Ozempic

— THERAPEUTIC CATEGORIES —
  • Diabetes
PAGE CONTENTS
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  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • Ozempic Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Semaglutide 2mg/3mL (0.68mg/mL), 4mg/3mL (1.34mg/mL), 8mg/3mL (2.68mg/mL); per prefilled pen; soln for SC inj.

    Pharmacological Class

    Glucagon-like peptide-1 (GLP-1) receptor agonist.

    How Supplied

    Single-patient-use prefilled pen—1 (w. NovoFine needles)

    How Supplied

    Ozempic is supplied as a clear, colorless solution in a prefilled, disposable, single-patient-use pen containing 0.68 mg/mL, 1.34 mg/mL or 2.68 mg/mL of semaglutide available in 1-count cartons:

    • 2mg/3mL (1 pen with 6 NovoFine Plus needles)

    • 2mg/1.5mL (1 pen with 6 NovoFine Plus needles)

    • 4mg/3mL (1 pen with 4 NovoFine Plus needles)

    • 8mg/3mL (1 pen with 4 NovoFine Plus needles)

    Storage

    Prior to first use, store the Ozempic pen in the refrigerator between 36ºF to 46ºF (2ºC to 8ºC). Do not freeze. Do not store directly adjacent to the refrigerator cooling element. Do not use Ozempic if it has been frozen. 

    After first use, the Ozempic pen can be stored for 56 days at controlled room temperature (59°F to 86°F; 15°C to 30°C) or in a refrigerator (36°F to 46°F; 2°C to 8°C). Do not freeze. Keep the pen cap on when not in use. Ozempic should be protected from excessive heat and sunlight.

    Manufacturer

    Novo Nordisk

    Generic Availability

    NO

    Mechanism of Action

    Semaglutide selectively binds to and activates the GLP-1 receptor, thus reducing blood glucose through a mechanism where it stimulates insulin secretion and lowers glucagon secretion, both in a glucose-dependent manner. The mechanism of blood glucose lowering also involves a minor delay in gastric emptying in the early postprandial phase.

    Ozempic Indications

    Indications

    As adjunct to diet and exercise, to improve glycemic control in adults with type 2 diabetes mellitus (T2DM). To reduce the risk of major cardiovascular (CV) events (eg, CV death, non-fatal MI or non-fatal stroke) in adults with T2DM and established CV disease.

    Limitations of Use

    Not studied in those with a history of pancreatitis. Not for treating type 1 diabetes.

    Ozempic Dosage and Administration

    Adult

    Give by SC inj in abdomen, thigh, or upper arm; rotate inj sites. Initially 0.25mg once weekly for 4 weeks, then increase to 0.5mg once weekly. If additional control needed after at least 4 weeks, may increase to 1mg once weekly. If additional control needed after at least 4 weeks on the 1mg dosage, may then increase to max 2mg once weekly.

    Children

    <18yrs: not established.

    Administration

    • Give subcutaneously to the abdomen, thigh, or upper arm. Use a different injection site each week.

    • Inspect visually before each use. Do not use Ozempic if particulate matter and coloration is observed.

    • If Ozempic is used with insulin, advise patients to give as separate injections and to never mix the products. Both Ozempic and insulin may be injected into the same body region, but the injections should not be adjacent to each other.

    Ozempic Contraindications

    Contraindications

    History (personal or family) of medullary thyroid carcinoma. Multiple endocrine neoplasia syndrome type 2.

    Ozempic Boxed Warnings

    Boxed Warning

    Risk of thyroid C-cell tumors.

    Boxed 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.

    • Not known whether Ozempic causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans.

    • Contraindicated in patients with a personal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Counsel regarding the risk for MTC and inform patients of symptoms of thyroid tumors.

    • Counsel patients associated with the potential risk of MTC and inform patients of symptoms associated with thyroid tumors (eg, mass in the neck, dysphagia, dyspnea, persistent hoarseness).

    • Monitor routinely serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC. 

