Wegovy 1.7 mg FlexTouch solution for injection in pre-filled pen
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
Wegovy 0.25 mg FlexTouch pre-filled pen injection solution
Wegovy 0.5 mg FlexTouch pre-filled pen injection solution
Wegovy 1 mg FlexTouch pre-filled pen injection solution
Wegovy 1.7 mg FlexTouch pre-filled pen injection solution
Wegovy 2.4 mg FlexTouch pre-filled pen injection solution
semaglutide
This medicinal product is subject to additional monitoring, which will allow quicker identification of new safety information. You can help by reporting any side effects you may experience. Information on how to report side effects is included at the end of section 4.
Read all of this leaflet carefully before you start using this medicine, because it contains important information for you.
- Keep this leaflet, as you may need to read it again.
- If you have any questions, ask your doctor, pharmacist, or nurse.
- This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
- If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are side effects not listed in this leaflet. See section 4.
Leaflet contents
- What Wegovy is and what it is used for
- What you need to know before using Wegovy
- How to use Wegovy
- Possible side effects
- How to store Wegovy
- Contents of the pack and other information
1. What Wegovy is and what it is used for
What Wegovy is
Wegovy is a weight-loss and weight-maintenance medicine that contains the active substance semaglutide. It is similar to a naturally occurring hormone called glucagon-like peptide-1 (GLP-1) that is released from the intestine after eating. It works by acting on areas (receptors) in the brain that control appetite, making you feel fuller and less hungry, and reducing your cravings for food. This helps you eat less and lose body weight. Wegovy may also help prevent heart disease.
What Wegovy is used for
Wegovy is used together with diet and physical activity to lose weight and help maintain weight control. It is used in adults who have
- a BMI of 30 kg/m² or higher (obesity), or
- a BMI of at least 27 kg/m² but below 30 kg/m² (overweight) who have weight-related health problems (such as diabetes, high blood pressure, abnormal blood fat levels, breathing problems during sleep called "obstructive sleep apnoea", or history of heart attack, stroke, or vascular problems).
BMI (Body Mass Index) is a measure of weight in relation to height.
Wegovy is used together with diet and physical activity for weight management in adolescents aged 12 years and older who have
- obesity and
- body weight >60 kg.
As an adolescent patient, you should only continue using Wegovy if you have lost at least 5% of your BMI after 12 weeks of treatment with the 2.4 mg dose or the highest tolerated dose (see section 3). Consult your doctor before continuing.
2. What you need to know before using Wegovy
Do not use Wegovy
- if you are allergic to semaglutide or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before starting to use Wegovy.
Wegovy is not recommended if:
- you are using other weight-loss products,
- you have type 1 diabetes,
- you have severely reduced kidney function,
- you have severely reduced liver function,
- you have severe heart failure,
- you have diabetic eye disease (retinopathy).
There is limited experience with Wegovy in patients:
- aged 85 years or older,
- with liver problems.
Consult your doctor if you fall into any of the above categories.
If you know you are going to undergo surgery requiring anaesthesia (a state of sleep), inform your doctor that you are taking Wegovy.
- Dehydration
During treatment with Wegovy, you may experience nausea, vomiting, or diarrhoea. These side effects may cause dehydration (loss of fluids). It is important to drink enough fluids to prevent dehydration. This is especially important if you have kidney problems. If you have any concerns, speak to your doctor.
- Inflammation of the pancreas
If you have severe and persistent pain in the stomach area (see section 4), contact your doctor immediately, as this could be a symptom of inflammation of the pancreas (acute pancreatitis).
- People with type 2 diabetes
Wegovy cannot be used as a substitute for insulin. Do not use Wegovy in combination with other medicines containing GLP-1 receptor agonists (such as liraglutide, dulaglutide, exenatide, or lixisenatide).
- Low blood sugar level (hypoglycaemia)
Taking sulfonylurea or insulin together with Wegovy may increase the risk of low blood sugar (hypoglycaemia). For information on the warning signs of low blood sugar, see section 4. Your doctor may ask you to monitor your blood sugar levels. This will help your doctor decide whether the dose of sulfonylurea or insulin needs to be adjusted to reduce the risk of low blood sugar.
