Drug Safety-related Labeling Changes (SrLC)

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WEGOVY (NDA-215256)

(SEMAGLUTIDE)

Safety-related Labeling Changes Approved by FDA Center for Drug Evaluation and Research (CDER)

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11/27/2024 (SUPPL-15)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.6 Severe Gastrointestinal Adverse Reactions

Newly added subsection:

Use of WEGOVY has been associated with gastrointestinal adverse reactions, sometimes severe [see Adverse Reactions (6.1)]. In WEGOVY clinical trials, severe gastrointestinal adverse reactions were reported more frequently among patients receiving WEGOVY (4.1%) than placebo (0.9%).

WEGOVY is not recommended in patients with severe gastroparesis.

6 Adverse Reactions

Addition of the following to the bulleted line listing:

• Severe Gastrointestinal Adverse Reactions [see Warnings and Precautions (5.6)]

6.1 Clinical Trials Experience

Additions and/or revisions underlined:

…

Gastrointestinal Adverse Reactions

…

These reactions were most frequently reported during dosage escalation.

In the pediatric clinical trial, 62% of WEGOVY-treated patients and 42% of placebo-treated patients reported gastrointestinal adverse reactions.

…

8 Use in Specific Populations

8.4 Pediatric Use

Additions and/or revisions underlined:

…

Use of the 1.7 mg once weekly maintenance dosage of WEGOVY in pediatric patients is also supported by additional exposure-efficacy and safety analyses in pooled adult and pediatric patients.

…

17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)

PATIENT COUNSELING INFORMATION

Newly added information:

Severe Gastrointestinal Adverse Reactions

Inform patients of the potential risk of severe gastrointestinal adverse reactions. Instruct patients to contact their healthcare provider if they have severe or persistent gastrointestinal symptoms [see Warnings and Precautions (5.6)].

MEDICATION GUIDE

Additions and/or revisions underlined:

How should I use WEGOVY?

…

• Use WEGOVY with a reduced-calorie diet and increased physical activity.

  …

• If you miss doses of WEGOVY for 2 or more weeks, take your next dose on the regularly scheduled day or call your healthcare provider to talk about how to restart your treatment.

• You can take WEGOVY with or without food.

• If you take too much WEGOVY, call your healthcare provider or Poison Help line at 1-800-222-1222 or go to the nearest hospital emergency room right away. Advice is also available online at poisonhelp.org.

What are the possible side effects of Wegovy?

…

• increased risk of low blood sugar (hypoglycemia) in patients with type 2 diabetes, especially those who also take medicines to treat type 2 diabetes mellitus such as an insulin or a sulfonylureas. Low blood sugar in patients with type 2 diabetes who receive WEGOVY can be both a serious and common side effect.

  …

• severe stomach problems. Stomach problems, sometimes severe, have been reported in people who use WEGOVY. Tell your healthcare provider if you have stomach problems that are severe or will not go away.

…

11/01/2024 (SUPPL-21)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.10 Pulmonary Aspiration During General Anesthesia or Deep Sedation

Newly added subsection:

WEGOVY delays gastric emptying [see Clinical Pharmacology (12.2)]. 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.

Available data are insufficient to inform recommendations to mitigate the risk of pulmonary aspiration during general anesthesia or deep sedation in patients taking WEGOVY, including whether modifying preoperative fasting recommendations or temporarily discontinuing WEGOVY could reduce the incidence of retained gastric contents. Instruct patients to inform healthcare providers prior to any planned surgeries or procedures if they are taking WEGOVY.

6 Adverse Reactions

Addition of the following to the bulleted line listing:

Pulmonary Aspiration During General Anesthesia or Deep Sedation [see Warnings and Precautions (5.10)]

6.2 Postmarketing Experience

Additions and/or revisions underlined:

…

Pulmonary: Pulmonary aspiration has occurred in patients receiving GLP-1 receptor agonists undergoing elective surgeries or procedures requiring general anesthesia or deep sedation.

