WEGOVY® (semaglutide) is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to 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
- Adults with overweight in the presence of at least one weight-related comorbid condition.
Limitations of Use:
- Co-administration with other semaglutide-containing products or any GLP-1 receptor agonist is not recommended.
- The safety and efficacy of coadministration with other products for weight management have not been established.
- 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 a higher risk for development of pancreatitis on WEGOVY®.
IMPORTANT SAFETY INFORMATION
WARNING: RISK OF THYROID C-CELL TUMORS
See full prescribing information for complete boxed warning.
- In rodents, semaglutide causes thyroid C-cell tumors in clinically relevant exposures. It is unknown whether WEGOVY® causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans as the human relevance of semaglutide-induced rodent thyroid C-cell tumors has not been determined
- WEGOVY® 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 of MTC and symptoms of thyroid tumors.
Do not take WEGOVY® if you:
- Have a personal or family history of medullary thyroid carcinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN2).
- Have been diagnosed with Diabetes (Type 1)
- Have been diagnosed with pancreatitis or history of pancreatitis
- Have severe problems with your stomach, such as slowed emptying of your stomach (gastroparesis) or problems with digesting food
- Have a known allergy to semaglutide/any other GLP-1 drug or any of the inactive ingredients in WEGOVY®. Inactive ingredients include: di-sodium phosphate dihydrate, sodium chloride, water for injection, and hydrochloric acid or sodium hydroxide may be added to adjust pH.
- Have a history of suicidal attempts or active suicidal ideation
WARNINGS AND PRECAUTIONS
- Acute Pancreatitis: Has occurred in clinical trials. Discontinue promptly if pancreatitis is suspected. Do not restart if pancreatitis is confirmed.
- Acute Gallbladder Disease: Has occurred in clinical trials. If cholelithiasis is suspected, gallbladder studies and clinical follow-up are indicated.
- Hypoglycemia: Concomitant use with an insulin secretagogue or insulin may increase the risk of hypoglycemia, including severe hypoglycemia. Reducing the dose of insulin secretagogue or insulin may be necessary. Inform all patients of the risk of hypoglycemia and educate them on the signs and symptoms of hypoglycemia.
- Acute Kidney Injury: Has occurred. Monitor renal function when initiating or escalating doses of WEGOVY® in patients reporting severe adverse gastrointestinal reactions or in those with renal impairment reporting severe adverse gastrointestinal reactions.
- Hypersensitivity Reactions: Anaphylactic reactions and angioedema have been reported postmarketing. Discontinue WEGOVY® if suspected and promptly seek medical advice.
- Females and males of reproductive potential: Discontinue WEGOVY® at least 2 months before a planned pregnancy because of the long half-life of semaglutide.
- Pregnancy: May cause fetal harm. When pregnancy is recognized, discontinue WEGOVY® immediately.
- Diabetic Retinopathy Complications in Patients with Type 2 Diabetes: Has been reported in trials with WEGOVY®. Patients with a history of diabetic retinopathy should be monitored.
- Heart Rate Increase: Monitor heart rate at regular intervals.
- Suicidal Behavior and Ideation: Monitor for depression or suicidal thoughts. Discontinue WEGOVY® if symptoms develop.
Side Effects
Most common side effects (incidence ≥ 5%) in adults or pediatric patients aged 12 years and older are: nausea, diarrhea, vomiting, constipation, abdominal pain, headache, fatigue, dyspepsia, dizziness, abdominal distension, eructation, hypoglycemia in patients with type 2 diabetes, flatulence, gastroenteritis, gastroesophageal reflux disease, and nasopharyngitis.
To report SUSPECTED ADVERSE REACTIONS, contact the FDA at 1-800-FDA-1088 or
www.fda.gov/medwatchDRUG INTERACTIONS
WEGOVY® delays gastric emptying. May impact absorption of concomitantly administered oral medications. Use with caution.
USE IN SPECIFIC POPULATIONS
- Pregnancy: May cause fetal harm. When pregnancy is recognized, discontinue WEGOVY®.
- Females and Males of Reproductive Potential: Discontinue WEGOVY® at least 2 months before a planned pregnancy because of the long half-life of semaglutide.