PARTICIPANT GUIDE
CHANGE STARTS WITH
ZEPBOUND® (tirzepatide) INJECTION
Zepbound is proven to help adults with obesity achieve significant weight loss and maintain it long term,
and is proven to help adults with moderate-to-severe OSA and obesity achieve significant reductions in AHI1
In combination with a reduced-calorie diet and increased physical activity.
Zepbound should not be used for cosmetic weight loss.
Indications Limitations of Use
Zepbound is indicated in combination with a Zepbound contains tirzepatide.
reduced-calorie diet and increased physical activity: Coadministration with other
• to reduce excess body weight and maintain tirzepatide-containing products or
weight reduction long term in adults with obesity with any glucagon-like peptide-1 (GLP-1)
or adults with overweight in the presence of receptor agonist is not recommended.
at least one weight-related comorbid condition.
• to treat moderate-to-severe obstructive sleep
apnea (OSA) in adults with obesity.
Select Important Safety Information
WARNING: RISK OF THYROID C-CELL TUMORS
In rats, tirzepatide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors
at clinically relevant exposures. It is unknown whether Zepbound 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.
Zepbound 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 Zepbound 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 Zepbound.
AHI=apnea-hypopnea index; OSA=obstructive sleep apnea.
1. Zepbound. Prescribing Information. Lilly USA, LLC.
Zepbound®, LillyDirect®, and its delivery device base are registered trademarks owned or licensed by Eli Lilly and Company,
its subsidiaries, or affiliates. Other product/company names mentioned herein are the trademarks of their respective owners.
Please see Important Safety Information for Zepbound, including Boxed Warning about
possible thyroid tumors, including thyroid cancer, on pages 70-71 and accompanying
Prescribing Information and Medication Guide. Please see Instructions for Use.
PP-ZP-US-2232 08/2025 ©Lilly USA, LLC 2025. All rights reserved.
Not an actual patient.
2 Please click to access Important Safety Information for Zepbound, including Boxed Warning
about possible thyroid tumors, including thyroid cancer, on pages 70-71 and accompanying
Prescribing Information and Medication Guide. Please see Instructions for Use.
3 Please click to access Important Safety Information for Zepbound, including Boxed Warning
about possible thyroid tumors, including thyroid cancer, on pages 70-71 and accompanying
Prescribing Information and Medication Guide. Please see Instructions for Use.
4 Please click to access Important Safety Information for Zepbound, including Boxed Warning
about possible thyroid tumors, including thyroid cancer, on pages 70-71 and accompanying
Prescribing Information and Medication Guide. Please see Instructions for Use.
5 Please click to access Important Safety Information for Zepbound, including Boxed Warning
about possible thyroid tumors, including thyroid cancer, on pages 70-71 and accompanying
Prescribing Information and Medication Guide. Please see Instructions for Use.
6 Please click to access Important Safety Information for Zepbound, including Boxed Warning
about possible thyroid tumors, including thyroid cancer, on pages 70-71 and accompanying
Prescribing Information and Medication Guide. Please see Instructions for Use.
7 Please click to access Important Safety Information for Zepbound, including Boxed Warning
about possible thyroid tumors, including thyroid cancer, on pages 70-71 and accompanying
Prescribing Information and Medication Guide. Please see Instructions for Use.
8 Please click to access Important Safety Information for Zepbound, including Boxed Warning
about possible thyroid tumors, including thyroid cancer, on pages 70-71 and accompanying
Prescribing Information and Medication Guide. Please see Instructions for Use.
9 Please click to access Important Safety Information for Zepbound, including Boxed Warning
about possible thyroid tumors, including thyroid cancer, on pages 70-71 and accompanying
Prescribing Information and Medication Guide. Please see Instructions for Use.
10 Please click to access Important Safety Information for Zepbound, including Boxed Warning
about possible thyroid tumors, including thyroid cancer, on pages 70-71 and accompanying
Prescribing Information and Medication Guide. Please see Instructions for Use.
11 Please click to access Important Safety Information for Zepbound, including Boxed Warning
about possible thyroid tumors, including thyroid cancer, on pages 70-71 and accompanying
Prescribing Information and Medication Guide. Please see Instructions for Use.
