Mounjaro (Tirzepatide) Information Sheet

Indications for Mounjaro (Tirzepatide)

Mounjaro is indicated for adults with Type 2 diabetes to help improve glycemic control when used alongside proper diet and exercise. It is suitable for use in the following scenarios:

1. Monotherapy: For patients unable to tolerate metformin or for whom metformin is contraindicated.

2. Combination Therapy:

• With metformin.
• With metformin and a sulfonylurea.
• With metformin and an SGLT2 inhibitor.
• With basal insulin, with or without metformin.

Limitations of Use:
Mounjaro is not suitable for treating Type 1 diabetes or diabetic ketoacidosis. It has not been studied for use with short-acting, medium-acting, or dual-action insulin formulations.

Dosage and Administration

The dosing schedule for Mounjaro is straightforward and designed for ease of use:

• Starting Dose: Begin with 2.5 mg once weekly for 4 weeks. This is the initiation phase to allow the body to adjust to the medication.
• Maintenance Dose: After 4 weeks, increase the dose to 5 mg weekly. If additional glycemic control is needed, the dose can be increased in 2.5 mg increments every 4 weeks.
• Maximum Dose: The highest recommended dose is 15 mg once weekly.

Administration Instructions:

• Mounjaro is injected subcutaneously (under the skin) in the abdomen, thigh, or upper arm. Rotate injection sites with each dose to reduce the risk of irritation.
• Inspect the solution before use. It should appear clear to slightly yellow. Do not use if it appears cloudy or contains particles.
• Do not mix Mounjaro with insulin. If used concurrently, administer each medication as a separate injection in different locations.

Missed Dose:
If a dose is missed, it can be administered within 96 hours (4 days). If more than 4 days have passed, skip the missed dose and resume the regular schedule.

Storage and Stability of Mounjaro

Proper storage is essential to maintain the effectiveness of Mounjaro:

• Store in the refrigerator between 2°C to 8°C. Protect from light by keeping it in its original packaging.
• Do not freeze Mounjaro. Discard the medication if it has been frozen.
• For short periods, Mounjaro can be stored at room temperature (below 30°C). Single-dose pens and vials can be kept unrefrigerated for up to 21 days, while the multi-dose KwikPen can be stored for up to 30 days.

Contraindications

Mounjaro should not be used in the following situations:

• Patients with a personal or family history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
• Patients who are pregnant or breastfeeding.
• Individuals with known hypersensitivity to tirzepatide or any ingredients in the formulation.

Mechanism of Action of Mounjaro

Mounjaro works by mimicking two naturally occurring hormones: GIP and GLP-1. These hormones regulate blood sugar levels and appetite in the following ways:

1. Insulin Secretion: Enhances both the first and second phases of insulin release in response to glucose.

2. Glucagon Suppression: Reduces the production of glucagon, a hormone that increases blood sugar levels.

3. Gastric Emptying: Slows the rate at which food leaves the stomach, helping to control blood sugar spikes after meals and promoting a feeling of fullness.

4. Weight Reduction: By reducing appetite, Mounjaro often results in significant weight loss.

Warnings and Precautions

• Thyroid Tumors: Animal studies have shown an increased risk of thyroid C-cell tumors. While it is unknown if this applies to humans, patients should monitor for symptoms such as neck lumps, hoarseness, or difficulty swallowing.
• Pancreatitis: Cases of acute pancreatitis have been observed in clinical trials. Discontinue use if pancreatitis is suspected.
• Hypoglycemia: Using Mounjaro alongside sulfonylureas or insulin may increase the risk of hypoglycemia. Adjust the doses of these medications as needed.
• Gallbladder Disease: Some patients have reported gallbladder-related conditions, such as gallstones. Monitor for symptoms like severe abdominal pain or yellowing of the skin and eyes.
• Contraception: Mounjaro may reduce the effectiveness of oral contraceptives. Alternative or additional contraception methods are recommended.

Adverse Reactions

Common Side Effects:

• Gastrointestinal issues: Nausea, vomiting, diarrhea, and constipation.
• Fatigue and decreased appetite.
• Mild hypoglycemia, particularly when used with insulin.

Serious Side Effects:

• Pancreatitis.
• Severe hypoglycemia when combined with insulin or sulfonylureas.
• Possible thyroid C-cell tumors (rare).

Clinical Efficacy of Mounjaro

Clinical trials have shown that Mounjaro provides substantial benefits for individuals with Type 2 diabetes:

1. Reduction in HbA1c: Patients experienced reductions of up to 2.3% in HbA1c levels over 40 weeks.

2. Weight Loss: Significant weight reductions were observed, with some patients losing up to 7.8 kg.

3. Improved Glycemic Control: Mounjaro effectively lowered fasting and postprandial blood glucose levels.

Drug Interactions of tirzepatide

• Delayed Gastric Emptying: Mounjaro can slow the absorption of oral medications. Monitor other medications for reduced effectiveness.
• Oral Contraceptives: Effectiveness may be diminished. Consider alternative methods of contraception.
• Heart Rate-Increasing Drugs: Use caution when combining with medications that increase heart rate.