- Diabetic eye disease (retinopathy)
If you have diabetic eye disease and are using insulin, this medicine may worsen your vision and you may require treatment. Rapid improvements in blood sugar control may temporarily worsen diabetic eye disease. Inform your doctor if you have diabetic eye disease and experience eye problems while taking this medicine.
- Sudden changes in vision
If you experience sudden loss of vision or rapid worsening of vision during treatment with this medicine, consult your doctor immediately for advice. This could be due to a very rare adverse effect called non-arteritic anterior ischaemic optic neuropathy (NAION) (see section 4: Serious adverse effects). Your doctor may perform an eye examination and you may need to stop treatment with this medicine.
- Patients with delayed gastric emptying (gastroparesis)
If you have delayed gastric emptying, known as gastroparesis, using Wegovy may cause severe or serious gastrointestinal adverse effects. Talk to your doctor before using Wegovy.
Children and adolescents
The safety and efficacy of Wegovy have not been studied in children under 12 years of age, and its use is not recommended in this population.
Other medicines and Wegovy
Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might need to take any other medicines.
In particular, inform your doctor, pharmacist, or nurse if you are taking medicines containing the following:
- Warfarin or similar medicines taken by mouth to reduce blood clotting (oral anticoagulants). When starting treatment, for example with warfarin or similar medicines, frequent blood tests may be needed to monitor your blood clotting ability.
Pregnancy and breastfeeding
This medicine should not be used during pregnancy because it is unknown whether it may affect the unborn baby. Therefore, it is recommended to use contraception during treatment with this medicine. If you plan to become pregnant, you should stop taking this medicine at least two months in advance. If you become pregnant, think you might be pregnant, or plan to become pregnant while using this medicine, consult your doctor immediately, as you will need to stop treatment.
Do not use this medicine during breastfeeding, as it is unknown whether it is excreted in breast milk.
Driving and using machines
It is unlikely that Wegovy will affect your ability to drive or operate machinery. Some patients may experience dizziness while using Wegovy, mainly during the first 4 months of treatment (see section 4). If you feel dizzy, take extra care when driving or operating machinery. If you need further information, consult your doctor, pharmacist, or nurse.
People with type 2 diabetes
If you use this medicine in combination with sulfonylurea or insulin, you may experience low blood sugar (hypoglycaemia), which may impair your concentration. Avoid driving or operating machinery if you experience symptoms of low blood sugar. See section 2, “Warnings and precautions”, for information on the increased risk of low blood sugar, and section 4 for warning signs of low blood sugar. For additional information, consult your doctor.
Wegovy contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per dose; i.e., essentially “sodium-free”.
3. How to use Wegovy
Follow exactly the administration instructions given by your doctor. If in doubt, consult your doctor, pharmacist, or nurse again.
How much to use
Adults
The recommended dose is 2.4 mg once a week.
Treatment will start at a low dose, which will be gradually increased over 16 weeks of treatment.
- When you start using Wegovy, the starting dose is 0.25 mg once a week.
- Your doctor will instruct you to gradually increase the dose every 4 weeks until reaching the recommended dose of 2.4 mg once a week.
- Once you reach the recommended dose of 2.4 mg, do not increase this dose further.
- If you experience significant nausea or vomiting, speak with your doctor about possibly delaying the dose escalation or reducing to the previous dose until symptoms have improved.
You will typically be advised to follow the schedule in the table below.
Dose escalation | Weekly dose |
Weeks 1 to 4 | 0.25 mg |
Weeks 5 to 8 | 0.5 mg |
Weeks 9 to 12 | 1 mg |
Weeks 13 to 16 | 1.7 mg |
From week 17 onwards | 2.4 mg |
Your doctor will regularly review your treatment.
Adolescents (over 12 years of age)
For adolescents, the same dose-escalation schedule as for adults should be applied (see above). The dose should be increased up to 2.4 mg (maintenance dose) or until the maximum tolerated dose is reached. Weekly doses higher than 2.4 mg are not recommended.
