WEGOVY (Page 3 of 11)

5.9 Suicidal Behavior and Ideation

Suicidal behavior and ideation have been reported in clinical trials with other weight management products. Monitor patients treated with WEGOVY for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior. Discontinue WEGOVY in patients who experience suicidal thoughts or behaviors. Avoid WEGOVY in patients with a history of suicidal attempts or active suicidal ideation.

6 ADVERSE REACTIONS

The following serious adverse reactions are described below or elsewhere in the prescribing information:

Risk of Thyroid C-Cell Tumors [see Warnings and Precautions (5.1)]
Acute Pancreatitis [see Warnings and Precautions (5.2)]
Acute Gallbladder Disease [see Warnings and Precautions (5.3)]
Hypoglycemia [see Warnings and Precautions (5.4)]
Acute Kidney Injury [see Warnings and Precautions (5.5)]
Hypersensitivity [see Warnings and Precautions (5.6)]
Diabetic Retinopathy Complications in Patients with Type 2 Diabetes [see Warnings and Precautions (5.7)]
Heart Rate Increase [see Warnings and Precautions (5.8)]
Suicidal Behavior and Ideation [see Warnings and Precautions (5.9)]

6.1 Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.

WEGOVY was evaluated for safety in 3 randomized, double-blind, placebo-controlled trials that included 2116 patients with overweight or obesity treated with WEGOVY for up to 68 weeks and a 7 week off drug follow-up period. Baseline characteristics included a mean age of 48 years, 71% women, 72% White, 42% with hypertension, 19% with type 2 diabetes, 43% with dyslipidemia, 28% with a BMI greater than 40 kg/m2 , and 4% with cardiovascular disease.

In clinical trials, 6.8% of patients treated with WEGOVY and 3.2% of patients treated with placebo permanently discontinued treatment as a result of adverse reactions. The most common adverse reactions leading to discontinuation were nausea (1.8% versus 0.2%), vomiting (1.2% versus 0%), and diarrhea (0.7% versus 0.1%) for WEGOVY and placebo, respectively.

Adverse reactions reported in greater than or equal to 2% of WEGOVY-treated patients and more frequently than in placebo-treated patients are shown in Table 3.

Table 3. Adverse Reactions Occurring in > 2% of WEGOVY-treated Patients and More Frequently than with Placebo

Placebo

N = 1261

%

WEGOVY

N = 2116

%

Nausea

16

44

Diarrhea

16

30

Vomiting

6

24

Constipation

11

24

Abdominal Paina

10

20

Headache

10

14

Fatigueb

5

11

Dyspepsia

3

9

Dizziness

4

8

Abdominal Distension

5

7

Eructation

<1

7

Hypoglycemia in T2DMc

2

6

Flatulence

4

6

Gastroenteritis

4

6

Gastroesophageal Reflux Disease

3

5

Gastritisd

1

4

Gastroenteritis Viral

3

4

Hair Loss

1

3

a Includes abdominal pain, abdominal pain upper, abdominal pain lower, gastrointestinal pain, abdominal tenderness, abdominal discomfort and epigastric discomfort

b Includes fatigue and asthenia

c Defined as blood glucose <54 mg/dL with or without symptoms of hypoglycemia or severe hypoglycemia (requiring the assistance of another person) in patients with type 2 diabetes not on concomitant insulin (Study 2, WEGOVY N=403, Placebo N=402). See text below for further information regarding hypoglycemia in patients with and without type 2 diabetes. T2DM = type 2 diabetes mellitus

d Includes chronic gastritis, gastritis, gastritis erosive, and reflux gastritis

Acute Pancreatitis

In WEGOVY clinical trials, acute pancreatitis was confirmed by adjudication in 4 WEGOVY-treated patients (0.2 cases per 100 patient years) versus 1 in placebo-treated patients (less than 0.1 cases per 100 patient years). One additional case of acute pancreatitis was confirmed in a patient treated with WEGOVY in another clinical trial.

Acute Gallbladder Disease

In WEGOVY clinical trials, cholelithiasis was reported by 1.6% of WEGOVY-treated patients and 0.7% of placebo-treated patients. Cholecystitis was reported by 0.6% of WEGOVY-treated patients and 0.2% of placebo-treated patients.

