choose your upper arms, upper legs or stomach (keep a 5 cm distance from your belly button).

You may inject in the same body area each week, but make sure it is not in the same spot as used the last time.

2. Remove pen cap.

Pull the pen cap straight off your pen.

3. Inject wegovy^®

Press the pen firmly against your skin until the yellow bar has stopped moving.

If the yellow bar does not start moving, press the pen more firmly against your skin.

The injection takes about 5-10 seconds

Click 1

The injection starts.

Click 2

Keep holding for a few seconds until yellow bar stops moving.

Yellow bar has stopped moving. The injection is complete. Lift the pen slowly and safely dispose of the pen.

For information regarding your medicine please refer to the other side of this package leaflet.

• The pen is for a single injection of wegovy^® under the skin once a week and should be used by one person only.
• Always refer to the instructions on the other side of this package leaflet and ensure you have been shown how to use these pens by your doctor or nurse.
• Always keep wegovy^® pens out of sight and reach of children. Also, keep the pen cap away from children to prevent them from swallowing it.
• Treat your pen with care and do not expose it to any kind of liquid. Rough handling or misuse may cause your pen to give less than the full dose or no dose at all.
• Keep the pen cap on until you are ready to inject. Your pen will no longer be sterile if you store an unused pen without the cap, if you pull the pen cap off and put it on again, or if the pen cap is missing. This could lead to an infection.
• Be careful when handling your pen before use and do not touch the needle or the needle cover. The hidden needle can cause needle stick injuries.
• Each pen contains one weekly dose and cannot be reused. Dispose of it after use.

For information regarding storage see section 5 on the other side of this package leaflet.

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.