Mounjaro 15 mg/.5mL (Tirzepatide) 15 mg/0.5 mL Injection, solution

Tirzepatide, the active ingredient in MOUNJARO 15 mg/0.5 mL, is a glucose-dependent insulinotropic polypeptide (GIP) receptor and glucagon-like peptide-1 (GLP-1) receptor agonist presented as a 15 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 15 mg/0.5 mL as a licensed, GDP-compliant international pharmaceutical supplier serving hospitals, pharmacies, and clinics worldwide.

MOUNJARO 15 mg/0.5 mL is indicated for the management of type 2 diabetes mellitus and related metabolic conditions.

- Type 2 diabetes mellitus: Improves glycemic control in adults and pediatric patients 10 years of age and older. - Major adverse cardiovascular events: Reduces the risk of cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke in adults with type 2 diabetes mellitus who are at high risk for these events.

MOUNJARO 15 mg/0.5 mL may cause various side effects, ranging from common to serious.

Common Side Effects: - Nausea - Diarrhea - Decreased appetite - Vomiting - Constipation - Dyspepsia - 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

MOUNJARO 15 mg/0.5 mL should be used with caution in certain patient populations and conditions.

- Acute pancreatitis: Discontinue if suspected. - Hypoglycemia: Concomitant use with insulin secretagogues or insulin may increase the risk of hypoglycemia. - Hypersensitivity reactions: Discontinue 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: Not recommended in patients with severe gastroparesis. - Store at 2-8°C: Keep refrigerated, protect from light, do not freeze or shake.

MOUNJARO 15 mg/0.5 mL may interact with other medications, potentially affecting their absorption or efficacy.

Major Interactions (Avoid): - Oral medications: MOUNJARO delays gastric emptying and has the potential to impact the absorption of concomitantly administered oral medications.

Moderate Interactions (Monitor Closely): - Insulin secretagogues or insulin: Concomitant use may increase the risk of hypoglycemia. - Oral contraceptives: Advise females using oral contraceptives 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.