Clinical Information
Gen. Code and Des.
82355 semaglutide SUBCUT PEN INJCTR 0.25MG/0.5
GCN and Des.
49748 semaglutide SUBCUT PEN INJCTR 0.25MG/0.5
Strength
0.25MG
Dose Form
PEN INJECTOR (ML)
Product Category
RX Pharmaceuticals
Fine Line Class
850085008510 All Rx Products
DEA Class
NC
OMP Family
AHFS Class
68200600 INCRETIN MIMETICS
Active Ingredients
17424 semaglutide 910463682
These highlights do not include all the information needed to use WEGOVY® safely and effectively. See full prescribing information for WEGOVY.
WEGOVY (semaglutide) injection, for subcutaneous use
Initial U.S. Approval: 2017
WARNING: RISK OF THYROID C-CELL TUMORS
See full prescribing information for complete boxed warning.
•
In rodents, semaglutide causes thyroid C-cell tumors at 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 (5.1, 13.1).
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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 (4, 5.1).
RECENT MAJOR CHANGES
Indications and Usage (1) 12/2022
Dosage and Administration (2.1, 2.3) 12/2022
Warnings and Precautions (5.3, 5.6,5.8) 12/2022
INDICATIONS AND USAGE
WEGOVY is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to a reduced calorie diet and increased physical activity for chronic weight management in:
•
adult patients with an initial body mass index (BMI) of
o
30 kg/m2 or greater (obesity) or
o
27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid condition (e.g., hypertension, type 2 diabetes mellitus, or dyslipidemia) (1).
•
pediatric patients aged 12 years and older with an initial BMI at the 95th percentile or greater for age and sex (obesity) (1).
Limitations of Use:
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WEGOVY should not be used in combination with other semaglutide-containing products or any other GLP-1 receptor agonist (1).
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The safety and efficacy of coadministration with other products for weight loss have not been established (1).
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WEGOVY has not been studied in patients with a history of pancreatitis (1).
DOSAGE AND ADMINISTRATION
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Administer WEGOVY once weekly, on the same day each week, at any time of day, with or without meals (2.2).
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Inject subcutaneously in the abdomen, thigh or upper arm (2.2).
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In patients with type 2 diabetes, monitor blood glucose prior to starting and during WEGOVY treatment (2.2).
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Initiate at 0.25 mg once weekly for 4 weeks. In 4 week intervals, increase the dose until a dose of 2.4 mg is reached (2.3).
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The maintenance dose of WEGOVY is 2.4 mg once weekly (2.3).
DOSAGE FORMS AND STRENGTHS
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Injection: pre-filled, single-dose pen that delivers doses of 0.25 mg, 0.5 mg, 1 mg, 1.7 mg or 2.4 mg (3).
CONTRAINDICATIONS
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Personal or family history of medullary thyroid carcinoma or in patients with Multiple Endocrine Neoplasia syndrome type 2 (4, 5.1).
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Known hypersensitivity to semaglutide or any of the excipients in WEGOVY (4).
WARNINGS AND PRECAUTIONS
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Thyroid C-cell Tumors: See Boxed Warning (5.1).
•
Acute Pancreatitis: Has occurred in clinical trials. Discontinue promptly if pancreatitis is suspected. Do not restart if pancreatitis is confirmed (5.2).
•
Acute Gallbladder Disease: Has occurred in clinical trials. If cholelithiasis is suspected, gallbladder studies and clinical follow-up are indicated (5.3).
•
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 (5.4, 7.1).
•
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 (5.5).
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Hypersensitivity Reactions: Anaphylactic reactions and angioedema have been reported postmarketing. Discontinue WEGOVY if suspected and promptly seek medical advice (5.6).
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Diabetic Retinopathy Complications in Patients with Type 2 Diabetes: Has been reported in trials with semaglutide. Patients with a history of diabetic retinopathy should be monitored (5.7).
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Heart Rate Increase: Monitor heart rate at regular intervals (5.8).
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Suicidal Behavior and Ideation: Monitor for depression or suicidal thoughts. Discontinue WEGOVY if symptoms develop (5.9).
ADVERSE REACTIONS
Most common adverse reactions (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, and gastroesophageal reflux disease, and nasopharyngitis (6.1).
To report SUSPECTED ADVERSE REACTIONS, contact Novo Nordisk Inc., at 1-833-934-6891 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
WEGOVY delays gastric emptying. May impact absorption of concomitantly administered oral medications. Use with caution (7.2).
USE IN SPECIFIC POPULATIONS
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Pregnancy: May cause fetal harm. When pregnancy is recognized, discontinue WEGOVY (8.1).
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Females and Males of Reproductive Potential: Discontinue WEGOVY at least 2 months before a planned pregnancy because of the long half-life of semaglutide (8.3).
See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.
Revised: 12/2022
