Wegovy prescribing instructions pdf. Approval: 2017 Wegovy ® Product .

Wegovy prescribing instructions pdf • ®Administer WEGOVY once weekly, on the same day each week, at Administration Instructions a barrier method of contraception for 4 See full prescribing information for administration instructions. 9 16. com/wegovy. 4 Recommendations Regarding Missed Dose Document wegovy. 28 MB] Device/Product Name. • In patients with type 2 diabetes, monitor blood glucose prior to starting WEGOVY™ and during WEGOVY™ treatment. novo-pi. In addition to diet and exercise, to reduce risk of MACE (cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke) in adults with established CVD and either overweight or obesity, and for chronic weight management in patients with obesity ≥12 years and adults with overweight with at least one weight-related comorbidity. 4 Federal Food, Drug, and Cosmetic Act (FDCA) for Wegovy (semaglutide) injection. When administering semaglutide, the pen should be pressed firmly Semaglutide (Ozempic®, Wegovy ®) Classification Antidiabetic agent (Ozempic) Weight loss agent (Wegovy) Pharmacology . Contents of the pack and other information . 7 mg/0. • WEGOVY is injected under the skin (subcutaneously) of your stomach (abdomen), thigh, or upper Wegovy is effective at reducing weight in adults with obesity or who are overweight . Call your doctor right Ozempic, Mounjaro, Wegovy and Zepbound can all lead to long-term weight loss, but only Wegovy and Zepbound are approved by the FDA for this use. Know the medicines you take. What should I know while using Wegovy®? Things you should do ⦁Remind any doctor, dentist or pharmacist you visit that you are using Wegovy®. 4 . Form FDA 2253 is available at FDA. rotate) the site of injection for each administration. Then follow the dosage escalation Wegovy is administered once weekly at any time of the day, with or without meals. 18 MB] Attachment Product Information for Wegovy [Word, 1. When to use Ozempic® • You should use this medicine once a week on the same day each week if possible. X/0016 . 2 Important Monitoring and Administration Instructions 2. There may be new information. 3 Recommended Dosage . How to use wegovy 4. If needed, however, Wegovy ® can be kept outside of the refrigerator between 46 °F to 86 °F for up to 28 You can take Wegovy ® with or without food; If you need to change the day of the week, you may do so as long as your last dose of Wegovy ® was given 2 or more days before; If you take too much Wegovy ®, you may have severe nausea, severe vomiting, and severe low blood sugar. Change (i. • Inspect WEGOVY ® visually prior to each injection. 5 mL in single-dose pen or single-dose vial (3) You must submit final promotional materials and Prescribing Information, accompanied by a Form FDA 2253, at the time of initial dissemination or publication [21 CFR 314. Approval: 2017 WARNING: RISK OF THYROID C-CELL TUMORS 2. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment. Wegovy® works by causing you to feel fuller and less hungry. Wegovy 1 mg solution for injection in pre-filled pen . 1 Important Administration Instructions 2. What wegovy is and what it is used for What wegovy is wegovy is a medicine for weight loss and weight maintenance that contains the active substance semaglutide. 25 mg weekly, increasing gradually to 2. 4) -----DOSAGE FORMS AND STRENGTHS----- Injection: 2. 2 Recommended Dosage in Adults 2. WEGOVY comes in five strengths: 0. This Prior Approval sNDA provides for the addition of the following indication to the Prescribing Information, with corresponding revisions to the Medication Guide: • Wegovy is indicated in combination with a reduced calorie diet and increased Wegovy ® – A New Treatment for Obesity by Robert Kushner, MD What is Wegovy ®? Wegovy® is an injectable prescription medicine used for adults with obesity or overweight (excess weight) who also have weight-related medical problems to help them lose weight and keep the weight off. (2. ()Acute Gallbladder Disease: Has occurred in clinical trials. WEGOVY® (wee-GOH-vee) (semaglutide) injection, for subcutaneous use Read this Medication Guide and Instructions for Use before you start using WEGOVY and each time you get a refill. ()Acute Wegovy-pi-v0. 0 mg is £73. RED Note: Wegovy® is not interchangeable with the other licensed brand of semaglutide, Ozempic®, which is only licensed for the management of diabetes. 