What the FDA changed in 2024

Approved uses

Added in this revision

• +Added: Limitations of Use RYBELSUS is not indicated for use in patients with type 1 diabetes mellitus.

Removed in this revision

• -Removed: Limitations of Use • RYBELSUS has not been studied in patients with a history of pancreatitis.
• -Removed: Consider other antidiabetic therapies in patients with a history of pancreatitis. • RYBELSUS is not indicated for use in patients with type 1 diabetes mellitus.

Dosage and administration

This section was substantially rewritten in this revision: 16 entries added, 10 removed. A change this large is usually a reorganization of the document rather than a set of individual edits, so the wording is not quoted line by line.

Forms and strengths

Added in this revision

• +Added: RYBELSUS (semaglutide) tablets (formulation R2) are available as: • 1.5 mg: white to light yellow, round shaped debossed with "1.5" on one side and "novo" on the other side. • 4 mg: white to light yellow, round shaped debossed with "4" on one side and "novo" on the other side. • 9 mg: white to light yellow, round shaped debossed with "9" on one side and "novo" on the other side.

1 entry reworded without a change of meaning.

Warnings and precautions

Added in this revision

• +Added: 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 RYBELSUS.
• +Added: If pancreatitis is suspected, discontinue RYBELSUS and initiate appropriate management.
• +Added: Severe Gastrointestinal Adverse Reactions Use of RYBELSUS has been associated with gastrointestinal adverse reactions, sometimes severe.
• +Added: In RYBELSUS clinical trials, severe gastrointestinal adverse reactions were reported more frequently among patients receiving RYBELSUS (7 mg 0.6%, 14 mg 2%) than placebo (0.3%).
• +Added: RYBELSUS is not recommended in patients with severe gastroparesis.

Removed in this revision

• -Removed: Pancreatitis In glycemic control trials, pancreatitis was reported as a serious adverse event in 6 RYBELSUS-treated patients (0.1 events per 100 patient years) versus 1 in comparator-treated patients (<0.1 events per 100 patient years).
• -Removed: If pancreatitis is suspected, RYBELSUS should be discontinued and appropriate management initiated; if confirmed, RYBELSUS should not be restarted.

3 entries reworded without a change of meaning.

Adverse reactions

Added in this revision

• +Added: The safety of RYBELSUS (formulation R2 - 1.5 mg, 4 mg and 9 mg strengths) and RYBELSUS (formulation R1 - 3 mg, 7, mg and 14 mg strengths) has been established as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus based on adequate and well-controlled studies of RYBELSUS (formulation R1) in adult patients with type 2 diabetes mellitus.
• +Added: Below is a display of the safety results of the adequate and well-controlled studies of RYBELSUS (formulation R1) in adult patients with type 2 diabetes mellitus.
• +Added: Gastrointestinal Adverse Reactions In the pool of placebo-controlled trials, gastrointestinal adverse reactions occurred more frequently among patients who received RYBELSUS than placebo: RYBELSUS 14 mg once daily (41%), RYBELSUS 7 mg once daily (32%) and placebo (21%), including severe reactions (RYBELSUS 14 mg 2.0%, RYBELSUS 7 mg 0.6%, placebo 0.3%).
• +Added: A greater percentage of patients who received RYBELSUS 14 mg once daily (8%) and RYBELSUS 7 mg once daily (4%) discontinued treatment due to gastrointestinal adverse reactions than patients who received placebo (1%).
• +Added: In addition to the reactions in Table 2, the following gastrointestinal adverse reactions with a frequency of <5% occurred in RYBELSUS-treated patients (frequencies listed, respectively, as 14 mg once daily, 7 mg once daily and placebo): abdominal distension (3%, 2% and 1%), dyspepsia (0.6%, 3%, 0.6%), eructation (2%, 0.6%, 0%,), flatulence (1%, 2%, 0%), gastroesophageal reflux disease (2%, 2%, 0.3%) and gastritis (2%, 2%, 0.8%).
• +Added: Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. • Gastrointestinal: ileus • Hypersensitivity: anaphylaxis, angioedema, rash, urticaria • Hepatobiliary: cholecystitis, cholelithiasis requiring cholecystectomy • Nervous system disorders: dizziness, dysesthesia, dysgeusia • Pulmonary: Pulmonary aspiration has occurred in patients receiving GLP-1...