17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)

PATIENT COUNSELING INFORMATION

Newly added information:

Pulmonary Aspiration During General Anesthesia or Deep Sedation

Inform patients that WEGOVY may cause their stomach to empty more slowly which may lead to complications with anesthesia or deep sedation during planned surgeries or procedures. Instruct patients to inform healthcare providers prior to any planned surgeries or procedures if they are taking WEGOVY [see Warnings and Precautions (5.10)].

MEDICATION GUIDE

Additions and/or revisions underlined:

Before using WEGOVY, tell your healthcare provider if you have any other medical conditions, including if you:

…

• are scheduled to have surgery or other procedures that use anesthesia or deep sleepiness (deep sedation).

…

What are the possible side effects of WEGOVY?

WEGOVY may cause serious side effects, including:

…

• food or liquid getting into the lungs during surgery or other procedures that use anesthesia or deep sleepiness (deep sedation). WEGOVY may increase the chance of food getting into your lungs during surgery or other procedures. Tell all your healthcare providers that you are taking WEGOVY before you are scheduled to have surgery or other procedures.

03/08/2024 (SUPPL-11)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.2 Acute Pancreatitis

Additions and revisions underlined:

There is limited experience from clinical trials with WEGOVY in patients with a history of pancreatitis. It is unknown if patients with a history of pancreatitis are at higher risk for development of pancreatitis on WEGOVY.

5.4 Hypoglycemia

Additions and revisions underlined:

Patients with diabetes mellitus taking WEGOVY in combination with insulin or an insulin secretagogue (e.g., sulfonylurea) may have an increased risk of hypoglycemia, including severe hypoglycemia. Hypoglycemia has been observed in patients treated with semaglutide at doses of 0.5 and 1 mg in combination with insulin. 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.

Inform patients of the risk of hypoglycemia and educate them on the signs and symptoms of hypoglycemia. In patients with diabetes, monitor blood glucose prior to starting WEGOVY and during WEGOVY treatment.

When initiating WEGOVY, consider reducing the dose of concomitantly administered insulin or insulin secretagogue (such as sulfonylureas) to reduce the risk of hypoglycemia [see Drug Interactions (7)].

6 Adverse Reactions

6.1 Clinical Trials Experience

Extensive changes; please refer to label

8 Use in Specific Populations

8.4 Pediatric Use

Additions and revisions underlined:

The safety and effectiveness of WEGOVY as an adjunct to a reduced calorie diet and increased physical activity for weight reduction and long-term maintenance have been established in pediatric patients aged 12 years and older with obesity.

8.5 Geriatric Use

Additions and revisions underlined:

In the WEGOVY clinical trials for weight reduction and long-term maintenance, 233 (9%) WEGOVY-treated patients were aged 65 to 75 years and 23 (1%) WEGOVY-treated patients were aged 75 years and older [see Clinical Studies (14.2)]. In a cardiovascular outcomes trial, 2656 (30%) WEGOVY-treated patients were aged 65 to 75 years and 703 (8%) WEGOVY-treated patients were aged 75 years and older [see Clinical Studies (14.1)]. No overall difference in effectiveness was observed between patients aged 65 years and older and younger adult patients. In the cardiovascular outcomes trial, patients aged 75 years and older reported more fractures of the hip and pelvis on WEGOVY than on placebo. Patients aged 75 years and older (WEGOVY- treated and placebo-treated) reported more serious adverse reactions overall compared to younger adult patients [see Adverse Reactions (6.1)].

17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)

Medication Guide

Additions and revisions underlined:

• WEGOVY is an injectable prescription medicine used with a reduced calorie diet and increased physical activity:

  • to reduce the risk of major cardiovascular events such as death, heart attack, or stroke in adults with known heart disease and with either obesity or overweight.

  • that may help adults and children aged 12 years and older with obesity, or some adults with overweight who also have weight-related medical problems, to help them lose excess body weight and keep the weight off.

. . .

The most common side effects of WEGOVY in adults or children aged 12 years and older may include:

• low blood sugar in people

  . . .

07/21/2023 (SUPPL-7)

Approved Drug Label (PDF)

6 Adverse Reactions

6.1 Clinical Trials Experience

(Additions and/or revisions underlined)

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.

