Mounjaro 12.5 mg KwikPen

Mounjaro may provide several potential benefits when used appropriately as part of an individualized treatment plan.

• Helps Improve Blood Sugar Control- Tirzepatide helps regulate insulin and glucagon activity, improving fasting and post-meal blood glucose levels.

• Once-Weekly Administration- Mounjaro is administered only once each week and can be injected at any time of day, with or without food.

• Helps Control Appetite- Activation of GIP and GLP-1 receptors may increase fullness and reduce appetite, helping some patients manage food intake.

• May Support Weight Reduction- Reduced hunger and food intake during tirzepatide treatment may contribute to body-weight reduction, although individual results vary.

• Higher Dose-Escalation Option- The 12.5 mg strength provides an intermediate step between 10 mg and 15 mg when additional treatment effect is required and 10 mg has been tolerated.

• Convenient Multi-Dose KwikPen- One Mounjaro 12.5 mg KwikPen contains four fixed weekly doses, providing approximately four weeks of treatment when used as directed.

Tirzepatide is a dual GIP and GLP-1 receptor agonist. These receptors influence insulin production, glucagon secretion, appetite, digestion and blood glucose regulation.

Mounjaro works through several complementary actions:

• It increases insulin release when blood glucose levels are elevated.

• It helps reduce inappropriate glucagon secretion.

• It slows gastric emptying.

• It increases feelings of fullness.

• It may reduce appetite and overall food intake.

• These combined effects can improve blood glucose control and may support body-weight reduction.

The risk of hypoglycemia increases when Mounjaro is used with insulin or insulin-secretagogue medicines such as sulfonylureas, and adjustment of those medicines may sometimes be necessary.

Mounjaro treatment is started at a lower dose and increased gradually. A patient may be increased to 12.5 mg once weekly after taking 10 mg once weekly for at least four weeks, when additional treatment effect is required and the previous dose has been tolerated. If necessary, the dose may later be increased to 15 mg after at least four weeks on 12.5 mg. The maximum recommended dosage for adults is 15 mg once weekly.

Patients should not move directly to 12.5 mg or change their dose without medical guidance. Gradual dose escalation is important because gastrointestinal side effects can become more noticeable after the dose is increased.

Common Side Effects of Mounjaro 12.5 mg: Common side effects include nausea, diarrhea, reduced appetite, vomiting, constipation, indigestion and abdominal pain. These effects may become more noticeable following a dose increase and often improve as treatment continues.

Serious Side Effects of Mounjaro 12.5 mg: Serious reactions may include pancreatitis, severe allergic reactions, gallbladder problems, dehydration-related kidney injury and low blood sugar, particularly when used with insulin or sulfonylureas. Seek medical attention if severe or unusual symptoms occur.

Mounjaro may not be appropriate for everyone. Patients should not use it, or should obtain medical advice before treatment, if they:

• Are allergic to tirzepatide or any ingredient in Mounjaro.

• Have previously experienced a serious hypersensitivity reaction to tirzepatide.

• Have a personal or family history of medullary thyroid carcinoma (MTC).

• Have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).

• Are pregnant or planning pregnancy.

• Have previously experienced pancreatitis.

• Have severe gastroparesis or severe gastrointestinal disease.

• Have diabetic retinopathy requiring monitoring.

• Use insulin or a sulfonylurea and have not discussed the risk of hypoglycemia.

• Are scheduled for surgery or another procedure involving general anesthesia or deep sedation.

Tirzepatide delays gastric emptying and can therefore affect the absorption of some medicines taken by mouth.

Particular attention may be required with:

• Insulin: may increase the risk of hypoglycemia.

• Sulfonylureas: may increase the risk of low blood glucose.

• Warfarin, digoxin and other narrow-therapeutic-index medicines: additional monitoring may be needed.

• Medicines requiring rapid or predictable absorption: delayed gastric emptying may affect their action.

• Oral hormonal contraceptives: effectiveness may be reduced after starting tirzepatide or increasing the dose.

Patients using oral hormonal contraceptives should discuss switching to a non-oral contraceptive method or adding a barrier method for 4 weeks following each Mounjaro dose increase. Always tell the treating healthcare professional about prescription medicines, over-the-counter products, vitamins and supplements being used.

Unused KwikPen

• Store in a refrigerator at 2°C to 8°C (36°F to 46°F).

• Keep the pen protected from light.

• Do not freeze.

• Do not use a pen that has been frozen.

• Protect the medicine from excessive heat.

After First Use

After first use, Mounjaro KwikPen may be stored unrefrigerated at a temperature not above 30°C (86°F) for up to 30 days and should then be discarded. Each pen contains four intended weekly doses, and excess solution remaining after the four doses should not be used as an additional injection.