Removed in this revision

• -Removed: Gastrointestinal Adverse Reactions In the pool of placebo-controlled trials, gastrointestinal adverse reactions occurred more frequently among patients receiving RYBELSUS than placebo (placebo 21%, RYBELSUS 7 mg 32%, RYBELSUS 14 mg 41%).
• -Removed: More patients receiving RYBELSUS 7 mg (4%) and RYBELSUS 14 mg (8%) discontinued treatment due to gastrointestinal adverse reactions than patients receiving placebo (1%).
• -Removed: In addition to the reactions in Table 1, the following gastrointestinal adverse reactions with a frequency of <5% were associated with RYBELSUS (frequencies listed, respectively, as placebo; 7 mg; 14 mg): abdominal distension (1%, 2%, 3%), dyspepsia (0.6%, 3%, 0.6%), eructation (0%, 0.6%, 2%), flatulence (0%, 2%, 1%), gastroesophageal reflux disease (0.3%, 2%, 2%), and gastritis (0.8%, 2%, 2%).
• -Removed: Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
• -Removed: Gastrointestinal: ileus Hypersensitivity: anaphylaxis, angioedema, rash, urticaria Hepatobiliary: cholecystitis, cholelithiasis requiring cholecystectomy Nervous system disorders: dizziness, dysgeusia Pulmonary: Pulmonary aspiration has occurred in patients receiving GLP-1 receptor agonists undergoing elective surgeries or procedures requiring general anesthesia or deep sedation.

9 entries reworded without a change of meaning.

Drug interactions

Removed in this revision

• -Removed: When coadministering oral medications instruct patients to closely follow RYBELSUS administration instructions.

2 entries reworded without a change of meaning.

Dosage and administration

Added in this revision

• +Added: Follow the dosage escalation below to reduce the risk of gastrointestinal adverse reactions.

Warnings and precautions

Added in this revision

• +Added: In the pool of placebo-controlled trials, severe gastrointestinal adverse reactions occurred more frequently among patients receiving MOUNJARO (5 mg 1.3%, 10 mg 0.4%, 15 mg 1.2%) than placebo (0.9%).
• +Added: Pulmonary Aspiration During General Anesthesia or Deep Sedation MOUNJARO delays gastric emptying.
• +Added: 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.
• +Added: Available data are insufficient to inform recommendations to mitigate the risk of pulmonary aspiration during general anesthesia or deep sedation in patients taking MOUNJARO, including whether modifying preoperative fasting recommendations or temporarily discontinuing MOUNJARO could reduce the incidence of retained gastric contents.
• +Added: Instruct patients to inform healthcare providers prior to any planned surgeries or procedures if they are taking MOUNJARO.

1 entry reworded without a change of meaning.

Adverse reactions

1 entry reworded without a change of meaning.

Warnings and precautions

Added in this revision

• +Added: Pulmonary Aspiration During General Anesthesia or Deep Sedation RYBELSUS delays gastric emptying.
• +Added: 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.
• +Added: Available data are insufficient to inform recommendations to mitigate the risk of pulmonary aspiration during general anesthesia or deep sedation in patients taking RYBELSUS, including whether modifying preoperative fasting recommendations or temporarily discontinuing RYBELSUS could reduce the incidence of retained gastric contents.
• +Added: Instruct patients to inform healthcare providers prior to any planned surgeries or procedures if they are taking RYBELSUS.

2 entries reworded without a change of meaning.

Adverse reactions

Added in this revision

• +Added: Gastrointestinal: ileus Hypersensitivity: anaphylaxis, angioedema, rash, urticaria Hepatobiliary: cholecystitis, cholelithiasis requiring cholecystectomy Nervous system disorders: dizziness, dysgeusia Pulmonary: Pulmonary aspiration has occurred in patients receiving GLP-1 receptor agonists undergoing elective surgeries or procedures requiring general anesthesia or deep sedation.

Removed in this revision

• -Removed: Gastrointestinal: ileus Hypersensitivity: anaphylaxis, angioedema, rash, urticaria Hepatobiliary: cholecystitis, cholelithiasis requiring cholecystectomy Nervous system disorders: dizziness, dysgeusia

1 entry reworded without a change of meaning.

