MOUNJARO

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 [see Warnings and Precautions ( 5.1 ) and Nonclinical Toxicology ( 13.1 )]. 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) [see Contraindications ( 4 )] . 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 [see Contraindications ( 4 ) and Warnings and Precautions ( 5.1 )]. WARNING: RISK OF THYROID C-CELL TUMORS See full prescribing information for complete boxed warning. Tirzepatide causes thyroid C-cell tumors in rats. It is unknown whether MOUNJARO causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans as the human relevance of tirzepatide-induced rodent thyroid C-cell tumors has not been determined ( 5.1 , 13.1 ). 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 of MTC and symptoms of thyroid tumors ( 4 , 5.1 ).

5 WARNINGS AND PRECAUTIONS Acute Pancreatitis: Has been observed in patients treated with GLP-1 receptor agonists, or MOUNJARO. Discontinue if pancreatitis is suspected. ( 5.2 ) Hypoglycemia with Concomitant Use of Insulin Secretagogues or Insulin: Concomitant use with an insulin secretagogue or insulin may increase the risk of hypoglycemia, including severe hypoglycemia. Reducing dose of insulin secretagogue or insulin may be necessary. ( 5.3 ) Hypersensitivity Reactions: Serious hypersensitivity reactions (e.g., anaphylaxis and angioedema) have been reported. Discontinue MOUNJARO if suspected and promptly seek medical advice. ( 5.4 ) Acute Kidney Injury Due to Volume Depletion: Monitor renal function in patients reporting adverse reactions that could lead to volume depletion. ( 5.5 ) Severe Gastrointestinal Adverse Reactions: Use has been associated with gastrointestinal adverse reactions, sometimes severe. MOUNJARO is not recommended in patients with severe gastroparesis. ( 5.6 ) Diabetic Retinopathy Complications in Patients with a History of Diabetic Retinopathy: Has not been studied in patients with non-proliferative diabetic retinopathy requiring acute therapy, proliferative diabetic retinopathy, or diabetic macular edema. Monitor patients with a history of diabetic retinopathy for progression. ( 5.7 ) Acute Gallbladder Disease: Has occurred in clinical trials. If cholelithiasis is suspected, gallbladder studies and clinical follow-up are indicated. ( 5.8 ) Pulmonary Aspiration During General Anesthesia or Deep Sedation: Has been reported in patients receiving GLP-1 receptor agonists undergoing elective surgeries or procedures. Instruct patients to inform healthcare providers of any planned surgeries or procedures. ( 5.9 ) Never share a MOUNJARO KwikPen between patients, even if the pen needle is changed. ( 5.10 ) 5.1 Risk of Thyroid C-Cell Tumors In both sexes of rats, tirzepatide caused a dose-dependent and treatment-duration-dependent increase in the incidence of thyroid C-cell tumors (adenomas and carcinomas) in a 2-year study at clinically relevant plasma exposures [see Nonclinical Toxicology ( 13.1 )] . 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 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. 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. 5.2 Acute Pancreatitis Acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis, has been observed in patients treated with GLP-1 receptor agonists, or MOUNJARO [see Adverse Reactions ( 6 )] . After initiation of MOUNJARO, observe patients carefully for signs and symptoms of acute pancreatitis, which may include persistent or severe abdominal pain (sometimes radiating to the back) and which may or may not be accompanied by nausea or vomiting. If pancreatitis is suspected, discontinue MOUNJARO and initiate appropriate management. 