Zepbound® (tirzepatide) KwikPen 7.5 mg/0.6 mL

Product Description: Zepbound® (tirzepatide) KwikPen 7.5 mg/0.6 mL

Zepbound® (tirzepatide) is a once-weekly injectable prescription medication indicated for chronic weight management as an adjunct to a reduced-calorie diet and increased physical activity. The 7.5 mg/0.6 mL KwikPen is a multi-dose delivery system intended for patients who have completed at least four weeks at the 5 mg dosage and require further therapeutic escalation to achieve weight loss objectives.

Product Specifications

• Dosage Strength: 7.5 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: A dual agonist of the GIP and GLP-1 receptors that modulates metabolic signaling, slows gastric emptying, and increases satiety to facilitate caloric restriction.

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 & Tolerance: This dose represents a clinical escalation. Healthcare providers should monitor patients for increased gastrointestinal side effects, such as nausea, vomiting, or diarrhea, which may occur as the dosage increases.

• Device Safety: As a multi-dose KwikPen, patients must use a new, sterile needle for every weekly injection and ensure the device is primed correctly according to the “Instructions for Use” provided with the pen.

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

• Hypoglycemia: Risk is elevated in patients also utilizing insulin or secretagogues; monitor blood glucose levels and consider dose adjustments for concurrent medications if necessary.

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.

• Protection: Keep the pen in its original container to protect it from light and excessive heat. Inspect the solution before use; it should be clear and colorless to slightly yellow, and free of 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.