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Medical Information | Non-US Health Care Professionals
Important Safety Information | Patient Site
Prescribing Information
Ozempic® (semaglutide) injection 0.5 mg, 1 mg, or 2 mg logo

Prescribing Information
Important Safety Information | Patient Site

For adult patients with type 2 diabetes, treated with diet and exercise.

Ozempic® is indicated to reduce the risk of MACE for adults with T2D and established CVD1,a

When pills are no longer enough

Help your Orlando patients realize the potential with Ozempic®

Unmatched glycemic control

Superior results vs Trulicity® (in SUSTAIN 7)b and as an add-on to basal insulin, and statistically significant results vs study-titrated Lantus®.1,2

Significant weight reduction1,2,c

Ozempic® is not indicated for weight loss.

Significant reduction in risk of MACE1,a,d

Evaluated in a 2-year CVOT vs placebo in adults with type 2 diabetes and established CVD.

aMajor adverse CV events (MACE)=CV death, nonfatal MI, or nonfatal stroke.
bSUSTAIN 7 included 0.5 mg and 1 mg doses for Ozempic® and 0.75 mg and 1.5 mg doses for Trulicity®.
cWeight change was a secondary endpoint in clinical trials.
dResults apply to Ozempic® plus standard of care vs standard of care alone in SUSTAIN 6 trial for patients with T2D and established CVD.

T2D=type 2 diabetes; CVD=cardiovascular disease; CVOT=cardiovascular outcomes trial; CV=cardiovascular; MI=myocardial infarction.

Ozempic® vs Trulicity®

Superior A1C reductions vs Trulicity® (in SUSTAIN 7)b in adult patients with type 2 diabetes on metformin.2

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Resources for starting patients

Whether you’re starting your patients on Ozempic® in person or via telehealth, use these quick links to find helpful information, videos, and downloadable resources to share with patients.

Ozempic® vs Trulicity®

Explore the results of a head-to-head trial of 2 once-weekly GLP-1 RA therapies from one of the primary investigators, Richard Pratley, MD.

Ozempic® vs Lantus®

Statistically significant A1C reductions and weight reductions shown vs study‑titrated Lantus®, delivered in a once-weekly injection.1,3 Learn more about the efficacy and safety results of the SUSTAIN 4 clinical trial.

Ozempic® vs Lantus®

Listen to endocrinologist Craig Wierum, MD, FACE, discuss GLP-1 RA therapy and see the results of a head-to-head trial with Lantus®.

Pen shown delivers doses of 0.25 mg or 0.5 mg.

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Important Safety Information for Ozempic® (semaglutide) injection 0.5 mg or 1 mg

WARNING: RISK OF THYROID C-CELL TUMORS

  • In rodents, semaglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures. It is unknown whether Ozempic® causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans as 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 and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Counsel patients regarding the potential risk for MTC with the use of Ozempic® and inform them of symptoms of thyroid tumors (eg, a mass in the neck, dysphagia, dyspnea, persistent hoarseness). Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with Ozempic®.

Indications and Limitations of Use

Ozempic® (semaglutide) injection 0.5 mg or 1 mg is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus and to reduce the risk of major adverse cardiovascular (CV) events (CV death, nonfatal myocardial infarction, or nonfatal stroke) in adults with type 2 diabetes mellitus and established CV disease.

  • Ozempic® has not been studied in patients with a history of pancreatitis. Consider other antidiabetic therapies in patients with a history of pancreatitis.
  • Ozempic® is not indicated for use in patients with type 1 diabetes mellitus.

Important Safety Information cont.

Contraindications

  • Ozempic® is contraindicated in patients with a personal or family history of MTC or in patients with MEN 2, and in patients with a prior hypersensitivity reaction to semaglutide or to any of the excipients in Ozempic®. Serious hypersensitivity reactions including anaphylaxis and angioedema have been reported with Ozempic®.