5.3 Hypoglycemia with Concomitant Use of Insulin Secretagogues or Insulin Patients receiving MOUNJARO in combination with an insulin secretagogue (e.g., sulfonylurea) or insulin may have an increased risk of hypoglycemia, including severe hypoglycemia [see Adverse Reactions ( 6.1 ), Drug Interactions ( 7.1 )] . The risk of hypoglycemia may be lowered by a reduction in 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. 5.4 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 reaction to tirzepatide or any of the excipients in MOUNJARO [see Contraindications ( 4 ), Adverse Reactions ( 6.2 )] . Anaphylaxis and angioedema have been reported with GLP-1 receptor agonists. Use caution in patients with a history of angioedema or anaphylaxis with a GLP-1 receptor agonist because it is unknown whether such patients will be predisposed to these reactions with MOUNJARO. 5.5 Acute Kidney Injury Due to Volume Depletion There have been postmarketing reports of acute kidney injury, in some cases requiring hemodialysis, in patients treated with GLP-1 receptor agonists, or MOUNJARO. The majority of the reported events occurred in patients who experienced gastrointestinal adverse reactions leading to dehydration such as nausea, vomiting, or diarrhea [see Adverse Reactions ( 6 )] . Monitor renal function in patients reporting adverse reactions to MOUNJARO that could lead to volume depletion, especially during dosage initiation and escalation of MOUNJARO. 5.6 Severe Gastrointestinal Adverse Reactions Use of MOUNJARO has been associated with gastrointestinal adverse reactions, sometimes severe [see Adverse Reactions ( 6 )] . In the pool of placebo-controlled trials in adults, severe gastrointestinal adverse reactions occurred more frequently among patients receiving MOUNJARO (5 mg 1.3%, 10 mg 0.4%, 15 mg 1.2%) than placebo (0.9%). Severe gastrointestinal adverse reactions have also been reported postmarketing with GLP-1 receptor agonists. MOUNJARO is not recommended in patients with severe gastroparesis. 5.7 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. 5.8 Acute Gallbladder Disease Acute events of gallbladder disease such as cholelithiasis or cholecystitis have been reported in GLP-1 receptor agonist trials and postmarketing. In MOUNJARO placebo-controlled clinical trials in adults, acute gallbladder disease (cholelithiasis, biliary colic, and cholecystectomy) 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. 5.9 Pulmonary Aspiration During General Anesthesia or Deep Sedation MOUNJARO delays gastric emptying [see Clinical Pharmacology ( 12.2 )] . There have been rare postmarketing reports of pulmonary aspiration in patients receiving GLP-1 receptor agonists undergoing elective surgeries or procedures requiring general anesthesia or deep sedation who had residual gastric contents despite reported adherence to preoperative fasting recommendations. Available data are insufficient to inform recommendations to mitigate the risk of pulmonary aspiration during general anesthesia or deep sedation in patients taking MOUNJARO, including whether modifying preoperative fasting recommendations or temporarily discontinuing MOUNJARO could reduce the incidence of retained gastric contents. Instruct patients to inform healthcare providers prior to any planned surgeries or procedures if they are taking MOUNJARO. 5.10 Never Share a MOUNJARO KwikPen Between Patients Never share MOUNJARO KwikPen between patients, even if the pen needle is changed. Sharing poses a risk for transmission of blood-borne pathogens.