    Ozempic Warnings/Precautions

    Warnings/Precautions

    Risk of thyroid C-cell tumors; inform patients of potential risk and symptoms. History of pancreatitis; consider other antidiabetics. Monitor for pancreatitis; discontinue if suspected; do not restart if confirmed. History of diabetic retinopathy; monitor for progression. Do not reuse or share pens or needles between patients. History of anaphylaxis or angioedema with other GLP-1 receptor agonist. Discontinue if hypersensitivity reactions occur. Acute gallbladder disease (eg, cholelithiasis, cholecystitis). Perform gallbladder studies and clinical follow-up if cholelithiasis is suspected. Monitor renal function when initiating or escalating dose. Pregnancy. Females of reproductive potential: discontinue ≥2 months prior to planned pregnancy. Nursing mothers.

    Warnings/Precautions

    Risk of Thyroid C-Cell Tumors

    • Not known whether Ozempic causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans.

    • Counsel patients associated with the potential risk of MTC and inform patients of symptoms associated with thyroid tumors (eg, mass in the neck, dysphagia, dyspnea, persistent hoarseness).

    • Monitor routinely serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC. This may increase the risk of unnecessary procedures. Patients with MTC usually have calcitonin values >50 ng/L.

    • Evaluate further if serum calcitonin is found to be elevated, or if thyroid nodules are noted on physical examination.

    Acute Pancreatitis

    • Following initiation, monitor carefully for signs and symptoms of acute pancreatitis, including persistent severe abdominal pain, sometimes radiating to the back, and which may or may not be accompanied by vomiting.

    • Discontinue treatment if acute pancreatitis is suspected and initiate appropriate management. Do not restart treatment if acute pancreatitis is confirmed.

    Diabetic Retinopathy Complications

    • Risk of temporary worsening of diabetic retinopathy with a rapid improvement in glucose control.

    • Ozempic has not been studied for the effect of long-term glycemic control on diabetic retinopathy complications.

    • Monitor patients for progression of diabetic retinopathy in patients with a history of diabetic retinopathy.

    Hypoglycemia with Concomitant Use of Insulin Secretagogues or Insulin 

    • Patients taking Ozempic in combination with an insulin secretagogue or insulin may have an increased risk of hypoglycemia.

    • Advise patients of the risk of the signs and symptoms of hypoglycemia.

    • May reduce risk of hypoglycemia by lowering the dose of concomitant insulin secretagogue.

    Acute Kidney Injury 

    • Postmarketing reports of acute kidney injury and worsening of chronic renal failure.

    • Monitor renal function when initiating or escalating doses of Ozempic in patients reporting severe adverse GI reactions. 

    Hypersensitivity

    • Discontinue and treat promptly per standard of care if hypersensitivity reactions occur, then monitor until signs and symptoms resolve.

    • Use caution in patients with a history of anaphylaxis or angioedema with another GLP-1 receptor agonist.

    Acute Gallbladder Disease

    • Initiate gallbladder studies and appropriate clinical follow-up if cholelithiasis is suspected.

    Pregnancy Considerations

    Risk Summary

    • Based on animal reproduction studies, there may be potential risks to the fetus from exposure to semaglutide during pregnancy.

    Clinical Considerations

    • Disease-associated maternal and/or embryo/fetal risk: Poorly controlled diabetes during pregnancy increases the maternal risk for diabetic ketoacidosis, preeclampsia, spontaneous abortions, preterm delivery, and delivery complications. Poorly controlled diabetes increases the fetal risk for major birth defects, stillbirth, and macrosomia related morbidity.

     

    Nursing Mother Considerations

    Risk Summary

    • Consider the developmental and health benefits of breastfeeding, along with the mother’s clinical need for Ozempic and any potential adverse effects on the breastfed infant from Ozempic or from the underlying maternal condition.

    Geriatric Considerations

    • There are no overall differences in safety or efficacy between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

    Other Considerations for Specific Populations

    Females and Males of Reproductive Potential

    • Discontinue treatment in women at least 2 months before planned pregnancy.

    Ozempic Pharmacokinetics

    Absorption

    Absolute bioavailability: 89%. Maximum concentration of semaglutide is reached 1 to 3 days postdose.