Warnings and precautions

Added in this revision

• +Added: Pulmonary Aspiration During General Anesthesia or Deep Sedation SAXENDA delays gastric emptying.
• +Added: 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.
• +Added: Available data are insufficient to inform recommendations to mitigate the risk of pulmonary aspiration during general anesthesia or deep sedation in patients taking SAXENDA, including whether modifying preoperative fasting recommendations or temporarily discontinuing SAXENDA could reduce the incidence of retained gastric contents.
• +Added: Instruct patients to inform healthcare providers prior to any planned surgeries or procedures if they are taking SAXENDA.

Adverse reactions

1 entry reworded without a change of meaning.

Warnings and precautions

Added in this revision

• +Added: Pulmonary Aspiration During General Anesthesia or Deep Sedation VICTOZA delays gastric emptying.
• +Added: 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.
• +Added: Available data are insufficient to inform recommendations to mitigate the risk of pulmonary aspiration during general anesthesia or deep sedation in patients taking VICTOZA, including whether modifying preoperative fasting recommendations or temporarily discontinuing VICTOZA could reduce the incidence of retained gastric contents.
• +Added: Instruct patients to inform healthcare providers prior to any planned surgeries or procedures if they are taking VICTOZA.

Adverse reactions

1 entry reworded without a change of meaning.

Dosage and administration

Added in this revision

• +Added: Follow the dosage escalation below to reduce the risk of gastrointestinal adverse reactions.
• +Added: After 4 weeks, the dosage may be increased to 1.5 mg once weekly for additional glycemic control.

Removed in this revision

• -Removed: Increase the dosage to 1.5 mg once weekly for additional glycemic control.

1 entry reworded without a change of meaning.

Warnings and precautions

Added in this revision

• +Added: Severe Gastrointestinal Adverse Reactions Use of TRULICITY has been associated with gastrointestinal adverse reactions, sometimes severe.
• +Added: In the pool of placebo-controlled trials, severe gastrointestinal adverse reactions were reported more frequently among patients receiving TRULICITY (0.75 mg 2.2%, 1.5 mg 4.3%) than placebo (1.4%).
• +Added: Pulmonary Aspiration During General Anesthesia or Deep Sedation TRULICITY delays gastric emptying.
• +Added: 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.
• +Added: Available data are insufficient to inform recommendations to mitigate the risk of pulmonary Aspiration During General anesthesia or deep sedation in patients taking TRULICITY, including whether modifying preoperative fasting recommendations or temporarily discontinuing TRULICITY could reduce the incidence of retained gastric contents.
• +Added: Instruct patients to inform healthcare providers prior to any planned surgeries or procedures if they are taking TRULICITY.

Removed in this revision

• -Removed: Severe Gastrointestinal Disease Use of TRULICITY may be associated with gastrointestinal adverse reactions, sometimes severe.

Adverse reactions

1 entry reworded without a change of meaning.

Approved uses

Added in this revision

• +Added: ZEPBOUND ® is indicated in combination with a reduced-calorie diet and increased physical activity to reduce excess body weight and maintain weight reduction long term in adults with obesity or adults with overweight in the presence of at least one weight-related comorbid condition.

Removed in this revision

• -Removed: ZEPBOUND ® is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index (BMI) of: 30 kg/m 2 or greater (obesity) or 27 kg/m 2 or greater (overweight) in the presence of at least one weight-related comorbid condition (e.g., hypertension, dyslipidemia, type 2 diabetes mellitus, obstructive sleep apnea, or cardiovascular disease).
• -Removed: The safety and efficacy of ZEPBOUND in combination with other products intended for weight management, including prescription drugs, over-the-counter drugs, and herbal preparations, have not been established.
• -Removed: ZEPBOUND has not been studied in patients with a history of pancreatitis.

Dosage and administration

Added in this revision

• +Added: Follow the dosage escalation below to reduce the risk of gastrointestinal adverse reactions.
• +Added: The 2.5 mg dosage is for treatment initiation and is not approved as a maintenance dosage.
• +Added: Administer ZEPBOUND in combination with a reduced-calorie diet and increased physical activity.

Removed in this revision

• -Removed: Patient Selection Select adult patients for ZEPBOUND treatment as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management based on their BMI.
• -Removed: Table 1 presents a chart for determining BMI based on height and weight.
• -Removed: BMI is calculated by dividing weight (in kilograms) by height (in meters) squared.
• -Removed: The 2.5 mg dosage is for treatment initiation and is not intended for chronic weight management.

1 entry reworded without a change of meaning.