12 Please click to access Important Safety Information for Zepbound, including Boxed Warning
about possible thyroid tumors, including thyroid cancer, on pages 70-71 and accompanying
Prescribing Information and Medication Guide. Please see Instructions for Use.
13 Please click to access Important Safety Information for Zepbound, including Boxed Warning
about possible thyroid tumors, including thyroid cancer, on pages 70-71 and accompanying
Prescribing Information and Medication Guide. Please see Instructions for Use.
14 Please click to access Important Safety Information for Zepbound, including Boxed Warning
about possible thyroid tumors, including thyroid cancer, on pages 70-71 and accompanying
Prescribing Information and Medication Guide. Please see Instructions for Use.
15 Please click to access Important Safety Information for Zepbound, including Boxed Warning
about possible thyroid tumors, including thyroid cancer, on pages 70-71 and accompanying
Prescribing Information and Medication Guide. Please see Instructions for Use.
16 Please click to access Important Safety Information for Zepbound, including Boxed Warning
about possible thyroid tumors, including thyroid cancer, on pages 70-71 and accompanying
Prescribing Information and Medication Guide. Please see Instructions for Use.
17 Please click to access Important Safety Information for Zepbound, including Boxed Warning
about possible thyroid tumors, including thyroid cancer, on pages 70-71 and accompanying
Prescribing Information and Medication Guide. Please see Instructions for Use.
18 Please click to access Important Safety Information for Zepbound, including Boxed Warning
about possible thyroid tumors, including thyroid cancer, on pages 70-71 and accompanying
Prescribing Information and Medication Guide. Please see Instructions for Use.
19 Please click to access Important Safety Information for Zepbound, including Boxed Warning
about possible thyroid tumors, including thyroid cancer, on pages 70-71 and accompanying
Prescribing Information and Medication Guide. Please see Instructions for Use.
20 Please click to access Important Safety Information for Zepbound, including Boxed Warning
about possible thyroid tumors, including thyroid cancer, on pages 70-71 and accompanying
Prescribing Information and Medication Guide. Please see Instructions for Use.
21 Please click to access Important Safety Information for Zepbound, including Boxed Warning
about possible thyroid tumors, including thyroid cancer, on pages 70-71 and accompanying
Prescribing Information and Medication Guide. Please see Instructions for Use.
22 Please click to access Important Safety Information for Zepbound, including Boxed Warning
about possible thyroid tumors, including thyroid cancer, on pages 70-71 and accompanying
Prescribing Information and Medication Guide. Please see Instructions for Use.
23 Please click to access Important Safety Information for Zepbound, including Boxed Warning
about possible thyroid tumors, including thyroid cancer, on pages 70-71 and accompanying
Prescribing Information and Medication Guide. Please see Instructions for Use.
24 Please click to access Important Safety Information for Zepbound, including Boxed Warning
about possible thyroid tumors, including thyroid cancer, on pages 70-71 and accompanying
Prescribing Information and Medication Guide. Please see Instructions for Use.
25 Please click to access Important Safety Information for Zepbound, including Boxed Warning
about possible thyroid tumors, including thyroid cancer, on pages 70-71 and accompanying
Prescribing Information and Medication Guide. Please see Instructions for Use.
26 Please click to access Important Safety Information for Zepbound, including Boxed Warning
about possible thyroid tumors, including thyroid cancer, on pages 70-71 and accompanying
Prescribing Information and Medication Guide. Please see Instructions for Use.
27 Please click to access Important Safety Information for Zepbound, including Boxed Warning
about possible thyroid tumors, including thyroid cancer, on pages 70-71 and accompanying
Prescribing Information and Medication Guide. Please see Instructions for Use.
28 Please click to access Important Safety Information for Zepbound, including Boxed Warning
about possible thyroid tumors, including thyroid cancer, on pages 70-71 and accompanying
Prescribing Information and Medication Guide. Please see Instructions for Use.
29 Please click to access Important Safety Information for Zepbound, including Boxed Warning
about possible thyroid tumors, including thyroid cancer, on pages 70-71 and accompanying
Prescribing Information and Medication Guide. Please see Instructions for Use.
30 Please click to access Important Safety Information for Zepbound, including Boxed Warning
about possible thyroid tumors, including thyroid cancer, on pages 70-71 and accompanying
Prescribing Information and Medication Guide. Please see Instructions for Use.
