Zepbound® (tirzepatide) 12.5 mg/0.5 mL Prefilled Pens (4)

Product Description: Zepbound® (tirzepatide) 12.5 mg/0.5 mL

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 in adults with an initial body mass index (BMI) of:

• 30 kg/m² or greater (obesity), or

• 27 kg/m² or greater (overweight) in the presence of at least one weight-related comorbid condition (e.g., hypertension, type 2 diabetes mellitus, or dyslipidemia).

Product Specifications

• Dosage Strength: 12.5 mg per 0.5 mL.

• Presentation: Prefilled Pens.

• Quantity: 4 Single-Dose Prefilled Pens per carton (providing a 28-day supply for once-weekly administration).

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

• Mechanism of Action: A dual agonist of the glucose-dependent insulinotropic polypeptide (GIP) receptor and the glucagon-like peptide-1 (GLP-1) receptor. It modulates metabolic pathways to reduce appetite, increase satiety, and improve glycemic control.

Important Safety Information

WARNING: RISK OF THYROID C-CELL TUMORS In rodents, tirzepatide causes thyroid C-cell tumors. It is unknown whether Zepbound causes thyroid C-cell 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).

Key Clinical Considerations

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

• Gastrointestinal Adverse Reactions: The most common reactions are nausea, diarrhea, vomiting, constipation, abdominal pain, and dyspepsia. These symptoms are often dose-dependent and may occur during dose escalation.

• Acute Gallbladder Disease: Events such as cholelithiasis or cholecystitis have been reported; patients should be monitored for symptoms.

• Hypoglycemia: There is an increased risk of hypoglycemia when used concomitantly with insulin or insulin secretagogues.

• Injection Technique: Patients should be trained on proper rotation of injection sites and the use of the prefilled pen mechanism to ensure accurate dosing.

Storage and Handling

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

• Room Temperature: If necessary, the pen may be kept at room temperature (up to 86°F or 30°C) for up to 21 days.

• Protection: Keep pens in the original carton to protect from light. Do not freeze.

Disclaimer: This information is intended for professional reference only and does not constitute medical advice. Please consult the full FDA-approved Prescribing Information, including the Medication Guide and Instructions for Use, for complete clinical details.