How to administer Wegovy
Wegovy is administered as an injection under the skin (subcutaneous injection). Do not inject it into a vein or into a muscle.
- The best areas for administering the injection are the front of the upper arm, the upper legs, or the stomach.
- Before using the pen for the first time, your doctor, pharmacist, or nurse will show you how to use it.
Detailed instructions on how to use the pen can be found on the other side of this leaflet.
People with type 2 diabetes
Inform your doctor if you have type 2 diabetes. Your doctor may adjust the dose of your diabetes medication to prevent your blood sugar level from dropping too low.
When to use Wegovy
- You should use this medicine once a week, and, if possible, on the same day each week.
- The injection can be given at any time of day, regardless of meals.
If necessary, you may change the day of your weekly injection of this medicine, provided at least 3 days have passed since your last injection. Once you have selected the new administration day, you should continue with the weekly dosing schedule.
If you use more Wegovy than you should
Contact your doctor immediately. You may experience side effects such as nausea, vomiting, or diarrhea, which could lead to dehydration (loss of fluids).
If you forget to use Wegovy
If you forget to inject a dose and:
- 5 days or fewer have passed since you should have used Wegovy, take it as soon as you remember. Then take your next dose as usual on the scheduled day.
- more than 5 days have passed since you should have used Wegovy, skip the missed dose. Then take your next dose as usual on the next scheduled day.
Do not administer a double dose to make up for missed doses.
If you stop using Wegovy
Do not stop treatment with this medicine without consulting your doctor.
If you have any further questions about 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 everyone gets them.
Serious side effects
Frequent (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)
- Inflammation of the pancreas (acute pancreatitis). Symptoms of an inflamed pancreas may include severe and prolonged stomach pain, which may radiate to the back. If you experience such symptoms, seek medical attention immediately.
Rare (may affect up to 1 in 1,000 people)
- Severe allergic reactions (anaphylactic reactions, angioedema). You must seek medical help and inform your doctor immediately if you experience symptoms such as difficulty breathing, swelling, dizziness, rapid heartbeat, sweating, loss of consciousness, or rapid swelling under the skin in areas such as the face, throat, arms, and legs, which can be potentially fatal if swelling in the throat blocks the airways.
Very rare (may affect up to 1 in 10,000 people)
- A condition affecting the eye called non-arteritic anterior ischaemic optic neuropathy (NAION), which may cause painless vision loss in one eye. You should contact your doctor immediately if you experience sudden vision loss or a progressive worsening of vision (see section 2: “Sudden changes in vision”).
Frequency not known (cannot be estimated from available data)
- Intestinal obstruction. A severe form of constipation with other symptoms such as stomach pain, abdominal swelling, vomiting, etc.
Other side effects
Very common (may affect more than 1 in 10 people)
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headache
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nausea
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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
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these are mainly observed during dose escalation and usually resolve over time.
Common (may affect up to 1 in 10 people)
- feeling dizzy
- stomach discomfort or indigestion
- burping
- gas (flatulence)
- stomach bloating
- inflamed stomach (gastritis); symptoms include stomach pain, nausea, or vomiting
- reflux or heartburn; also known as “gastroesophageal reflux disease”
- gallstones
- hair loss
- injection site reactions
- change in taste of food or drink
- change in skin sensation
- low blood sugar level (hypoglycaemia) in patients with type 2 diabetes.
Warning signs of low blood sugar may appear suddenly. They may include cold sweat, pale and cold skin, headache, rapid heartbeat, nausea or excessive hunger, changes in vision, drowsiness or weakness, nervousness, anxiety or confusion, difficulty concentrating, or tremors.
Your doctor will advise you on how to treat low blood sugar and what to do if you notice these warning signs.
You are more likely to experience low blood sugar if you are also taking a sulfonylurea or insulin. Your doctor may reduce the dose of these medicines before you start using this medicine.
Uncommon (may affect up to 1 in 100 people)
- low blood pressure
- feeling dizzy or lightheaded when standing up or sitting down due to a drop in blood pressure
- rapid heartbeat
- increased pancreatic enzymes (such as lipase and amylase) in blood tests
- delayed stomach emptying.
