Zepbound® (tirzepatide) 10 mg/0.5 mL Prefilled Pens (4)

Product Description: Zepbound® (tirzepatide)

Zepbound® (tirzepatide) is an 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).

Specifications: 10 mg/0.5 mL

• Active Ingredient: Tirzepatide.

• Dosage Strength: 10 mg per 0.5 mL solution.

• Administration: Subcutaneous injection (typically administered once weekly).

• Mechanism of Action: Tirzepatide is a dual glucose-dependent insulinotropic polypeptide (GIP) receptor and glucagon-like peptide-1 (GLP-1) receptor agonist. It acts by mimicking the effects of incretin hormones, which regulate appetite and caloric intake by increasing feelings of satiety and slowing gastric emptying.

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 Contraindications & Warnings

• Contraindications: Patients with a personal or family history of MTC or MEN 2; patients with a known serious hypersensitivity to tirzepatide or any of the excipients in Zepbound.

• Pancreatitis: Discontinue use if pancreatitis is suspected.

• Hypoglycemia: Risk may be increased when used in combination with insulin or insulin secretagogues.

• Gallbladder Disease: Acute events of gallbladder disease (e.g., cholelithiasis or cholecystitis) have been reported.

• Gastrointestinal Disease: Use is not recommended in patients with severe gastrointestinal disease, including severe gastroparesis.

Common Adverse Reactions

The most common adverse reactions reported in clinical trials (typically $\ge 5\%$) include:

• Nausea

• Diarrhea

• Vomiting

• Constipation

• Abdominal pain

• Dyspepsia

• Injection site reactions

• Fatigue

• Hypersensitivity reactions

• Eructation (belching)

• Hair loss (alopecia)

• Gastroesophageal reflux disease (GERD)

Disclaimer: This information is for professional informational purposes only and does not constitute medical advice, diagnosis, or treatment. Always refer to the official FDA-approved Full Prescribing Information (including the Medication Guide) for comprehensive clinical data and safety instructions.