Warnings and precautions

Added in this revision

• +Added: Pulmonary Aspiration During General Anesthesia or Deep Sedation ZEPBOUND delays gastric emptying.
• +Added: 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.
• +Added: Available data are insufficient to inform recommendations to mitigate the risk of pulmonary aspiration during general anesthesia or deep sedation in patients taking ZEPBOUND, including whether modifying preoperative fasting recommendations or temporarily discontinuing ZEPBOUND could reduce the incidence of retained gastric contents.
• +Added: Instruct patients to inform healthcare providers prior to any planned surgeries or procedures if they are taking ZEPBOUND.

8 entries reworded without a change of meaning.

Adverse reactions

1 entry reworded without a change of meaning.

Drug interactions

2 entries reworded without a change of meaning.

Approved uses

Added in this revision

• +Added: QSYMIA is indicated in combination with a reduced-calorie diet and increased physical activity to reduce excess body weight and maintain weight reduction long term in: Adults and pediatric patients aged 12 years and older with obesity Adults with overweight in the presence of at least one weight-related comorbid condition Limitations of Use The effect of QSYMIA on cardiovascular morbidity and mortality has not been established.

Removed in this revision

• -Removed: QSYMIA is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in: Adults with an initial body mass index (BMI) of: 30 kg/m 2 or greater (obese), or 27 kg/m 2 or greater (overweight) in the presence of at least one weight-related comorbidity such as hypertension, type 2 diabetes mellitus, or dyslipidemia Pediatric patients aged 12 years and older with an initial BMI in the 95 th percentile or greater standardized for age and sex.
• -Removed: Limitations of Use The effect of QSYMIA on cardiovascular morbidity and mortality has not been established.

Dosage and administration

Removed in this revision

• -Removed: Patient Selection Adults Select adult patients for QSYMIA treatment based on BMI.
• -Removed: Determine the patient's BMI by dividing weight (in kilograms) by height (in meters) squared.
• -Removed: A BMI conversion table based on height [inches (in) or centimeters (cm)] and weight [pounds (lb) or kilograms (kg)] is provided below (see Table 1).
• -Removed: Pediatric Patients Aged 12 Years and Older Select pediatric patients for QSYMIA treatment based on BMI percentile.
• -Removed: See Table 2 for BMI percentiles by age and sex for pediatric patients aged 12 years and older.

9 entries reworded without a change of meaning.

Contraindications

1 entry reworded without a change of meaning.

Warnings and precautions

Removed in this revision

• -Removed: Increase in Heart Rate QSYMIA can cause an increase in resting heart rate.
• -Removed: A higher percentage of QSYMIA-treated adults and pediatric patients aged 12 years and older experienced heart rate increases from baseline of more than 5, 10, 15, and 20 beats per minute (bpm) compared to placebo-treated patients.
• -Removed: The clinical significance of a heart rate elevation with QSYMIA treatment is unclear, especially for patients with cardiac and cerebrovascular disease.
• -Removed: Measure resting heart rate regularly in all patients taking QSYMIA, especially patients with cardiac or cerebrovascular disease and when initiating or increasing the dosage of QSYMIA.
• -Removed: QSYMIA has not been studied in patients with recent or unstable cardiac or cerebrovascular disease and therefore use is not recommended.
• -Removed: Advise patients to inform their healthcare provider of palpitations or feelings of a racing heartbeat while at rest during QSYMIA treatment.
• -Removed: For patients who experience a sustained increase in resting heart rate while taking QSYMIA, reduce the dosage or discontinue QSYMIA.
• -Removed: Risk of Hypoglycemia in Patients with Type 2 Diabetes Mellitus on Antidiabetic Therapy Weight loss may increase the risk of hypoglycemia in patients with type 2 diabetes mellitus treated with insulin and/or insulin secretagogues (e.g., sulfonylureas).
• -Removed: QSYMIA has not been studied in combination with insulin.
• -Removed: Measure blood glucose levels prior to starting QSYMIA and during QSYMIA treatment in patients with type 2 diabetes on antidiabetic medication.
• -Removed: The risk of hypoglycemia may be lowered by a reduction of the dosage of insulin and/or insulin secretagogues.
• -Removed: If a patient develops hypoglycemia after starting QSYMIA, appropriate changes should be made to the antidiabetic drug regimen.
• -Removed: Risk of Hypotension in Patients Treated with Antihypertensive Medications In hypertensive patients being treated with antihypertensive medications, weight loss may increase the risk of hypotension and associated symptoms including dizziness, lightheadedness, and syncope.
• -Removed: Measure blood pressure prior to starting QSYMIA and during QSYMIA treatment in patients being treated for hypertension.
• -Removed: If a patient develops symptoms associated with low blood pressure after starting QSYMIA, appropriate changes should be made to the antihypertensive drug regimen.

