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 * Prescribing Information
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Information

All doses of this medicine are now available. Learn the latest information.

Learn how to identify compounded/counterfeit tirzepatide and its potential
risks.


FOR ADULTS WITH TYPE 2 DIABETES (T2D) AS AN ADJUNCT TO DIET AND EXERCISE TO
IMPROVE GLYCEMIC CONTROL.

GETTING PATIENTS
STARTED
Right
FORMULARY COVERAGE
AND SAVINGS
Right
CLINICAL DATA
Right

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.


MOUNJARO: SUPERIOR A1C REDUCTION. UNMATCHED WEIGHT RESULTS.1


MOUNJARO WORKS DIFFERENTLY1

A single molecule that activates the GIP and GLP-1 receptors in the body.1

GIP=glucose-dependent insulinotropic polypeptide; GLP-1=glucagon-like peptide-1.



LEARN MORE
Right


SUPERIOR A1C REDUCTION ACROSS CLINICAL TRIALS1*



EXPLORE THE RESULTS
Right


UNMATCHED WEIGHT RESULTS ACROSS CLINICAL TRIALS1†

Mounjaro is not indicated for weight loss.

Change in weight was a secondary endpoint.



DISCOVER THE DATA
Right

*Across the five phase 3 SURPASS studies, mean reductions in A1C with Mounjaro
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; and for comparators, 0.1% and 0.9% for placebo,
1.9% for Ozempic® 1 mg, 1.3% for Tresiba®, and 1.4% for insulin glargine. p<0.05
for superiority vs. study comparators, adjusted for multiplicity.1

†Across the five phase 3 SURPASS studies, mean reductions in body weight ranged
from 12 lb to 17 lb for the 5-mg dose, 15 lb to 21 lb for the 10-mg dose, and 17
lb to 25 lb for the 15-mg dose; and for comparators, mean change was -2 lb and
+4 lb for placebo, -13 lb for Ozempic® 1 mg, +4 lb for Tresiba, and +4 lb for
insulin glargine. p<0.05 for superiority vs. study comparators, adjusted for
multiplicity.1

Select 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.

Resources are available to help your patients get off to a good start

Mounjaro Commercial and Part D access is better than ever before. 90% of adults
with type 2 diabetes and Commercial or Medicare insurance may be eligible to
access Mounjaro through their insurance provider.* Go to Formulary Coverage and
Savings Support to view coverage in your area.2

*Represents Commercial and Medicare Formulary data.

Source: Managed Markets Insights & Technology (MMIT) LLC 06/03/2024 for
insurance. Data on File for Medicare insurance, Lilly USA, LLC; DOF-TR-US-0043.
Subject to change without notice by a health plan or state. Please contact the
plan or state for the most current information.

This information is not a guarantee of coverage or payment (partial or full).
Actual benefits are determined by each plan administrator in accordance with its
respective policy and procedures.

Employers and employer groups may also offer additional benefit designs which
may be different than described.



Reference:

 1. Mounjaro. Prescribing Information. Lilly USA, LLC.
 2. Data on File. Lilly USA, LLC. DOF-TR-US-0043.

Important Safety Information and Indication or Indications. Select to Expand.
IMPORTANT SAFETY INFORMATION INDICATION Important Safety Information and
Indication or Indications. Select to Expand.
Important Safety Information. Select to Expand. IMPORTANT SAFETY INFORMATION
Important Safety Information. Select to Expand.


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. Serious hypersensitivity
reactions including anaphylaxis and angioedema have been reported with 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

Serious hypersensitivity reactions (e.g., anaphylaxis, angioedema) have been
reported in patients treated with Mounjaro. 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 23MAY2023

Indication or Indications. Select to Expand. INDICATION Indication or
Indications. Select to Expand.


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.

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This site is intended for US health care professionals.
Mounjaro® and its delivery device base are registered trademarks owned or
licensed by Eli Lilly and Company, its subsidiaries, or affiliates. Mounjaro is
available by prescription only.
Ozempic® and Tresiba® are registered trademarks of Novo Nordisk A/S.
TRICARE® is a registered trademark of the Department of Defense (DoD), DHA.
Other product/company names mentioned herein are the trademarks of their
respective owners.

PP-TR-US-0168 07/2024 ©Lilly USA, LLC 2024. All rights reserved.


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