Warnings and Precautions

  • Risk of Thyroid C-Cell Tumors: Patients should be referred to an endocrinologist for further evaluation if serum calcitonin is measured and found to be elevated or thyroid nodules are noted on physical examination or neck imaging.
  • Pancreatitis: Acute and chronic pancreatitis have been reported in clinical studies. Observe patients carefully for signs and symptoms of pancreatitis (persistent severe abdominal pain, sometimes radiating to the back with or without vomiting). If pancreatitis is suspected, discontinue Ozempic® promptly, and if pancreatitis is confirmed, do not restart.
  • Diabetic Retinopathy Complications: In a 2-year trial involving patients with type 2 diabetes and high cardiovascular risk, more events of diabetic retinopathy complications occurred in patients treated with Ozempic® (3.0%) compared with placebo (1.8%). The absolute risk increase for diabetic retinopathy complications was larger among patients with a history of diabetic retinopathy at baseline than among patients without a known history of diabetic retinopathy.
    Rapid improvement in glucose control has been associated with a temporary worsening of diabetic retinopathy. The effect of long-term glycemic control with semaglutide on diabetic retinopathy complications has not been studied. Patients with a history of diabetic retinopathy should be monitored for progression of diabetic retinopathy.
  • Never Share an Ozempic® Pen Between Patients: Ozempic® pens must never be shared between patients, even if the needle is changed. Pen-sharing poses a risk for transmission of blood-borne pathogens.
  • Hypoglycemia: Patients receiving Ozempic® in combination with an insulin secretagogue (eg, sulfonylurea) or insulin may have an increased risk of hypoglycemia, including severe hypoglycemia. Inform patients using these concomitant medications of the risk of hypoglycemia and educate them on the signs and symptoms of hypoglycemia.
  • Acute Kidney Injury: There have been postmarketing reports of acute kidney injury and worsening of chronic renal failure, which may sometimes require hemodialysis, in patients treated with GLP-1 receptor agonists. Some of these events have been reported in patients without known underlying renal disease. A majority of the reported events occurred in patients who had experienced nausea, vomiting, diarrhea, or dehydration. Monitor renal function when initiating or escalating doses of Ozempic® in patients reporting severe adverse gastrointestinal reactions.
  • Hypersensitivity: Serious hypersensitivity reactions (eg, anaphylaxis, angioedema) have been reported in patients treated with Ozempic®. If hypersensitivity reactions occur, discontinue use of Ozempic®; treat promptly per standard of care, and monitor until signs and symptoms resolve. Use caution in a patient with a history of angioedema or anaphylaxis with another GLP-1 receptor agonist.

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

  • When initiating Ozempic®, consider reducing the dose of concomitantly administered insulin secretagogue (such as sulfonylureas) or insulin to reduce the risk of hypoglycemia.
  • Ozempic® causes a delay of gastric emptying and has the potential to impact the absorption of concomitantly administered oral medications, so caution should be exercised.

Use in Specific Populations

  • There are limited data with semaglutide use in pregnant women to inform a drug-associated risk for adverse developmental outcomes. Discontinue Ozempic® in women at least 2 months before a planned pregnancy due to the long washout period for semaglutide.

Please click here for Ozempic® Prescribing Information, including Boxed Warning.

 

References:

  1. Ozempic® [package insert]. Plainsboro, NJ: Novo Nordisk Inc.; March 2022.
  2. Pratley RE, Aroda VR, Lingvay I, et al, on behalf of the SUSTAIN 7 investigators. Semaglutide versus dulaglutide once weekly in patients with type 2 diabetes (SUSTAIN 7): a randomised, open-label, phase 3b trial. Lancet Diabetes Endocrinol. 2018;6(4):275-286.
  3. Aroda VR, Bain SC, Cariou B, et al. Efficacy and safety of once-weekly semaglutide versus once-daily insulin glargine as add-on to metformin (with or without sulfonylureas) in insulin-naïve patients with type 2 diabetes (SUSTAIN 4): a randomized, open-label, parallel-group, multicenter, multinational, phase 3a trial. Lancet Diabetes Endocrinol. 2017;5(5):355-366.