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BUD: 10/12/2025Additional Information
• Chronic weight management in adults with obesity (BMI =30 kg/m²) or overweight (BMI =27 kg/m²) with weight-related comorbidities.
• Adjunct to diet and exercise for glycemic control in type 2 diabetes mellitus (T2DM).
Note: This is a compounded product and not FDA-approved for these uses.
• Thyroid C-Cell Tumors: Rodent studies show risk; human relevance unknown.
• Pancreatitis: Discontinue if suspected.
• Hypoglycemia: Monitor when used with insulin or sulfonylureas.
• Gastrointestinal Effects: Nausea, vomiting, diarrhea; may lead to dehydration or acute kidney injury.
• Compounding Risks: Potential for dosing errors, contamination, or use of unapproved salt forms (e.g., semaglutide sodium) .
• BMI and weight for weight management.
• HbA1c and blood glucose for T2DM.
• Renal function, electrolytes, and signs of pancreatitis or gallbladder disease.
• Adverse effects related to compounding (e.g., injection site reactions, unexpected side effects) .
DescriptionSemaglutide 2.5mg/ml 3ml (ANVX) is a compounded formulation of semaglutide, a glucagon-like peptide-1 (GLP-1) receptor agonist approved for chronic weight management and type 2 diabetes mellitus (T2DM). This formulation is designed for subcutaneous administration once weekly, mimicking the pharmacokinetic profile of FDA-approved brands like Wegovy® and Ozempic®, though it is not itself FDA-approved. Semaglutide works by enhancing glucose-dependent insulin secretion, suppressing glucagon release, slowing gastric emptying, and promoting satiety through central GLP-1 receptor activation in the hypothalamus, thereby supporting weight loss and glycemic control. Unlike FDA-approved semaglutide products (e.g., Wegovy®, Ozempic®), which are supplied in single-dose pens with precise dosing mechanisms, this compounded formulation may present risks such as dosing inaccuracies, stability concerns, and potential adulteration, as noted in FDA warnings about unapproved semaglutide versions. Healthcare providers should exercise caution when considering compounded semaglutide, ensuring it is reserved for patients whose needs cannot be met by commercially available FDA-approved products and verifying that the compounding pharmacy adheres to state and federal regulations to mitigate risks of contamination, incorrect dosing, or use of non-pharmaceutical grade active ingredients.
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