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