31 Please click to access Important Safety Information for Zepbound, including Boxed Warning
about possible thyroid tumors, including thyroid cancer, on pages 70-71 and accompanying
Prescribing Information and Medication Guide. Please see Instructions for Use.
32 Please click to access Important Safety Information for Zepbound, including Boxed Warning
about possible thyroid tumors, including thyroid cancer, on pages 70-71 and accompanying
Prescribing Information and Medication Guide. Please see Instructions for Use.
33 Please click to access Important Safety Information for Zepbound, including Boxed Warning
about possible thyroid tumors, including thyroid cancer, on pages 70-71 and accompanying
Prescribing Information and Medication Guide. Please see Instructions for Use.
34 Please click to access Important Safety Information for Zepbound, including Boxed Warning
about possible thyroid tumors, including thyroid cancer, on pages 70-71 and accompanying
Prescribing Information and Medication Guide. Please see Instructions for Use.
35 Please click to access Important Safety Information for Zepbound, including Boxed Warning
about possible thyroid tumors, including thyroid cancer, on pages 70-71 and accompanying
Prescribing Information and Medication Guide. Please see Instructions for Use.
36 Please click to access Important Safety Information for Zepbound, including Boxed Warning
about possible thyroid tumors, including thyroid cancer, on pages 70-71 and accompanying
Prescribing Information and Medication Guide. Please see Instructions for Use.
37 Please click to access Important Safety Information for Zepbound, including Boxed Warning
about possible thyroid tumors, including thyroid cancer, on pages 70-71 and accompanying
Prescribing Information and Medication Guide. Please see Instructions for Use.
38 Please click to access Important Safety Information for Zepbound, including Boxed Warning
about possible thyroid tumors, including thyroid cancer, on pages 70-71 and accompanying
Prescribing Information and Medication Guide. Please see Instructions for Use.
39 Please click to access Important Safety Information for Zepbound, including Boxed Warning
about possible thyroid tumors, including thyroid cancer, on pages 70-71 and accompanying
Prescribing Information and Medication Guide. Please see Instructions for Use.
40 Please click to access Important Safety Information for Zepbound, including Boxed Warning
about possible thyroid tumors, including thyroid cancer, on pages 70-71 and accompanying
Prescribing Information and Medication Guide. Please see Instructions for Use.
41 Please click to access Important Safety Information for Zepbound, including Boxed Warning
about possible thyroid tumors, including thyroid cancer, on pages 70-71 and accompanying
Prescribing Information and Medication Guide. Please see Instructions for Use.
42 Please click to access Important Safety Information for Zepbound, including Boxed Warning
about possible thyroid tumors, including thyroid cancer, on pages 70-71 and accompanying
Prescribing Information and Medication Guide. Please see Instructions for Use.
43 Please click to access Important Safety Information for Zepbound, including Boxed Warning
about possible thyroid tumors, including thyroid cancer, on pages 70-71 and accompanying
Prescribing Information and Medication Guide. Please see Instructions for Use.
44 Please click to access Important Safety Information for Zepbound, including Boxed Warning
about possible thyroid tumors, including thyroid cancer, on pages 70-71 and accompanying
Prescribing Information and Medication Guide. Please see Instructions for Use.
45 Please click to access Important Safety Information for Zepbound, including Boxed Warning
about possible thyroid tumors, including thyroid cancer, on pages 70-71 and accompanying
Prescribing Information and Medication Guide. Please see Instructions for Use.
46 Please click to access Important Safety Information for Zepbound, including Boxed Warning
about possible thyroid tumors, including thyroid cancer, on pages 70-71 and accompanying
Prescribing Information and Medication Guide. Please see Instructions for Use.
47 Please click to access Important Safety Information for Zepbound, including Boxed Warning
about possible thyroid tumors, including thyroid cancer, on pages 70-71 and accompanying
Prescribing Information and Medication Guide. Please see Instructions for Use.
48 Please click to access Important Safety Information for Zepbound, including Boxed Warning
about possible thyroid tumors, including thyroid cancer, on pages 70-71 and accompanying
Prescribing Information and Medication Guide. Please see Instructions for Use.
