Wegovy 0,5 mg flextouch solucion inyectable en pluma precargada
Introduction
Patient Information Leaflet
Wegovy 0.25 mg FlexTouch pre-filled pen injectable solution
Wegovy 0.5 mg FlexTouch pre-filled pen injectable solution
Wegovy 1 mg FlexTouch pre-filled pen injectable solution
Wegovy 1.7 mg FlexTouch pre-filled pen injectable solution
Wegovy 2.4 mg FlexTouch pre-filled pen injectable solution
semaglutide
This medicine is subject to additional monitoring, which will speed up the detection of new information about its safety. You can contribute by reporting any adverse effects you may experience. The final part of section 4 includes information on how to report these adverse effects.
Read this leaflet carefully before you start using this medicine, because it contains important information for you.
- Keep this leaflet, as you may need to read it again.
- If you are unsure, consult your doctor, pharmacist or nurse.
- This medicine has been prescribed for you only; do not give it to others even if they have similar symptoms, as it may harm them.
- If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.
1. What is Wegovy and how is it used
What is Wegovy
Wegovy is a weight loss and maintenance medication that contains the active ingredient semaglutide. It is similar to a naturally occurring hormone called glucagon-like peptide-1 (GLP-1) that is released from the intestine after eating. It works by acting on regions (receptors) in the brain that control appetite, causing you to feel fuller and less hungry, and to experience less food cravings. This will help you eat fewer foods and reduce your body weight. Wegovy may also help prevent heart disease.
How is Wegovy used
Wegovy is used in combination with diet and exercise to lose weight and help maintain weight control. It is used in adults who have
- a body mass index (BMI) of 30 kg/m² or higher (obesity) or
- a BMI of at least 27 kg/m², but less than 30 kg/m² (overweight) who have health problems related to weight (such as diabetes, high blood pressure, abnormal levels of fats in the blood, sleep apnea, or a history of heart attack, stroke, or vascular problems).
The body mass index (BMI) is a measure of weight in relation to height.
Wegovy is used in combination with diet and exercise for weight control in adolescents aged 12 years and older with
- obesity and
- body weight > 60 kg.
As a teenage patient, you should only continue using Wegovy if you have lost at least 5% of your BMI after 12 weeks of treatment with the 2.4 mg dose or the maximum tolerated dose (see section 3). Consult your doctor before continuing.
2. What you need to know before starting to use Wegovy
No use Wegovy
- if you are allergic to semaglutide or any of the other components of this medication (listed in section6).
Warnings and precautions
Consult your doctor, pharmacist, or nurse before starting to use Wegovy.
This medication is not recommended for use if:
- you are using other weight loss products,
- you have type1 diabetes,
- you have severely reduced kidney function,
- you have severely reduced liver function,
- you have severe heart failure,
- you have diabetic eye disease (retinopathy).
There is limited experience with Wegovy in patients:
- 85years or older,
- with liver problems,
- with severe stomach or intestinal problems that cause delayed stomach emptying (gastroparesia) or any inflammatory intestinal disease.
Consult your doctor if you fall into any of the above cases.
If you are planning to undergo surgery under anesthesia (sleep state), inform your doctor that you are taking Wegovy.
- Dehydration
During treatment with Wegovy, you may experience nausea, vomiting, or diarrhea. These side effects can cause dehydration (loss of fluids). It is essential to drink enough liquid to prevent dehydration. This is especially important if you have kidney problems. If you have any doubts or concerns, consult your doctor.
- Pancreatitis
If you experience severe and persistent pain in the stomach area (see section 4), seek medical attention immediately, as it could be a symptom of acute pancreatitis.
- People with type2 diabetes
Wegovy cannot be used as a substitute for insulin. Do not use Wegovy in combination with other medications that contain GLP-1 receptor agonists (such as liraglutide, dulaglutide, exenatide, or lixisenatide).
