MOUNJARO 7.5 mg/.5mL (Tirzepatide INJECTION, SOLUTION) 7.5 mg/.5mL

MOUNJARO 7.5 mg/0.5mL is a medication used in the management of type 2 diabetes mellitus. It is designed to improve glycemic control and reduce the risk of major adverse cardiovascular events in patients with type 2 diabetes who are at high risk for these events.

• 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 (CV death, non-fatal myocardial infarction, or non-fatal stroke) in adults with type 2 diabetes mellitus who are at high risk for these events.

• Tirzepatide, the active ingredient in MOUNJARO, is a dual glucose-dependent insulinotropic polypeptide (GIP) receptor and glucagon-like peptide-1 (GLP-1) receptor agonist. It enhances first- and second-phase insulin secretion and reduces glucagon levels in a glucose-dependent manner. This action helps to lower fasting and postprandial glucose concentrations, decrease food intake, and reduce body weight in patients with type 2 diabetes mellitus.

MOUNJARO 7.5 mg/0.5mL may cause various side effects, ranging from common to serious. It is important to be aware of these potential effects when using this medication.

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

MOUNJARO 7.5 mg/0.5mL should be used with caution, and certain precautions should be observed to ensure safe and effective treatment. Patients and healthcare providers should be aware of the following:

• Acute Pancreatitis: Discontinue MOUNJARO if pancreatitis is suspected.
• Hypoglycemia: Concomitant use with an insulin secretagogue or insulin may increase the risk of hypoglycemia; dose adjustment may be necessary.
• Hypersensitivity Reactions: Discontinue MOUNJARO if a serious hypersensitivity reaction occurs 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: MOUNJARO is 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 7.5 mg/0.5mL may interact with other medications, potentially affecting its efficacy or increasing the risk of adverse effects. It is important to be aware of these interactions when using this medication.

Major Interactions (Avoid)

• Insulin Secretagogues: Concomitant use may increase the risk of hypoglycemia; dose adjustment may be necessary.
• Insulin: Concomitant use may increase the risk of hypoglycemia; dose adjustment may be necessary.

Moderate Interactions (Monitor Closely)

• Oral Medications: MOUNJARO delays gastric emptying and has the potential to impact the absorption of concomitantly administered oral medications; caution should be exercised.
• Other GLP-1 Receptor Agonists: Concomitant use may increase the risk of gastrointestinal adverse reactions; monitor closely.