    Distribution

    Mean apparent volume of distribution: approximately 12.5L. >99% plasma albumin bound.

    Metabolism

    Proteolytic cleavage of the peptide backbone and sequential beta-oxidation of the fatty acid sidechain.

    Elimination

    Apparent clearance in patients with type 2 diabetes: approximately 0.05 L/h. Elimination half-life: ~1 week. Semaglutide will be present in circulation for about 5 weeks after the last dose. Primary excretion routes of semaglutide: urine and feces.

    Ozempic Interactions

    Interactions

    Concomitant insulin; administer as separate injections not adjacent to each other. Increased risk of hypoglycemia with concomitant insulin secretagogues (eg, sulfonylureas) or insulin; consider reducing dose of these. May affect absorption of concomitant oral drugs (delayed gastric emptying); caution.

    Ozempic Adverse Reactions

    Adverse Reactions

    Nausea, vomiting, diarrhea, abdominal pain, constipation; rare: pancreatitis, acute renal injury, hypersensitivity reactions.

    Ozempic Clinical Trials

    Clinical Trials

    Monotherapy Use of Ozempic in Patients with Type 2 Diabetes Mellitus 

    • The efficacy of Ozempic as monotherapy was evaluated in a 30-week double-blind trial (NCT02054897) in 388 patients with type 2 diabetes who were inadequately controlled with diet and exercise. Patients were randomly assigned to Ozempic 0.5mg or 1mg once weekly or placebo.

    • Ozempic 0.5mg and 1mg once weekly achieved a statistically significant reduction in HbA1c at week 30 vs placebo. Patients treated with Ozempic 0.5mg had a change in HbA1c of -1.4% at week 30 (difference from placebo, -1.2 [95% CI, -1.5, -0.9]; P <.0001); patients treated with Ozempic 1mg had a change in HbA1c of -1.6% at week 30 (difference from placebo, -1.4 [95% CI, -1.7, -1.1]; P <.0001).

    • Ozempic 0.5mg and 1mg treatment arms also had greater mean changes in body weight from baseline to week 30 vs placebo (-3.8kg, -4.7kg vs -1.2kg, respectively).

     

    Combination Therapy Use of Ozempic in Patients with Type 2 Diabetes Mellitus 

    Combination with metformin and/or thiazolidinediones

    • The efficacy of Ozempic was evaluated in a 56-week double-blind trial (NCT01930188) in 1231 patients with type 2 diabetes. Patients were randomly assigned to Ozempic 0.5mg or 1mg once weekly or sitagliptin 100mg once daily, plus metformin (94%) and/or thiazolidinediones (6%).

    • Ozempic 0.5mg and 1mg once weekly achieved a statistically significant reduction in HbA1c compared with sitaglitin.

    • Patients treated with Ozempic 0.5mg had a change in HbA1c of -1.3% at week 56 (difference from sitagliptin, -0.6 [95% CI, -0.7, -0.4]; P <.0001); patients treated with Ozempic 1mg had a change in HbA1c of  -1.5% at week 56 (difference from sitagliptin, -0.8 [95% CI, -0.9, -0.6]; P <.0001).

    • Ozempic 0.5mg and 1mg treatment arms also had greater mean changes in body weight from baseline to week 56 vs sitagliptin (-4.2kg, -5.5kg vs -1.7kg, respectively).

    Combination with metformin or metformin with sulfonylurea

    • The efficacy of Ozempic was evaluated in a 56-week open-label trial (NCT01885208) in 813 patients with type 2 diabetes on metformin alone (49%), metformin with sulfonylurea (45%), or other (6%). Patients were randomly assigned to Ozempic 1mg once weekly or exenatide 2mg once weekly.

    • Ozempic 1mg once weekly achieved a statistically significant reduction in HbA1c compared with exenatide.

    • Patients treated with Ozempic 1mg had a change in HbA1c of  -1.4% at week 56 (difference from exenatide, -0.5 [95% CI, -0.7, -0.3]; P <.0001).

    • Ozempic 1mg treatment arms also had greater mean changes in body weight from baseline to week 56 vs exenatide (-4.8kg vs -2.0kg, respectively).

