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

Starting patients on once-weekly Ozempic® (semaglutide) injection

See how to adjust your patients’ doses and add Ozempic® to your EHR system.

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

NEWS FROM OZEMPIC®

The Ozempic® Pen that delivers 0.25 mg and 0.5 mg doses is now available in 3 mL.1

Learn More

A1C control within your control: Ozempic® once-weekly dose options for a range of T2D patients

Gradual dose escalation designed to help patients adjust to therapy1,a

Progress with Ozempic® (semaglutide) injection
How Ozempic® (semaglutide) injection escalates

aThe starting dose of 0.25 mg is a nontherapeutic dose.

  • Administer Ozempic® once weekly on the same day each week, at any time of the day, with or without meals
  • The maximum recommended dosage is 2 mg once weekly
  • The day of weekly administration can be changed if necessary as long as the time between 2 doses is at least 2 days (>48 hours)
  • If a dose is missed, administer Ozempic® as soon as possible within 5 days after the missed dose. If more than 5 days have passed, skip the missed dose and administer the next dose on the regularly scheduled day. In each case, patients can then resume their regular once-weekly dosing schedule
Ozempic® Information Sheet
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Ozempic® Information Sheet
Information for you and your practice on the pen transition for the pen that delivers 0.25 mg and 0.5 mg doses in March 2023.
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Ozempic® Dosing Brochure
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Ozempic® Dosing Brochure
Detailed dosing and other information for each Ozempic® pen, including escalation schema, EHR information, patient starter kit, and savings offers.
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Prescribing Information | Important Safety Information
Ozempic® Dosing Tear Pad
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Ozempic® Dosing Tear Pad
Information to help your patients understand the proper dosing schedule for Ozempic®.
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Prescribing Information | Important Safety Information

Prescribing Ozempic® in your EHR system1

According to the CDC, patients at a higher risk should ensure they have access to several weeks of medications and supplies in case they need to stay home. Learn how to prescribe 1‑month and 3‑month supplies of Ozempic®.

Calendar icon

Ozempic® 0.25 mg or 0.5 mg dose
(2 mg/3 mL subcutaneous pen injector)

3 mL Ozempic® (semaglutide) injection Pen and packaging label

NDC: 0169-4181-13


Days supply:
• Sample/initial (42 days)
• 1-month supply (28 days)


Intent of prescription:
• Sample or initial prescription for new starts
• 1-month prescription for maintenance on 0.5 mg


Strength: 2 mg per 3 mL (0.68 mg/mL)


Dosage form: Solution


SIG:
• Sample or initial Rx: Inject 0.25 mg SC once weekly for 4 weeks, then 0.5 mg SC once weekly for 2 weeks
• Maintenance Rx: Inject 0.5 mg SC once weekly for 4 weeks


Dispense quantity: 3 mL


Dispense quantity unit of measure: mL ONLY


Needles: 6 included


Number of boxes: 1 box

Three calendar icons

Ozempic® 0.25 mg or 0.5 mg dose
(2 mg/3 mL subcutaneous pen injector)

Red label Ozempic® (semaglutide) injection Pen and packaging label

NDC: 0169-4181-13


Days supply:
3-month supply (84 days)


Intent of prescription:
3-month prescription for maintenance on 0.5 mg


Strength: 2 mg per 3 mL (0.68 mg/mL)


Dosage form: Solution


SIG: Maintenance Rx: Inject 0.5 mg SC once weekly for 12 weeks


Dispense quantity: 9 mL


Dispense quantity unit of measure: mL ONLY


Needles: 18 included


Number of boxes: 3 boxes

Calendar icon

Ozempic® 1 mg dose
(4 mg/3 mL subcutaneous pen injector)

Ozempic® (semaglutide) injection pen box

NDC: 0169-4130-13


Days supply:
1-month supply (28 days)
 


Intent of prescription:
1-month prescription for maintenance on 1 mg
 


Strength: 4 mg per 3 mL (1.34 mg/mL)