- Hypoglycemia
Combining Wegovy with sulfonylurea or insulin may increase the risk of experiencing low blood sugar (hypoglycemia). To know the warning signs of low blood sugar, see section 4. Your doctor may ask you to measure your blood sugar levels. This will help your doctor decide if you need to adjust the dose of sulfonylurea or insulin to reduce the risk of low blood sugar.
- Diabetic eye disease (retinopathy)
If you have diabetic eye disease and are using insulin, this medication may worsen your vision and may require treatment. Sudden improvements in blood sugar control may temporarily worsen diabetic eye disease. Inform your doctor if you have diabetic eye disease and experience eye problems while taking this medication.
Children and adolescents
Wegovy has not been studied in children under 12years of age, and its use is not recommended in this population.
Other medications and Wegovy
Inform your doctor, pharmacist, or nurse if you are using, have used recently, or may need to use any other medication.
Particularly, inform your doctor, pharmacist, or nurse if you are using medications that contain:
- Warfarin or other oral anticoagulants taken by mouth to reduce blood clotting. When starting treatment with warfarin or similar medications, you may need to have frequent blood tests to determine your blood clotting ability.
Pregnancy and breastfeeding
This medication should not be used during pregnancy because its effects on the fetus are unknown. Therefore, it is recommended to use contraceptive methods during the use of this medication. If you become pregnant or are planning to become pregnant, you should discontinue the use of this medication at least two months in advance. If you become pregnant or are pregnant, consult your doctor immediately, as you should discontinue your treatment.
This medication should not be used during breastfeeding, as its excretion in breast milk is unknown.
Driving and operating machinery
It is unlikely that Wegovy will affect your ability to drive and operate machinery. Some patients may feel dizzy when using Wegovy, mainly during the first 4months of treatment (see section4). If you feel dizzy, exercise extra caution when driving or operating machinery. If you need more information, consult your doctor, pharmacist, or nurse.
People with type2 diabetes
If you use this medication in combination with sulfonylurea or insulin, you may experience low blood sugar (hypoglycemia), which may reduce your ability to concentrate. Avoid driving or operating machinery if you experience any symptoms of low blood sugar. See section2, “Warnings and precautions” for information on the increased risk of low blood sugar and section4 to know the warning signs of low blood sugar. For additional information, consult your doctor.
Wegovy contains sodium
This medication contains less than 1mmol of sodium (23mg) per dose; it is essentially “sodium-free.”
3. How to use Wegovy
Follow exactly the administration instructions indicated by your doctor. In case of doubt, consult your doctor, pharmacist, or nurse again.
How much to use
Adults
The recommended dose is 2.4mg once a week.
Treatment will start with a low dose that will be gradually increased over 16weeks of treatment.
- When starting to use Wegovy, the initial dose is 0.25mg once a week.
- Your doctor will tell you to gradually increase the dose every 4weeks until reaching the recommended dose of 2.4mg once a week.
- Once you reach the recommended dose of 2.4mg, do not increase this dose further.
- If you feel very uncomfortable due to nausea or vomiting, talk to your doctor about the possibility of delaying the dose escalation or reducing the dose to the previous one until the symptoms have improved.
Normally, you will be told to follow the following table.
Dose escalation | Weekly dose |
Weeks 1 to 4 | 0.25mg |
Weeks 5 to 8 | 0.5mg |
Weeks 9 to 12 | 1mg |
Weeks 13 to 16 | 1.7mg |
From week 17 | 2.4mg |
Your doctor will evaluate your treatment regularly.
Adolescents (over 12years)
For adolescents, the same dose escalation schedule as for adults (see above) should be applied. The dose should be increased to 2.4mg (maintenance dose) or until the maximum tolerated dose is reached. Weekly doses above 2.4mg are not recommended.
How to administer Wegovy
Wegovy is administered as a subcutaneous injection under the skin. Do not inject it into a vein or muscle.
- The best areas for administering the injection are the frontal area of the upper arm, the upper part of the legs, or the abdomen.
