Zepbound® (tirzepatide) 10 mg/0.5 mL Vial

Product Description: Zepbound® (tirzepatide) 10 mg/0.5 mL Vial

Zepbound® (tirzepatide) is a once-weekly injectable prescription medication used as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management. The 10 mg/0.5 mL dosage is a therapeutic maintenance dose, typically utilized for patients who have successfully transitioned through lower titration steps (2.5 mg, 5 mg, and 7.5 mg) and require this higher strength to achieve or maintain weight loss goals.

Product Specifications

• Dosage Strength: 10 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: A potent dual agonist of the GIP and GLP-1 receptors. It regulates metabolic pathways to promote significant reductions in body weight by slowing gastric emptying and modulating appetite centers in the brain to increase satiety.

Important Safety Information

WARNING: RISK OF THYROID C-CELL TUMORS

Tirzepatide has been shown to cause thyroid C-cell tumors in rodent models. 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

• Dose Escalation & Tolerance: At the 10 mg dosage, clinical monitoring for gastrointestinal adverse reactions (nausea, vomiting, diarrhea, abdominal pain) is critical. Patients should be assessed for signs of dehydration resulting from these side effects.

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

• Preparation: Because this is a vial presentation, patients or caregivers must be trained in the use of sterile, single-use syringes to ensure an accurate 0.5 mL dose is drawn and administered weekly.

• Hypoglycemia: Increased risk exists when used concomitantly with insulin or insulin secretagogues; dose adjustment for these medications may be necessary.

Storage and Handling

• Refrigeration: Keep vials stored 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. The solution should be clear and colorless to slightly yellow; do not use if the solution is cloudy or contains particulate matter.

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.