Adverse reactions

1 entry reworded without a change of meaning.

Drug interactions

1 entry reworded without a change of meaning.

Approved uses

Added in this revision

• +Added: WEGOVY is indicated in combination with a reduced calorie diet and increased physical activity: • to reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke) in adults with established cardiovascular disease and either obesity or overweight. • to reduce excess body weight and maintain weight reduction long term in: Adults and pediatric patients aged 12 years and older with obesity;
• +Added: Adults with overweight in the presence of at least one weight-related comorbid condition.
• +Added: Limitations of Use • WEGOVY contains semaglutide.
• +Added: Coadministration with other semaglutide-containing products or with any other GLP-1 receptor agonist is not recommended.

Removed in this revision

• -Removed: WEGOVY is indicated as an adjunct to a reduced calorie diet and increased physical activity for chronic weight management in: • adults with an initial body mass index (BMI) of: o 30 kg/m 2 or greater (obesity) or o 27 kg/m 2 or greater (overweight) in the presence of at least one weight-related comorbid condition (e.g., hypertension, type 2 diabetes mellitus, or dyslipidemia) • pediatric patients aged 12 years and older with an initial BMI at the 95th percentile or greater standardized for age...

Dosage and administration

Added in this revision

• +Added: Recommended Dosage Regimen for Adults Maintenance Dosage • The maintenance dosage of WEGOVY in adults is either 2.4 mg (recommended) or 1.7 mg once weekly.
• +Added: Consider treatment response and tolerability when selecting the maintenance dosage.
• +Added: Recommended Dosage in Pediatric Patients Aged 12 Years and Older Dosage Initiation and Escalation • Initiate WEGOVY according to the dosage escalation schedule in Table 2 to minimize gastrointestinal adverse reactions. • If patients do not tolerate a dose during dosage escalation, consider delaying dosage escalation for 4 weeks. • The 0.25 mg, 0.5 mg, and 1 mg once-weekly dosages are initiation and escalation dosages and are not approved as maintenance dosages.
• +Added: Recommended Dosage Regimen for Pediatric Patients Aged 12 Years and Older a Not approved as maintenance dosages b See Dosage Modifications for Adverse Reactions Maintenance Dosage • The maintenance dosage of WEGOVY in pediatric patients aged 12 years and older is 2.4 mg once weekly.
• +Added: Dosage Modifications for Adverse Reactions • If patients do not tolerate the 2.4 mg once weekly maintenance dosage, the maintenance dosage may be reduced to 1.7 mg once weekly. • Discontinue WEGOVY if the patient cannot tolerate the 1.7 mg once-weekly dosage.

Removed in this revision

• -Removed: Patient Selection Adult Patients Select adult patients for WEGOVY treatment as an adjunct to a reduced calorie diet and increased physical activity for chronic weight management based on the BMI values provided in Table 1.
• -Removed: Table 1 presents a chart for determining BMI based on height and weight.
• -Removed: BMI is calculated by dividing weight (in kilograms) by height (in meters) squared.
• -Removed: BMI Conversion Chart Pediatric Patients Aged 12 Years and Older Select pediatric patients aged 12 years and older for WEGOVY treatment as an adjunct to a reduced calorie diet and increased physical activity for chronic weight management based on the BMI values provided in Tables 1 and 2.
• -Removed: Table 1 presents a chart for determining BMI based on height and weight.
• -Removed: Table 2 presents BMI cut-offs for obesity in pediatric patients aged 12 years and older, determined based on the CDC age- and sex-specific growth charts.
• -Removed: Dosage Escalation Schedule Maintenance Dosage Adult Patients • The maintenance dosage of WEGOVY is 2.4 mg injected subcutaneously once weekly. • If patients do not tolerate the maintenance 2.4 mg once-weekly dosage, the dosage can be temporarily decreased to 1.7 mg once weekly, for a maximum of 4 weeks.
• -Removed: After 4 weeks, increase WEGOVY to the maintenance 2.4 mg once-weekly dosage.
• -Removed: Discontinue WEGOVY if the patient cannot tolerate the 2.4 mg dosage.
• -Removed: Pediatric Patients Aged 12 Years and Older • The recommended maintenance dosage of WEGOVY is 2.4 mg injected subcutaneously once weekly. • If patients do not tolerate the maintenance 2.4 mg once-weekly dosage, the maintenance dosage may be reduced to 1.7 mg once weekly.
• -Removed: Discontinue WEGOVY if the patient cannot tolerate the 1.7 mg dose.