- Before using the pen for the first time, your doctor, pharmacist, or nurse will teach you how to use it.
You will find detailed instructions on how to use the pen on the other side of this leaflet.
People with type2 diabetes
Inform your doctor if you have type2 diabetes. Your doctor may adjust your diabetes medication dose to avoid a decrease in blood sugar levels.
When to use Wegovy
- You should use this medication once a week and, if possible, on the same day of the week.
- You can administer the injection at any time of the day, regardless of meals.
If necessary, you can change the day of the weekly injection of this medication, provided that at least 3days have passed since the last injection. Once the new administration day has been selected, you should continue with the weekly dosing schedule.
If you use more Wegovy than you should
Talk to your doctor immediately. You may experience side effects such as nausea, vomiting, or diarrhea, which can cause dehydration (loss of fluids).
If you forget to use Wegovy
If you forget to inject a dose and:
- 5days or less have passed since you should have used Wegovy, use it as soon as you remember. Then, inject the next dose as usual, on the scheduled day.
- More than 5days have passed since you should have used Wegovy, skip the missed dose. Then, inject the next dose as usual, on the scheduled day.
Do not administer a double dose to compensate for the missed doses.
If you interrupt treatment with Wegovy
Do not stop treatment with this medication without consulting your doctor.
If you have any other questions about using this medication, ask your doctor, pharmacist, or nurse.
4. Possible Adverse Effects
Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Severe side effects
Common(may affect up to 1 in 10people)
- Diabetic retinopathy complications. If you have diabetes, inform your doctor if you experience eye problems, such as changes in vision, during treatment with this medicine.
Uncommon(may affect up to 1 in 100people)
- Acute pancreatitis. Symptoms of an inflamed pancreas may include severe and prolonged stomach pain, which may radiate to the back. If you experience such symptoms, seek immediate medical attention.
Rare(may affect up to 1 in 10,000people)
- Severe allergic reactions (anaphylactic reactions, angioedema). Seek medical help and inform your doctor immediately if you experience symptoms such as difficulty breathing, swelling, dizziness, rapid heartbeat, sweating, and loss of consciousness or rapid swelling under the skin in areas such as the face, throat, arms, and legs, which can be potentially fatal if the throat swelling blocks the airways.
Frequency not known(cannot be estimated from available data)
- Intestinal obstruction. A severe form of constipation with other symptoms such as stomach pain, abdominal swelling, vomiting, etc.
Other side effects
Very common(may affect more than 1 in 10people)
- Headache
- Nausea
- Vomiting
- Diarrhea
- Constipation
- Stomach pain
- Feeling of weakness or fatigue
- These are mainly observed during dose escalation and generally disappear over time.
Common(may affect up to 1 in 10people)
- Dizziness
- Stomach discomfort or indigestion
- Belching
- Gas (flatulence)
- Abdominal swelling
- Stomach inflammation (gastritis); symptoms include stomach pain, nausea, or vomiting
- Reflex or heartburn; also known as "gastroesophageal reflux disease"
- Bile stones
- Hair loss
- Reactions at the injection site
- Change in the taste of food or drink
- Change in skin sensation
- Low blood sugar (hypoglycemia) in patients with type 2 diabetes.
The warning signs of low blood sugar may appear suddenly. They may include cold sweat, pale and cold skin, headache, rapid heartbeat, nausea, or excessive appetite, changes in vision, drowsiness, or feeling weak, nervousness, anxiety, or confusion, difficulty concentrating, or tremors.
Your doctor will instruct you on how to treat low blood sugar and what to do if you observe these warning signs.
It is more likely to lower blood sugar if you also use a sulfonylurea or insulin. Your doctor may reduce the dose of these medications before starting this medicine.
Uncommon(may affect up to 1 in 100people)
- Low blood pressure
- Sensation of dizziness or drowsiness when standing or sitting 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 type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through thenational reporting system included in theAppendix V. By reporting side effects, you can contribute to providing more information on the safety of this medicine.