Reporting of side effects
If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the national reporting system listed in Appendix V.
By reporting side effects, you can help provide more information on the safety of this medicine.
5. Storage of Wegovy
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label of the pen and on the outer packaging after "EXP". The expiry date refers to the last day of the month indicated.
Before opening
Store in a refrigerator (between 2 °C and 8 °C). Do not freeze. Keep away from the cooling element of the refrigerator.
During use
- The pen may be stored for up to 6 weeks either at below 30 °C or in a refrigerator (between 2 °C and 8 °C), kept away from the cooling element. Do not freeze Wegovy, and do not use if it has been frozen.
- When not in use, keep the cap on to protect the pen from light.
Do not use this medicine if you notice that the solution is not clear and colourless.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Wegovy
- The active substance is semaglutide.
Wegovy 0.25 mg FlexTouch injectable solution
Each pre-filled pen contains 1 mg of semaglutide in 1.5 ml (0.68 mg/ml).
Wegovy 0.5 mg FlexTouch injectable solution
1.5 ml: each pre-filled pen contains 2 mg of semaglutide in 1.5 ml (1.34 mg/ml).
3 ml: each pre-filled pen contains 2 mg of semaglutide in 3 ml (0.68 mg/ml).
Wegovy 1 mg FlexTouch injectable solution
Each pre-filled pen contains 4 mg of semaglutide in 3 ml (1.34 mg/ml).
Wegovy 1.7 mg FlexTouch injectable solution
Each pre-filled pen contains 6.8 mg of semaglutide in 3 ml (2.27 mg/ml).
Wegovy 2.4 mg FlexTouch injectable solution
Each pre-filled pen contains 9.6 mg of semaglutide in 3 ml (3.2 mg/ml).
- The other components are disodium phosphate dihydrate, propylene glycol, phenol, hydrochloric acid/sodium hydroxide (for pH adjustment), water for injections. See also section 2 “Wegovy contains sodium” for more information about sodium.
Appearance of Wegovy and contents of the pack
Wegovy is a clear, colourless injectable solution in a pre-filled pen.
Each pre-filled pen contains 4 doses. After injecting the 4 doses, some solution may remain in the pen even when administered correctly. Any remaining solution is insufficient for a full dose and the pen should be discarded.
Wegovy 0.25, 0.5, 1, and 1.7 mg FlexTouch injectable solution is available in the following pack size:
1 pre-filled pen and 4 NovoFine Plus disposable needles.
Wegovy 2.4 mg FlexTouch injectable solution is available in the following pack sizes:
1 pre-filled pen and 4 NovoFine Plus disposable needles.
3 pre-filled pens and 12 NovoFine Plus disposable needles.
Only certain pack sizes may be marketed.
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
Date of the most recent revision of this leaflet:
Other sources of information
Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.