4 mg is indicated as an adjunct to a reduced calorie diet and increased physical activity for chronic weight management in adults with an initial body mass 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 Administer WEGOVY® once weekly, on the same day each week, at any time of day, with or without meals (2. • WEGOVY is injected under the skin (subcutaneously) of your stomach (abdomen), thigh, or upper This file provides important details and instructions regarding Wegovy®, a semaglutide injection used for chronic weight management. The Wegovy pen is for single use in one patient HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use WEGOVY safely and effectively. 5 30. This Prior Approval sNDA provides for updates to the Prescribing Information and Medication Guide to include Wegovy (semaglutide) 1. 6. 68 mg of semaglutide. How should I use WEGOVY? • Read the Instructions for Use that comes with WEGOVY. 5 mg, 1 mg, 1. • Initiate at 0. 1 Recommended Dosage 2. It is also effective in adolescents with obesity, but there were not enough data on overweight adolescents. Monitoring Importance: Regularly track weight and glucose levels for safety. I am a member of the public based in GB →. Wegovy ® pen is a dial-a-dose pen that contains four of your prescribed doses of Wegovy glucose prior to starting WEGOVY ® and during WEGOVY treatment [see Warnings and Precautions (5. 2). 4 mg is indicated in combination with a reduced calorie diet and increased physical activity:. WEGOVY ® (semaglutide) injection 2. Inject subcutaneously Download PDF > Standard Print; Large Print; Instructions For Use > Wegovy® FlexTouch® Consumer Medicine Information (CMI) summary. How to use wegovy . WARNING: RISK OF THYROID C CELL TUMORS full prescribing information for complete boxed warning. Do not use Wegovy™ if particulate matter or colouration is seen. Cosmetic Act (FDCA) for Wegovy (semaglutide) injection. 7 mg once-weekly (2. Approval: 2017 Acute Pancreatitis: Has been observed in patients treated with GLP-1 receptor agonists, including WEGOVY. 5 mg/0. Description: FDA-Approved Indication . 2 Geriatrics Geriatrics (> 65 years of age): In the Wegovy® clinical trials, 233 (8. pdf), Text File (. The list price of semaglutide (Wegovy) 2. Annex I_1. 3. One pre-filled pen contains 1. If thyroid cancer happens, it may be deadly if not found and treated early. The information referred to may not comply with Australian regulatory requirements. Initial U. 1). 4 mg, along with a reduced calorie diet and increased physical activity, is used to reduce the risk of major cardiovascular (CV) events such as death, heart attack, or stroke in adults with known heart MG/DOSE); Rybelsus; Wegovy Brand Names: Canada Ozempic (0. 3 Recommended Dosage in Pediatric Patients Aged 12 to incorporate Wegovy® alongside the prescribing of Liraglutide (Saxenda®). increase WEGOVY™ to the maintenance 2. 7 mg • n I your fifth month, you’ll increase your weekly dose to 2. e. AU24NNM00004 | July 2024. Please talk with your doctor to find out your specific dosing schedule. 25/04/2024 : 10/06/2024 . 6 17. WEGOVY semaglutide injection, for subcutaneous use Initial U. Dosing Strategy: Start at 0. Approval: 2017 Wegovy ® Product Patients should be advised to read the instruction for use included in the package leaflet carefully before administering Wegovy. 4 mg - Free download as PDF File (. In patients with type 2 diabetes, monitor blood glucose prior to starting and during WEGOVY treatment (2. If patients do not tolerate a dose during dose escalation, consider delaying dose escalation for 4 weeks; The maintenance dose of Wegovy ® in adults is either 2. How do I use Wegovy®? in the full CMI. 5 16. This dose has shown efficacy in clinical trials and is the recommended maintenance dose per the prescribing information. 5 mL 0. Please print, type or write legibly in blue or black ink. The FULL PRESCRIBING INFORMATION: CONTENTS* WARNING: RISK OF THYROID C-CELL TUMORS 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION 2. 25 mg solution for injection (Aust R 424390) One mL of solution contains 0. 4 mg dose. The injection site can be changed without dose adjustment. Achieving optimal weight-loss results with Wegovy™ requires reaching and staying at the full dose Wegovy™ comes in 5 different dose strengths. Scroll to ISI What is Wegovy ®?. Administer Wegovy™ subcutaneously in the abdomen, thigh, or upper arm. Only use if This website has been developed by Novo Nordisk UK to provide information about: Wegovy ® (semaglutide injection) for Great Britain (GB). 