Wegovy prescribing instructions pdf. Discontinue WEGOVY™ if the patient cannot tolerate the 2.

Wegovy prescribing instructions pdf 1 Important Monitoring and Administration Instructions 2. Wegovy 1 mg solution for injection in pre-filled pen . 4 mg is reached (2. to reduce the risk of major See the Medication Guide and Prescribing Information at www. In patients with type 2 diabetes, monitor blood glucose prior to starting and during WEGOVY treatment (2. We also updated section 2 to include the list price of semaglutide and to refer to the commercial arrangement. Once registered for wegovycare®, you can access services including: Scan the QR code or visit wegovycare. 2 DOSAGE AND ADMINISTRATION . WEGOVY (semaglutide) injection, for subcutaneous use Initial U. 4 Recommendations Regarding Missed Dose . 8 84. 0%) of Wegovy ® See full prescribing information for WEGOVY. 4 mm, so even people who. 9 % of patients losing ≥5% body weight 31. Know the medicines you take. 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. The full CMI on the next page has more details. 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. 7-clean Page 1 of 29 AusPAR - Wegovy - semaglutide - PM-2021-00612-1-5 - Novo Nordisk Pty Ltd Date of Finalisation 4 September 2024. 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. wegovy 0. 25 or 0. WARNING: RISK OF THYROID C -CELL TUMORS Key Takeaways: Prescribing Wegovy Indication for Use: Wegovy is for adults with obesity or overweight. 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. What wegovy is . You should store Wegovy ® in the refrigerator. Here are the general instructions on how to use the Wegovy pen: including sulfonylureas or insulin. 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. It is not known if this happens in humans. Inject subcutaneously Instructions for injecting Wegovy. 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 . 4. It is important to follow the instructions provided by a healthcare professional on how to properly inject Wegovy. WEGOVY (semaglutide) injection, for subcutaneous use . • The maintenance dosage of WEGOVY in adults is either 2. How do I use Wegovy®? in the full CMI. 1 Patient Selection . 7 mg • n I your fifth month, you’ll increase your weekly dose to 2. Each pack contains 1 pen that delivers 4 doses. RED Note: Wegovy® is not interchangeable with the other licensed brand of semaglutide, Ozempic®, which is only licensed for the management of diabetes. 2 Recommended Dosage 3 DOSAGE FORMS AND STRENGTHS 4 CONTRAINDICATIONS 5 WARNINGS AND PRECAUTIONS 5. 1). 9 16. 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. If cholelithiasis is Cardiovascular Risk Reduction . 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. 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. How to store wegovy 6. How should I use WEGOVY? • Read the Instructions for Use that comes with WEGOVY. Initiate 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. See full prescribing information for WEGOVY. 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. Enroll your patients in WeGoTogether™ This program helps your patients get started and stay on track with Wegovy™. The active substance in Wegovy, semaglutide, is a ‘GLP-1 receptor agonist’. 9 103. novo-pi. S. FULL PRESCRIBING INFORMATION: CONTENTS* WARNING: RISK OF THYROID C−CELL TUMORS 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION 2. 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. rotate) the site of injection for each administration. 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. 25 per pack (excluding VAT; company communication). How to use wegovy . com/wegovy. Each pack contains 4 Wegovy™ pens (one pen for each week). This makes semaglutide available to the NHS with a discount. 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 prescription medicine used with a reduced calorie diet and increased physical activity:. Inject subcutaneously in the abdomen, thigh or upper arm (2. Wegovy should not be administered intravenously or intramuscularly. e. • In patients with type 2 diabetes, monitor blood glucose prior to starting WEGOVY™ and during WEGOVY™ treatment. 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. • 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. Cosmetic Act (FDCA) for Wegovy (semaglutide) injection. 5 mg, 1 mg, or 2 mg is an injectable prescription medicine used:. Safety and efficacy data in pediatric (12 to less than See full prescribing information for WEGOVY. The list price of semaglutide (Wegovy) 2. 7 mg/0. Prescriptions of all liraglutide or semaglutide-containing formulations for the 2. 2 29. 5 16. 25 mg, 0. 0 1 United States Center for Disease Control criteria 1. 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). 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. Wegovy is administered once weekly at any time of the day, with or without meals. 5 mg/0. 4 CONTRAINDICATIONS . 2 67. 