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The Mounjaro Experience, Designed For Patients Like Julia1

MEET JULIA

Unhappy with her A1C and weight, concerned about life with T2D*

*A patient you may see.

  • Recently diagnosed with T2D
  • Not to her A1C goal on metformin
  • With her T2D, she struggles with her weight despite her efforts with diet and exercise

An elevated A1C and excess weight contribute to the burden of T2D2-4

Get patients started on Mounjaro

Image of a Mounjaro pen, a prescription, and a Mounjaro Savings Card

Start your patients with a sample (2.5 mg) and a prescription (5 mg)

Provide patients a 1-month† sample of Mounjaro 2.5 mg

Samples include 4 once-weekly pens and information about the Mounjaro Savings Program.

See Savings Card Terms and Conditions.

†One month is defined as 28 days and 4 pens.

Starting and continuing once-weekly Mounjaro‡

The 2.5 mg dose is for treatment initiation and is not intended for glycemic control.

The 2.5 mg dose is for treatment initiation and is not intended for glycemic control.

‡Consider patient history and monitor for tolerability and side effects.

Start Mounjaro1:

  • Initiate with the 2.5-mg dose
  • After 4 weeks on the 2.5-mg dose, increase to the 5-mg dose

If additional glycemic control is needed, you can continue to increase the dose by 2.5-mg increments after at least 4 weeks on the current dose. The maximum dose is 15 mg once weekly.

Mounjaro savings card

Download a savings card for your eligible, commercially insured patients

SEE THE SAVINGS

Writing Mounjaro1

More doses to help achieve individual glycemic goals1

The 2.5 mg dose is for treatment initiation and is not intended for glycemic control.

  • A single-use, once-weekly, auto-injection pen with a hidden needle
  • Available in 6 doses: a 2.5-mg starting dose and 5-mg, 7.5-mg, 10-mg, 12.5-mg, and 15-mg doses

1-MONTH SUPPLY (28 DAYS)

3-MONTH SUPPLY (84 DAYS)

Storing and dispensing the Mounjaro pen1

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

  • If needed, each single-dose pen can be stored unrefrigerated at temperatures not to exceed 86°F (30°C) for up to 21 days
  • Do not freeze Mounjaro. Do not use Mounjaro if frozen
  • Store Mounjaro in the original carton to protect from light

Getting patients started1

As you get your patients started on Mounjaro, here is some information that may help the conversation.

Calendar icon

It's taken once weekly1

Injectable pen icon

It's in a single-dose pen with a no-see needle2

A1C icon

It helps control blood sugar1

  • Mounjaro can help lower A1C and blood glucose levels
  • In clinical trials, average A1C reductions ranged from 1.8% to 2.1% for the 5-mg dose, 1.7% to 2.4% for the 10-mg dose, and 1.7% to 2.4% for the 15-mg dose

Select Important Safety Information

Risk of Thyroid C-cell Tumors: Counsel patients regarding the potential risk for MTC with the use of Mounjaro and inform them of symptoms of thyroid tumors (e.g., a mass in the neck, dysphagia, dyspnea, persistent hoarseness). Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with Mounjaro. Such monitoring may increase the risk of unnecessary procedures, due to the low test specificity for serum calcitonin and a high background incidence of thyroid disease. Significantly elevated serum calcitonin values may indicate MTC and patients with MTC usually have calcitonin values >50 ng/L. If serum calcitonin is measured and found to be elevated, the patient should be further evaluated. Patients with thyroid nodules noted on physical examination or neck imaging should also be further evaluated.

SC=subcutaneous; T2D=type 2 diabetes.

References:

  1. Mounjaro. Prescribing Information. Lilly USA, LLC.
  2. National Heart, Lung, and Blood Institute. Clinical Guidelines on the Identification, Evaluation, and Treatment of Overweight and Obesity in Adults. The Evidence Report. National Institutes of Health; 1998. NIH publication 98-4083. Accessed February 25, 2022. http://www.nhlbi.nih.gov/guidelines/obesity/ob_gdlns.pdf
  3. Van Gaal L, Scheen A. Weight management in type 2 diabetes:current and emerging approaches to treatment. Diabetes Care. 2015;38(6):1161-1172.
  4. Wing RR, Look AHEAD Research Group. Does lifestyle intervention improve health of adults with overweight/obesity and type 2 diabetes? Findings from the look AHEAD randomized trial. Obesity. 2021;29(8):1246-1258.
  5. Mounjaro. Instructions for Use. Lilly USA, LLC.
  6. Data on File. Lilly USA LLC. DOF-TR-US-0005.

Indication

Mounjaro (tirzepatide), an injectable prescription medicine, is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Limitations of Use: Mounjaro has not been studied in patients with a history of pancreatitis. Mounjaro is not indicated for use in patients with type 1 diabetes mellitus.

Important Safety Information

WARNING: RISK OF THYROID C-CELL TUMORS

In both male and female rats, tirzepatide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures. It is unknown whether Mounjaro causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans as human relevance of tirzepatide-induced rodent thyroid C-cell tumors has not been determined.

Mounjaro is contraindicated in patients with a personal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Counsel patients regarding the potential risk for MTC with the use of Mounjaro and inform them of symptoms of thyroid tumors (e.g., a mass in the neck, dysphagia, dyspnea, persistent hoarseness). Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with Mounjaro.