Instructions on how to use the Wegovy pen | |
Read these instructions carefully before starting to use your weekly Wegovy FlexTouch pen and consult your doctor, nurse, or pharmacist about how to correctly inject Wegovy. The Wegovy pen is a dosing pen that contains your four prescribed doses of Wegovy, corresponding to four weekly injections. Use the table inside the outer packaging cover to track how many injections you have used and how many doses remain in the pen. Wegovy is available in five different pens, each containing one of the following prescribed doses of semaglutide:
Always check the label on the pen to ensure it contains the prescribed dose of Wegovy. Your pen is designed to be used with disposable 30G, 31G, and 32G needles up to 8 mm in length. The package contains:
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1 Prepare the pen with a new needle | |
Check the name and concentration of your pen to ensure it contains the prescribed dose of Wegovy. Remove the pen cap. (See Figure A). |
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Check that the solution in your pen is clear and colorless. Look through the pen window. If Wegovy appears cloudy or colored, do not use the pen. (See Figure B). |
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Always use a new needle for each injection. Take a needle when you are ready to administer your injection. Check that the paper tab and outer needle cap are undamaged, as damage may compromise sterility. If you notice any damage, use a new needle. Remove the paper tab. (See Figure C). |
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Place the needle straight onto the pen. Screw it on tightly. (See Figure D). |
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The needle is covered by two caps. You must remove both caps. If you forget to remove both caps, Wegovy will not be injected. Remove the outer needle cap and keep it for later. You will need it after the injection to safely remove the needle from the pen. Remove the inner needle cap and discard it. A drop of Wegovy may appear at the needle tip. You should continue checking the flow if this is the first time using a new pen. See "Check flow with each new pen". Never use a bent or damaged needle. For more information on handling needles, refer to the section "About needles" below these instructions. (See Figure E). |
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Check flow with each new pen | |
If your Wegovy pen is already in use, go to "2 Select dose". Check the flow of Wegovy only before the first injection with each new pen. Turn the dose selector until the flow check symbol appears (). (See Figure F). |
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Ensure the flow check symbol aligns with the dose indicator. (See Figure G). |
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Check flow | |
Hold the pen with the needle pointing upward. Press and hold the dose button until the dose counter returns to . The must align with the dose indicator. A drop of Wegovy should appear at the needle tip. This drop indicates the pen is ready for use. If no drop appears, check flow again. This should only be done twice. If still no drop appears, change the needle and check flow again. Do not use the pen if no drop of Wegovy appears. (See Figure H). |
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2 Select dose | |
Turn the dose selector until the dose counter stops and displays the selected dose. (See Figure I). |
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The dotted line () on the dose counter will guide you to your dose. The dose selector clicks differently when turned forward, backward, or past the dose. You will hear a "click" each time you turn the selector. Do not count the clicks of the pen. (See Figure J). |
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When the selected dose aligns with the dose indicator, the dose has been selected. In this image, the dose is shown as an example. If the dose counter stops before reaching the prescribed dose, refer to the section "Do you have enough Wegovy?" below these instructions. (See Figure K). |
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Choose the injection site Choose the upper arms, upper legs, or stomach (keep 5 cm away from the navel). You may inject in the same body area each week, but ensure it is not the same spot used previously. |
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3 Inject the dose | |
Insert the needle under the skin. Ensure you can see the dose counter. Do not touch the dose counter with your fingers, as this may interrupt the injection. (See Figure L). |
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Press and hold the dose button until appears in the dose counter. (See Figure M). Keep holding the dose button with the needle under the skin and count slowly to 6. The must align with the dose indicator. You may hear or feel a click as the dose counter returns to . (See Figure N). |
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Remove the needle from the skin. If the needle is removed too early, a stream of Wegovy may leak from the needle tip, and the full dose will not be administered. If bleeding occurs at the injection site, apply light pressure to stop it. You may see a drop of Wegovy at the needle tip after injection. This is normal and does not affect the dose. (See Figure O). |
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4 After the injection | |
Place the needle tip into the outer needle cap on a flat surface without touching the needle or the outer cap. Once the needle is covered, press the outer cap down firmly and completely. (See Figure P). |
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Unscrew the needle and dispose of it carefully according to instructions from your doctor, nurse, pharmacist, or local authorities. Never attempt to reinsert the inner needle cap, as you may accidentally prick yourself. Always dispose of the needle immediately after each injection to prevent needle blockage, contamination, infections, and incorrect dosing. Never store the pen with the needle attached. (See Figure Q). |
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Replace the pen cap after each use to protect Wegovy from light. (See Figure R). |
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When the pen is empty, dispose of it without the needle according to instructions from your doctor, nurse, pharmacist, or local authorities. The pen cap and empty box may be discarded in household waste. | |
About needles | |
How to identify a blocked or damaged needle
How to proceed with a blocked needle
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Pen maintenance | |
Handle your pen with care. Rough handling or misuse may lead to inaccurate dosing. If this occurs, you may not achieve the desired effect from Wegovy.
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Do you have enough Wegovy? | |
If the dose counter stops before reaching the prescribed dose, there is not enough Wegovy left for a full dose. Discard the pen and use a new Wegovy pen. |
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Important information | |
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