Zepbound® (tirzepatide) 15 mg/0.5 mL Vial

Product Description: Zepbound® (tirzepatide) 15 mg/0.5 mL Vial

Zepbound® (tirzepatide) is a once-weekly injectable prescription medication indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management. The 15 mg/0.5 mL dosage represents the maximum recommended therapeutic dose for Zepbound, designed for patients who have successfully completed the titration schedule and require this level to achieve their weight loss and metabolic goals.

Product Specifications

• Dosage Strength: 15 mg per 0.5 mL.

• Presentation: Single-dose vial (Requires the use of sterile, single-use syringes and needles for administration).

• Indication: Chronic weight management in adults with an initial BMI of $\ge 30\text{ kg/m}^2$ (obesity) or $\ge 27\text{ kg/m}^2$ (overweight) with at least one weight-related comorbid condition.

• Administration: Subcutaneous injection once weekly in the abdomen, thigh, or upper arm.

• Mechanism of Action: As a potent dual GIP and GLP-1 receptor agonist, tirzepatide modulates metabolic pathways to enhance satiety and decrease appetite, while slowing gastric emptying to support significant, sustained weight reduction.

Important Safety Information

WARNING: RISK OF THYROID C-CELL TUMORS

Tirzepatide has been shown to cause thyroid C-cell tumors in rodent studies. It is unknown whether Zepbound causes these tumors, including medullary thyroid carcinoma (MTC), in humans. Zepbound is contraindicated in patients with a personal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).

Clinical Considerations

• High-Dose Monitoring: At the 15 mg level, the incidence of gastrointestinal adverse events (nausea, vomiting, diarrhea, abdominal pain) may be at its highest. Patients should be monitored for signs of dehydration and nutritional deficiency.

• Contraindications: History of MTC/MEN 2; known serious hypersensitivity to tirzepatide or any product components.

• Preparation: Because this is a vial presentation, precise technique is required. Users must be trained to use a sterile, single-use syringe to withdraw and administer the exact 0.5 mL dose once weekly.

• Hypoglycemia: The risk of hypoglycemia is highest when this dose is combined with insulin or insulin secretagogues. Healthcare providers should review and adjust concurrent diabetes medications accordingly.

Storage and Handling

• Refrigeration: Store at 36°F to 46°F (2°C to 8°C).

• Room Temperature: If necessary, the vial may be stored at room temperature (up to 86°F or 30°C) for a maximum of 21 days.

• Stability: Store in the original carton to protect from light. Do not freeze. Inspect the solution before each use; it should be clear and colorless to slightly yellow. Do not use if the solution is cloudy, discolored, or contains particulates.

Disclaimer: This information is provided for professional reference only and does not constitute medical advice, diagnosis, or treatment. Always refer to the official FDA-approved Prescribing Information, Medication Guide, and Instructions for Use for comprehensive clinical guidance.