5. Conservation of Wegovy
Keep this medication out of the sight and reach of children.
Do not use this medication after the expiration date that appears on the pen label and on the packaging after “CAD”. The expiration date is the last day of the month indicated.
Before opening
Store in the refrigerator (between 2°C and 8°C). Do not freeze. Keep away from the refrigerator's cooling component.
During use
- The pen can be stored for 6 weeks if stored at a temperature not exceeding 30°C or in the refrigerator (between 2°C and 8°C) away from the cooling component. Do not freeze Wegovy and do not use if it has frozen.
- When not using the pen, leave the cap on to protect it from light.
Do not use this medication if you observe that the solution is not transparent and colorless.
Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. This will help protect the environment.
6. Contents of the packaging and additional information
Composition of Wegovy
- The active ingredient is semaglutide.
Wegovy 0.25mg FlexTouch injectable solution
Each pre-filled pen contains 1mg of semaglutide in 1.5ml (0.68mg/ml).
Wegovy 0.5mg FlexTouch injectable solution
1.5ml: each pre-filled pen contains 2mg of semaglutide in 1.5ml (1.34mg/ml).
3ml: each pre-filled pen contains 2mg of semaglutide in 3ml (0.68mg/ml).
Wegovy 1mg FlexTouch injectable solution
Each pre-filled pen contains 4mg of semaglutide in 3ml (1.34mg/ml).
Wegovy 1.7mg FlexTouch injectable solution
Each pre-filled pen contains 6.8mg of semaglutide in 3ml (2.27mg/ml).
Wegovy 2.4mg FlexTouch injectable solution
Each pre-filled pen contains 9.6mg of semaglutide in 3ml (3.2mg/ml).
- The other components are disodium phosphate dihydrate, propylene glycol, phenol, hydrochloric acid/sodium hydroxide (for pH adjustment), and water for injection. See also the section2 “Wegovy contains sodium” for more information on sodium.
Appearance of Wegovy and packaging contents
Wegovy is a transparent and colorless injectable solution in a pre-filled pen.
Each pre-filled pen contains 4doses.
Wegovy 0.25, 0.5, 1, and 1.7mg FlexTouch injectable solution is available in the following package size:
1pre-filled pen and 4disposable NovoFine Plus needles.
Wegovy 2.4mg FlexTouch injectable solution is available in the following package sizes:
1pre-filled pen and 4disposable NovoFine Plus needles.
3pre-filled pens and 12disposable NovoFine Plus needles
Only some package sizes may be marketed.
Marketing Authorization Holder
Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd
Demark
Manufacturer
Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd
Demark
Novo Nordisk Production SAS
45, Avenue d’Orléans
28000 Chartres
France
Last update of this leaflet:
Other sources of information
The detailed information on this medicine is available on the website of the European Medicines Agency:http://www.ema.europa.eu.