Dosage form: Solution


SIG:
Maintenance Rx: Inject 1 mg SC once weekly for 4 weeks


 


Dispense quantity: 3 mL


Dispense quantity unit of measure: mL ONLY


Needles: 4 included


Number of boxes: 1 box

Three calendar icons

Ozempic® 1 mg dose
(4 mg/3 mL subcutaneous pen injector)

Ozempic® (semaglutide) injection pen box

NDC: 0169-4130-13


Days supply:
3-month supply (84 days)


Intent of prescription:
3-month prescription for maintenance on 1 mg


Strength: 4 mg per 3 mL (1.34 mg/mL)


Dosage form: Solution


SIG: Maintenance Rx: Inject 1 mg SC once weekly for 12 weeks


Dispense quantity: 9 mL


Dispense quantity unit of measure: mL ONLY


Needles: 12 included


Number of boxes: 3 boxes

Calendar icon

Ozempic® 2 mg dose
(8 mg/3 mL subcutaneous pen injector)

Ozempic® (semaglutide) injection pen box

NDC: 0169-4772-12


Days supply:
1-month supply (28 days)
 


Intent of prescription:
1-month prescription for maintenance on 2 mg
 


Strength: 8 mg per 3 mL (2.68 mg/mL)


Dosage form: Solution


SIG:
Maintenance Rx: Inject 2 mg SC once weekly for 4 weeks


 


Dispense quantity: 3 mL


Dispense quantity unit of measure: mL ONLY


Needles: 4 included


Number of boxes: 1 box

Three calendar icons

Ozempic® 2 mg dose
(8 mg/3 mL subcutaneous pen injector)

Ozempic® (semaglutide) injection pen box

NDC: 0169-4772-12


Days supply:
3-month supply (84 days)


Intent of prescription:
3-month prescription for maintenance on 2 mg


Strength: 8 mg per 3 mL (2.68 mg/mL)


Dosage form: Solution


SIG: Maintenance Rx: Inject 2 mg SC once weekly for 12 weeks


Dispense quantity: 9 mL


Dispense quantity unit of measure: mL ONLY


Needles: 12 included


Number of boxes: 3 boxes

IMPORTANT

Ozempic® (semaglutide) injection - Ozempic® 0.25 mg or 0.5 mg dose, 2 mg/1.5 mL (subcutaneous solution, 1 pen) will no longer be available starting in March 2023.

It is important to begin ePrescribing Ozempic® (semaglutide) injection - Ozempic®, 0.25 mg or 0.5 mg dose, 2 mg/3 mL (subcutaneous solution, 1 pen) as soon as it is available for selection in the EHR, starting in March 2023.

Please ensure to update all your refills, scripts, and any previously saved favorites in the EHR to Ozempic® (semaglutide) injection - Ozempic® 0.25 mg or 0.5 mg dose, 2 mg/3 mL (subcutaneous solution, 1 pen).

Saving Ozempic® as a favorite in the EHR

If your EHR allows you to save your frequently used prescriptions to a “favorites” list, be sure to add Ozempic® for quicker access. Please include dosing, dispense quantity unit of measure, and patient instructions to help ePrescribe Ozempic® accurately.

Get patients started on Ozempic® with the Patient Starter Kit

You can get these helpful tools by speaking to your Novo Nordisk sales representative.

Ozempic® pen in patient starter kit

Inside this Patient Starter Kit:

Ozempic® Pen

6-week starter pen with needles

Learn about the Ozempic® instructions

Instructions on how to use the pen

Learn about the Cornerstones4Care® Diabetes Health Coach support program

Information on the Cornerstones4Care® free support program

Learn about the Ozempic® savings card

Ozempic® Savings Card

Ozempic® (semaglutide) injection Pen and patient starter kit

See coverage details

More ways to help your patients with T2D

Ozempic® pen icon

Ozempic® is available in a multiuse pen with needles included1

See pen 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.

 

Reference:

  1. Ozempic® [package insert]. Plainsboro, NJ: Novo Nordisk Inc.; October 2022.
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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