Welcome to our latest edition of the Guidelines+ Monographs Series, where we delve into the medication semaglutide, marketed under the brand name Ozempic® by Novo Nordisk. Ozempic is a glucagon-like peptide 1 (GLP-1) receptor agonist indicated 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 and 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. It was initially approved in 2017.
In the following sections, we will provide a comprehensive overview of semaglutide and analyze its positioning across various guidelines for its approved indications.
Note* - This Guidelines+ Monographs for semaglutide (Ozempic) is current as of April 2025. Consult our clinical guidelines library and/or or medication information look up tool to ensure you are always accessing the most current information.
Without further delay, let’s jump in!
Medication Overview:
- Brand name: Ozempic
- Generic name: semaglutide
- Manufacturer(s): Novo Nordisk
- Initial FDA Approval: 2017
Indications and FDA Approval Details
| Indicated Condition | Indicated | Age | Date Approved |
|---|---|---|---|
| Type 2 diabetes mellitus | as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus | Adults | Mar 28, 2022 |
| Type 2 diabetes mellitus and established cardiovascular disease | to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes mellitus and established cardiovascular disease | Adults | Jan 16, 2020 |
| Type 2 diabetes mellitus and chronic kidney 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 | Adults | Jan 28, 2025 |
WARNING: RISK OF THYROID C−CELL TUMORS
See full prescribing information for complete boxed warning.
- In rodents, semaglutide causes thyroid C-cell tumors. It is unknown whether OZEMPIC® causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans as the human relevance of semaglutide-induced rodent thyroid C-cell tumors has not been determined.
- OZEMPIC® is contraindicated in patients with a personal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Counsel patients regarding the potential risk of MTC and symptoms of thyroid tumors.
Dosage and Administration
- 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.
- If additional glycemic control is needed, increase the dosage to 2 mg once weekly after at least 4 weeks on the 1 mg dosage.
- 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.
Dosage Forms and Strengths
- Injection: 2 mg/3 mL (0.68 mg/mL) available in:
- Single-patient-use pen that delivers 0.25 mg or 0.5 mg per injection
- Injection: 4 mg/3 mL (1.34 mg/mL) available in:
- Single-patient-use pen that delivers 1 mg per injection
- Injection: 8 mg/3 mL (2.68 mg/mL) available in:
- Single-patient-use pen that delivers 2 mg per injection
Contraindications
- Personal or family history of MTC or in patients with MEN 2.
- Serious hypersensitivity reaction to semaglutide or any of the excipients in OZEMPIC®
Warnings and Precautions
Acute Pancreatitis: Has been observed in patients treated with GLP-1 receptor agonists, including semaglutide. 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.
- 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.
Adverse Reactions
- The most common adverse reactions, reported in ≥5% of patients treated with OZEMPIC® are: nausea, vomiting, diarrhea, abdominal pain and constipation.
Drug Interactions
- Oral Medications: OZEMPIC® delays gastric emptying. May impact absorption of concomitantly administered oral medications. Use with caution.
Now that we’ve covered the basic monograph information for Ozempic, let’s take a closer look at how it is currently recommended in various clinical practice guidelines.
Specific Inclusions of Semaglutide in the Guidelines (2023-2025)
| Society | Publication Date | Guideline | Recommendation | Strength of Recommendation |
|---|---|---|---|---|
| ADA | December 2024 | Standards of Care in Diabetes—2025 | In people with diabetes and overweight or obesity, the preferred pharmacotherapy should be a glucagon like peptide 1 receptor agonist or dual glucose-dependent insulinotropic polypeptide and glucagon-like peptide 1 receptor agonist with greater weight loss efficacy (i.e., semaglutide or tirzepatide), especially considering their added weight-independent benefits (e.g., glycemic and cardiometabolic). | Grade A |
| ADA | December 2024 | Standards of Care in Diabetes—2025 | To reduce cardiovascular risk and kidney disease progression in people with type 2 diabetes and CKD, a glucagon-like peptide 1 agonist with demonstrated benefit in this population is recommended. A | Grade A |
AHA / ASA | October 2024 | Primary Prevention of Stroke | Glucagon-like protein-1 receptor agonists are recommended in patients with diabetes and high cardiovascular risk or established cardiovascular disease. | Strong |
| ACC / AHA / AACVPR / APMA / ABC / SCAI / SVM / SVN / SVS / SIR / VESS | May 2024 | Management of Lower Extremity Peripheral Artery Disease | In patients with PAD and type 2 diabetes, use of glucogon-like peptide-1 agonists (liraglutide and semaglutide) are effective to reduce the risk of MACE. | Strong |
| ACP | April 2024 | Newer Pharmacologic Treatments in Adults With Type 2 Diabetes | ACP recommends adding a sodium–glucose cotransporter-2 (SGLT-2) inhibitor or glucagon-like peptide-1 (GLP-1) agonist to metformin and lifestyle modifications in adults with type 2 diabetes and inadequate glycemic control (strong recommendation; high-certainty evidence).- Use an SGLT-2 inhibitor to reduce the risk for all-cause mortality, major adverse cardiovascular events, progression of chronic kidney disease, and hospitalization due to congestive heart failure.- Use a GLP-1 agonist to reduce the risk for all-cause mortality, major adverse cardiovascular events, and stroke. | Strong |
| KDIGO | March 2024 | Evaluation and Management of Chronic Kidney Disease | In adults with T2D and CKD who have not achieved individualized glycemic targets despite use of metformin and SGLT2 inhibitor treatment, or who are unable to use those medications, we recommend a long-acting GLP-1 RA. | Strong |
| AHA / ACC / ACCP / ASPC / NLA / PCNA | August 2023 | Management of Patients With Chronic Coronary Disease | For patients with CCD and overweight or obesity in whom pharmacologic therapy is warranted for further weight reduction, a GLP-1 receptor agonist can be beneficial in addition to counseling for diet and physical activity and it is reasonable to choose semaglutide over liraglutide. | Moderate |
This concludes our Guidelines+ Monographs for semaglutide (Ozempic). This list is current as of April 2025, and may be updated over time as new indications are approved and/or new guidelines published or updated. Sign up for alerts and stay informed on the latest published guidelines and articles.
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