Semaglutide

Wegovy

• 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.
• to reduce excess body weight and maintain weight reduction long term in: Adults and pediatric patients aged 12 years and older with obesity; Adults with overweight in the presence of at least one weight-related comorbid condition.
• Coadministration with other semaglutide-containing products or with any other GLP-1 receptor agonist is not recommended.

Ozempic injection

• as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
• to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes mellitus and established cardiovascular disease.
• to reduce the risk of sustained eGFR decline, end-stage kidney disease and cardiovascular death in adults with type 2 diabetes mellitus and chronic kidney disease.

Rybelsus and Ozempic tablets

• as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
• to reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke) in adults with type 2 diabetes mellitus who are at high risk for these events.

Wegovy

2.4 mg/0.75 mL Injection: pre-filled, single-dose pen that delivers doses of 0.25 mg, 0.5 mg, 1 mg, 1.7 mg or 2.4 mg.

Ozempic injection

• Injection: 2 mg/3 mL (0.68 mg/mL) for 4 doses of 0.25 mg and 2 doses of 0.5 mg or 4 doses of 0.5 mg, 4 mg/3 mL (1.34 mg/mL) for 4 doses of 1 mg, and 8 mg/3 mL (2.68 mg/mL) for 4 doses of 2 mg in...
• Injection: 0.25 mg, 0.5 mg or 1 mg per 0.5 mL in a single-dose prefilled syringe

Rybelsus and Ozempic tablets

• RYBELSUS tablets: 3 mg, 7 mg and 14 mg
• OZEMPIC tablets: 1.5 mg, 4 mg and 9 mg

Wegovy

• 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.
• Inject subcutaneously in the abdomen, thigh or upper arm.
• In patients with type 2 diabetes, monitor blood glucose prior to starting and during WEGOVY treatment.
• Initiate at 0.25 mg once weekly for 4 weeks. Then follow the dosage escalation schedule, titrating every 4 weeks to achieve the maintenance dosage.
• The maintenance dosage of WEGOVY in adults is either 2.4 mg (recommended) or 1.7 mg once weekly.
• The maintenance dosage of WEGOVY in pediatric patients aged 12 years and older is 2.4 mg once weekly. Important Monitoring and Administration Instructions

Ozempic injection

• Administer once weekly at any time of day, with or without meals.
• Start at 0.25 mg once weekly. After 4 weeks, increase the dosage to 0.5 mg once weekly.
• If additional glycemic control is needed, increase the dosage to 1 mg once weekly after at least 4 weeks on the 0.5 mg dose.
• To reduce the risk of sustained eGFR decline, end-stage kidney disease and cardiovascular death, increase the dosage to 1 mg once weekly after at least 4 weeks on the 0.5 mg dosage.
• If a dose is missed, administer within 5 days of missed dose.
• Inject subcutaneously in the abdomen, thigh, or upper arm. Important Administration Instructions

Rybelsus and Ozempic tablets

• Take RYBELSUS or OZEMPIC tablets orally once daily on an empty stomach in the morning with water (up to 4 ounces of water); do not take with other liquids besides water.
• Swallow tablets whole. Do not split, crush, chew or dissolve in any solution.
• After taking RYBELSUS or OZEMPIC tablets, wait at least 30 minutes before eating food, drinking beverages or taking other oral medications.
• See the Full Prescribing Information for instructions on switching between RYBELSUS and OZEMPIC tablets and from OZEMPIC injections to RYBELSUS or OZEMPIC tablets. Recommended Starting, Escalation and Maintenance Dosage of RYBELSUS and OZEMPIC Tablets RYBELSUS
• On Day 61 or thereafter, if: No additional glycemic control is needed, maintain the dosage at 7 mg orally once daily.; Additional glycemic control is needed, increase the dosage to 14 mg orally once daily. OZEMPIC Tablets

Wegovy

• Most common adverse reactions (incidence ≥ 5%) in adults or pediatric patients aged 12 years and older are: nausea, diarrhea, vomiting, constipation, abdominal pain, headache, fatigue, dyspepsia, dizziness, abdominal distension, eructation, hypoglycemia in patients with type 2 diabetes, flatulence, gastroenteritis, gastroesophageal reflux disease, and nasopharyngitis.
• most common adverse reactions leading to discontinuation were nausea (1.8% versus 0.2%), vomiting (1.2% versus 0%), and diarrhea (0.7% versus 0.1%) for WEGOVY and placebo, respectively.

Ozempic injection

most common adverse reactions reported in ≥5% of patients treated with OZEMPIC are: nausea, vomiting, diarrhea, abdominal pain and constipation.

Rybelsus and Ozempic tablets

Most common adverse reactions (incidence ≥5%) are nausea, abdominal pain, diarrhea, decreased appetite, vomiting and constipation.

Wegovy

• Acute Pancreatitis: Has occurred in clinical trials. Discontinue promptly if pancreatitis is suspected. Do not restart if pancreatitis is confirmed.
• Acute Gallbladder Disease: Has occurred in clinical trials. If cholelithiasis is suspected, gallbladder studies and clinical follow-up are indicated.
• Hypoglycemia: Concomitant use with insulin or an insulin secretagogue may increase the risk of hypoglycemia, including severe hypoglycemia. Reducing the dose of insulin or insulin secretagogue may be necessary. Inform all patients of the risk of hypoglycemia and educate them on the signs and symptoms of hypoglycemia.
• Acute Kidney Injury: Has occurred. Monitor renal function when initiating or escalating doses of WEGOVY in patients reporting severe adverse gastrointestinal reactions or in those with renal impairment reporting severe adverse gastrointestinal reactions.
• Hypersensitivity Reactions: Anaphylactic reactions and angioedema have been reported postmarketing. Discontinue WEGOVY if suspected and promptly seek medical advice.
• Diabetic Retinopathy Complications in Patients with Type 2 Diabetes: Has been reported in trials with semaglutide. Patients with a history of diabetic retinopathy should be monitored.
• Heart Rate Increase: Monitor heart rate at regular intervals.
• Suicidal Behavior and Ideation: Monitor for depression or suicidal thoughts. Discontinue WEGOVY if symptoms develop. Risk of Thyroid C-Cell Tumors In mice and rats, semaglutide caused a dose-dependent and treatment-duration-dependent increase in the incidence of thyroid C-cell tumors (adenomas and carcinomas) after lifetime exposure at clinically relevant plasma exposures.

