Mounjaro 12.5 mg/0.5 mL pre-filled single-dose pen

Mounjaro 12.5 mg/0.5 mL pre-filled single-dose pen

Mounjaro® (tirzepatide) is a once-weekly injectable medication indicated for the treatment of adults with type 2 diabetes mellitus, used to improve glycemic control as an adjunct to diet and exercise. It is also being investigated and prescribed off-label for weight management in some cases, under medical supervision.

Dosage Strength

12.5 mg/0.5 mL solution in a pre-filled, single-dose pen. Administered subcutaneously once weekly, on the same day each week

Mechanism of Action

Tirzepatide is a first-in-class dual GIP (glucose-dependent insulinotropic polypeptide) and GLP-1 (glucagon-like peptide-1) receptor agonist. It mimics the effects of these natural incretin hormones to:

Enhance insulin secretion in a glucose-dependent manner. Suppress glucagon secretion. Slow gastric emptying. Reduce appetite and food intake. This dual agonist action provides a synergistic approach to glucose control and weight reduction.

Indications

Mounjaro® is FDA-approved for:

• Adults with type 2 diabetes mellitus to improve blood sugar levels in combination with diet and exercise

Note: Not for use in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis.

 

Administration Instructions

Inject subcutaneously into the abdomen, thigh, or upper arm. Rotate injection sites weekly. The pen is pre-filled and ready to use; do not mix with insulin in the same injection. Store in a refrigerator (36°F to 46°F); may be stored at room temperature (up to 86°F) for up to 21 days.

Important Safety Information

Contraindications:

• Personal or family history of medullary thyroid carcinoma (MTC)

• Patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)

• Known hypersensitivity to tirzepatide or any of its components

Warnings and Precautions:

 

• Risk of thyroid C-cell tumors—monitor for symptoms such as neck mass, dysphagia, or hoarseness

• Hypoglycemia, particularly when used with sulfonylureas or insulin

• Gastrointestinal side effects (nausea, vomiting, diarrhea) are common, particularly during dose escalation

• Pancreatitis, gallbladder disease, and acute kidney injury have been reported

• Not recommended during pregnancy or breastfeeding

Common Side Effects

Nausea, Diarrhea, Decreased appetite, Vomiting, Constipation, Abdominal pain

Titration Schedule (if starting from a lower dose)

Initial dose: 2.5 mg once weekly for 4 weeks,Increase to 5 mg, then titrate every 4 weeks to 7.5 mg, 10 mg, and then to 12.5 mg as needed, 12.5 mg is an intermediate dose; maximum dose available is 15 mg, Patient Counseling Tips, Administer on the same day each week, with or without meals, Educate patients on recognizing signs of hypoglycemia, Advise patients to notify healthcare provider of severe GI symptoms or signs of thyroid tumors, Inform patients that weight loss may occur as part of the treatment