WEGOVY- semaglutide injection, solution
WARNING: RISK OF THYROID C-CELL TUMORS
- In rodents, semaglutide causes dose-dependent and treatment-duration-dependent 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 human relevance of semaglutide-induced rodent thyroid C-cell tumors has not been determined [see Warnings and Precautions (5.1) and Nonclinical Toxicology (13.1)].
- 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) [see Contraindications (4)]. Counsel patients regarding the potential risk for MTC with the use of WEGOVY and inform them of symptoms of thyroid tumors (e.g. a mass in the neck, dysphagia, dyspnea, persistent hoarseness). Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with WEGOVY [see Contraindications (4) and Warnings and Precautions (5.1)].
1 INDICATIONS AND USAGE
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 [see Dosage and Administration (2.1)]:
- 30 kg/m2 or greater (obesity) or
- 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)
- pediatric patients aged 12 years and older with an initial BMI at the 95th percentile or greater standardized for age and sex (obesity) [see Dosage and Administration ( 2.1)]
Limitation of Use
- WEGOVY contains semaglutide and should not be coadministered with other semaglutide-containing products or with any other GLP-1 receptor agonist.
- The safety and effectiveness of WEGOVY in combination with other products intended for weight loss, including prescription drugs, over-the-counter drugs, and herbal preparations, have not been established.
- WEGOVY has not been studied in patients with a history of pancreatitis [see Warnings and Precautions (5.2)].
2 DOSAGE AND ADMINISTRATION
2.1 Patient Selection
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. Table 1 presents a chart for determining BMI based on height and weight. BMI is calculated by dividing weight (in kilograms) by height (in meters) squared.
- Table 1. 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. Table 1 presents a chart for determining BMI based on height and weight. 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.
- Table 2. BMI Cut-offs for Obesity by Sex and Age for Pediatric Patients Aged 12 Years and Older (CDC Criteria)
Body mass index (kg/m2)
at 95% Percentile
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