6 ADVERSE REACTIONS The following serious adverse reactions are described below or elsewhere in the prescribing information: Risk of Thyroid C-cell Tumors [see Warnings and Precautions ( 5.1 )] Acute Pancreatitis [see Warnings and Precautions ( 5.2 )] Hypoglycemia with Concomitant Use of Insulin Secretagogues or Insulin [see Warnings and Precautions ( 5.3 )] Hypersensitivity Reactions [see Warnings and Precautions ( 5.4 )] Acute Kidney Injury Due to Volume Depletion [see Warnings and Precautions ( 5.5 )] Severe Gastrointestinal Adverse Reactions [see Warnings and Precautions ( 5.6 )] Diabetic Retinopathy Complications in Patients with a History of Diabetic Retinopathy [see Warnings and Precautions ( 5.7 )] Acute Gallbladder Disease [see Warnings and Precautions ( 5.8 )] Pulmonary Aspiration During General Anesthesia or Deep Sedation [see Warnings and Precautions ( 5.9 )] The most common adverse reactions, reported in ≥5% of patients treated with MOUNJARO are nausea, diarrhea, decreased appetite, vomiting, constipation, dyspepsia, and abdominal pain. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adverse Reactions in the Clinical Trials of Adults with Type 2 Diabetes Mellitus Pool of Two Placebo-Controlled Clinical Trials in Adults The data in Table 1 are derived from 2 placebo-controlled trials [1 monotherapy trial (SURPASS-1) and 1 trial in combination with basal insulin with or without metformin (SURPASS-5)] in adult patients with type 2 diabetes mellitus [see Clinical Studies ( 14.2 , 14.4 )] . These data reflect exposure of 718 patients to MOUNJARO and a mean duration of exposure to MOUNJARO of 36.6 weeks. The mean age of patients was 58 years, 4% were 75 years or older and 54% were male. The population was 57% White, 27% Asian, 13% American Indian or Alaska Native, and 3% Black or African American; 25% identified as Hispanic or Latino ethnicity. At baseline, patients had type 2 diabetes mellitus for an average of 9.1 years with a mean HbA1c of 8.1%. As assessed by baseline fundoscopic examination, 13% of the population had retinopathy. At baseline, eGFR was ≥90 mL/min/1.73 m 2 in 53%, 60 to 90 mL/min/1.73 m 2 in 39%, 45 to 60 mL/min/1.73 m 2 in 7%, and 30 to 45 mL/min/1.73 m 2 in 1% of patients. Pool of Seven Controlled Clinical Trials Adverse reactions were also evaluated in a larger pool of adult patients with type 2 diabetes mellitus participating in seven controlled clinical trials which included two placebo-controlled trials (SURPASS-1 and -5), three trials of MOUNJARO in combination with metformin, sulfonylureas, and/or SGLT2 Inhibitors (SURPASS-2, -3, -4) [see Clinical Studies ( 14.3 )] and two additional trials conducted in Japan. In this pool, a total of 5119 adult patients with type 2 diabetes mellitus were treated with MOUNJARO for a mean duration of 48.1 weeks. The mean age of patients was 58 years, 4% were 75 years or older and 58% were male. The population was 65% White, 24% Asian, 7% American Indian or Alaska Native, and 3% Black or African American; 38% identified as Hispanic or Latino ethnicity. At baseline, patients had type 2 diabetes mellitus for an average of 9.1 years with a mean HbA1c of 8.3%. As assessed by baseline fundoscopic examination, 15% of the population had retinopathy. At baseline, eGFR was ≥90 mL/min/1.73 m 2 in 52%, 60 to 90 mL/min/1.73 m 2 in 40%, 45 to 60 mL/min/1.73 m 2 in 6%, and 30 to 45 mL/min/1.73 m 2 in 1% of patients. Common Adverse Reactions Table 1 shows common adverse reactions, not including hypoglycemia, associated with the use of MOUNJARO in the pool of placebo-controlled trials in adults. These adverse reactions occurred more commonly on MOUNJARO than on placebo and occurred in at least 5% of patients treated with MOUNJARO. Table 1: Adverse Reactions in Pool of Placebo-Controlled Trials Reported in ≥5% of MOUNJARO-treated Adult Patients with Type 2 Diabetes Mellitus Note: Percentages reflect the number of patients who reported at least 1 occurrence of the adverse reaction. Adverse Reaction Placebo (N=235) % MOUNJARO 5 mg (N=237) % MOUNJARO 10 mg (N=240) % MOUNJARO 15 mg (N=241) % Nausea 4 12 15 18 Diarrhea 9 12 13 17 Decreased Appetite 1 5 10 11 Vomiting 2 5 5 9 Constipation 1 6 6 7 Dyspepsia 3 8 8 5 Abdominal Pain 4 6 5 5 In the pool of seven clinical trials in adults, the types and frequency of common adverse reactions, not including hypoglycemia, were similar to those listed in Table 1 . Gastrointestinal Adverse Reactions In the pool of placebo-controlled trials in adults, gastrointestinal adverse reactions occurred more frequently among patients receiving MOUNJARO than placebo (placebo 20.4%, MOUNJARO 5 mg 37.1%, MOUNJARO 10 mg 39.6%, MOUNJARO 15 mg 43.6%). More patients receiving MOUNJARO 5 mg (3.0%), MOUNJARO 10 mg (5.4%), and MOUNJARO 15 mg (6.6%) discontinued treatment due to gastrointestinal adverse reactions than patients receiving placebo (0.4%). The majority of reports of nausea, vomiting, and/or diarrhea occurred during dose escalation and decreased over time. The following gastrointestinal adverse reactions were reported more frequently in MOUNJARO-treated adult patients than placebo-treated patients (frequencies listed, respectively, as: placebo; 5 mg; 10 mg; 15 mg): eructation (0.4%, 3.0%, 2.5%, 3.3%), flatulence (0%, 1.3%, 2.5%, 2.9%), gastroesophageal reflux disease (0.4%, 1.7%, 2.5%, 1.7%), abdominal distension (0.4%, 0.4%, 2.9%, 0.8%). Other Adverse Reactions in Adults Hypoglycemia Table 2 summarizes the incidence of hypoglycemic events in the placebo-controlled trials in adults. Table 2: Hypoglycemia Adverse Reactions in Placebo-Controlled Trials in Adult Patients with Type 2 Diabetes Mellitus Note: Percentages reflect the number of patients who reported at least 1 episode of hypoglycemia in respective categories. * Reflects the study treatment period. Data include events occurring during 4 weeks of treatment-free safety follow up. Events after introduction of a new glucose-lowering treatment are excluded. ** Episodes requiring the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Placebo % MOUNJARO 5 mg % MOUNJARO 10 mg % MOUNJARO 15 mg % Monotherapy (40 weeks)* N=115 N=121 N=119 N=120 Blood glucose <54 mg/dL 1 0 0 0 Severe hypoglycemia** 0 0 0 0 Add-on to Basal Insulin with or without Metformin (40 weeks)* N=120 N=116 N=119 N=120 Blood glucose <54 mg/dL 13 16 19 14 Severe hypoglycemia** 0 0 2 1 Hypoglycemia was more frequent when MOUNJARO was used in combination with a sulfonylurea [see Clinical Studies ( 14 )] . In an adult clinical trial up to 104 weeks of treatment, when administered with a sulfonylurea, hypoglycemia (glucose level <54 mg/dL) occurred in 13.8%, 9.9%, and 12.8%, and severe hypoglycemia occurred in 0.5%, 0%, and 0.6% of patients treated with MOUNJARO 5 mg, 10 mg, and 15 mg, respectively. Acute Pancreatitis In clinical studies, 14 events of acute pancreatitis were confirmed by adjudication in 13 MOUNJARO-treated adult patients (0.23 patients per 100 years of exposure) versus 3 events in 3 comparator-treated patients (0.11 patients per 100 years of exposure). Heart Rate Increase In the pool of placebo-controlled trials, treatment of adults with MOUNJARO resulted in a mean increase in heart rate of 2 to 4 beats per minute compared to a mean increase of 1 beat per minute in placebo-treated patients. Episodes of sinus tachycardia, associated with a concomitant increase from baseline in heart rate of ≥15 beats per minute, also were reported in 4.3%, 4.6%, 5.9% and 10% of subjects treated with placebo, MOUNJARO 5 mg, 10 mg, and 15 mg, respectively. For patients enrolled in Japan, these episodes were reported in 7% (3/43), 