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Ozempic® (semaglutide) injection 0.5 mg, 1 mg, or 2 mg logo
Important Safety Information | Patient Site
Prescribing Information
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Ozempic® (semaglutide) injection 0.5 mg, 1 mg, or 2 mg logo

Prescribing Information
Important Safety Information | Patient Site

We are experiencing temporary supply constraints, which means some pharmacies may not have certain Ozempic® dosages in stock. Product continues to be manufactured and shipped, so please have patients call their pharmacy to check on availability. If you have questions, please reach out to your local Novo Nordisk representative.

Preferred GLP-1 RA

For adult patients with type 2 diabetes, treated with diet and exercise to improve glycemic control 

For adults with T2D and established CVD, to reduce risk of MACE1,b

See Limitations of Use

Ozempic® (semaglutide) injection Tri-Zone with the power of 3

For adult patients with type 2 diabetes, treated with
diet and exercise to improve glycemic control 

For adults with T2D and established CVD,
to reduce risk of MACE1,b

See Limitations of Use

For adult patients with type 2 diabetes, treated with
diet and exercise to improve glycemic control 

For adults with T2D and established CVD,
to reduce risk of MACE1,b

See Limitations of Use

Ozempic®
TRI-ZONE

with the power of 3

5-year anniversary logo
#1 icon

PRESCRIBED BRAND IN THE
GLP-1 RA 
CLASS WORLDWIDE 
FOR PATIENTS WITH T2Da

Dollar sign icon

More coverage than ever before2

Find out more

Learn about glycemic control with Ozempic®

POWERFUL
GLYCEMIC CONTROL1,3

See A1C results
Learn about Ozempic® CVOT

PROVEN CV
RISK REDUCTION1,b

View CVOT results

In adults with T2D and ASCVD

Learn about weight results with Ozempic®

COMPELLING
WEIGHT LOSS1,3,c

Examine weight data

Ozempic® is not indicated for weight loss.

Learn about glycemic control with Ozempic®

POWERFUL
GLYCEMIC CONTROL1,3

See A1C results
Learn about Ozempic® CVOT

PROVEN CV
RISK REDUCTION1,b

View CVOT results

In adults with T2D and ASCVD

Learn about weight results with Ozempic®

COMPELLING
WEIGHT LOSS1,3,c

Examine weight data

Ozempic® is not indicated for weight loss.

More coverage than ever before2

Novo Nordisk has savings and coverage tools to help you get your patients started on Ozempic (semaglutide) injection

Find out more

aBased on internal analysis by Novo Nordisk using data from the following source: IQVIA Monthly MIDAS database, Measure: Volume sales, ATC3 A10S, for the time period MAT 09.2022 reflecting estimates of real-world activity. Copyright IQVIA. All rights reserved.
bComposite MACE endpoint in SUSTAIN 6 included: CV death, nonfatal MI, or nonfatal stroke. 
cWeight change was a secondary endpoint in clinical trials.

T2D=type 2 diabetes; CVD=cardiovascular disease; MACE=major adverse cardiovascular event; GLP-1 RA=glucagon-like peptide-1 receptor agonist; CV=cardiovascular; ASCVD=atherosclerotic cardiovascular disease; MI=myocardial infarction; HR=hazard ratio.

Ozempic® is available in 3 multiuse pens for A1C control1

Get more details about the Ozempic® Pen dose options and find resources for helping your patients get started.

Learn more
Learn more
Yellow, blue, and red label Ozempic® Pens

Resources for starting patients

Whether you’re starting your patients on Ozempic® in person or via telehealth, use these quick links to find all the resources you need.

Get resources
Learn about Ozempic® CVOT
Dollar sign icon

More coverage than ever before2

Novo Nordisk has savings and coverage tools to help you get your patients started on Ozempic (semaglutide) injection

Find out more

aBased on internal analysis by Novo Nordisk using data from the following source: IQVIA Monthly MIDAS database, Measure: Volume sales, ATC3 A10S, for the time period MAT 09.2022 reflecting estimates of real-world activity. Copyright IQVIA. All rights reserved.
bComposite MACE endpoint in SUSTAIN 6 included: CV death, nonfatal MI, or nonfatal stroke. 
cWeight change was a secondary endpoint in clinical trials.

T2D=type 2 diabetes; CVD=cardiovascular disease; MACE=major adverse cardiovascular event; GLP-1 RA=glucagon-like peptide-1 receptor agonist; CV=cardiovascular; ASCVD=atherosclerotic cardiovascular disease; MI=myocardial infarction; HR=hazard ratio.

Ozempic® is available in 3 multiuse pens for A1C control1

Get more details about the Ozempic® Pen dose options and find resources for helping your patients get started.

Learn more
Learn more
Yellow, blue, and red label Ozempic® (semaglutide) injection Pens

Resources for starting patients

Whether you’re starting your patients on Ozempic® in person or via telehealth, use these quick links to find all the resources you need.

Get resources
Learn about Ozempic® CVOT

Fresh coffee, fresh takes on managing T2D

Time for a coffee break? Join Nurse Practitioner Lisa Coco as she talks T2D with other leading experts in diabetes care.

Watch full episodes

Fresh coffee, fresh takes on managing T2D

Time for a coffee break? Join Nurse Practitioner Lisa Coco as she talks T2D with other leading experts in diabetes care.

Watch full episodes
Coffee with Coco

The Ozempic® TRI-ZONE with the power of 3

More ways to help your patients with T2D

Check your patients' coverage and co-pay for Ozempic®

Check your patients' coverage and view savings offer

See details »


Ozempic® resources

Resources are available to help patients start on Ozempic®

See resources »

Important Safety Information for Ozempic® (semaglutide) injection

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, 1 mg, or 2 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 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.
  • Acute Gallbladder Disease: Acute events of gallbladder disease such as cholelithiasis or cholecystitis have been reported in GLP-1 receptor agonist trials and postmarketing. In placebo-controlled trials, cholelithiasis was reported in 1.5% and 0.4% of patients treated with Ozempic® 0.5 mg and 1 mg, respectively, and not reported in placebo-treated patients. If cholelithiasis is suspected, gallbladder studies and appropriate clinical follow-up are indicated.

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.; October 2022.
  2. Data on file. Novo Nordisk Inc. Plainsboro, NJ.
  3. 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.
Diabetes
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Ozempic®, Cornerstones4Care®, NovoCare®, NovoFine Plus®, NovoFine®, and NovoTwist® are registered trademarks and novoMEDLINK™ is a trademark of Novo Nordisk A/S.

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