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

Prescribing Information
Important Safety Information | Patient Site

Ozempic® (semaglutide) injection is available in 3 multi-use pens for more A1C control1

The Ozempic® injection is supplied as a clear, colorless solution in a prefilled, disposable, single-patient-use pen in the following packaging configurations:

Thinnest needle (32G, 4 mm) on a once-weekly GLP-1 RA included with each pen1

Red Label


Pen that delivers doses of 0.25 mg and 0.5 mg

Contains 2 mg of Ozempic®
Delivers only the starting dose of 0.25 mg and a maintenance dose of 0.5 mg

Red Ozempic® pen

Includes

x6

Ozempic®  pen needle
Red label Ozempic® (semaglutide) injection Pen includes 6 needles

Blue Label


Pen that delivers doses of 1 mg

Contains 4 mg of Ozempic®
Delivers only the maintenance dose of 1 mg

Blue Ozempic® pen

Includes

x4

Ozempic®  pen needle
Blue label Ozempic® (semaglutide) injection pen includes 4 needles

Yellow Label


Pen that delivers doses of 2 mg

Contains 8 mg of Ozempic®
Delivers only the maximum maintenance dose of 2 mg

Yellow Ozempic® pen

Includes

x4

Ozempic®  pen needle
Yellow label Ozempic® (semaglutide) injection pen includes 4 needles

Steps to deliver your dose1

No matter if a patient is initiating, maintaining, or escalating their Ozempic® dose, inform them to follow these steps for proper administration. Instruct your patients to use a new needle for each injection and to never share pens to avoid contamination or infection. 

1Prepare

  • Wash hands with soap and water
  • Check the name and colored label on the pen and ensure the Ozempic® medicine is clear and colorless
  • Take a new needle and push onto the pen and turn to tighten
  • Always use a new needle with each injection. Instruct patients to never reuse or share needles with other people. Never use a bent or damaged needle
Hand holding Ozempic® pen showing the label and that the pen is clear and colorless

2Select

  • For first-time use with each new pen, check the flow by turning the selector until the dose counter shows the flow-check symbol () then press and hold the dose button until a drop appears at the needle tip
  • Only check the Ozempic® flow on the first-time use of each new pen
  • Turn the dose selector until the dose counter stops and shows the correct prescribed dose
Hand turning the Ozempic® pen dose selector

3Inject

  • Insert the needle into the skin and make sure you can see the dose counter
  • Press and hold down the dose button until the dose counter shows 0, and continue pressing the dose button while keeping the needle in the skin
  • Count 6 seconds while keeping the dose button pressed. If the needle is removed earlier, a stream of OZEMPIC® may come from the needle tip. If this happens, the full dose will not be delivered
  • After injection, carefully remove the needle and dispose of it properly, then put the cap back on the pen and store properly
Hand injecting Ozempic® dose

Using the pen

Ozempic® is injected under the skin of the abdomen, thigh, or upper arm (NOT into a muscle or vein). Patients should change (rotate) the injection site with each injection and not use the same site for each injection. Tell your patients to choose the injection site and wipe the skin with an alcohol swab and to let the injection site dry before they inject their dose. 

See the full instructions for use

Injection sites labeled on the body
Ozempic<sup>®</sup> Demonstration Pen (0.25 mg, 0.5 mg)
Ozempic® Demonstration Pen (0.25 mg, 0.5 mg)
For demonstration and training only. Not for patients or injection into humans. Does not contain medicine. Only to be used by a health care professional. Needles are not included.
Add to order
Prescribing Information | Important Safety Information
Prescribing Information | Important Safety Information
Ozempic® Pen Instructions for Use
(3:43)
Ozempic® Pen Instructions for Use
An overview for patients on how to use the Ozempic® Pen, this easy-to-follow video illustrates how they can administer Ozempic®. You may also view illustrated step-by-step instructions.
Watch video
Prescribing Information | Important Safety Information

Learn how to dose and prescribe Ozempic®

See details

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Patient resources page

Resources are available to help patients start on Ozempic®

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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 Usage

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
  • to reduce the risk of major adverse cardiovascular (CV) events (CV death, nonfatal myocardial infarction, or nonfatal stroke) in adults with type 2 diabetes and established CV disease
  • to reduce the risk of sustained eGFR decline, end-stage kidney disease, and cardiovascular death in adults with type 2 diabetes and chronic kidney disease

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 further evaluated if serum calcitonin is measured and found to be elevated or thyroid nodules are noted on physical examination or neck imaging
  • Acute Pancreatitis: Acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis, has been observed in patients treated with GLP-1 receptor agonists, including semaglutide. 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® and initiate appropriate management
  • 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 (e.g., 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 Due to Volume Depletion: There have been postmarketing reports of acute kidney injury, in some cases requiring hemodialysis, in patients treated with semaglutide. The majority of reported events occurred in patients who experienced gastrointestinal reactions leading to dehydration such as nausea, vomiting, or diarrhea. Monitor renal function in patients reporting adverse reactions to Ozempic® that could lead to volume depletion, especially during dosage initiation and escalation
  • Severe Gastrointestinal Adverse Reactions: Use of Ozempic® has been associated with gastrointestinal adverse reactions, sometimes severe. In Ozempic® clinical trials, severe gastrointestinal adverse reactions were reported more frequently among patients receiving Ozempic® (0.5 mg 0.4%, 1 mg 0.8%) than placebo (0%). Ozempic® is not recommended in patients with severe gastroparesis
  • Hypersensitivity: Serious hypersensitivity reactions (e.g., 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
  • Pulmonary Aspiration During General Anesthesia or Deep Sedation: Ozempic® delays gastric emptying. There have been rare postmarketing reports of pulmonary aspiration in patients receiving GLP-1 receptor agonists undergoing elective surgeries or procedures requiring general anesthesia or deep sedation who had residual gastric contents despite reported adherence to preoperative fasting recommendations. Instruct patients to inform healthcare providers prior to any planned surgeries or procedures if they are taking Ozempic®

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.
Diabetes
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