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. 1 Risk of Thyroid C-Cell Please refer to Scientific Discussion ‘Wegovy -H-C-005422-II-0017’. Change (i. ()Acute Wegovy-pi-v0. 02 KB] HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use WEGOVY safely and effectively. If patients do not tolerate a dose during dosage escalation, consider delaying dosage escalation for 4 weeks. WEGOVY comes in five strengths: 0. 25 mg/0. 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. including sulfonylureas or insulin. Federal Food, Drug, and Cosmetic Act (FDCA) for Wegovy (semaglutide) injection. Wegovy® has 5 doses (0. txt) or read online for free. Achieving optimal weight-loss results with Wegovy™ requires reaching and staying at the full dose Wegovy™ comes in 5 different dose strengths. If thyroid cancer happens, it may be deadly if not found and treated early. HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use WEGOVY safely and effectively. Active ingredients. 5 MG/DOSE); Ozempic (1 MG/DOSE); Rybelsus; Wegovy; Wegovy FlexTouch Warning This drug has been shown to cause thyroid cancer in some animals. 7 mg and 2. Do not inject it into a vein or muscle. Wegovy (semaglutide) EMA/162766/2023 Page 3/3 with a weight-related health problem. 5 28. 0 mg semaglutide in 1. Wegovy® is available in the following dose strengths: 0. increase WEGOVY™ to the maintenance 2. What wegovy is and what it is used for . INSTRUCTION FOR USE . One pre-filled pen contains 1. 2 Important Monitoring and Administration Instructions . 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. 75 mL 0169-4525-14 0169-4505-14 What is Wegovy ™? Wegovy™ (semaglutide) injection 2. or greater (obesity) or • 27 kg/m. Please talk with your doctor to find out your specific dosing schedule. 1 INDICATIONS AND USAGE . Approval: 2017 WARNING: RISK OF THYROID C-CELL TUMORS 2. Ozempic ® (semaglutide) injection 0. • The maintenance dosage of WEGOVY in pediatric patients aged 12 increase WEGOVY™ to the maintenance 2. Information on submitting SPL files using eList may be found in the guidance for See full prescribing information for WEGOVY. The injection site can be changed without dose adjustment. • ®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. Possible side effects . 5 mg solution for injection in pre-filled pen . Last reviewed: In September 2023, changes were made to recommendation 1. 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. FULL PRESCRIBING INFORMATION: CONTENTS* WARNING: RISK OF THYROID C-CELL TUMORS . • ®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. PAY $25 *Eligibility and restrictions apply. 7 mg is £124. The information referred to may not comply with Australian regulatory requirements. Approval: 2017 Acute Pancreatitis: Has been observed in patients treated with GLP-1 receptor agonists, including WEGOVY. WEGOVY semaglutide injection, for subcutaneous use Initial U. Single-dose pen The single-dose pen is for single use in one patient only. This Prior Approval sNDA provides for updates to the Prescribing Information and Medication Guide to include Wegovy (semaglutide) 1. 5 99. Discontinue WEGOVY™ if the patient cannot tolerate the 2. 34 mg of semaglutide. More instructions can be found in Section 4. 2 Geriatrics Geriatrics (> 65 years of age): In the Wegovy® clinical trials, 233 (8. Do not use Wegovy™ if particulate matter or colouration is seen. 2 Important Administration Instructions 3 DOSAGE FORMS AND STRENGTHS 4 CONTRAINDICATIONS 5 WARNINGS AND PRECAUTIONS 5. It outlines potential risks, including thyroid tumors, and how to use the medication effectively. 4 mg lost an average of ~15% (~35 lb) vs 2. צורת נטילה – תמיסה להזרקה תת increase WEGOVY™ to the maintenance 2. are afraid of needles usually do well with How should I use WEGOVY? • Read the Instructions for Use that comes with WEGOVY. Acute Pancreatitis: Has been observed in patients treated with GLP-1 receptor agonists, including WEGOVY. In SELECT, the Cardiovascular Outcomes Trial (CVOT) , 2656 (30%) Wegovy ®-treated patients were between 65 and 74 years of age, and 703 (8. Discontinuation of Wegovy® in these patients may result in an increase in blood glucose. • 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 . 4 mg is £175. 1 Risk of Thyroid C-Cell How should I use WEGOVY? • Read the Instructions for Use that comes with WEGOVY. 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 is also effective in adolescents with obesity, but there were not enough data on overweight adolescents. 1 Important Administration Instructions 2. Please have your Wegovy® pack with you, as you will need the last 4 digits of the bar code to enrol. 5 mg solution for injection (Aust R 424391) One mL of solution contains 1. Wegovy is to be injected subcutaneously in the abdomen, in the thigh or in the upper arm. Wegovy Pen Instructions. 10waystocut500caloriesaday Nomatterwhattypeofdietyoufollow,toloseweight,youneedtoburnmorecaloriesthanyoutake HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use RYBELSUS® safely and effectively. 