Mounjaro 10 mg/.5mL (Tirzepatide) 10 mg/0.5 mL Injection, solution

Tirzepatide, the active ingredient in MOUNJARO 10 mg/0.5mL, is a glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist presented as a 10 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 10 mg/0.5mL as a licensed, GDP-compliant international pharmaceutical supplier serving hospitals, pharmacies, and clinics worldwide.

MOUNJARO 10 mg/0.5mL is indicated for the management of type 2 diabetes mellitus through its action on GIP and GLP-1 pathways.

- 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 10 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

MOUNJARO 10 mg/0.5mL should be used with caution and certain precautions should be observed.

- Acute Pancreatitis: Discontinue if suspected. - Hypoglycemia: Monitor closely when used with insulin secretagogues or insulin. - Hypersensitivity Reactions: Discontinue if suspected and seek medical advice. - 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. - Store at 2-8°C: Keep refrigerated, protect from light, do not freeze or shake.

MOUNJARO 10 mg/0.5mL may interact with other medications, requiring careful monitoring or avoidance.

Major Interactions (Avoid): - Oral Contraceptives: Advise females to switch to a non-oral contraceptive method or add a barrier method of contraception for 4 weeks after initiation and for 4 weeks after each dose escalation.

Moderate Interactions (Monitor Closely): - Oral Medications: MOUNJARO delays gastric emptying and has the potential to impact the absorption of concomitantly administered oral medications. - Insulin Secretagogues or Insulin: Concomitant use may increase the risk of hypoglycemia, including severe hypoglycemia. Reducing dose of insulin secretagogue or insulin may be necessary.