49 Please click to access Important Safety Information for Zepbound, including Boxed Warning
about possible thyroid tumors, including thyroid cancer, on pages 70-71 and accompanying
Prescribing Information and Medication Guide. Please see Instructions for Use.
50 Please click to access Important Safety Information for Zepbound, including Boxed Warning
about possible thyroid tumors, including thyroid cancer, on pages 70-71 and accompanying
Prescribing Information and Medication Guide. Please see Instructions for Use.
51 Please click to access Important Safety Information for Zepbound, including Boxed Warning
about possible thyroid tumors, including thyroid cancer, on pages 70-71 and accompanying
Prescribing Information and Medication Guide. Please see Instructions for Use.
52 Please click to access Important Safety Information for Zepbound, including Boxed Warning
about possible thyroid tumors, including thyroid cancer, on pages 70-71 and accompanying
Prescribing Information and Medication Guide. Please see Instructions for Use.
53 Please click to access Important Safety Information for Zepbound, including Boxed Warning
about possible thyroid tumors, including thyroid cancer, on pages 70-71 and accompanying
Prescribing Information and Medication Guide. Please see Instructions for Use.
54 Please click to access Important Safety Information for Zepbound, including Boxed Warning
about possible thyroid tumors, including thyroid cancer, on pages 70-71 and accompanying
Prescribing Information and Medication Guide. Please see Instructions for Use.
55 Please click to access Important Safety Information for Zepbound, including Boxed Warning
about possible thyroid tumors, including thyroid cancer, on pages 70-71 and accompanying
Prescribing Information and Medication Guide. Please see Instructions for Use.
56 Please click to access Important Safety Information for Zepbound, including Boxed Warning
about possible thyroid tumors, including thyroid cancer, on pages 70-71 and accompanying
Prescribing Information and Medication Guide. Please see Instructions for Use.
57 Please click to access Important Safety Information for Zepbound, including Boxed Warning
about possible thyroid tumors, including thyroid cancer, on pages 70-71 and accompanying
Prescribing Information and Medication Guide. Please see Instructions for Use.
58 Please click to access Important Safety Information for Zepbound, including Boxed Warning
about possible thyroid tumors, including thyroid cancer, on pages 70-71 and accompanying
Prescribing Information and Medication Guide. Please see Instructions for Use.
59 Please click to access Important Safety Information for Zepbound, including Boxed Warning
about possible thyroid tumors, including thyroid cancer, on pages 70-71 and accompanying
Prescribing Information and Medication Guide. Please see Instructions for Use.
60 Please click to access Important Safety Information for Zepbound, including Boxed Warning
about possible thyroid tumors, including thyroid cancer, on pages 70-71 and accompanying
Prescribing Information and Medication Guide. Please see Instructions for Use.
61 Please click to access Important Safety Information for Zepbound, including Boxed Warning
about possible thyroid tumors, including thyroid cancer, on pages 70-71 and accompanying
Prescribing Information and Medication Guide. Please see Instructions for Use.
62 Please click to access Important Safety Information for Zepbound, including Boxed Warning
about possible thyroid tumors, including thyroid cancer, on pages 70-71 and accompanying
Prescribing Information and Medication Guide. Please see Instructions for Use.
63 Please click to access Important Safety Information for Zepbound, including Boxed Warning
about possible thyroid tumors, including thyroid cancer, on pages 70-71 and accompanying
Prescribing Information and Medication Guide. Please see Instructions for Use.
64 Please click to access Important Safety Information for Zepbound, including Boxed Warning
about possible thyroid tumors, including thyroid cancer, on pages 70-71 and accompanying
Prescribing Information and Medication Guide. Please see Instructions for Use.
65 Please click to access Important Safety Information for Zepbound, including Boxed Warning
about possible thyroid tumors, including thyroid cancer, on pages 70-71 and accompanying
Prescribing Information and Medication Guide. Please see Instructions for Use.
66 Please click to access Important Safety Information for Zepbound, including Boxed Warning
about possible thyroid tumors, including thyroid cancer, on pages 70-71 and accompanying
Prescribing Information and Medication Guide. Please see Instructions for Use.
