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) receptor and glucagon-like peptide-1 (GLP-1) receptor agonist presented as a 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, and to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes mellitus 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 indicated for the treatment of type 2 diabetes mellitus and for reducing the risk of major adverse cardiovascular events in adults with type 2 diabetes mellitus who are at high risk for these events. 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.

- 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.

MOUNJARO 5 mg/0.5mL may cause various side effects, ranging from common to serious or rare. Patients should be aware of these potential adverse reactions and consult their healthcare provider if they experience any concerning symptoms.

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

Serious or Rare Side Effects: - Acute pancreatitis: Discontinue if suspected. - Hypoglycemia with concomitant use of insulin secretagogues or insulin: Reducing dose of insulin secretagogue or insulin may be necessary. - Hypersensitivity reactions: Serious reactions such as anaphylaxis and angioedema have been reported. - Acute kidney injury due to volume depletion: Monitor renal function in patients reporting adverse reactions that could lead to volume depletion. - Severe gastrointestinal adverse reactions: MOUNJARO is not recommended in patients with severe gastroparesis. - Diabetic retinopathy complications: Monitor patients with a history of diabetic retinopathy for progression.

MOUNJARO 5 mg/0.5mL should be used with caution, and certain precautions should be taken to ensure safe and effective treatment. Patients and healthcare providers should be aware of the following precautions and warnings.

- Acute pancreatitis: Discontinue if pancreatitis is suspected. - Hypoglycemia with concomitant use of insulin secretagogues or insulin: Reducing dose of insulin secretagogue or insulin may be necessary. - Hypersensitivity reactions: Discontinue MOUNJARO if suspected and promptly seek medical advice. - Acute kidney injury due to volume depletion: Monitor renal function in patients reporting adverse reactions that could lead to volume depletion. - Severe gastrointestinal adverse reactions: MOUNJARO is not recommended in patients with severe gastroparesis. - Diabetic retinopathy complications: 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 5 mg/0.5mL may interact with other medications, potentially affecting its efficacy or increasing the risk of adverse reactions. Patients and healthcare providers should be aware of these interactions and monitor closely.

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. - Other medications that affect gastrointestinal motility: May increase the risk of gastrointestinal adverse reactions.