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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.

Frequently asked questions about Ozempic® (semaglutide) injection

About Ozempic® ▾
Taking Ozempic® ▾
Patient support ▾
About Ozempic® ▾
Taking Ozempic® ▾
Patient support ▾

About Ozempic®

What is Ozempic®?

Ozempic® (pronounced Oh-ZEM-pick) is a once-weekly injection 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.

How does Ozempic® work in T2D?

Ozempic® lowers fasting and postprandial blood glucose by stimulating insulin secretion in a glucose-dependent manner.1

Ozempic® causes a minor delay in gastric emptying, thereby reducing the rate at which glucose appears in circulation postprandially.1

See full mechanism of action.

Will Ozempic® help my patients lose weight?

Ozempic® is not indicated for weight loss.

While the primary endpoint in the majority of Ozempic® clinical trials was mean change in A1C, mean change in body weight was generally evaluated as a confirmatory secondary endpoint. Review A1C and weight results from the Ozempic® studies for additional information and see the Prescribing Information.

How does Ozempic® compare to other once-weekly glucagon-like peptide-1 receptor agonist (GLP-1 RA) therapies?

See the A1C and weight results from a 40-‍week, randomized, open-label, active-controlled trial in 1201 adult patients with type 2 diabetes comparing Ozempic® 0.5 mg to Trulicity® 0.75 mg and Ozempic® 1 mg to Trulicity® 1.5 mg.2

Can Ozempic® be used in combination with basal insulin?

Basal insulin can be combined with either dose of once-weekly Ozempic® and titrated as needed.1 Review the A1C reductions of Ozempic® in combination with basal insulin.

Patients receiving Ozempic® in combination with an insulin secretagogue (eg, sulfonylurea) or insulin may have an increased risk of hypoglycemia, including severe hypoglycemia.

What are the side effects of Ozempic®?

The most common adverse reactions, reported in ≥5% of patients treated with Ozempic® are nausea, vomiting, diarrhea, abdominal pain, and constipation.1

Learn about the safety profile for Ozempic®.

How do I write a prescription for Ozempic®?

See how to prescribe a 1-month or 3-month supply of Ozempic® in your EHR system here.

Red, blue, and yellow label Ozempic® (semaglutide) injection Pens stacked horizontally

Taking Ozempic®

What doses are available for Ozempic®?

Ozempic® is available in the following doses:

  • A 0.25 mg starting dose and a maintenance dose of 0.5 mg, both available in a red-label pen1
  • A maintenance dose of 1 mg available in a blue-label pen
  • A maximum maintenance dose of 2 mg available in a yellow-label pen

The 0.25 mg dose is intended for treatment initiation and is not effective for glycemic control.

How is the Ozempic® Pen used?

Instructions for using the pen can be found here.

How is the Ozempic® (semaglutide) injection Pen used video thumbnail

How often is Ozempic® taken?

Ozempic® should be administered by a patient once weekly on the same day each week, at any time of the day, with or without meals.

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 patient misses a dose, they should administer Ozempic® as soon as possible within 5 days after the missed dose. If more than 5 days have passed, the patient should 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.

What is the best time to take Ozempic®?

Administer Ozempic® once weekly on the same day each week, at any time of the day, with or without meals.

How is Ozempic® packaged? How many pens per box?

The Ozempic® injection is supplied as a clear, colorless solution in a prefilled, disposable, single-patient-use pen in the following packaging configurations1:

Red-label pen (starting March 2023)1:

  • Contains 2 mg of semaglutide in a 3 mL (0.68 mg/mL) pen
  • Delivers doses of 0.25 mg or 0.5 mg per injection
  • Includes 6 NovoFine® Plus needles
  •  NDC: 0169-4181-13

Blue-label pen:

  • Contains 4 mg of semaglutide in a 3 mL (1.34 mg/mL) pen
  • Delivers doses of 1 mg per injection
  • Includes 4 NovoFine® Plus needles
  • NDC: 0169-4130-13

Yellow-label pen:

  • Contains 8 mg of semaglutide in a 3 mL (2.68 mg/mL) pen
  • Delivers doses of 2 mg per injection
  • Includes 4 NovoFine® Plus needles
  • NDC: 0169-4772-12

How should Ozempic® be stored?

Prior to first use (until expiration date): Ozempic® should be refrigerated at 36°F to 46°F (2°C to 8°C).

After first use (up to 56 days): Ozempic® should be stored at room temperature 59°F to 86°F (15°C to 30°C) or refrigerated at 36°F to 46°F (2°C to 8°C).

Do not store in the freezer or directly adjacent to the refrigerator cooling element. Do not freeze Ozempic® and do not use Ozempic® if it has been frozen.

Keep the pen cap on when not in use. Ozempic® should be protected from excessive heat and sunlight.

How has the Ozempic® Pen that delivers 0.25 mg and 0.5 mg doses packaging changed?

Starting March 2023, the packaging has changed, however there will still be one pen per box.

The transition of the Ozempic® Pen to a 3 mL pen allows all doses of Ozempic® to be supplied in the same device with clear differentiation in pen packaging.

Will the Ozempic® Pen that delivers 0.25 mg and 0.5 mg doses require a new prescription?

Starting March 2023, the red-label Ozempic® Pen that delivers 0.25 mg and 0.5 mg doses has been updated.

Because of this, the pen has a different NDC number and will require a new prescription.1

NDC: 0169-4181-13

Please see the Dosing & Prescribing page for other details about prescribing Ozempic® in your EHR.

Will the updated Ozempic® Pen that delivers 0.25 mg and 0.5 mg doses affect cost and coverage?

The cost, coverage, and patient co-pay assistance will remain the same between the existing 1.5 mL pen and the new 3 mL pen that delivers 0.25 mg or 0.5 mg doses.

Ozempic® patient support

Can patients save on their Ozempic® prescriptions?

Eligible patients pay as little as $25 for a 1‑month, 2‑month, or 3‑month prescription.a

Patients can get the Ozempic® Savings Card by texting BEGIN to 21848 or registering on OzempicSavings.com.b

The Ozempic® 2-month and 3-month savings offers are intended to help patients minimize gaps in therapy.

aApplies to eligible commercially insured patients with coverage for Ozempic®. Maximum savings of $150 for a 1-month supply, $300 for a 2-month supply, and $450 for a 3-month supply. Month is defined as 28 days. Offer is good for up to 24 months. Eligibility and restrictions apply.
bMessage and data rates may apply. Check with your mobile service provider. See Terms and Conditions of Use at Ozempic.com/terms.

Are there support programs available?

Patients can connect with a Diabetes Health Coach who can help answer questions about their prescription, diet, and exercise. They can call 1‑866‑696‑4090, Monday through Friday, 9:00 am to 6:00 pm ET or visit OzempicSupport.com to get started. The Diabetes Health Coach is available by phone, text, or email on a schedule that’s convenient for your patients.

Patients can also watch My Type 2 Transformation, a video series where a team of experts helps two adults learn how to manage their type 2 diabetes.

Is there an Ozempic® patient starter kit?

Yes! Patients can download a digital patient starter kit at OzempicQuickResources.com. The kit includes information on:

  • Taking and storing Ozempic®
  • Using the Ozempic® Pen
  • Managing side effects
  • Savings and support programs

More ways to help your patients with T2D

Ozempic® resources

Resources are available to help patients start on Ozempic®

See resources »


Ozempic® dosing

See how to dose the Ozempic® Pen

See dosing details »

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. 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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