5mL 0. Only use if WEGOVY- semaglutide injection, solution Novo Nordisk-----HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use WEGOVY safely and effectively. Serious Warnings and Precautions Administer WEGOVY once weekly as an adjunct to diet and increased physical activity, on the same day each week, at any time of day, with or without meals (2. 0%) of Wegovy ® See full prescribing information for WEGOVY. This was an application for a group of variations. 8 84. • ®Wegovy should be used with a reduced calorie meal plan Wegovy™ solution should be inspected visually prior to each injection and should be clear, colourless, and contain no particles. 10waystocut500caloriesaday Nomatterwhattypeofdietyoufollow,toloseweight,youneedtoburnmorecaloriesthanyoutake HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use RYBELSUS® safely and effectively. 5 28. Further information relevant to the Australian environment is available from Novo Nordisk (Australia) or via What is the difference between Wegovy® and Ozempic®? Wegovy® and Ozempic® both contain the same active ingredient, semaglutide. How to inject Wegovy. 5 mg, or 15 mg per 0. 4 Information and Instructions for completing the form can be See full prescribing information for WEGOVY. WARNING: RISK OF THYROID C -CELL TUMORS WEGOVY safely and effectively. 1. Novo Nordisk Request PDF | (157) Prescribing Ozempic and Wegovy for Weight Loss is Associated with an Increased Risk of Erectile Dysfunction and Hypogonadism in Non-Diabetic Males | Introduction The use of increase WEGOVY™ to the maintenance 2. • In a separate 2-year medical study, adults taking Wegovy® 2. 4mg) for overweight and obesity. Administration Method: Administer via subcutaneous injection in specified areas. Wegovy® (semaglutide injection) Product Monograph Page 5 of 60 15. 3 DOSAGE FORMS AND STRENGTHS Injection: clear, colorless solution available in 5 pre-filled, Detailed instructions for use are on the other side of this package leaflet. Click here ®for Prescribing Information, including Boxed Warning, for Saxenda (liraglutide) injection 3 mg. 5mg/0. Patients should be advised to read the instruction for use included in the package leaflet carefully before administering the medicinal product. com. • Wegovy® contains semaglutide and should not be used with other semaglutide-containing products or other GLP-1 receptor agonist medicines • It is not known if Wegovy® is safe and effective when taken with other prescription, over-the-counter, or herbal weight loss products • ®It is not known if Wegovy can be used safely in people with prescribing of SEMAGLUTIDE injection (Wegovy® ), by specialists only, for managing overweight and obesity within a specialist weight management service, in accordance with NICE TA875. 4 mg once-weekly. • Your healthcare provider should show you how to use WEGOVY before you use it for the first time. 7 mg/ 0. 4 mg/0. צורת נטילה – תמיסה להזרקה תת increase WEGOVY™ to the maintenance 2. PAY $25 *Eligibility and restrictions apply. 25 mg solution for injection in pre-filled pen . It outlines potential risks, including thyroid tumors, and how to use the medication effectively. pdf NovoCare ® and Wegovy are registered trademarks of Novo Nordisk A/S. HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use WEGOVY® safely and effectively. 5 mL 1. Prescribing Strength NDC Days Supply Dispense Quantity Recommended SIG 0. It is to be injected subcutaneously in the abdomen, in the thigh or in the upper arm. 4 mg is an injectable prescription medicine used with a reduced calorie diet and increased physical activity:. Wegovy Pen Instructions. The pen injection device is different. Wegovy should not be administered intravenously or intramuscularly. 4 100. 7-clean Page 1 of 29 AusPAR - Wegovy - semaglutide - PM-2021-00612-1-5 - Novo Nordisk Pty Ltd Date of Finalisation 4 September 2024. (c) Replacement of a biological AS with : one of a slightly different molecular structure . Approval: 2017 WARNING: RISK OF THYROID C Over 1 year and 4 months (68 weeks), a medical study looked at the effect and safety of Wegovy ® in adolescents with obesity. 