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

Tirzepatide, the active ingredient in MOUNJARO 5 mg/0.5mL, is a glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist presented as a 5 mg/0.5mL injection 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, and to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes who are at high risk for these events.

GNH USA supplies MOUNJARO 5 mg/0.5mL as a licensed, GDP-compliant international pharmaceutical supplier serving hospitals, pharmacies, and clinics worldwide.

MOUNJARO 5 mg/0.5mL is a medication that acts on the GIP and GLP-1 pathways to help regulate blood sugar levels. It is indicated for the following uses:

- 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. - Cardiovascular risk reduction: Reduces the risk of major adverse cardiovascular events in adults with type 2 diabetes who are at high risk for these events.

MOUNJARO 5 mg/0.5mL can cause various side effects, ranging from common to serious or rare.

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

MOUNJARO 5 mg/0.5mL should be used with caution and certain precautions should be observed.

- Administration: Administer subcutaneously in the abdomen, thigh, or back of the upper arm; rotate injection sites with each dose. - Monitoring: Regularly monitor blood glucose levels, especially when used with insulin secretagogues or insulin. - Anesthesia: Inform healthcare providers of MOUNJARO use before surgeries or procedures involving anesthesia or deep sedation. - Gallbladder disease: Clinical follow-up is indicated if cholelithiasis is suspected. - Diabetic retinopathy: Monitor patients with a history of diabetic retinopathy for progression. - Storage: Store MOUNJARO in the refrigerator between 36°F to 46°F (2°C to 8°C). If needed, each single-dose pen or single-dose vial can be stored at room temperature up to 86°F (30°C) for up to 21 days. Do not freeze MOUNJARO. Store in the original carton to protect from light.

MOUNJARO 5 mg/0.5mL can interact with other medications, which may require dose adjustments or close monitoring.

Major Interactions (Avoid): - Insulin secretagogues: Increased risk of hypoglycemia; consider reducing the dose of the insulin secretagogue. - Insulin: Increased risk of hypoglycemia; consider reducing the dose of insulin.

Moderate Interactions (Monitor Closely): - Oral medications: MOUNJARO delays gastric emptying and may impact the absorption of concomitantly administered oral medications. - Sulfonylureas: Increased risk of hypoglycemia; monitor blood glucose levels closely.