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/0.5 mL 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 is an injectable prescription medicine that works by directly activating GIP and GLP-1 pathways to help regulate blood sugar. It is not known if MOUNJARO is safe and effective for use in children under 10 years of age.

MOUNJARO is a GLP-1 receptor agonist used in the management of type 2 diabetes mellitus and related conditions. It is indicated for:

- Type 2 diabetes mellitus: 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. - Cardiovascular risk reduction: To reduce the risk of major adverse cardiovascular events (CV death, non-fatal myocardial infarction, or non-fatal stroke) 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, including weight loss and weight maintenance, in adults with an initial Body Mass Index (BMI) of 30 kg/m² or greater, or 27 kg/m² to < 30 kg/m² in the presence of at least one weight-related comorbid condition.

MOUNJARO may cause various side effects, ranging from common to serious or rare. Common Side Effects:

- Nausea - Diarrhea - Decreased appetite - Vomiting - Constipation - Indigestion - Stomach (abdominal) pain

Serious or Rare Side Effects:

- Acute pancreatitis: Discontinue if suspected. - Hypoglycemia: Increased risk when used with insulin secretagogues or insulin. - Hypersensitivity reactions: Serious reactions such as anaphylaxis and angioedema have been reported. - 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 complications: Monitor patients with a history of diabetic retinopathy for progression. - Acute gallbladder disease: Gallbladder studies and clinical follow-up are indicated if cholelithiasis is suspected.

MOUNJARO should be used with caution and certain precautions should be observed. Acute pancreatitis: Discontinue if suspected. Hypoglycemia: Concomitant use with an insulin secretagogue or insulin may increase the risk of hypoglycemia, including severe hypoglycemia. Reducing dose of insulin secretagogue or insulin may be necessary. Hypersensitivity reactions: Serious hypersensitivity reactions (e.g., anaphylaxis and angioedema) have been reported. Discontinue MOUNJARO if suspected and promptly seek medical advice. Acute kidney injury: Monitor renal function in patients reporting adverse reactions that could lead to volume depletion. Severe gastrointestinal adverse reactions: Use has been associated with gastrointestinal adverse reactions, sometimes severe. MOUNJARO is not recommended in patients with severe gastroparesis. Store at 2-8°C: Keep refrigerated, protect from light, do not freeze or shake.

MOUNJARO may interact with other medications, potentially affecting its efficacy or increasing the risk of adverse effects. Major Interactions (Avoid):

- Insulin secretagogues: Concomitant use may increase the risk of hypoglycemia. - Insulin: Concomitant use may increase the risk of hypoglycemia.

Moderate Interactions (Monitor Closely):

- Oral medications: MOUNJARO delays gastric emptying and has the potential to impact the absorption of concomitantly administered oral medications. Caution should be exercised when oral medications are concomitantly administered with MOUNJARO. - Other GLP-1 receptor agonists: Monitor for increased risk of gastrointestinal side effects. - Other medications affecting gastrointestinal motility: Monitor for increased risk of gastrointestinal side effects.