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) receptor and glucagon-like peptide-1 (GLP-1) receptor agonist presented as a 2.5 mg/0.5mL injection, solution for subcutaneous use. It is used 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 indicated for the management of type 2 diabetes mellitus and related conditions.

- Type 2 diabetes mellitus: Improves glycemic control in adults and pediatric patients 10 years of age and older. - Cardiovascular risk reduction: Reduces the risk of major adverse cardiovascular events in adults with type 2 diabetes mellitus who are at high risk for these events. - Weight management: As an adjunct to a reduced-calorie diet and increased physical activity for weight management in adults with obesity or overweight with at least one weight-related comorbid condition.

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

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

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.

- Acute pancreatitis: Discontinue if suspected. - Hypoglycemia: Monitor blood glucose levels when used with insulin secretagogues or insulin. - Hypersensitivity reactions: Discontinue if suspected and seek medical advice promptly. - Acute kidney injury: Monitor renal function in patients reporting adverse reactions that could lead to volume depletion. - Severe gastrointestinal adverse reactions: 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.