Mounjaro is contraindicated in patients with a personal or family history of MTC or in patients with MEN 2, and in patients with known serious hypersensitivity to tirzepatide or any of the excipients in Mounjaro.

Risk of Thyroid C-cell Tumors

Counsel patients regarding the potential risk for MTC with the use of Mounjaro and inform them of symptoms of thyroid tumors (e.g., a mass in the neck, dysphagia, dyspnea, persistent hoarseness). Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with Mounjaro. Such monitoring may increase the risk of unnecessary procedures, due to the low test specificity for serum calcitonin and a high background incidence of thyroid disease. Significantly elevated serum calcitonin values may indicate MTC and patients with MTC usually have calcitonin values >50 ng/L. If serum calcitonin is measured and found to be elevated, the patient should be further evaluated. Patients with thyroid nodules noted on physical examination or neck imaging should also be further evaluated.

Pancreatitis

Acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis, has been observed in patients treated with GLP-1 receptor agonists. Pancreatitis has been reported in Mounjaro clinical trials. Mounjaro has not been studied in patients with a prior history of pancreatitis. It is unknown if patients with a history of pancreatitis are at higher risk for development of pancreatitis on Mounjaro. Observe patients for signs and symptoms, including persistent severe abdominal pain sometimes radiating to the back, which may or may not be accompanied by vomiting. If pancreatitis is suspected, discontinue Mounjaro and initiate appropriate management.

Hypoglycemia with Concomitant Use of Insulin Secretagogues or Insulin

Concomitant use with an insulin secretagogue (e.g., sulfonylurea) or insulin may increase the risk of hypoglycemia, including severe hypoglycemia. The risk of hypoglycemia may be lowered by reducing the dose of sulfonylurea (or other concomitantly administered insulin secretagogue) or insulin. Inform patients using these concomitant medications of the risk of hypoglycemia and educate them on the signs and symptoms of hypoglycemia.

Hypersensitivity Reactions

Hypersensitivity reactions, sometimes severe, have been reported with Mounjaro in clinical trials. If hypersensitivity reactions occur, discontinue use of Mounjaro; treat promptly per standard of care, and monitor until signs and symptoms resolve. Do not use in patients with a previous serious hypersensitivity to Mounjaro. Use caution in patients with a history of angioedema or anaphylaxis with a GLP-1 receptor agonist because it is unknown if such patients will be predisposed to these reactions with Mounjaro.

Acute Kidney Injury

Mounjaro has been associated with gastrointestinal adverse reactions, which include nausea, vomiting, and diarrhea. These events may lead to dehydration, which if severe could cause acute kidney injury. In patients treated with GLP-1 receptor agonists, there have been postmarketing reports of acute kidney injury and worsening of chronic renal failure, sometimes requiring hemodialysis. Some of these events have been reported in patients without known underlying renal disease. A majority of reported events occurred in patients who had experienced nausea, vomiting, diarrhea, or dehydration. Monitor renal function when initiating or escalating doses of Mounjaro in patients with renal impairment reporting severe adverse gastrointestinal reactions.

Severe Gastrointestinal Disease

Use of Mounjaro has been associated with gastrointestinal adverse reactions, sometimes severe. Mounjaro has not been studied in patients with severe gastrointestinal disease, including severe gastroparesis, and is therefore not recommended in these patients.

Diabetic Retinopathy Complications in Patients with a History of Diabetic Retinopathy

Rapid improvement in glucose control has been associated with a temporary worsening of diabetic retinopathy. Mounjaro has not been studied in patients with non-proliferative diabetic retinopathy requiring acute therapy, proliferative diabetic retinopathy, or diabetic macular edema. Patients with a history of diabetic retinopathy should be monitored for progression of diabetic retinopathy.

Acute Gallbladder Disease

In clinical trials, acute gallbladder disease was reported by 0.6% of Mounjaro-treated patients and 0% of placebo-treated patients. If cholelithiasis is suspected, gallbladder diagnostic studies and appropriate clinical follow-up are indicated.

The most common adverse reactions reported in ≥5% of Mounjaro-treated patients in placebo-controlled trials were nausea, diarrhea, decreased appetite, vomiting, constipation, dyspepsia, and abdominal pain.

Drug Interactions

When initiating Mounjaro, consider reducing the dose of concomitantly administered insulin secretagogues (such as sulfonylureas) or insulin to reduce the risk of hypoglycemia. Mounjaro delays gastric emptying, and thereby has the potential to impact the absorption of concomitantly administered oral medications, so caution should be exercised.

Pregnancy

Limited data on Mounjaro use in pregnant women are available to inform on drug-associated risk for major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Based on animal reproduction studies, there may be risks to the fetus from exposure to tirzepatide. Use only if potential benefit justifies the potential risk to the fetus.

Lactation

There are no data on the presence of tirzepatide in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Mounjaro and any potential adverse effects on the breastfed infant from Mounjaro or from the underlying maternal condition.

Females of Reproductive Potential

Advise females using oral hormonal contraceptives to switch to a non-oral contraceptive method, or add a barrier method of contraception for 4 weeks after initiation and for 4 weeks after each dose escalation.

Pediatric Use

Safety and effectiveness of Mounjaro have not been established and use is not recommended in patients less than 18 years of age.

Please click to access Prescribing Information, including Boxed Warning about possible thyroid tumors, including thyroid cancer, and Medication Guide.
Please see Instructions for Use included with the pen.

TR HCP ISI MAY2022