Powerful glycemic control with weight loss with Ozempic® (semaglutide) pill1,4
Ozempic® is not indicated for weight loss
Demonstrated injectable-like efficacy vs liraglutide 1.8 mg1,2
Comparable A1C reduction vs liraglutide 1.8 mg (injectable GLP-1 RA)
when added to metformin with or without SGLT-2i
Primary endpoint:
Mean change in A1C from baseline at Week 26:
Ozempic® tablets 1.5 mg, 4 mg, and 9 mg are an updated formulation with increased bioavailability. This updated formulation is established with comparable mean exposure and peak concentration. The safety and effectiveness of Ozempic® tablets were established through adequate and well-controlled studies of semaglutide tablets 3 mg, 7 mg, and 14 mg.1,5
PIONEER 4, PIONEER 2, and PIONEER 3 primary endpoint: Mean change in A1C from baseline at Week 26.1-4
PIONEER 4: In a double-blind, double-dummy trial with a primary endpoint of mean change in A1C from baseline to Week 26, 711 adult patients with type 2 diabetes receiving metformin alone or metformin with an SGLT-2i were randomized to semaglutide tablets 14 mg (n=285), liraglutide 1.8 mg subcutaneous injection (n=284), or placebo (n=142), all once daily.2
Adverse events in PIONEER 4 (a head-to-head trial vs liraglutide 1.8 mg)2
- Comparator AE rates are not an adequate basis for comparison of safety between products1
- Because clinical trials are conducted under widely varying conditions, AE rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice1
aData are n (%).
AE=adverse event; SGLT-2i=sodium-glucose co-transporter-2 inhibitor.
Superior vs liraglutide 1.8 mg (injectable GLP-1 RA)1,2
when added to metformin with or without SGLT-2i
PIONEER 4 confirmatory secondary endpoint: Mean change in body weight from baseline to Week 26
Ozempic® pill is not indicated for weight loss
Mean change in body weight from baseline:
Ozempic® tablets 1.5 mg, 4 mg, and 9 mg are an updated formulation with increased bioavailability. This updated formulation is established with comparable mean exposure and peak concentration. The safety and effectiveness of Ozempic® tablets were established through adequate and well-controlled studies of semaglutide tablets 3 mg, 7 mg, and 14 mg.1,5
PIONEER 4, PIONEER 2, and PIONEER 3 primary endpoint: Mean change in A1C from baseline at Week 26.1-4
PIONEER 4: In a double-blind, double-dummy trial with a primary endpoint of mean change in A1C from baseline to Week 26, 711 adult patients with type 2 diabetes receiving metformin alone or metformin with an SGLT-2i were randomized to semaglutide tablets 14 mg (n=285), liraglutide 1.8 mg subcutaneous injection (n=284), or placebo (n=142), all once daily.2
Weight loss results at Week 521,2
PIONEER 4 confirmatory secondary endpoint:
Mean change in body weight from baseline to Week 52
Ozempic® pill is not indicated for weight loss.
Mean change in body weight from baseline:
CI=confidence interval; ETD=estimated treatment difference; SGLT-2i=sodium-glucose co-transporter-2 inhibitor.
Reduce A1C with Ozempic® pill1,3
Superior A1C reduction vs Jardiance® 25 mg
when added to metformin
Primary endpoint:
Mean change in A1C from baseline at Week 26:
Ozempic® tablets 1.5 mg, 4 mg, and 9 mg are an updated formulation with increased bioavailability. This updated formulation is established with comparable mean exposure and peak concentration. The safety and effectiveness of Ozempic® tablets were established through adequate and well-controlled studies of semaglutide tablets 3 mg, 7 mg, and 14 mg.1,5
PIONEER 4, PIONEER 2, and PIONEER 3 primary endpoint: Mean change in A1C from baseline at Week 26.1-4
PIONEER 2: In an open-label trial with a primary endpoint of mean change in A1C from baseline to Week 26, 822 adult patients with type 2 diabetes receiving metformin were randomized to semaglutide tablets 14 mg (n=412) or Jardiance® 25 mg (n=410), both once daily.3
Adverse events in PIONEER 21,3
- Comparator AE rates are not an adequate basis for comparison of safety between products1
- Because clinical trials are conducted under widely varying conditions, AE rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice1
AE=adverse event.