67 Please click to access Important Safety Information for Zepbound, including Boxed Warning
about possible thyroid tumors, including thyroid cancer, on pages 70-71 and accompanying
Prescribing Information and Medication Guide. Please see Instructions for Use.
68 Please click to access Important Safety Information for Zepbound, including Boxed Warning
about possible thyroid tumors, including thyroid cancer, on pages 70-71 and accompanying
Prescribing Information and Medication Guide. Please see Instructions for Use.
69 Please click to access Important Safety Information for Zepbound, including Boxed Warning
about possible thyroid tumors, including thyroid cancer, on pages 70-71 and accompanying
Prescribing Information and Medication Guide. Please see Instructions for Use.
Important Safety Information for Zepbound® (tirzepatide) injection
WARNING: RISK OF THYROID C-CELL TUMORS renal failure, which may sometimes require hemodialysis. Some of these events have
In rats, tirzepatide causes dose-dependent and treatment-duration- been reported in patients without known underlying renal disease. A majority of the
dependent thyroid C-cell tumors at clinically relevant exposures. It is reported events occurred in patients who had experienced nausea, vomiting,
unknown whether Zepbound causes thyroid C-cell tumors, including diarrhea, or dehydration. Monitor renal function in patients reporting adverse reactions
medullary thyroid carcinoma (MTC), in humans as human relevance of to Zepbound that could lead to volume depletion.
tirzepatide-induced rodent thyroid C-cell tumors has not been determined. Acute Gallbladder Disease: Treatment with Zepbound and GLP-1 receptor agonists
Zepbound is contraindicated in patients with a personal or family history of is associated with an increased occurrence of acute gallbladder disease. In a pool of
MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). two clinical trials of Zepbound (SURMOUNT-1 and SURMOUNT-2), cholelithiasis was
Counsel patients regarding the potential risk for MTC with the use of reported in 1.1% of Zepbound-treated patients and 1.0% of placebo-treated patients,
Zepbound and inform them of symptoms of thyroid tumors (e.g., a mass in cholecystitis was reported in 0.7% of Zepbound-treated patients and 0.2% of placebo-
the neck, dysphagia, dyspnea, persistent hoarseness). Routine monitoring treated patients, and cholecystectomy was reported in 0.2% of Zepbound-treated
of serum calcitonin or using thyroid ultrasound is of uncertain value for patients and no placebo-treated patients. Acute gallbladder events were associated
early detection of MTC in patients treated with Zepbound. with weight reduction. Similar rates of cholelithiasis were reported in Zepbound clinical
trials for weight reduction and in Zepbound trials for OSA. If cholecystitis is suspected,
gallbladder diagnostic studies and appropriate clinical follow-up are indicated.
Contraindications: Zepbound is contraindicated in patients with a personal or
family history of MTC or in patients with MEN 2, and in patients with known Acute Pancreatitis: Acute pancreatitis, including fatal and non-fatal hemorrhagic or
serious hypersensitivity to tirzepatide or any of the excipients in Zepbound. necrotizing pancreatitis, has been observed in patients treated with GLP-1 receptor
Serious hypersensitivity reactions including anaphylaxis and angioedema agonists or tirzepatide. In clinical trials of tirzepatide for a different indication, 14 events
have been reported with tirzepatide. of acute pancreatitis were confirmed by adjudication in 13 tirzepatide-treated patients
(0.23 patients per 100 years of exposure) versus 3 events in 3 comparator-treated
Risk of Thyroid C-cell Tumors: Counsel patients regarding the potential risk for MTC
patients (0.11 patients per 100 years of exposure). In a pool of two Zepbound clinical
with the use of Zepbound and inform them of symptoms of thyroid tumors (e.g., a mass
trials (SURMOUNT-1 and SURMOUNT-2), 0.2% of Zepbound-treated patients had
in the neck, dysphagia, dyspnea, persistent hoarseness). Routine monitoring of serum
acute pancreatitis confirmed by adjudication (0.14 patients per 100 years of exposure)
calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC
versus 0.2% of placebo-treated patients (0.15 patients per 100 years of exposure).