3 DOSAGE FORMS AND STRENGTHS Injection: clear, colorless solution available in 5 pre-filled, Wegovy is administered by a weekly subcutaneous (SC) injection. 4 mg is an injectable Refer to Instructions for Use within the Prescribing Information for how to use the Wegovy™ pen. 4 mg is reached (2. How to store wegovy . along with diet and exercise to improve blood Wegovy ® (semaglutide) injection 2. 7 mg subcutaneous weekly as an additional maintenance dose for use as an adjunct to a reduced calorie diet and Evidence-based recommendations on semaglutide (Wegovy) for managing overweight and obesity in adults. The medication is typically administered using a pre-filled, single-dose pen. 4 % change from baseline HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use WEGOVY safely and effectively. 6 30. In SELECT, the Cardiovascular Outcomes Trial (CVOT) , 2656 (30%) Wegovy ®-treated patients were between 65 and 74 years of age, and 703 (8. If patients do not tolerate a dose during dosage escalation, consider delaying dosage escalation for 4 weeks. g. 0%) Wegovy ®-treated patients were between 65 and 74 years of age and 23 (1%) were ≥ 75 years of age. 5 99. Approval: 2017 . EMEA/H/C/005422/X/0016 : II/0020/G . Do not use Wegovy™ if particulate matter or colouration WegovyTM (semaglutide) injection 2. It should be noted that Prescribing Wegovy involves a medical assessment of the patient to determine the suitability. Hypoglycemia: Concomitant use with insulin or שם התרופה – וויגובי (™Wegovy) החומר הפעיל – סמגלוטייד (Semaglutide) יצרן – נובו נורדיסק (Novo Nordisk) ארץ הייצור – דנמרק מאושרת לשימוש בארה"ב משנת 2021, בישראל משנת 2023 האם דרוש מרשם רופא? כן. 5 mL solution. 48 MB] AusPAR Wegovy [Word, 8. 4 Recommendations Regarding Missed Dose . including sulfonylureas or insulin. 6% (~6 lb) for adults taking placebo* • 77% of adults taking Wegovy® lost 5% or more weight to starting WEGOVY ® and during WEGOVY treatment [see Warnings and Precautions (5. Each pack contains 1 pen that delivers 4 doses. The full CMI on the next page has more details. Wegovy® should be used along with a reduced calorie diet and increased physical activity. After a 3-month (12-week) screening period in which each participant received behavioral lifestyle therapy (counseling about healthy nutrition and physical activity), participants were then randomly assigned to two groups. 1 Important Monitoring and Administration Instructions 2. 7 mg is £124. UK24SEMO00130 November 2024 Administer WEGOVY once weekly as an adjunct to diet and increased physical activity, on the same day each week, at any time of day, with or without meals (2. These challenges include: Treatment disruptions: The shortage can disrupt treatment plans, leaving healthcare providers with limited options for prescribing Wegovy to their patients. Wegovy is administered once weekly at any time of the day, with or without meals. Before injecting the pen, check the expiration date on the back of the Wegovy (semaglutide injection) Cardiovascular Page: 1 of 3 Effective Date: 1/13/2025 . In patients with type 2 diabetes, monitor blood glucose prior to WEGOVY is an injectable prescription medicine that may help adults and children aged 12 years and older with obesity, or some adults with excess weight (overweight) who also have Before using your pen for the first time, read the Instructions for Use and Medication Guide that come with your pen pack, and talk to your health care provider about how to use WegovyTM 2. It acts in the same way as GLP-1 (a natural hormone in the body) and, among other things, appears to regulate appetite by increasing a person’s feelings of fullness, Click here for Prescribing Information, including Boxed Warning, for Wegovy™. Wegovy® is available in the following dose strengths: 0. 3 DOSAGE FORMS AND STRENGTHS Injection: clear, colorless solution available in 5 pre-filled, As part of your Wegovy ® treatment, you are eligible to join wegovycare® and access free support and information. See full prescribing information for WEGOVY®. 5 mg, 5 mg, 7. 4 mm, so even people who. Wegovy® has 5 doses (0. 3 Recommended Dosage 2. Each pack contains 4 Wegovy™ pens (one pen for each week). to reduce the risk of major See the Medication Guide and Prescribing Information at www. If cholelithiasis is Cardiovascular Risk Reduction . Do not inject it into a vein or muscle. 1 Patient Selection . 75 mL 2. 