Adverse Reactions in Clinical Trials in Adults with Obesity or Overweight

WEGOVY 2.4 mg Subcutaneous Weekly Dosage

WEGOVY was evaluated for safety in 3 randomized, double-blind, placebo-controlled trials that included 2,116 adult patients with overweight or obesity treated with 2.4 mg WEGOVY for up to 68 weeks and a 7 week off drug follow-up period [see Clinical Studies (14.1)]. Baseline characteristics included a mean age of 48 years, 71% women, 72% White, 14% Asian, 9% Black or African American, and 5% reported as other or unknown; and 85% were not Hispanic or Latino ethnicity, 13% were Hispanic or Latino ethnicity and 2% reported as unknown. The baseline characteristics were 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 2.4 mg 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 clinical trials in adults and greater than or equal to 2% of WEGOVY-treated patients and more frequently than in placebo-treated patients are shown in Table 5.

WEGOVY 1.7 mg Subcutaneous Weekly Dosage

WEGOVY 1.7 mg subcutaneous weekly was evaluated for safety in a 68-week, randomized, double-blind, parallel-group, placebo-controlled trial in 401 patients with overweight or obesity. Adverse reactions observed with WEGOVY 1.7 mg were similar to those reported with WEGOVY 2.4 mg.

…

Table 6 shows adverse reactions reported in greater than or equal to 3% of WEGOVY-treated pediatric patients and more frequently than in the placebo group from a study in pediatric patients aged 12 years and older.

…

Gastrointestinal Adverse Reactions

In clinical trials in adults, 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 adult patients included dyspepsia, abdominal pain, abdominal distension, eructation, flatulence, gastroesophageal reflux disease, gastritis, and hemorrhoids. These reactions increased during dose escalation.

In a pediatric clinical trial, 62% of WEGOVY-treated patients and 42% of placebo-treated patients reported gastrointestinal disorders. The most frequently reported reactions were nausea (42% vs. 18%), vomiting (36% vs. 10%), and diarrhea (22% vs. 19%). Other gastrointestinal-related reactions that occurred at a higher incidence than placebo among WEGOVY-treated pediatric patients included abdominal pain, constipation, eructation, gastroesophageal reflux disease, dyspepsia, and flatulence.

Permanent discontinuation of treatment as a result of a gastrointestinal adverse reaction occurred in 4.3% of WEGOVY-treated adult patients versus 0.7% of placebo-treated patients. In a pediatric clinical trial, 2.3% of patients treated with WEGOVY versus 1.5% of patients who received placebo discontinued treatment as a result of gastrointestinal adverse reactions.

Injection Site Reactions

In clinical trials in adults, 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).

Hypersensitivity Reactions

Serious hypersensitivity reactions (e.g., anaphylaxis, angioedema) have been reported with WEGOVY.

In a pediatric clinical trial, rash was reported in 3% of WEGOVY-treated patients and 0% of placebo-treated patients, and urticaria was reported in 3% of WEGOVY-treated patients and 0% of placebo-treated patients. In adult clinical trials, allergic reactions occurred in 8/50 (16%) of WEGOVY-treated patients with anti- semaglutide antibodies and in 114/1659 (7%) of WEGOVY-treated patients who did not develop anti- semaglutide antibodies [see Clinical Pharmacology (12.6)].

Dysgeusia

In clinical trials in adults, 1.7% of WEGOVY-treated patients and 0.5% of placebo-treated patients reported dysgeusia.

…

8 Use in Specific Populations

(Additions and/or revisions underlined)

Pregnancy

WEGOVY may cause fetal harm. Advise patients to inform their healthcare provider of a known or suspected pregnancy. Advise patients who are exposed to WEGOVY during pregnancy to contact Novo Nordisk at 1-877- 390-2760 or www.wegovypregnancyregistry.com [see Use in Specific Populations (8.1)].

