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

MOUNJARO 5 mg/0.5mL is a medication that acts on the GIP and GLP-1 pathways to help regulate blood sugar levels. 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 as an adjunct to diet and exercise.
• Cardiovascular risk reduction: Reduces the risk of major adverse cardiovascular events in adults with type 2 diabetes who are at high risk for these events.

• Tirzepatide, the active ingredient in MOUNJARO, is a dual glucose-dependent insulinotropic polypeptide (GIP) 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 5 mg/0.5mL can cause various side effects, ranging from common to serious or rare.

Common Side Effects

• Nausea
• Diarrhea
• Decreased appetite
• Vomiting
• Constipation
• Indigestion
• Abdominal pain

Serious or Rare Side Effects

• Acute pancreatitis: Discontinue if suspected.
• Hypoglycemia: Increased risk when used with insulin secretagogues or insulin.
• Hypersensitivity reactions: Serious reactions such as anaphylaxis and angioedema have been reported.
• 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.

MOUNJARO 5 mg/0.5mL should be used with caution and certain precautions should be observed.

• Administration: Administer subcutaneously in the abdomen, thigh, or back of the upper arm; rotate injection sites with each dose.
• Monitoring: Regularly monitor blood glucose levels, especially when used with insulin secretagogues or insulin.
• Anesthesia: Inform healthcare providers of MOUNJARO use before surgeries or procedures involving anesthesia or deep sedation.
• Gallbladder disease: Clinical follow-up is indicated if cholelithiasis is suspected.
• Diabetic retinopathy: Monitor patients with a history of diabetic retinopathy for progression.
• Storage: Store MOUNJARO in the refrigerator between 36°F to 46°F (2°C to 8°C). If needed, each single-dose pen or single-dose vial can be stored at room temperature up to 86°F (30°C) for up to 21 days. Do not freeze MOUNJARO. Store in the original carton to protect from light.

MOUNJARO 5 mg/0.5mL can interact with other medications, which may require dose adjustments or close monitoring.

Major Interactions (Avoid)

• Insulin secretagogues: Increased risk of hypoglycemia; consider reducing the dose of the insulin secretagogue.
• Insulin: Increased risk of hypoglycemia; consider reducing the dose of insulin.

Moderate Interactions (Monitor Closely)

• Oral medications: MOUNJARO delays gastric emptying and may impact the absorption of concomitantly administered oral medications.
• Sulfonylureas: Increased risk of hypoglycemia; monitor blood glucose levels closely.