5. Last reviewed: In September 2023, changes were made to recommendation 1. WEGOVY (semaglutide) injection, for subcutaneous use . • You can give yourself the injection at any time of the day – regardless of meals. When administering semaglutide, the pen should be pressed firmly WEGOVY- semaglutide injection, solution Novo Nordisk-----HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use WEGOVY safely and effectively. This NDA provides for the use of Wegovy (semaglutide) injection as an adjunct to a reduced calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index (BMI) of: • 30 kg/m. 3 DOSAGE FORMS AND STRENGTHS . complete the study. Complete ALL information on the form. 3). This will allow quick identification of new Detailed instructions for use are on the other side of this leaflet. *Sections or subsections omitted from the full prescribing information are not listed. 9%]) of Wegovy 0. The prescribing of both Wegovy® and Saxenda® are restricted to SWL commissioned tier 3 and 4 weight management services in line with NICE TA875 and TA664 respectively. Discontinue promptly if pancreatitis is suspected. The active substance in Wegovy, semaglutide, is a ‘GLP-1 receptor agonist’. What you need to know before you use wegovy 3. 25 mg/0. Possible side effects . Once registered for wegovycare®, you can access services including: Scan the QR code or visit wegovycare. 25 per pack (excluding VAT; company communication). • Use WEGOVY exactly as your healthcare provider tells you to. • The maintenance dosage of WEGOVY in pediatric patients aged 12 increase WEGOVY™ to the maintenance 2. Discontinuation of Wegovy® in these patients may result in an increase in blood glucose. 25 or 0. 4 CONTRAINDICATIONS . S. Refer to the accompanying Instructions for Use for complete administration instructions with illustrations. Placebo Wegovy Placebo Wegovy Placebo Wegovy Body Weight at baseline (kg) 105. wegovy is a medicine for weight loss and weight maintenance that contains the active substance semaglutide. Before you use your WEGOVY pen for the first Click here for Prescribing Information, including Boxed Warning, for Wegovy™. txt) or read online for free. pdf, Subject nursing, from University of Puerto Rico, Rio Piedras, Length: 15 pages THYROID C−CELL TUMORS 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION 2. Inject subcutaneously in the abdomen, thigh or upper arm (2. Only use if solution is clear, colorless, and contains no particles. 2 Important Monitoring and Administration Instructions . Information on submitting SPL files using eList may be found in the guidance for See full prescribing information for WEGOVY. See full prescribing information for WEGOVY. This guide will help you: Learn how to use your pen Understand the dosing schedule Know what to expect Access support and savings Your next step begins here HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use WEGOVY safely and effectively. wegovy 0. Only use if Scroll to ISI What is Ozempic ®?. to reduce the risk of major cardiovascular events such as death, heart attack, or stroke in adults with known heart disease and with either obesity or overweight. SmPC : Please refer to the scientific discussion . Wegovy is an injectable weight loss medication that should be administered as a once-weekly subcutaneous injection. The injection site Wegovy™ solution should be inspected visually prior to each injection and should be clear, colourless, and contain no particles. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine. Please have your Wegovy® pack with you, as you will need the last 4 digits of the bar code to enrol. WARNING: RISK OF THYROID C-CELL TUMORS See the Wegovy ® Prescribing Information for details. 4 mg Wegovy® indications Novo Nordisk produces Wegovy® in a single dose device pen and does not provide or sell semaglutide to anyone for compounding. The injection site Wegovy is administered once weekly at any time of the day, with or without meals. Acute Pancreatitis: Has been observed in patients treated with GLP-1 receptor agonists, including WEGOVY. Call your health care provider or go to the nearest hospital emergency room right away if you HIGHLIGHTS OF PRESCRIBING INFORMATION WEGOVY safely and effectively. 9 103. Submit a separate form for each medication. 4 mg is £175. • • RECENT MAJOR ⦁Wegovy® is given as an injection under the skin (subcutaneous injection). 