Hypoglycemia

Patients with Type 2 Diabetes

In a trial of patients with type 2 diabetes and BMI greater than or equal to 27 kg/m2 , clinically significant hypoglycemia (defined as a plasma glucose less than 54 mg/dL) was reported in 6.2% of WEGOVY-treated patients versus 2.5% of placebo-treated patients. A higher rate of clinically significant hypoglycemic episodes was reported with WEGOVY (semaglutide 2.4 mg) versus semaglutide 1 mg (10.7 vs. 7.2 episodes per 100 patient years of exposure, respectively); the rate in the placebo-treated group was 3.2 episodes per 100 patient years of exposure. In addition, one episode of severe hypoglycemia requiring intravenous glucose was reported in a WEGOVY-treated patient versus none in placebo-treated patients. The risk of hypoglycemia was increased when WEGOVY was used with a sulfonylurea.

Patients without Type 2 Diabetes

Episodes of hypoglycemia have been reported with GLP-1 receptor agonists in patients without type 2 diabetes mellitus. In WEGOVY clinical trials in patients without type 2 diabetes mellitus, there was no systematic capturing or reporting of hypoglycemia.

Acute Kidney Injury

Acute kidney injury occurred in clinical trials in 7 patients (0.4 cases per 100 patient years) receiving WEGOVY versus 4 patients (0.2 cases per 100 patient years of exposure) receiving placebo. Some of these adverse reactions occurred in association with gastrointestinal adverse reactions or dehydration. In addition, 2 patients treated with WEGOVY had acute kidney injury with dehydration in other clinical trials. The risk of renal adverse reactions with WEGOVY was increased in patients with a history of renal impairment (trials included 65 patients with a history of moderate or severe renal impairment at baseline), and occurred more frequently during dose titration.

Retinal Disorders in Patients with Type 2 Diabetes

In a trial of patients with type 2 diabetes and BMI greater than or equal to 27 kg/m2 , retinal disorders were reported by 6.9% of patients treated with WEGOVY (semaglutide 2.4 mg), 6.2% of patients treated with semaglutide 1 mg, and 4.2% of patients treated with placebo. The majority of events were reported as diabetic retinopathy (4.0%, 2.7%, and 2.7%, respectively) and non-proliferative retinopathy (0.7%, 0%, and 0%, respectively).

Increase in Heart Rate

Mean increases in resting heart rate of 1 to 4 beats per minute (bpm) were observed with routine clinical monitoring in WEGOVY-treated patients compared to placebo in clinical trials. In trials in which patients were randomized prior to dose-escalation, more patients treated with WEGOVY, compared with placebo, had maximum changes from baseline at any visit of 10 to 19 bpm (41% versus 34%, respectively) and 20 bpm or more (26% versus 16%, respectively).

Hypotension and Syncope

Adverse reactions related to hypotension (hypotension, orthostatic hypotension, and decreased blood pressure) were reported in 1.3% of WEGOVY-treated patients versus 0.4% of placebo-treated patients and syncope was reported in 0.8% of WEGOVY-treated patients versus 0.2% of placebo-treated patients. Some reactions were related to gastrointestinal adverse reactions and volume loss associated with WEGOVY. Hypotension and orthostatic hypotension were more frequently seen in patients on concomitant antihypertensive therapy.

Appendicitis

Appendicitis (including perforated appendicitis) occurred in 10 (0.5%) WEGOVY-treated patients and 2 (0.2%) patients receiving placebo.

Gastrointestinal Adverse Reactions

In clinical trials, 73% of WEGOVY-treated patients and 47% of patients receiving placebo reported gastrointestinal disorders. The most frequently reported reactions were nausea (44% vs. 16%), vomiting (25% vs. 6%), and diarrhea (30% vs. 16%). Other common reactions that occurred at a higher incidence among WEGOVY-treated patients included dyspepsia, abdominal pain, abdominal distension, eructation, flatulence, gastroesophageal reflux disease, gastritis, and hemorrhoids. These reactions increased during dose escalation.

Permanent discontinuation of treatment as a result of a gastrointestinal adverse reaction occurred in 4.3% of WEGOVY-treated patients versus 0.7% of placebo-treated patients.

Injection Site Reactions

In clinical trials, 1.4% of WEGOVY-treated patients and 1.0% of patients receiving placebo experienced injection site reactions (including injection site pruritus, erythema, inflammation, induration, and irritation).

Laboratory Abnormalities

Patients treated with WEGOVY had a mean increase from baseline in amylase of 16% and lipase of 39%. These changes were not observed in the placebo group. The clinical significance of elevations in lipase or amylase with WEGOVY is unknown in the absence of other signs and symptoms of pancreatitis.

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