Zepbound® (tirzepatide) KwikPen 12.5 mg/0.6 mL

Product Description: Zepbound® (tirzepatide) KwikPen 12.5 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 12.5 mg/0.6 mL KwikPen is a high-potency multi-dose delivery system, typically reserved for patients who have reached this advanced titration stage to further their progress toward their weight loss and metabolic targets.

Product Specifications

• Dosage Strength: 12.5 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 glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptors. It modulates metabolic pathways to induce satiety, delay gastric emptying, and significantly decrease caloric intake.

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 this advanced dosage, patients may experience an increased intensity of gastrointestinal adverse events (e.g., severe nausea, vomiting, or diarrhea). Close clinical monitoring for signs of dehydration is recommended.

• Device Safety: As a multi-dose device, users must attach a new, sterile needle for every weekly injection and prime the pen as instructed to ensure accurate dosage delivery.

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

• Hypoglycemia: There is an elevated risk of hypoglycemia when used concurrently with insulin or insulin secretagogues; healthcare providers should monitor patients and adjust concurrent medications as needed.

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 (up to 86°F or 30°C) for a maximum of 30 days.

• Stability: Store in the original carton to protect from light and heat. Inspect the solution before use; it 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.