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 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use Prior to initiation, train patients and caregivers on proper injection technique [see Instructions for Use]. Here are the general instructions on how to use the Wegovy pen: including sulfonylureas or insulin. 0 28. Active ingredients. HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use WEGOVY safely and effectively. PRIOR AUTHORIZATION POLICY POLICY: Weight Loss – Glucagon-Like Peptide-1 Agonists Prior Authorization Policy • Saxenda® (liraglutide subcutaneous injection – Novo Nordisk) • ®Wegovy (semaglutide subcutaneous injection – Novo Nordisk) • Zepbound® (tirzepatide subcutaneous injection − Eli Lilly) REVIEW DATE: 07/12/2023; selected revision 07/26/2023, Wegovy® (semaglutide injection) Product Monograph Page 6 of 60 • In patients with Type 2 diabetes mellitus, monitor blood glucose prior to starting and during Wegovy® treatment. 2 67. The dosing is slightly different. 4 47. • ®Inspect WEGOVY visually prior to each injection. Follow the instructions provided and use Wegovy® until your doctor tells you Proprietary Name: Wegovy (which was adapted from the prescribing information) to minimize gastrointestinal adverse reactions. Prescriptions of all liraglutide or semaglutide-containing formulations for the 2. Instructions for use studies with rodents, Wegovy® and medicines that work like Wegovy® caused thyroid tumors, including thyroid cancer. 75 mL 0169-4525-14 0169-4505-14 What is Wegovy ™? Wegovy™ (semaglutide) injection 2. Single-dose pen The single-dose pen is for single use in one patient only. Wegovy (semaglutide) EMA/162766/2023 Page 3/3 with a weight-related health problem. 4)]. 5 mg and 1. For six 28-day . 1 INDICATIONS AND USAGE . More instructions can be found in Section 4. • Prior to initiation of WEGOVY®, train patients on proper injection technique. 7 mg and 2. Approval: 2017 WARNING: RISK OF THYROID C What to know about prescribing Wegovy™ How to prescribe once-weekly Wegovy™ Wegovy™ comes in 5 packs (one for each strength). WARNING: RISK OF THYROID C -CELL TUMORS Key Takeaways: Prescribing Wegovy Indication for Use: Wegovy is for adults with obesity or overweight. If you are worried about using this medicine, speak to your doctor or pharmacist. Semaglutide is a human glucagon-like peptide 1 (GLP-1) receptor agonist (incretin mimetic). 3 DOSAGE FORMS AND STRENGTHS Injection: clear, colorless solution available in 5 pre-filled, Indications and Usage. . Wegovy pen Wegovy_ patient education - Free download as PDF File (. NOTE: The prescribing physician (PCP or Specialist) should, in most cases, complete the form. 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 These highlights do not include all the information needed to use WEGOVY safely and effectively. Your doctor may Wegovy ® FlexTouch ® 0. WEGOVY- semaglutide injection, solution A-S Medication Solutions-----HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use WEGOVY safely and effectively. AusPAR Wegovy [PDF, 2. Wegovy (semaglutide)has been approved as an adjunct to a reduced-energy diet and increased physical activity for chronic weight management (including weight loss and weight maintenance) in adults. Cancel Contact us. 5 mg, 10 mg, 12. 2 tions for Use for complete administration instructions with illustrations. 4 mg lost an average of ~15% (~35 lb) vs 2. It is important to follow the instructions provided by a healthcare professional on how to properly inject Wegovy. Wegovy pen Instructions Wegovy) Injection 2. See full prescribing information for RYBELSUS. gov. In studies, Zepbound has led to a 21% weight loss in adults using the highest dose, while Wegovy has led to About Wegovy® (semaglutide) injection 2. studies with rodents, Wegovy® and medicines that work like Wegovy® caused thyroid tumors, including thyroid cancer. 74 MB] Attachment Product Information for Wegovy [PDF, 1018. Wegovy. 0 1 United States Center for Disease Control criteria 1. If cholelithiasis is suspected, gallbladder studies and clinical follow-up are indicated (). Discover information, education and resources for Wegovy® (semaglutide 2. Injecting Wegovy is convenient because of the pen design, but you must follow the instructions shared by your healthcare provider. 25, In the Wegovy ® phase 3a weight management clinical trials, 233 (9. 2 Important Administration Instructions 3 DOSAGE FORMS AND STRENGTHS 4 CONTRAINDICATIONS 5 WARNINGS AND PRECAUTIONS 5. 