7.1% (3/42), 9.3% (4/43), and 23% (10/43) of patients treated with placebo, MOUNJARO 5 mg, 10 mg, and 15 mg, respectively. The clinical relevance of heart rate increases is uncertain. Hypersensitivity Reactions Hypersensitivity reactions have been reported with MOUNJARO in the pool of placebo-controlled trials in adults, sometimes severe (e.g., urticaria and eczema); hypersensitivity reactions were reported in 3.2% of MOUNJARO-treated patients compared to 1.7% of placebo-treated patients. In the pool of seven clinical trials in adults , hypersensitivity reactions occurred in 106/2,570 (4.1%) of MOUNJARO-treated adult patients with anti-tirzepatide antibodies and in 73/2,455 (3.0%) of MOUNJARO-treated patients who did not develop anti-tirzepatide antibodies. In the clinical trial in pediatric patients 10 years of age and older, hypersensitivity reactions occurred in 2/50 (4%) of MOUNJARO-treated pediatric patients with anti-tirzepatide antibodies and in 0/43 (0%) of MOUNJARO-treated pediatric patients who did not develop anti-tirzepatide antibodies [see Clinical Pharmacology ( 12.6 )]. Injection Site Reactions In the pool of placebo-controlled trials in adults, injection site reactions were reported in 3.2% of MOUNJARO-treated patients compared to 0.4% of placebo-treated patients. In the pool of seven clinical trials, injection site reactions occurred in 119/2,570 (4.6%) of MOUNJARO-treated adult patients with anti-tirzepatide antibodies and in 18/2,455 (0.7%) of MOUNJARO-treated adult patients who did not develop anti-tirzepatide antibodies. In the clinical trial in pediatric patients 10 years of age and older, injection site reactions occurred in 3/50 (6%) of MOUNJARO-treated pediatric patients with anti-tirzepatide antibodies and in 0/43 (0%) of MOUNJARO-treated pediatric patients who did not develop anti-tirzepatide antibodies [see Clinical Pharmacology ( 12.6 )]. Acute Gallbladder Disease In the pool of placebo-controlled clinical trials in adults, acute gallbladder disease (cholelithiasis, biliary colic and cholecystectomy) was reported by 0.6% of MOUNJARO-treated patients and 0% of placebo-treated patients. Dysesthesia In the pool of placebo-controlled clinical trials in adults, dysesthesia was reported by 0.4%, 0.4%, and 0.4% of patients treated with MOUNJARO 5 mg, 10 mg, and 15 mg, respectively. No events were reported by patients receiving placebo. Dysgeusia In the pool of placebo-controlled clinical trials in adults, dysgeusia was reported by 0.1% of MOUNJARO-treated patients and 0% of placebo-treated patients. Laboratory Abnormalities Amylase and Lipase Increase In the pool of placebo-controlled adult clinical trials, treatment with MOUNJARO resulted in mean increases from baseline in serum pancreatic amylase concentrations of 33% to 38% and serum lipase concentrations of 31% to 42%. Placebo-treated patients had a mean increase from baseline in pancreatic amylase of 4% and no changes were observed in lipase. The clinical significance of elevations in lipase or amylase with MOUNJARO is unknown in the absence of other signs and symptoms of pancreatitis. Adverse Reactions in the Clinical Trial of Pediatric Patients 10 Years of Age and Older with Type 2 Diabetes Mellitus MOUNJARO was administered to 97 pediatric patients 10 years of age and older with type 2 diabetes mellitus for a mean duration of 39.9 weeks [see Clinical Studies ( 14.5 )] . The mean age was 15 years and 61% of patients were female. The population was 58% White, 11% Black or African American, 6% Asian, 20% American Indian or Alaska Native, and 5% were other races; 66% identified as Hispanic or Latino ethnicity. At baseline, pediatric patients had type 2 diabetes mellitus for an average of 2.4 years with a mean HbA1c of 8.0%. The incidences of adverse reactions reported in pediatric