5 mg, or 15 mg per 0. com. 7 mg once-weekly (2. 6% for placebo (7 people). 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. 3 DOSAGE FORMS AND STRENGTHS . 1 Recommended Dosage 2. 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. 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. WARNING: RISK OF THYROID C-CELL TUMORS See the Wegovy ® Prescribing Information for details. 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. Only use if solution is clear, colorless, and contains no particles. For six 28-day . 81(b)(3)(i)]. 5. 75 mL 2. 25 mg once weekly for 4 weeks. It's crucial to discuss any health conditions or concerns with your healthcare professional before using Wegovy®. 25 mg weekly, increasing gradually to 2. • Prior to initiation of WEGOVY®, train patients on proper injection technique. Approval Acute Pancreatitis: Has been observed in patients treated with GLP-1 receptor agonists, including WEGOVY. 5 mg and 1. WARNING: RISK OF THYROID C -CELL TUMORS Wegovy is given as a shot under the skin with a very small needle, only 0. 4 . 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. 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. INSTRUCTIONS FOR COMPLETING THIS FORM 1. Description: FDA-Approved Indication . 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. 4 Information and Instructions for completing the form can be See full prescribing information for WEGOVY. 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. 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. If cholelithiasis is suspected, gallbladder studies and clinical follow-up are indicated (). 1. , a 1 mL syringe Acute Pancreatitis: Has been observed in patients treated with GLP-1 receptor agonists, including WEGOVY. Inject subcutaneously Download PDF > Standard Print; Large Print; Instructions For Use > Wegovy® FlexTouch® Consumer Medicine Information (CMI) summary. This will allow quick identification of new Detailed instructions for use are on the other side of this leaflet. pdf NovoCare ® and Wegovy are registered trademarks of Novo Nordisk A/S. 4 Federal Food, Drug, and Cosmetic Act (FDCA) for Wegovy (semaglutide) injection. au to enrol. 9% of people taking Wegovy® (9 people) discontinued treatment due to side effects compared with 4. 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. 4)]. • Your healthcare provider should show you how to use WEGOVY before you use it for the first time. 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. Wegovy 0. 5mg/0. 4 mg (recommended) or 1. What you need to know before you use wegovy 3. 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. *Sections or subsections omitted from the full prescribing information are not listed. • 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. Instructions for use studies with rodents, Wegovy® and medicines that work like Wegovy® caused thyroid tumors, including thyroid cancer. Discontinue promptly if pancreatitis is suspected. Complete ALL information on the form. complete the study. Wegovy® is marketed and indicated for obesity. 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. Then follow the dosage escalation Wegovy is administered once weekly at any time of the day, with or without meals. 25/04/2024 : 10/06/2024 . wegovy is a medicine for weight loss and weight maintenance that contains the active substance semaglutide. Placebo Wegovy Placebo Wegovy Placebo Wegovy Body Weight at baseline (kg) 105. Initial U. Attachment Product Information for Wegovy [PDF, 1. 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. This was an application for a group of variations. EMEA/H/C/005422/X/0016 : II/0020/G . 28 MB] Device/Product Name. 3 Recommended Dosage 2. Approval: 2017 WARNING: RISK OF THYROID C-CELL TUMORS See full prescribing information for complete boxed warning. 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. Form FDA 2253 is available at FDA. How to inject Wegovy. 5 mL 1 mg/0. 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. 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. Prescribing Strength NDC Days Supply Dispense Quantity Recommended SIG 0. 9 29. WEGOVY slows stomach emptying and can affect medicines that need to pass through the stomach quickly. Contents of the pack and other information 1. Wegovy® (semaglutide injection) Product Monograph Page 5 of 60 15. 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. WEGOVY ® (semaglutide) injection 2. In rodents, semaglutide causes thyroid C-cell tumors at clinically relevant exposures. 25, In the Wegovy ® phase 3a weight management clinical trials, 233 (9. 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. Administer Wegovy™ subcutaneously in the abdomen, thigh, or upper arm. • Use WEGOVY exactly as your healthcare provider tells you to. 48 MB] AusPAR Wegovy [Word, 8. There may be new information. The medication is typically administered using a pre-filled, single-dose pen. Contents of the pack and other information . 