Comparable vs Jardiance® 25 mg1,3
when added to metformin
PIONEER 2 confirmatory secondary endpoint: Mean change in body weight from baseline to Week 26
Ozempic® pill is not indicated for weight loss
Mean change in baseline body weight:
Ozempic® tablets 1.5 mg, 4 mg, and 9 mg are an updated formulation with increased bioavailability. This updated formulation is established with comparable mean exposure and peak concentration. The safety and effectiveness of Ozempic® tablets were established through adequate and well-controlled studies of semaglutide tablets 3 mg, 7 mg, and 14 mg.1,5
PIONEER 4, PIONEER 2, and PIONEER 3 primary endpoint: Mean change in A1C from baseline at Week 26.1-4
PIONEER 2: In an open-label trial with a primary endpoint of mean change in A1C from baseline to Week 26, 822 adult patients with type 2 diabetes receiving metformin were randomized to semaglutide tablets 14 mg (n=412) or Jardiance® 25 mg (n=410), both once daily.3
Weight loss results at Week 523
PIONEER 2 secondary endpoint: Mean change in body weight from baseline to Week 52
Ozempic® pill is not indicated for weight loss.
Mean change in body weight from baseline:
Cl=confidence interval; ETD=estimated treatment difference.
Reduce A1C with Ozempic® pill1,4
Superior A1C reduction vs Januvia® 100 mg
when added to metformin with or without sulfonylurea
Primary endpoint:
Mean change in A1C from baseline at Week 26:
Ozempic® tablets 1.5 mg, 4 mg, and 9 mg are an updated formulation with increased bioavailability. This updated formulation is established with comparable mean exposure and peak concentration. The safety and effectiveness of Ozempic® tablets were established through adequate and well-controlled studies of semaglutide tablets 3 mg, 7 mg, and 14 mg.1,5
PIONEER 4, PIONEER 2, and PIONEER 3 primary endpoint: Mean change in A1C from baseline at Week 26.1-4
PIONEER 3: In a double-blind, double-dummy trial with a primary endpoint of mean change in A1C from baseline to Week 26, 1864 adult patients with type 2 diabetes receiving metformin alone or metformin with a sulfonylurea were randomized to semaglutide tablets 14 mg (n=465), 7 mg (n=466), 3 mg (n=466), or Januvia® 100 mg (n=467), all once daily.4
Adverse events in PIONEER 31,4
- Comparator AE rates are not an adequate basis for comparison of safety between products1
- Because clinical trials are conducted under widely varying conditions, AE rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice1
AE=adverse event.
Superior vs Januvia® 100 mg1,4
when added to metformin with or without sulfonylurea
PIONEER 3 confirmatory secondary endpoint:
Mean change in body weight from baseline to Week 26
Ozempic® pill is not indicated for weight loss.
Mean change in body weight from baseline:
Ozempic® tablets 1.5 mg, 4 mg, and 9 mg are an updated formulation with increased bioavailability. This updated formulation is established with comparable mean exposure and peak concentration. The safety and effectiveness of Ozempic® tablets were established through adequate and well-controlled studies of semaglutide tablets 3 mg, 7 mg, and 14 mg.1,5
PIONEER 4, PIONEER 2, and PIONEER 3 primary endpoint: Mean change in A1C from baseline at Week 26.1-4
PIONEER 3: In a double-blind, double-dummy trial with a primary endpoint of mean change in A1C from baseline to Week 26, 1864 adult patients with type 2 diabetes receiving metformin alone or metformin with a sulfonylurea were randomized to semaglutide tablets 14 mg (n=465), 7 mg (n=466), 3 mg (n=466), or Januvia® 100 mg (n=467), all once daily.4
Weight loss results at Week 521,4
PIONEER 3 secondary endpoint: Mean change in body weight from baseline to Week 52
Ozempic® pill is not indicated for weight loss.
Mean change in body weight from baseline:
CI=confidence interval; ETD=estimated treatment difference.
More ways to help your patients with T2D
Learn more about getting patients started on Ozempic® pill
STUDY DESIGNS
PIONEER 2: Head-to-head vs Jardiance® (empagliflozin)1,3
Study design: 52-week, randomized, open-label, multinational, phase 3a trial, designed to assess the efficacy and safety of semaglutide tablets vs Jardiance®, both in addition to metformin monotherapy.
Patients: A total of 822 adult patients with inadequately controlled T2D (A1C 7.0%-10.5%) and receiving a stable dose of metformin were randomized to semaglutide tablets 14 mg (n=412) or Jardiance® 25 mg (n=410), both once daily.
Primary endpoint: Change in A1C from baseline to Week 26.
Confirmatory secondary endpoint: Change in body weight from baseline to Week 26.
Supportive secondary endpoints: Proportion of patients achieving A1C <7% or ≤6.5% at Weeks 26 and 52 and mean changes from baseline to Week 52 in A1C and body weight.
PIONEER 3: Head-to-head vs Januvia® (sitagliptin)1,4
Study design: 78-week, randomized, double-blind, double-dummy, active controlled, parallel-group, phase 3a trial designed to assess the efficacy and assess long-term adverse event profile of once-daily semaglutide tablets vs Januvia® in addition to metformin with or without sulfonylurea.
