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

MOUNJARO 7.5 mg/0.5mL is indicated for the treatment of type 2 diabetes mellitus and for weight management. 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. It is also used to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes mellitus who are at high risk for these events.

• Type 2 diabetes mellitus: Improves glycemic control as an adjunct to diet and exercise.
• Weight management: Used for weight loss and weight maintenance in adults with obesity or overweight with weight-related comorbid conditions.
• 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.

• Tirzepatide, the active ingredient in MOUNJARO 7.5 mg/0.5mL, is a dual glucose-dependent insulinotropic polypeptide (GIP) receptor and glucagon-like peptide-1 (GLP-1) receptor agonist. It selectively binds to and activates both the GIP and GLP-1 receptors, enhancing first- and second-phase insulin secretion and reducing glucagon levels in a glucose-dependent manner. This mechanism 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 side effects, which can be categorized as common or serious. Common side effects are typically mild and may resolve with continued use, while serious side effects are rare but require immediate medical attention.

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.
• 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: Not recommended in patients with severe gastroparesis.

MOUNJARO 7.5 mg/0.5mL should be used with caution in certain patient populations and conditions. Precautions include monitoring for specific adverse reactions and proper storage to maintain efficacy and safety.

• Acute pancreatitis: Discontinue if pancreatitis is suspected.
• Hypoglycemia: Concomitant use with an insulin secretagogue or insulin may increase the risk of hypoglycemia, including severe hypoglycemia. Reducing the dose of insulin secretagogue or insulin may be necessary.
• Hypersensitivity reactions: Serious hypersensitivity reactions (e.g., anaphylaxis and angioedema) have been reported. Discontinue MOUNJARO 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 7.5 mg/0.5mL may interact with other medications, potentially altering their effectiveness or increasing the risk of adverse reactions. It is important to monitor for these interactions and adjust treatment as necessary.

Major Interactions (Avoid)

• Insulin secretagogues or insulin: Concomitant use may increase the risk of hypoglycemia, including severe hypoglycemia.
• Oral medications: MOUNJARO delays gastric emptying and has the potential to impact the absorption of concomitantly administered oral medications.

Moderate Interactions (Monitor Closely)

• Other GLP-1 receptor agonists: Monitor for increased risk of gastrointestinal adverse reactions.
• Other medications that delay gastric emptying: Monitor for increased risk of gastrointestinal adverse reactions.
• Medications metabolized by CYP enzymes: Monitor for changes in the effectiveness or side effects of these medications.