Wegovy prescribing instructions pdf. 0 mg semaglutide in 1.

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