Patients: 1864 adult patients with inadequately controlled type 2 diabetes (7.0%-10.5%) receiving metformin alone or metformin with a sulfonylurea were randomized to semaglutide tablets 14 mg (n=465), 7 mg (n=466), 3 mg (n=466), or Januvia® 100 mg (n=467), all once daily.
Primary endpoint: Change in A1C from baseline to Week 26.
Key secondary endpoint: Change in body weight from baseline to Week 26.
Additional secondary endpoints included: Proportion of patients achieving A1C <7% at Weeks 26, 52, and 78 and mean changes from baseline to Week 52 in A1C and body weight.
PIONEER 4: Head-to-head vs liraglutide 1.8 mg1,2
Study design: 52-week, randomized, double-blind, double-dummy, active controlled, and placebo-controlled phase 3a trial designed to assess the safety and efficacy of semaglutide tablets vs subcutaneously injected GLP-1 RA, liraglutide.
Patients: 711 adult patients with T2D receiving metformin alone or metformin with an SGLT-2i were randomized to semaglutide tablets 14 mg (n=285), liraglutide 1.8 mg subcutaneous injection (n=284), or placebo (n=142), all once daily.
Primary endpoint: Change in A1C from baseline to Week 26.
Confirmatory secondary endpoint: Change in body weight from baseline to Week 26.
Supportive secondary endpoints: Proportions of patients achieving A1C <7% at Week 26 and Week 52.
SGLT-2i=sodium-glucose co-transporter-2 inhibitor; T2D=type 2 diabetes.
Important Safety Information for Ozempic®
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 or 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 (e.g., 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®
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 prior serious 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 nonfatal 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 acute pancreatitis, which may include persistent or severe abdominal pain (sometimes radiating to the back), with or without nausea or 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® injection (3%) compared to placebo (1.8%). In a pooled analysis of glycemic control trials, patients reported diabetic retinopathy related adverse reactions during the trial (4.2% with semaglutide tablets and 3.8% with comparator). 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.
Rapid improvement in glucose control has been associated with a temporary worsening of diabetic retinopathy. 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 (GI) Adverse Reactions: Use of Ozempic® has been associated with GI adverse reactions, sometimes severe. In clinical trials, severe GI adverse reactions were reported more frequently among patients who received Ozempic® injection (0.5 mg 0.4%, 1 mg 0.8%) than placebo (0%); and severe GI adverse reactions were reported more frequently among patients who received semaglutide tablets (7 mg 0.6%, 14 mg 2%) than placebo (0.3%). Severe GI adverse reactions have also been reported postmarketing with GLP-1 receptor agonists. 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® injection 0.5 mg and 1 mg, respectively, and not reported in placebo-treated patients. In placebo-controlled trials to improve glycemic control, cholelithiasis was reported in 1% of patients treated with semaglutide tablets 7 mg. In a 4-year CV outcomes trial (Trial 7), cholelithiasis was reported in 1.1% of patients treated with semaglutide tablets 14 mg and in 0.9% of placebo-treated patients. In Trial 7, cholecystitis was reported in 1.1% treated with semaglutide tablets 14 mg and in 0.7% of 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 taking Ozempic® are nausea, vomiting, diarrhea, abdominal pain, and constipation. Decreased appetite was also reported in ≥5% of patients taking semaglutide tablets
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. Monitor the effects of oral medications concomitantly administered with Ozempic®. Consider increased clinical or laboratory monitoring for medications that have a narrow therapeutic index or that require clinical monitoring
Use in Specific Populations
- Pregnancy: Available data with semaglutide use in pregnant women are not sufficient to determine a drug associated risk for major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Discontinue Ozempic® in women at least 2 months before a planned pregnancy due to the long washout period for semaglutide
- Lactation: A clinical lactation study reported semaglutide concentrations below the lower limit of quantification in human breast milk. However, salcaprozate sodium (SNAC) and/or its metabolites are present in human milk. Because of the unknown potential for serious adverse reactions in the breastfed infant due to the possible accumulation of SNAC, an absorption enhancer for Ozempic® tablets, and because there are alternative formulations of semaglutide that do not contain SNAC that can be used during lactation, advise patients that breastfeeding is not recommended during treatment with Ozempic® tablets
Please click here for Ozempic® injection Prescribing Information, including Boxed Warning.
Please click here for Ozempic® tablets Prescribing Information, including Boxed Warning.