    Combination with metformin or metformin with sulfonylurea

    • The efficacy of Ozempic was evaluated in a 30-week open-label trial (NCT02128932) in 1089 patients with type 2 diabetes. Patients were randomly assigned to Ozempic 0.5mg or 1mg once weekly or insulin glargine once daily, plus background therapy with metformin (48%), or metformin and sulfonylurea (51%).

    • Ozempic 0.5mg and 1mg once weekly achieved a statistically significant reduction in HbA1c compared with insulin glargine.

    • Patients treated with Ozempic 0.5mg had a change in HbA1c of -1.2% at week 30 (difference from insulin glargine, -0.3 [95% CI, -0.5, -0.1]; P <.0001); patients treated with Ozempic 1mg had a change in HbA1c of -1.5% at week 30 (difference from  insulin glargine, -0.6 [95% CI, -0.8, -0.4]; P <.0001).

    • Ozempic 0.5mg and 1mg treatment arms also had greater mean changes in body weight from baseline to week 30 vs insulin glargine (-3.2kg, -4.7kg vs 0.9kg, respectively).

    Combination with metformin or metformin with sulfonylurea

    • The efficacy of Ozempic was evaluated in a 40-week double-blind trial (NCT03989232) in 961 patients with type 2 diabetes currently treated with metformin with or without sulfonylurea. Patients were randomly assigned to Ozempic 2mg or 1mg once weekly.

    • Ozempic 2mg once weekly achieved a statistically significant reduction in HbA1c compared with Ozempic 1mg.

    • Patients treated with Ozempic 2mg had a change in HbA1c of -2.1% at week 40 (difference from Ozempic 1mg, -0.2 [95% CI, -0.31, -0.04]; P <.01).

    • The Ozempic 2mg arm also had greater mean changes in body weight from baseline to week 40 vs Ozempic 1mg (-6.4kg vs -5.6kg, respectively). This was not statistically significant.

    Combination with basal insulin

    • The efficacy of Ozempic was evaluated in a 30-week double-blind trial (NCT02305381) in 397 patients with type 2 diabetes who are inadequately controlled with basal insulin, with or without metformin. Patients were randomly assigned to Ozempic 0.5mg or 1mg once weekly, or placebo.

    • Ozempic 0.5mg and 1mg once weekly achieved a statistically significant reduction in HbA1c at week 30 compared with placebo.

    • Patients treated with Ozempic 0.5mg had a change in HbA1c of -1.3% at week 30 (difference from placebo, -1.1 [95% CI, -1.4, -0.8]; P <.0001); patients treated with Ozempic 1mg had a change in HbA1c of -1.7% at week 30 (difference from placebo, -1.6 [95% CI, -1.8, -1.3]; P <.0001).

    • Ozempic 0.5mg and 1mg treatment arms also had greater mean changes in body weight from baseline to week 30 vs placebo (-3.5kg, -6.0kg vs -1.2kg, respectively).

     

    Cardiovascular Outcomes Trial of Ozempic in Patients with Type 2 Diabetes Mellitus and Cardiovascular Disease 

    • The approval was based on data from the 2-year, multicenter, double-blind, placebo-controlled SUSTAIN 6 trial that assessed the risk of MACE when adding Ozempic or placebo to standard of care in adults with diabetes and established CV disease (N=3297). 

    • Patients were randomly assigned 1:1 to receive Ozempic 0.5mg or 1mg once weekly or placebo. The primary endpoint was the time to first occurrence of MACE, defined as CV death, nonfatal myocardial infarction, or nonfatal stroke.

    • Treatment with Ozempic significantly reduced the risk of MACE occurrence by 26% vs placebo (estimated hazard ratio [HR] for time to first MACE, 0.74 [95% CI, 0.58-0.95]; P <.001); the primary composite endpoint occurred in 6.6% of the Ozempic group vs 8.9% of the placebo arm. 

    Ozempic Note

    Not Applicable

    Ozempic Patient Counseling

    Cost Savings Program

    Ozempic Savings Program

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