GLP-1 Semaglutide 10mg (10mg/1mL)

Route: Subcutaneous (SC) injection, once weekly.

Administer as a subcutaneous injection into the abdomen, outer thigh, or upper arm. Rotate injection sites within the same body region each week. Do not inject into the same exact site consecutively. Clean the injection site with an alcohol swab and allow to dry. Do not mix semaglutide with insulin in the same syringe. Do not administer intravenously or intramuscularly. Use a small-gauge needle (27–31G) with a precision dosing syringe. Discard any unused portion appropriately; do not pool between vials.

All dosing is prescriber-determined based on indication (glycemic management vs. weight management), patient tolerance, and clinical response. Titration is essential to minimize gastrointestinal adverse effects. Representative titration frameworks used in FDA-approved semaglutide products:

• Starting dose: 0.25 mg once weekly for 4 weeks (tolerability dose).
• Titration: Increase in 0.25–0.5 mg increments every 4 weeks as tolerated toward the therapeutic target dose.
• Therapeutic maintenance range (prescriber-determined): Typically 0.5–2.4 mg weekly depending on indication and tolerance; this vial (10 mg/1 mL) supports multiple weeks of lower-dose use or fewer weeks at higher doses per the prescriber's protocol.
• Final dose, titration schedule, and treatment duration are prescriber-directed. Dose escalation should be paused if GI intolerance occurs.

• Semaglutide: Semaglutide binds and activates the GLP-1 receptor (GLP-1R), a G-protein–coupled receptor coupled to adenylyl cyclase via Gs, increasing intracellular cAMP. Pancreatic β-cell GLP-1R activation enhances glucose-dependent insulin secretion (insulin release only when blood glucose is elevated, reducing hypoglycemia risk) and promotes β-cell proliferation while suppressing glucagon secretion from α-cells. Gastrointestinal GLP-1R activation slows gastric emptying, reducing postprandial glucose excursions. Hypothalamic GLP-1R activation suppresses appetite, reduces food cravings, and enhances satiety signaling. Two key structural modifications give semaglutide its extended half-life (~7 days): (1) a C18 fatty diacid chain promotes reversible albumin binding, prolonging plasma half-life and reducing renal clearance; (2) Aib (α-aminoisobutyric acid) substitution at position 8 shields the molecule from DPP-4 enzyme degradation.

Clinical Context: Semaglutide's FDA-approved indications (in brand-name products) include adjunctive therapy for type 2 diabetes (Ozempic®, Rybelsus®), chronic weight management in adults with obesity or overweight with comorbidities (Wegovy®), and cardiovascular risk reduction in patients with established cardiovascular disease. Prescribers directing compounded semaglutide use it within these evidence-based clinical contexts under patient-specific prescriptions.

Monitoring Considerations:

• Glycemic: Monitor HbA1c, fasting glucose; adjust concomitant insulin or sulfonylurea doses to reduce hypoglycemia risk.
• Weight: Track BMI and body weight at each visit during titration and maintenance.
• Renal: Monitor renal function in patients with pre-existing kidney disease, particularly if GI side effects cause dehydration; acute kidney injury has been reported.
• Thyroid: Counsel patients regarding the FDA black box warning for thyroid C-cell tumors observed in rodent studies; obtain personal and family history of medullary thyroid carcinoma and MEN2 before initiating.
• Retinopathy: Evaluate patients with a history of diabetic retinopathy before initiating; rapid glucose lowering has been associated with worsening retinopathy in some patients.
• GI symptoms: Monitor nausea, vomiting, and diarrhea particularly during titration; dehydration risk is real.

Contraindications:

• Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN 2) syndrome.
• Type 1 diabetes mellitus.
• Known hypersensitivity to semaglutide or any excipient (anaphylaxis and angioedema reported).

Warnings & Precautions:

• Thyroid C-cell tumors (Black Box Warning): Semaglutide caused dose-dependent thyroid C-cell tumors in rodent studies; human relevance is unknown. Contraindicated in patients with personal or family history of MTC or MEN2. Counsel all patients regarding this risk.
• Pancreatitis: cases have been reported; discontinue if pancreatitis is suspected.
• Gallbladder disease: cholelithiasis and cholecystitis reported; monitor for biliary symptoms.
• Acute kidney injury: usually secondary to dehydration from GI side effects; ensure adequate hydration.
• Diabetic retinopathy: monitor patients with retinopathy at baseline; rapid glucose reduction may transiently worsen retinopathy.
• Suicidal ideation: avoid in patients with history of suicidal behavior; monitor for mood changes.
• Rebound weight gain: approximately two-thirds of weight lost is regained within 1 year of discontinuation.

Drug Interactions:

• Insulin and insulin secretagogues (sulfonylureas): increased hypoglycemia risk; reduce insulin/sulfonylurea dose when initiating.
• Oral medications with narrow therapeutic index: semaglutide slows gastric emptying, potentially delaying absorption; monitor drugs such as warfarin, digoxin, thyroid hormones.
• Other GLP-1 receptor agonists or tirzepatide: contraindicated in combination.
• Beta-blockers, MAO inhibitors, quinolones, SSRIs, salicylates: may augment hypoglycemic effects.
• Corticosteroids, thiazide diuretics, furosemide: may attenuate glycemic efficacy.

Common Side Effects: Nausea (very common, up to 44% at therapeutic doses), vomiting, diarrhea, constipation, abdominal pain, decreased appetite, dyspepsia, and dysgeusia. Injection-site reactions (erythema, pain). Fatigue, headache. Hair loss (alopecia) reported with weight-loss protocols.

Store the compounded vial under refrigeration at 2–8°C (36–46°F). Protect from light; store in carton until use. Do not freeze — freezing degrades the peptide. Once punctured, the vial may be stored refrigerated; use within the beyond-use date (BUD) assigned by Genesis Compounding on the prescription label. Allow to reach room temperature for a few minutes before injection for patient comfort. Inspect visually before each use — discard if cloudy, discolored, or particulate matter is present.

How is this compounded semaglutide different from Ozempic® or Wegovy®?

This is a 503A compounded preparation of semaglutide prepared by Genesis Compounding per individual patient prescription. It is not FDA-approved as a compounded drug and has not undergone the FDA's drug approval process. The active ingredient, semaglutide, is the same GLP-1 receptor agonist as in brand-name products, but prescribers must ensure the compounded product is clinically appropriate for each patient.

How do I inject this correctly?

Use a small-gauge needle (27–31G) and inject subcutaneously into the abdomen, outer thigh, or upper arm once weekly. Rotate sites. Do not inject into the same spot each week. Do not mix with insulin in the same syringe. Your prescriber will provide full injection technique guidance.

What should I do if I experience nausea?

Nausea is the most common side effect and typically peaks during dose escalation. Eating smaller meals, eating slowly, avoiding high-fat foods, and staying hydrated can help. Nausea generally improves after the first few weeks at each dose level. Do not escalate the dose while experiencing significant GI side effects — inform your prescriber.

Is there a risk of thyroid cancer?

Semaglutide carries an FDA black box warning regarding thyroid C-cell tumors observed in animal studies. The relevance to humans is unknown. Semaglutide is contraindicated in anyone with a personal or family history of medullary thyroid carcinoma or MEN2. Report any neck mass, dysphagia, or hoarseness to your prescriber promptly.

How should I store this vial?

Refrigerate at 2–8°C. Never freeze. Protect from light. Inspect before each use. Use before the beyond-use date on the label assigned by Genesis Compounding.