Indications and Usage
Ozempic® (semaglutide) injection 0.5 mg, 1 mg, or 2 mg and Ozempic® (semaglutide) tablets 4 mg or 9 mg are indicated:
- as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes
Ozempic® injection is indicated:
- 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
Ozempic® tablets are indicated:
- to reduce the risk of major adverse cardiovascular (CV) events (CV death, nonfatal myocardial infarction, or nonfatal stroke) in adults with type 2 diabetes who are at high risk for these events
Important Safety Information for Ozempic®
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 or 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 (e.g., 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®
Important Safety Information for Ozempic®
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 or 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 (e.g., 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®
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 prior serious 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 nonfatal 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 acute pancreatitis, which may include persistent or severe abdominal pain (sometimes radiating to the back), with or without nausea or 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® injection (3%) compared to placebo (1.8%). In a pooled analysis of glycemic control trials, patients reported diabetic retinopathy related adverse reactions during the trial (4.2% with semaglutide tablets and 3.8% with comparator). 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.
Rapid improvement in glucose control has been associated with a temporary worsening of diabetic retinopathy. 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 (GI) Adverse Reactions: Use of Ozempic® has been associated with GI adverse reactions, sometimes severe. In clinical trials, severe GI adverse reactions were reported more frequently among patients who received Ozempic® injection (0.5 mg 0.4%, 1 mg 0.8%) than placebo (0%); and severe GI adverse reactions were reported more frequently among patients who received semaglutide tablets (7 mg 0.6%, 14 mg 2%) than placebo (0.3%). Severe GI adverse reactions have also been reported postmarketing with GLP-1 receptor agonists. 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® injection 0.5 mg and 1 mg, respectively, and not reported in placebo-treated patients. In placebo-controlled trials to improve glycemic control, cholelithiasis was reported in 1% of patients treated with semaglutide tablets 7 mg. In a 4-year CV outcomes trial (Trial 7), cholelithiasis was reported in 1.1% of patients treated with semaglutide tablets 14 mg and in 0.9% of placebo-treated patients. In Trial 7, cholecystitis was reported in 1.1% treated with semaglutide tablets 14 mg and in 0.7% of 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 taking Ozempic® are nausea, vomiting, diarrhea, abdominal pain, and constipation. Decreased appetite was also reported in ≥5% of patients taking semaglutide tablets
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. Monitor the effects of oral medications concomitantly administered with Ozempic®. Consider increased clinical or laboratory monitoring for medications that have a narrow therapeutic index or that require clinical monitoring
Use in Specific Populations
- Pregnancy: Available data with semaglutide use in pregnant women are not sufficient to determine a drug associated risk for major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Discontinue Ozempic® in women at least 2 months before a planned pregnancy due to the long washout period for semaglutide
- Lactation: A clinical lactation study reported semaglutide concentrations below the lower limit of quantification in human breast milk. However, salcaprozate sodium (SNAC) and/or its metabolites are present in human milk. Because of the unknown potential for serious adverse reactions in the breastfed infant due to the possible accumulation of SNAC, an absorption enhancer for Ozempic® tablets, and because there are alternative formulations of semaglutide that do not contain SNAC that can be used during lactation, advise patients that breastfeeding is not recommended during treatment with Ozempic® tablets
Please click here for Ozempic® injection Prescribing Information, including Boxed Warning.
Please click here for Ozempic® tablets Prescribing Information, including Boxed Warning.
Indications and Usage
Ozempic® (semaglutide) injection 0.5 mg, 1 mg, or 2 mg and Ozempic® (semaglutide) tablets 4 mg or 9 mg are indicated:
- as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes
Ozempic® injection is indicated:
- 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
Ozempic® tablets are indicated:
- to reduce the risk of major adverse cardiovascular (CV) events (CV death, nonfatal myocardial infarction, or nonfatal stroke) in adults with type 2 diabetes who are at high risk for these events
References:
- Ozempic tablets. Prescribing information. Novo Nordisk Inc.
- Pratley R, Amod A, Hoff ST, et al. Oral semaglutide versus subcutaneous liraglutide and placebo in type 2 diabetes (PIONEER 4): a randomised, double-blind, phase 3a trial. Lancet. 2019;394(10192):39-50. doi:10.1016/S0140-6736(19)31271-1
- Rodbard HW, Rosenstock J, Canani LH, et al; PIONEER 2 Investigators. Oral semaglutide versus empagliflozin in patients with type 2 diabetes uncontrolled on metformin: the PIONEER 2 trial. Diabetes Care. 2019;42(12):2272-2281. doi:10.2337/dc19-0883
- Rosenstock J, Allison D, Birkenfeld AL, et al; PIONEER 3 Investigators. Effect of additional oral semaglutide vs sitagliptin on glycated hemoglobin in adults with type 2 diabetes uncontrolled with metformin alone or with sulfonylurea: the PIONEER 3 randomized clinical trial. JAMA. 2019;321(15):1466-1480. doi:10.1001/jama.2019.2942
- Nielsen MS, Brøndsted L, Kankam M, et al. A bioequivalence study of two formulations of oral semaglutide in healthy participants. Diabetes Ther. 2025;16(2):269-287. doi:10.1007/s13300-024-01674-8