1 to refer to the company’s commercial arrangement. In 4 week intervals, increase the dose until a dose of 2. au to enrol. or greater (obesity) or • 27 kg/m. • The maintenance dosage of WEGOVY in adults is either 2. 2 29. What you need to know before you use wegovy . Contents of the pack and other information 1. 2 . It is not known if Wegovy ® will cause thyroid tumors or a type of thyroid cancer called medullary thyroid How does Wegovy® work? Wegovy® is similar to a natural hormone called glucagonlike peptide- -1 (GLP-1) that is released from the intestine after a meal. FULL PRESCRIBING INFORMATION: CONTENTS* WARNING: RISK OF THYROID C−CELL TUMORS 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION 2. What wegovy is . 25 mg, 0. 2 105. 3 17. 4. 9% of people taking Wegovy® (9 people) discontinued treatment due to side effects compared with 4. What wegovy is and what it is used for . 2 28. The first-and-only medicine indicated for both HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use WEGOVY safely and effectively. 5 WARNINGS AND PRECAUTIONS . Enroll your patients in WeGoTogether™ This program helps your patients get started and stay on track with Wegovy™. 9 29. Initiate at 0. are afraid of needles usually do well with How should I use WEGOVY? • Read the Instructions for Use that comes with WEGOVY. 4 mg. phone: 902 542 0990; fax: 855 962 2375. The Wegovy pen is a user-friendly device designed to facilitate the administration of the medication. 7 106. WARNING: RISK OF THYROID C -CELL TUMORS Wegovy is given as a shot under the skin with a very small needle, only 0. Approval: 2017 WARNING: RISK OF THYROID C-CELL TUMORS See full prescribing information for complete boxed warning. 4 mg solution for injection in pre-filled pen semaglutide This medicine is subject to additional monitoring. Ozempic ® (semaglutide) injection 0. Possible side effects 5. 53 per pack, and of 0. 1 Risk of Thyroid C-Cell Please refer to Scientific Discussion ‘Wegovy -H-C-005422-II-0017’. 4 mg In addition to diet and exercise, to reduce risk of MACE (cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke) in adults with 2. It is not known if this happens in humans. Approval to starting WEGOVY® and during WEGOVY® treatment [see Warnings and Precautions (5. wegovy - Free download as PDF File (. Attachment Product Information for Wegovy [PDF, 1. You 2. WEGOVY (semaglutide) injection, for subcutaneous use Initial U. Instruct patients using the single-dose vial to use a syringe appropriate for dose administration (e. 5 MG/DOSE); Ozempic (1 MG/DOSE); Rybelsus; Wegovy; Wegovy FlexTouch Warning This drug has been shown to cause thyroid cancer in some animals. Hypoglycemia: Concomitant use with insulin or an insulin secretagogue may Wegovy ® (semaglutide) injection 2. 5 27. 4 mg (recommended) or 1. 0 mg semaglutide in 1. How to store wegovy 6. WEGOVY ® (semaglutide) injection. INSTRUCTIONS FOR COMPLETING THIS FORM 1. Federal Food, Drug, and Cosmetic Act (FDCA) for Wegovy (semaglutide) injection. 2 Recommended Dosage 3 DOSAGE FORMS AND STRENGTHS 4 CONTRAINDICATIONS 5 WARNINGS AND PRECAUTIONS 5. We also updated section 2 to include the list price of semaglutide and to refer to the commercial arrangement. Wegovy has been approved for weight management in obese adolescents ages 12 years and above (as an adjunct to a reduced-calorie diet and increased physical activity). FULL PRESCRIBING INFORMATION: CONTENTS* WARNING: RISK OF THYROID C-CELL TUMORS . Wegovy is to be injected subcutaneously in the abdomen, in the thigh or in the upper arm. It's crucial to discuss any health conditions or concerns with your healthcare professional before using Wegovy®. Intent: The intent of this policy/guideline is to provide information to the prescribing practitioner outlining the coverage criteria for Wegovy under the patient’s prescription drug benefit. INSTRUCTION FOR USE . 1 Risk of Thyroid C-Cell How should I use WEGOVY? • Read the Instructions for Use that comes with WEGOVY. 6% for placebo (7 people). Inject subcutaneously Instructions for injecting Wegovy. This video is based on the Instructions for Use that come with your Wegovy ® pen. Discontinue WEGOVY™ if the patient cannot tolerate the 2. Below is an example of a dosing schedule. Wegovy ® (semaglutide) injection 2. S Instructions Wegovy PI Novo Nordisk Wegovy™ semaglutide injection 2 4 mg tions for Use complete administration instructions with initial maternal body weight loss and reductions in gain food consumption In patients type diabetes 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. This makes semaglutide available to the NHS with a discount. 