in patients treated with Zepbound. Such monitoring may increase the risk of unnecessary
The exposure-adjusted incidence rate for treatment-emergent adjudication-confirmed
procedures, due to the low test specificity for serum calcitonin and a high background
pancreatitis in the pooled clinical studies for OSA was 0.84 patients per 100 years for
incidence of thyroid disease. Significantly elevated serum calcitonin values may indicate
Zepbound and 0 for placebo-treated patients. Observe patients for signs and
MTC and patients with MTC usually have calcitonin values >50 ng/L. If serum calcitonin
symptoms of pancreatitis, including persistent severe abdominal pain sometimes
is measured and found to be elevated, the patient should be further evaluated.
radiating to the back, which may or may not be accompanied by vomiting. If pancreatitis
Patients with thyroid nodules noted on physical examination or neck imaging
is suspected, discontinue Zepbound and initiate appropriate management.
should also be further evaluated.
Continuation of Zepbound after a confirmed diagnosis of pancreatitis should be
Severe Gastrointestinal Adverse Reactions: Use of Zepbound has been associated individually determined in the clinical judgment of a patient’s health care provider.
with gastrointestinal adverse reactions, sometimes severe. In a pool of two Zepbound
Hypersensitivity Reactions: There have been postmarketing reports of serious
clinical trials (SURMOUNT-1 and SURMOUNT-2), severe gastrointestinal adverse reactions
hypersensitivity reactions (e.g., anaphylaxis, angioedema) in patients treated with
were reported more frequently among patients receiving Zepbound
tirzepatide. In a pool of two Zepbound clinical trials (SURMOUNT-1 and SURMOUNT-2),
(5 mg 1.7%, 10 mg 2.5%, 15 mg 3.1%) than placebo (1.0%). Similar rates of severe
0.1% of Zepbound-treated patients had severe hypersensitivity reactions compared
gastrointestinal adverse reactions were observed in Zepbound clinical trials for weight
to no placebo-treated patients. Similar rates of severe hypersensitivity reactions were
reduction and in Zepbound clinical trials for obstructive sleep apnea (OSA). Zepbound
observed in Zepbound clinical trials for weight reduction and in Zepbound trials for
has not been studied in patients with severe gastrointestinal disease, including severe
OSA. If hypersensitivity reactions occur, advise patients to promptly seek medical
gastroparesis, and is therefore not recommended in these patients.
attention and discontinue use of Zepbound. Do not use in patients with a previous
Acute Kidney Injury: Use of Zepbound has been associated with acute kidney injury, serious hypersensitivity reaction to tirzepatide or any of the excipients in Zepbound.
which can result from dehydration due to gastrointestinal adverse reactions to Zepbound, Use caution in patients with a history of angioedema or anaphylaxis with a GLP-1
including nausea, vomiting, and diarrhea. In patients treated with GLP-1 receptor agonists, receptor agonist because it is unknown if such patients will be predisposed to these
there have been postmarketing reports of acute kidney injury and worsening of chronic reactions with Zepbound.
70
Important Safety Information (continued)
Hypoglycemia: Zepbound lowers blood glucose and can cause hypoglycemia. secretagogues (e.g., sulfonylureas) to reduce the risk of hypoglycemia. Zepbound
In a trial of patients with type 2 diabetes mellitus and BMI ≥27 kg/m2 (Study 2), delays gastric emptying and thereby has the potential to impact the absorption of
hypoglycemia (plasma glucose <54 mg/dL) was reported in 4.2% of Zepbound- concomitantly administered oral medications. Caution should be exercised when oral
treated patients versus 1.3% of placebo-treated patients. In this trial, patients medications are concomitantly administered with Zepbound. Monitor patients on oral
taking Zepbound in combination with an insulin secretagogue (e.g., sulfonylurea) medications dependent on threshold concentrations for efficacy and those with a
had increased risk of hypoglycemia (10.3%) compared to Zepbound-treated patients narrow therapeutic index (e.g., warfarin) when concomitantly administered with Zepbound.
not taking a sulfonylurea (2.1%). There is also increased risk of hypoglycemia in Pregnancy: Advise pregnant patients that weight loss is not recommended during
patients treated with tirzepatide in combination with insulin. Hypoglycemia has pregnancy and to discontinue Zepbound when a pregnancy is recognized. Available
also been associated with Zepbound and GLP-1 receptor agonists in adults without data with tirzepatide in pregnant patients are insufficient to evaluate for a drug-related
type 2 diabetes mellitus. Inform patients of the risk of hypoglycemia and educate risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes.