Instructions on how to use the Wegovy pen | |
Read these instructions carefullybefore starting to use your Wegovy FlexTouch weekly pen and consult with your doctor, nurse, or pharmacist on how to correctly inject Wegovy. The Wegovy pen is a dosing pen thatcontains your four prescribed doses of Wegovy, which correspond to the four weekly administrations. Use the table inside the outer packaging cover to keep track of how many injections you have used and how many doses are left in the pen. Wegovy is presented in five different pens, each of which contains one of the following prescribed doses of semaglutide: Always check the label of the pen to ensure that it contains the prescribed dose of Wegovy. Your pen is designed to be used with 30G, 31G, and 32G disposable needles up to 8mm in length. The package contains:
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1 Prepare the pen with a new needle | |
Check the name and concentrationof your pen to ensure that it contains the prescribed dose of Wegovy. Remove the pen cap. (See Figure A). | |
Check that the solution of your pen is transparent and colorless. Look through the pen window. If Wegovy has a turbid or colored appearance, do not use the pen. (See Figure B). | |
Always use a new needle for each injection. Take a needlewhen you are ready to administer the injection. Check that the paper clip and the outer needle cap are not damaged and may affect sterility. If you detect any damage, use a new needle. Remove the paper clip. (See Figure C). | |
Place the needle straight into the pen. Twist it until it is tight. (See Figure D). | |
The needle is covered by two caps. You must remove both caps. If you forget to remove both caps, Wegovy will not be administered. Remove the outer needle cap and save 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.You may see a drop of Wegovy at the needle tip. You must continue to check the flow of Wegovy if you are using 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 on handling needles, see the section“About needles”that follows these instructions. (See Figure E). | |
Check the flow with each new pen | |
If your Wegovy pen is already in use, go to “2 Dose selection”. Check the flow of Wegovy only before thefirst injection with each new pen. Turn the dose selector until you see the flow check symbol(). (See Figure F). | |
Make sure the flow check symbol corresponds to the dose indicator. (See Figure G). | |
Check the flow | |
Hold the pen with the needle pointing upwards. Keep the dose button pressed until the dose counter returns to. Theshould match the dose indicator. You should see a drop of Wegovy at the needle tip. This drop indicates that the pen is ready for use. If you do not see a drop, check the flow again.This should only be done twice. If you still do not see a drop,change the needle and check the flow again. Do not use the penif you still do not see a drop of Wegovy. (See Figure H). | |
2 Dose selection | |
Turn the dose selector until thedose counter stopsandshows the selected dose. (See Figure I). | |
The dose counter line () 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 dose selector. Do not count the clicks of the pen. (See Figure J). | |
When the selected dose matches the dose indicator, you have selected the dose.In this example, the doseis shown. If the dose counter stops before reaching the prescribed dose, see the section “Do you have enough Wegovy?”that follows these instructions. (See Figure K). | |
Choose the injection site Choose the upper arms, upper legs, or stomach (keep a distance of 5cm from the navel). You can inject in the same area of the body each week, but make sure it is not in the same spot as the previous week. | |
3 Injection of the dose | |
Insert the needle under the skin. Make sure you can see the dose counter.Do not touch the dose counter with your fingers. This may interrupt the injection. (See Figure L). | |
Keep the dose button pressed until the dose counter shows. (See Figure M). Keep the dose button pressed with the needle under the skin and count slowly to 6.Theshould match the dose indicator. You may hear or feel a click when the dose counter returns to. (See Figure N). | |
Remove the needle from the skin.If the needle is removed before, a jet of Wegovy may come out of the needle tip and the full dose will not be administered. If blood appears at the injection site, press gently on the area to stop the bleeding. You may see a drop of Wegovy at the needle tip after the injection. This is normal and does not affect the dose. (See Figure O). | |
4 After the injection | |
Insert the needle tip into the outer needle capon a flat surface without touching the needle or the outer needle cap. When the needle is covered,press the outer needle cap firmly and carefully. (See Figure P). | |
Twist off the needleand discard it carefully according to the instructions of your doctor, nurse, pharmacist, or local authorities. Never attempt to reattach the inner needle cap,as you may prick yourself with it. Discard the needle immediately after each injectionto avoid needle blockage, contamination, infections, and incorrect dosing.Never store the pen with the needle attached. (See Figure Q). | |
Place the pen capafter each use to protect Wegovy from light. (See Figure R). | |
When the pen is empty, discard it without a needle according to the instructions of your doctor, nurse, pharmacist, or local authorities. The pen cap and empty packaging can be disposed of in household waste. | |
About needles | |
How to identify a blocked or damaged needle
What to do with a blocked needle
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Maintenance of the pen | |
Treat your pen with care. Rough handling or misuse may cause inaccurate dosing. If this occurs, you may not get the desired effect of 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 for a full dose. Discard the pen and use a new Wegovy pen. | |
Important information | |
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