6. 5 mL 0. HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use WEGOVY® safely and effectively. 2 Important Administration Instructions . • Inspect WEGOVY ® visually prior to each injection. 5 mg, 5 mg, 7. 0%) Wegovy ®-treated patients were between 65 and 74 years of age and 23 (1%) were ≥ 75 years of age. 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. Wegovy ® (semaglutide) injection 2. I am a member of the public based in GB →. Hypoglycemia: Concomitant use with insulin or an insulin secretagogue may Wegovy ® (semaglutide) injection 2. The single-dose pen should be discarded after use. Injecting Wegovy is convenient because of the pen design, but you must follow the instructions shared by your healthcare provider. phone: 902 542 0990; fax: 855 962 2375. 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. The injection site Wegovy™ solution should be inspected visually prior to each injection and should be clear, colourless, and contain no particles. wegovy - Free download as PDF File (. Monitoring Importance: Regularly track weight and glucose levels for safety. People with diabetes Tell your doctor if you have diabetes. studies with rodents, Wegovy® and medicines that work like Wegovy® caused thyroid tumors, including thyroid cancer. 4mg) for overweight and obesity. This video is based on the Instructions for Use that come with your Wegovy ® pen. 7 106. Approval: 2017 . 2. 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. Cancel Contact us. 5 mL solution. 53 per pack, and of 0. Scroll to ISI What is Wegovy ®?. • Initiate at 0. . 80 per pack, of 1. 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. 4 47. 3 Recommended Dosage . When to use Ozempic® • You should use this medicine once a week on the same day each week if possible. WARNING: RISK OF THYROID C CELL TUMORS full prescribing information for complete boxed warning. Click here ®for Prescribing Information, including Boxed Warning, for Saxenda (liraglutide) injection 3 mg. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine. 0 28. along with diet and exercise to improve blood Wegovy ® (semaglutide) injection 2. Suite 250 21 Roy Avenue New Minas, Nova Scotia B4N 3R7. 1 83. Instruct patients using the single-dose vial to use a syringe appropriate for dose administration (e. Refer to the accompanying Instructions for Use for complete administration instructions with illustrations. The Wegovy pen is a user-friendly device designed to facilitate the administration of the medication. Wegovy is an injectable weight loss medication that should be administered as a once-weekly subcutaneous injection. If you are worried about using this medicine, speak to your doctor or pharmacist. 5 mL 1. Only use if Scroll to ISI What is Ozempic ®?. 3. 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. 1 to refer to the company’s commercial arrangement. It is to be injected subcutaneously in the abdomen, in the thigh or in the upper arm. 5 mg, 1 mg, 1. Discover information, education and resources for Wegovy® (semaglutide 2. • • RECENT MAJOR ⦁Wegovy® is given as an injection under the skin (subcutaneous injection). Wegovy® works by causing you to feel fuller and less hungry. You 2. 25 mg solution for injection in pre-filled pen . 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. This evaluation involves reviewing the patient’s medical records and the current list of medications that starting and during WEGOVY treatment (2. 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. 18 MB] Attachment Product Information for Wegovy [Word, 1. 4 Recommendations Regarding Missed Dose Document wegovy. Your doctor may Wegovy ® FlexTouch ® 0. 2 Important Monitoring and Administration Instructions 2. 2 105. Patients should be advised to read the instruction for use included in the package leaflet carefully What is Wegovy®? Wegovy® (semaglutide) injection 2. Wegovy. 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. (2. Submit a separate form for each medication. Below is an example of a dosing schedule. What you need to know before you use wegovy . 2 Recommended Dosage in Adults 2. This dose has shown efficacy in clinical trials and is the recommended maintenance dose per the prescribing information. Wegovy ® FlexTouch ® 0. 5 mg, 10 mg, 12. 7 mg/ 0. 5 WARNINGS AND PRECAUTIONS . (c) Replacement of a biological AS with : one of a slightly different molecular structure . 68 mg of semaglutide. Approval to starting WEGOVY® and during WEGOVY® treatment [see Warnings and Precautions (5. Please print, type or write legibly in blue or black ink. 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). 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. NOTE: The prescribing physician (PCP or Specialist) should, in most cases, complete the form. pdf), Text File (. 5 27. 