them on the signs and symptoms of hypoglycemia. In patients with diabetes mellitus, Based on animal reproduction studies, there may be risks to the fetus from exposure
monitor blood glucose prior to starting Zepbound and during Zepbound treatment. to tirzepatide during pregnancy. There will be a pregnancy exposure registry that monitors
The risk of hypoglycemia may be lowered by a reduction in the dose of insulin or pregnancy outcomes in women exposed to Zepbound (tirzepatide)
sulfonylurea (or other concomitantly administered insulin secretagogue). during pregnancy.
Diabetic Retinopathy Complications in Patients with Type 2 Diabetes Mellitus: Pregnant patients exposed to Zepbound and healthcare providers are encouraged to
Rapid improvement in glucose control has been associated with a temporary worsening contact Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979).
of diabetic retinopathy. Tirzepatide has not been studied in patients with non-proliferative
diabetic retinopathy requiring acute therapy, proliferative diabetic retinopathy, or Lactation: There are no data on the presence of tirzepatide or its metabolites in animal
diabetic macular edema. Patients with a history of diabetic retinopathy should be or human milk, the effects on the breastfed infant, or the effects on milk production.
monitored for progression of diabetic retinopathy. The developmental and health benefits of breastfeeding should be considered along
with the mother’s clinical need for Zepbound and any potential adverse effects on the
Suicidal Behavior and Ideation: Suicidal behavior and ideation have been reported breastfed infant from Zepbound or from the underlying maternal condition.
in clinical trials with other weight management products. Monitor patients treated with
Zepbound for the emergence or worsening of depression, suicidal thoughts or behaviors, Females and Males of Reproductive Potential: Use of Zepbound may reduce the
and/or any unusual changes in mood or behavior. Discontinue Zepbound in patients efficacy of oral hormonal contraceptives due to delayed gastric emptying. This delay
who experience suicidal thoughts or behaviors. Avoid Zepbound in patients with a is largest after the first dose and diminishes over time. Advise patients using oral hormonal
history of suicidal attempts or active suicidal ideation. contraceptives to switch to a non-oral contraceptive method, or add a barrier method
of contraception, for 4 weeks after initiation with Zepbound and for 4 weeks after each
Pulmonary Aspiration During General Anesthesia or Deep Sedation: Zepbound dose escalation.
delays gastric emptying. There have been rare postmarketing reports of pulmonary
aspiration in patients receiving GLP-1 receptor agonists undergoing elective surgeries Pediatric Use: The safety and effectiveness of Zepbound have not been established
or procedures requiring general anesthesia or deep sedation who had residual gastric in pediatric patients.
contents despite reported adherence to preoperative fasting recommendations. Please click to see accompanying Prescribing Information, including Boxed
Available data are insufficient to inform recommendations to mitigate the risk of Warning about possible thyroid tumors, including thyroid cancer, and
pulmonary aspiration during general anesthesia or deep sedation in patients taking Medication Guide.
Zepbound, including whether modifying preoperative fasting recommendations or Please see Instructions for Use.
temporarily discontinuing Zepbound could reduce the incidence of retained gastric
contents. Instruct patients to inform healthcare providers prior to any planned Zepbound is available as a 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, and 15 mg injection.
surgeries or procedures if they are taking Zepbound. ZP HCP ISI 20DEC2024
Most Common Adverse Reactions: The most common adverse reactions reported
in ≥5% of patients treated with Zepbound are nausea, diarrhea, vomiting, constipation, Zepbound®, LillyDirect®, and its delivery device base are
abdominal pain, dyspepsia, injection site reactions, fatigue, hypersensitivity reactions, registered trademarks owned or licensed by Eli Lilly and
Company, its subsidiaries, or affiliates. Other product/company
eructation, hair loss, and gastroesophageal reflux disease.
names mentioned herein are the trademarks of their
Drug Interactions: Zepbound lowers blood glucose. When initiating Zepbound, respective owners.
consider reducing the dose of concomitantly administered insulin or insulin PP-ZP-US-2232 08/2025 ©Lilly USA, LLC 2025.
All rights reserved.
71