Ozempic injection

• Acute Pancreatitis: Has been observed in patients treated with GLP-1 receptor agonists, including OZEMPIC. Discontinue if pancreatitis is suspected.
• Diabetic Retinopathy Complications: Has been reported in a clinical trial. Patients with a history of diabetic retinopathy should be monitored.
• Never share an OZEMPIC pen between patients, even if the needle is changed.
• Hypoglycemia: Concomitant use with an insulin secretagogue or insulin may increase the risk of hypoglycemia, including severe hypoglycemia. Reducing dose of insulin secretagogue or insulin may be necessary.
• Acute Kidney Injury Due to Volume Depletion: Monitor renal function in patients reporting adverse reactions that could lead to volume depletion.
• Severe Gastrointestinal Adverse Reactions: Use has been associated with gastrointestinal adverse reactions, sometimes severe. OZEMPIC is not recommended in patients with severe gastroparesis.
• Hypersensitivity Reactions: Serious hypersensitivity reactions (e.g., anaphylaxis and angioedema) have been reported. Discontinue OZEMPIC if suspected and promptly seek medical advice.
• Acute Gallbladder Disease: If cholelithiasis or cholecystitis are suspected, gallbladder studies are indicated.

Rybelsus and Ozempic tablets

• Acute Pancreatitis: Has been observed in patients treated with GLP-1 receptor agonists, including RYBELSUS or OZEMPIC tablets. Discontinue if pancreatitis is suspected.
• Diabetic Retinopathy Complications: Has been reported in a cardiovascular outcomes trial with semaglutide injection. Patients with a history of diabetic retinopathy should be monitored.
• Hypoglycemia with Concomitant Use of Insulin Secretagogues or Insulin: May increase the risk of hypoglycemia, including severe hypoglycemia. Reducing the dosage of insulin secretagogue or insulin may be necessary.
• Acute Kidney Injury Due to Volume Depletion: Monitor renal function in patients reporting adverse reactions that could lead to volume depletion.
• Severe Gastrointestinal Adverse Reactions: Use of RYBELSUS or OZEMPIC tablets has been associated with gastrointestinal adverse reactions, sometimes severe. RYBELSUS and OZEMPIC tablets are not recommended in patients with severe gastroparesis.
• Hypersensitivity Reactions: Serious hypersensitivity reactions (e.g., anaphylaxis and angioedema) have been reported. Discontinue RYBELSUS or OZEMPIC tablets if hypersensitivity reactions occur and monitor until signs and symptoms resolve.
• Acute Gallbladder Disease: If cholelithiasis or cholecystitis are suspected, gallbladder studies are indicated.
• Pulmonary Aspiration During General Anesthesia or Deep Sedation: Has been reported in patients receiving GLP-1 receptor agonists undergoing elective surgeries or procedures. Instruct patients to inform healthcare providers of any planned surgeries or procedures.

Wegovy

• Personal or family history of MTC or in patients with MEN 2.
• Known hypersensitivity to semaglutide or any of the excipients in WEGOVY.

Ozempic injection

• Personal or family history of MTC or in patients with MEN 2.
• Serious hypersensitivity reaction to semaglutide or any of the excipients in OZEMPIC.

Rybelsus and Ozempic tablets

• Personal or family history of MTC or in patients with MEN 2 syndrome type 2
• Prior serious hypersensitivity reaction to semaglutide or any of the excipients in OZEMPIC

Wegovy

• WEGOVY delays gastric emptying.
• May impact absorption of concomitantly administered oral medications.
• Use with caution.

Ozempic injection

• Oral Medications: OZEMPIC delays gastric emptying.
• May impact absorption of concomitantly administered oral medications.
• Use with caution.

Rybelsus and Ozempic tablets

• Other Oral Drugs: RYBELSUS and OZEMPIC tablets delay gastric emptying.
• Consider increased clinical or laboratory monitoring when co-administered with other oral medications that have a narrow therapeutic index or that require clinical monitoring.

Wegovy

Pregnancy Exposure Registry There will be a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to semaglutide during pregnancy. Pregnant women exposed to WEGOVY and healthcare providers are encouraged to contact Novo Nordisk at 1-877-390-2760 or www.wegovypregnancyregistry.com. Risk Summary Based on animal reproduction studies, there may be potential risks to the fetus from exposure to semaglutide during pregnancy.

Ozempic injection

There are limited data with semaglutide use in pregnant women to inform a drug-associated risk for adverse developmental outcomes. There are clinical considerations regarding the risks of poorly controlled diabetes in pregnancy (see Clinical Considerations). Based on animal reproduction studies, there may be potential risks to the fetus from exposure to semaglutide during pregnancy.

Rybelsus and Ozempic tablets

Available data with semaglutide use in pregnant women are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. There are clinical considerations regarding the risks of poorly controlled diabetes in pregnancy (see Clinical Considerations). Based on animal reproduction studies, there may be potential risks to the fetus from exposure to semaglutide during pregnancy.