Mounjaro 12.5 mg/.5mL (Tirzepatide) 12.5 mg/0.5 mL Injection, solution

Tirzepatide, the active ingredient in MOUNJARO 12.5 mg/0.5mL, is a glucose-dependent insulinotropic polypeptide (GIP) receptor and glucagon-like peptide-1 (GLP-1) receptor agonist presented as a 12.5 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 12.5 mg/0.5mL as a licensed, GDP-compliant international pharmaceutical supplier serving hospitals, pharmacies, and clinics worldwide.

MOUNJARO 12.5 mg/0.5mL is a GLP-1 receptor agonist used in the management of type 2 diabetes mellitus and related conditions. 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. - 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 12.5 mg/0.5mL may cause various side effects, which can be categorized as common or 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 - Pulmonary aspiration during general anesthesia or deep sedation

MOUNJARO 12.5 mg/0.5mL should be used with caution and certain precautions should be observed. These include:

- Acute Pancreatitis: Discontinue if suspected. - Hypoglycemia: Reduce the dose of insulin secretagogues or insulin if used concomitantly. - 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 12.5 mg/0.5mL may interact with other medications, which can be categorized as major or moderate interactions.

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 may impact the absorption of concomitantly administered oral medications. - Other GLP-1 Receptor Agonists: Monitor for increased risk of adverse effects. - Other GIP Receptor Agonists: Monitor for increased risk of adverse effects.