81(b)(3)(i)]. 4 mg (recommended) This guide will help you: Learn how to use your pen Understand the dosing schedule Know what to expect Access support and savings Your next step begins here Wegovy 0. Semaglutide activates the GLP-1 receptor in pancreatic beta cells leading to glucose-dependent insulin release. If needed, however, Wegovy ® can be kept outside of the refrigerator between 46°F to 86°F for up to 28 *Sections or subsections omitted from the full prescribing information are not listed. 5 mL 1 mg/0. Wegovy® is marketed and indicated for obesity. 02 KB] HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use WEGOVY safely and effectively. 25 mg (the dose you received in this kit) once per week in your first month • In your second month, increase your weekly dose to 0. Ozempic® is marketed and indicated for type 2 diabetes. In rodents, semaglutide causes thyroid C-cell tumors at clinically relevant exposures. You should store Wegovy ® in the refrigerator. 5 mg, 1 mg, or 2 mg is an injectable prescription medicine used:. The company has a commercial arrangement. WEGOVY slows stomach emptying and can affect medicines that need to pass through the stomach quickly. 4 mg is an injectable prescription medicine used for adults with obesity (BMI ≥30) or overweight (excess weight) (BMI ≥27) who also have weight-related medical problems to help them lose weight and keep the weight off. 80 per pack, of 1. 2 DOSAGE AND ADMINISTRATION . 5 mg solution for injection (Aust R 424391) One mL of solution contains 1. 5 mg solution for injection in pre-filled pen . 0 27. The single-dose pen should be discarded after use. Wegovy ® FlexTouch ® 0. 75 mL. People with diabetes Tell your doctor if you have diabetes. It is not known if Wegovy ® will cause thyroid tumors or a type of thyroid cancer called medullary thyroid to starting WEGOVY ® and during WEGOVY treatment [see Warnings and Precautions (5. Lifestyle Changes Required: Dosing with Wegovy™ • Start Wegovy™ with a dose of 0. 2. WARNING: RISK OF THYROID C -CELL TUMORS Administer WEGOVY once weekly as an adjunct to diet and increased physical activity, on the same day each week, at any time of day, with or without meals (2. 8%) Wegovy®-treated patients were between 65 and 75 years of age and a limited number (23 [0. Safety and efficacy data in pediatric (12 to less than See full prescribing information for WEGOVY. Wegovy 0. 9 % of patients losing ≥5% body weight 31. Semaglutide Prescribing Information, Medication Guide, and Instruction for Use), with the addition of any labeling changes in pending “Changes Being Effected” (CBE) supplements, as well as annual reportable changes not included in the enclosed labeling. This evaluation involves reviewing the patient’s medical records and the current list of medications that starting and during WEGOVY treatment (2. 1 83. 25 mg once weekly for 4 weeks. RYBELSUS (semaglutide) tablets, for oral use Initial U. 34 mg of semaglutide. Approval Acute Pancreatitis: Has been observed in patients treated with GLP-1 receptor agonists, including WEGOVY. 2 Important Administration Instructions . Medically speaking, Wegovy® is a glucagon-like-peptide-1 ⦁Wegovy® is given as an injection under the skin (subcutaneous injection). The Wegovy shortage poses significant challenges for healthcare providers trying to manage their patients' weight loss and health. 5 mg • In your third month, increase your weekly dose to 1 mg • In your fourth month, increase your weekly dose to 1. , a 1 mL syringe Acute Pancreatitis: Has been observed in patients treated with GLP-1 receptor agonists, including WEGOVY. Approval: 2017 WARNING: RISK OF THYROID C-CELL TUMORS Wegovy ® Product Patients should be advised to read the instruction for use included in the package leaflet carefully before administering Wegovy. Suite 250 21 Roy Avenue New Minas, Nova Scotia B4N 3R7. Indications and Usage. Patients should be advised to read the instruction for use included in the package leaflet carefully What is Wegovy®? Wegovy® (semaglutide) injection 2. afxp rcsaqx hudo ymysuc gjwvqs nwz wfmj vmmgiag hbere fqfak