17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)

17 PATIENT COUNSELING INFORMATION

(Additions and/or revisions underlined)

Pregnancy

WEGOVY may cause fetal harm. Advise patients to inform their healthcare provider of a known or suspected pregnancy. Advise patients who are exposed to WEGOVY during pregnancy to contact Novo Nordisk at 1-877- 390-2760 or www.wegovypregnancyregistry.com [see Use in Specific Populations (8.1)].

12/23/2022 (SUPPL-5)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.3 Acute Gallbladder Disease

Additions and revisions underlined:

Treatment with WEGOVY was associated with an increased occurrence of cholelithiasis and cholecystitis. The incidence of cholelithiasis and cholecystitis was higher in WEGOVY-treated pediatric patients aged 12 years and older than in WEGOVY-treated adults. In randomized clinical trials in adult patients, 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 adult patients and 0.2% of placebo-treated patients. In a clinical trial in pediatric patients aged 12 years and older, cholelithiasis was reported by 3.8% of WEGOVY-treated patients and 0% placebo-treated patients. Cholecystitis was reported by 0.8% of WEGOVY-treated pediatric patients and 0% placebo-treated patients [see Adverse Reactions (6.1)].

5.4 Hypoglycemia

Additions and revisions underlined:

WEGOVY lowers blood glucose and can cause hypoglycemia.

In a trial of adult patients with type 2 diabetes and BMI greater than or equal to 27 kg/m2, 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. One episode of severe hypoglycemia (requiring the assistance of another person) was reported in one WEGOVY-treated patient versus no placebo-treated patients.

5.7 Diabetic Retinopathy Complications in Patients with Type 2 Diabetes

Additions and revisions underlined:

In a trial of adult patients with type 2 diabetes and BMI greater than or equal to 27 kg/m2, diabetic retinopathy was reported by 4.0% of WEGOVY-treated patients and 2.7% placebo-treated patients [see Adverse Reactions (6.1)].

In a 2-year trial with semaglutide 0.5 mg and 1 mg once-weekly injection in adult patients with type 2 diabetes and high cardiovascular risk, diabetic retinopathy complications (which was a 4-component adjudicated endpoint) occurred in patients treated with semaglutide injection (3.0%) compared to placebo (1.8%).

5.8 Heart Rate Increase

Additions and revisions underlined:

Treatment with WEGOVY was associated with increases in resting heart rate. Mean increases in resting heart rate of 1 to 4 beats per minute (bpm) were observed in WEGOVY-treated adult patients compared to placebo in clinical trials. More adult 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). In a clinical trial in pediatric patients aged 12 years and older with normal baseline heart rate, more patients treated with WEGOVY compared to placebo had maximum changes in heart rate of 20 bpm or more (54% versus 39%) [see Adverse Reactions (6.1)].

6 Adverse Reactions

6.1 Clinical Trials Experience

Extensive changes related to new indication for patients aged 12 years and older; please refer to label

8 Use in Specific Populations

8.4 Pediatric Use

Extensive changes; please refer to label

8.5 Geriatric Use

Additions and revisions underlined:

In the WEGOVY clinical trials, 233 (9%) WEGOVY-treated patients were between 65 and 75 years of age and 23 (1%) WEGOVY-treated patients were 75 years of age and over [see Clinical Studies (14.1)]. No overall differences in safety or effectiveness have been observed between patients 65 years of age and older and younger adult patients.

17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)

Medication Guide

Additions and revisions underlined:

What is WEGOVY?

WEGOVY is an injectable prescription medicine that may help adults and children aged 12 years and older with obesity, or some adults with excess weight (overweight) who also have weight-related medical problems to help them lose weight and keep the weight off.

It is not known if WEGOVY is safe and effective for use in children under 12 years of age.

The most common side effects of WEGOVY in adults or children aged 12 years and older may include:

• nausea                 ·     stomach (abdomen) pain       ·     dizziness                             ·     stomach flu

• diarrhea                 ·     headache                             ·     feeling bloated                 ·     heartburn

• vomiting               ·     tiredness (fatigue)                 ·     belching                             ·     runny nose or sore throat

• constipation           ·     upset stomach                     ·     gas