Mounjaro 2.5 mg/.5mL (Tirzepatide) 2.5 mg/0.5 mL Injection, solution

Tirzepatide, the active ingredient in MOUNJARO 2.5 mg/0.5mL, is a glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist presented as a 2.5 mg/0.5mL injection, solution for subcutaneous use. It is indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus.

GNH USA supplies MOUNJARO 2.5 mg/0.5mL as a licensed, GDP-compliant international pharmaceutical supplier serving hospitals, pharmacies, and clinics worldwide.

MOUNJARO 2.5 mg/0.5mL is a GLP-1 receptor agonist used in the management of type 2 diabetes mellitus.

- Type 2 diabetes mellitus: Improves glycemic control in adults and pediatric patients 10 years of age and older as an adjunct to diet and exercise. - Weight management: As an adjunct to a reduced-calorie diet and increased physical activity for weight management in adults with an initial Body Mass Index (BMI) of 30 kg/m² or greater (obesity) or 27 kg/m² to < 30 kg/m² (overweight) in the presence of at least one weight-related comorbid condition.

MOUNJARO 2.5 mg/0.5mL may cause side effects, ranging from common to serious.

Common Side Effects: - Nausea - Diarrhea - Decreased appetite - Vomiting - Constipation - Indigestion - Abdominal pain - Dizziness

Serious or Rare Side Effects: - Acute pancreatitis - Hypoglycemia when used with insulin secretagogues or insulin - Hypersensitivity reactions, including anaphylaxis and angioedema - Acute kidney injury due to volume depletion - Severe gastrointestinal adverse reactions - Diabetic retinopathy complications in patients with a history of diabetic retinopathy - Acute gallbladder disease

MOUNJARO 2.5 mg/0.5mL should be used with caution and certain precautions should be observed.

- Pancreatitis: Discontinue if pancreatitis is suspected. - Hypoglycemia: Monitor blood glucose levels when used with insulin secretagogues or insulin. - Hypersensitivity: Discontinue if serious hypersensitivity reactions occur. - Renal function: Monitor in patients reporting adverse reactions that could lead to volume depletion. - Gastrointestinal conditions: Not recommended in patients with severe gastroparesis. - Diabetic retinopathy: Monitor patients with a history of diabetic retinopathy for progression. - Store at 2-8°C: Keep refrigerated, protect from light, do not freeze or shake.

MOUNJARO 2.5 mg/0.5mL may interact with other medications, requiring careful monitoring.

Major Interactions (Avoid): - Insulin secretagogues: Increased risk of hypoglycemia. - Insulin: Increased risk of hypoglycemia.

Moderate Interactions (Monitor Closely): - Oral medications: MOUNJARO delays gastric emptying and may impact the absorption of concomitantly administered oral medications. - Other GLP-1 receptor agonists: Potential for additive gastrointestinal side effects. - Other medications affecting gastrointestinal motility: Potential for additive gastrointestinal side effects.