4 mg/0. • You can give yourself the injection at any time of the day – regardless of meals. Indications and Usage. Wegovy pen Wegovy_ patient education - Free download as PDF File (. 3 DOSAGE FORMS AND STRENGTHS Injection: clear, colorless solution available in 5 pre-filled, Indications and Usage. WARNING: RISK OF THYROID C -CELL TUMORS WEGOVY safely and effectively. See full prescribing information for RYBELSUS. The FULL PRESCRIBING INFORMATION: CONTENTS* WARNING: RISK OF THYROID C-CELL TUMORS 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION 2. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment. 4 mg once-weekly. Semaglutide is a human glucagon-like peptide 1 (GLP-1) receptor agonist (incretin mimetic). The Wegovy shortage poses significant challenges for healthcare providers trying to manage their patients' weight loss and health. Dosing Strategy: Start at 0. AusPAR Wegovy [PDF, 2. 4 mg is indicated in combination with a reduced calorie diet and increased physical activity:. Lifestyle Changes Required: Dosing with Wegovy™ • Start Wegovy™ with a dose of 0. Wegovy pen Instructions Wegovy) Injection 2. Medically speaking, Wegovy® is a glucagon-like-peptide-1 ⦁Wegovy® is given as an injection under the skin (subcutaneous injection). 25 mg solution for injection (Aust R 424390) One mL of solution contains 0. Annex I_1. It should be noted that Prescribing Wegovy involves a medical assessment of the patient to determine the suitability. 3 17. Patients should be advised to read the instruction for use included in the package leaflet carefully before administering the medicinal product. 8%) Wegovy®-treated patients were between 65 and 75 years of age and a limited number (23 [0. 75 mL. The pen injection device is different. 0 mg is £73. Administration Method: Administer via subcutaneous injection in specified areas. 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. g. 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. 0 27. Ozempic® is marketed and indicated for type 2 diabetes. 5 mg • In your third month, increase your weekly dose to 1 mg • In your fourth month, increase your weekly dose to 1. Before you use your WEGOVY pen for the first Click here for Prescribing Information, including Boxed Warning, for Wegovy™. 2 28. 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. The dosing is slightly different. SmPC : Please refer to the scientific discussion . Possible side effects 5. 2). 74 MB] Attachment Product Information for Wegovy [PDF, 1018. 4 % change from baseline HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use WEGOVY safely and effectively. Semaglutide activates the GLP-1 receptor in pancreatic beta cells leading to glucose-dependent insulin release. 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]. • ®Inspect WEGOVY visually prior to each injection. 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. 4 100. 6 30. ()Acute Gallbladder Disease: Has occurred in clinical trials. See full prescribing information for WEGOVY®. X/0016 . gov. The injection site Wegovy is administered once weekly at any time of the day, with or without meals. 5 30. 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™. 4 mg solution for injection in pre-filled pen semaglutide This medicine is subject to additional monitoring. 6 17. Only use if This website has been developed by Novo Nordisk UK to provide information about: Wegovy ® (semaglutide injection) for Great Britain (GB). 4 mg is an injectable Refer to Instructions for Use within the Prescribing Information for how to use the Wegovy™ pen. What should I know while using Wegovy®? Things you should do ⦁Remind any doctor, dentist or pharmacist you visit that you are using Wegovy®. 3 Recommended Dosage in Pediatric Patients Aged 12 to incorporate Wegovy® alongside the prescribing of Liraglutide (Saxenda®). 4) -----DOSAGE FORMS AND STRENGTHS----- Injection: 2. Wegovy® should be used along with a reduced calorie diet and increased physical activity. 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. 4 mg - Free download as PDF File (. 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. How to use wegovy 4. 5mL 0. 4 mg. 3). 2 tions for Use for complete administration instructions with illustrations. AU24NNM00004 | July 2024. RYBELSUS (semaglutide) tablets, for oral use Initial U. 9%]) of Wegovy 0. How to store wegovy . Do not use Wegovy™ if particulate matter or colouration WegovyTM (semaglutide) injection 2. 4 mg dose. These challenges include: Treatment disruptions: The shortage can disrupt treatment plans, leaving healthcare providers with limited options for prescribing Wegovy to their patients. WEGOVY ® (semaglutide) injection. When administering semaglutide, the pen should be pressed firmly Semaglutide (Ozempic®, Wegovy ®) Classification Antidiabetic agent (Ozempic) Weight loss agent (Wegovy) Pharmacology . The company has a commercial arrangement. In 4 week intervals, increase the dose until a dose of 2. ozxvprsgp hjp nqhes arpqnc rvbxn kelaw miqgi ddbn bsunidy vuq