4 entries reworded without a change of meaning.

Forms and strengths

1 entry reworded without a change of meaning.

Contraindications

1 entry reworded without a change of meaning.

Warnings and precautions

Added in this revision

• +Added: There is limited experience from clinical trials with WEGOVY in patients with a history of pancreatitis.
• +Added: The use of WEGOVY (semaglutide 2.4 mg or 1.7 mg once weekly) in patients with type 1 diabetes mellitus or in combination with insulin has not been evaluated.

Removed in this revision

• -Removed: WEGOVY has not been studied in patients with a history of pancreatitis.
• -Removed: The addition of WEGOVY in patients treated with insulin has not been evaluated.

6 entries reworded without a change of meaning.

Adverse reactions

Added in this revision

• +Added: T2DM = type 2 diabetes mellitus d Includes chronic gastritis, gastritis, gastritis erosive, and reflux gastritis e Includes paresthesia, hyperesthesia, burning sensation, allodynia, dysesthesia, skin burning sensation, pain of skin, and sensitive skin In a cardiovascular outcomes trial, 8,803 patients were exposed to WEGOVY for a median of 37.3 months and 8,801 patients were exposed to placebo for a median of 38.6 months.
• +Added: Safety data collection was limited to serious adverse events (including death), adverse events leading to discontinuation, and adverse events of special interest.
• +Added: Sixteen percent (16%) of WEGOVY-treated patients and 8% of placebo-treated patients, respectively, discontinued study drug due to an adverse event.
• +Added: Additional information from this trial is included in subsequent sections below when relevant.
• +Added: In a cardiovascular outcomes trial in adult patients without type 2 diabetes, 3 episodes of serious hypoglycemia were reported in WEGOVY-treated patients versus 1 episode in placebo.
• +Added: Patients with a history of bariatric surgery (a risk factor for hypoglycemia) had more events of serious hypoglycemia while taking WEGOVY (2.3%, 2/87) than placebo (0%, 0/97).
• +Added: Gastrointestinal Adverse Reactions In clinical trials in adults, 73% of WEGOVY-treated patients and 47% of patients receiving placebo reported gastrointestinal adverse reactions, including severe reactions that were reported more frequently among patients receiving WEGOVY (4.1%) than placebo (0.9%).
• +Added: Hypersensitivity Reactions Serious hypersensitivity reactions (e.g., anaphylaxis, angioedema) have been reported with WEGOVY.
• +Added: Fractures In the cardiovascular outcomes trial in adults, more fractures of the hip and pelvis were reported on WEGOVY than on placebo in female patients: 1.0% (24/2448) vs. 0.2% (5/2424), and in patients ages 75 years and older: 2.4% (17/703) vs. 0.6% (4/663), respectively.
• +Added: Urolithiasis In a cardiovascular outcomes trial, 1.2% of WEGOVY-treated patients and 0.8% of patients receiving placebo reported urolithiasis, including serious reactions that were reported more frequently among patients receiving WEGOVY (0.6%) than placebo (0.4%).
• +Added: Dysgeusia In clinical trials in adults, 1.7% of WEGOVY-treated patients and 0.5% of placebo-treated patients reported dysgeusia.
• +Added: In the cardiovascular outcomes trial in adults, increases in total bilirubin greater than or equal to 3 times the upper limit of normal were observed in 0.3% (30/8585) of WEGOVY-treated patients versus 0.2% (14/8579) of placebo-treated patients.

Removed in this revision

• -Removed: Gastrointestinal Adverse Reactions In clinical trials in adults, 73% of WEGOVY-treated patients and 47% of placebo-treated patients reported gastrointestinal disorders.

15 entries reworded without a change of meaning.

Drug interactions

2 entries reworded without a change of meaning.

Dosage and administration

Added in this revision

• +Added: Instruct patients using the single-dose vial to use a syringe appropriate for dose administration (e.g., a 1 mL syringe capable of measuring a 0.5 mL dose).

Forms and strengths

1 entry reworded without a change of meaning.