Zepbound® (tirzepatide) KwikPen 5 mg/0.6 mL

Product Description: Zepbound® (tirzepatide) KwikPen 5 mg/0.6 mL

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 5 mg/0.6 mL KwikPen is a multi-dose pre-filled delivery system, typically serving as the first therapeutic maintenance dose following the initial 4-week titration period.

Product Specifications

• Dosage Strength: 5 mg per 0.6 mL.

• Presentation: KwikPen (Multi-dose pre-filled delivery system).

• 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: Functions as a dual GIP and GLP-1 receptor agonist, modulating metabolic signaling to increase feelings of satiety and decrease caloric intake.

Important Safety Information

WARNING: RISK OF THYROID C-CELL TUMORS

Tirzepatide has been shown to cause thyroid C-cell tumors in rodents. It is unknown if 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

• Titration Status: While 2.5 mg is the starting dose, 5 mg is the first established maintenance level. Healthcare providers should assess gastrointestinal tolerance (e.g., nausea, vomiting, diarrhea) during this transition.

• Device Use: The KwikPen requires the patient to attach a new, sterile needle for every injection. Training on proper needle attachment, pen priming, and site rotation is essential for accurate delivery.

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

• Hypoglycemia: Risk is increased when used concomitantly with insulin or insulin secretagogues; clinicians should evaluate the need for concurrent medication dose reduction.

Storage and Handling

• Before First Use: Store in the refrigerator at 36°F to 46°F (2°C to 8°C). Do not freeze.

• After First Use: The pen may be stored at room temperature (not exceeding 86°F or 30°C) for up to 30 days.

• Handling: Keep away from direct heat and light. Inspect the solution before use; it should be a clear, colorless to slightly yellow liquid, free of visible particles.

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