patients treated with MOUNJARO 5 mg and 10 mg subcutaneously once-weekly were consistent with those described above for adult patients with type 2 diabetes mellitus with the exception of a higher incidence of vomiting, abdominal pain, and hypoglycemia. During the 30-week placebo-controlled period of the study, vomiting occurred in 3%, 16%, and 12% of patients and abdominal pain occurred in 9%, 22%, and 15% of patients treated with placebo, MOUNJARO 5 mg, and 10 mg, respectively. No severe hypoglycemia episodes were reported during the trial. Table 3 summarizes the incidence of hypoglycemic events with blood glucose <54 mg/dL in the trial. Table 3: Hypoglycemia Adverse Reactions in the 30 Week Trial of MOUNJARO Added to Metformin or Basal Insulin, or Both in Pediatric Patients 10 Years of Age and Older with Type 2 Diabetes Mellitus Note: Percentages reflect the number of patients who reported at least 1 episode of blood glucose <54 mg/dL. a Events after the introduction of a new glucose-lowering treatment are excluded. Placebo % MOUNJARO 5 mg % MOUNJARO 10 mg % Add on to basal insulin with or without metformin a N=10 N=10 N=11 Blood glucose <54 mg/dL 10 30 27 Add on to metformin alone a N=24 N=22 N=22 Blood glucose <54 mg/dL 4 9 9 6.2 Postmarketing Experience The following adverse reactions have been reported during post-approval use of MOUNJARO. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Hypersensitivity : anaphylaxis, angioedema Gastrointestinal : acute pancreatitis, hemorrhagic and necrotizing pancreatitis sometimes resulting in death, ileus, intestinal obstruction, severe constipation including fecal impaction Pulmonary : Pulmonary aspiration has occurred in patients receiving GLP-1 receptor agonists undergoing elective surgeries or procedures requiring general anesthesia or deep sedation Renal : acute renal failure or worsening of chronic renal failure, sometimes requiring hemodialysis Skin and Subcutaneous Tissue : alopecia

<table width="100%"><caption>Table 1: Adverse Reactions in Pool of Placebo-Controlled Trials Reported in &#x2265;5% of MOUNJARO-treated Adult Patients with Type 2 Diabetes Mellitus </caption><col width="24.040%" align="left"/><col width="19.240%" align="left"/><col width="18.260%" align="left"/><col width="20.200%" align="left"/><col width="18.260%" align="left"/><tfoot><tr><td colspan="5" align="left" valign="top"><paragraph>Note: Percentages reflect the number of patients who reported at least 1 occurrence of the adverse reaction. </paragraph></td></tr></tfoot><tbody><tr><td align="left" valign="top" styleCode="Toprule Botrule Lrule Rrule"><content styleCode="bold">Adverse Reaction</content></td><td align="center" valign="top" styleCode="Toprule Botrule Rrule"><content styleCode="bold">Placebo (N=235) %</content></td><td align="center" valign="top" styleCode="Toprule Botrule Rrule"><content styleCode="bold">MOUNJARO 5 mg (N=237) %</content></td><td align="center" valign="top" styleCode="Toprule Botrule Rrule"><content styleCode="bold">MOUNJARO 10 mg (N=240) %</content></td><td align="center" valign="top" styleCode="Toprule Botrule Rrule"><content styleCode="bold">MOUNJARO 15 mg (N=241) %</content></td></tr><tr><td align="left" valign="middle" styleCode="Botrule Lrule Rrule">Nausea </td><td align="center" valign="top" styleCode="Botrule Rrule">4 </td><td align="center" valign="top" styleCode="Botrule Rrule">12 </td><td align="center" valign="top" styleCode="Botrule Rrule">15 </td><td align="center" valign="top" styleCode="Botrule Rrule">18 </td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule">Diarrhea </td><td align="center" valign="top" styleCode="Botrule Rrule">9 </td><td align="center" valign="top" styleCode="Botrule Rrule">12 </td><td align="center" valign="top" styleCode="Botrule Rrule">13 </td><td align="center" valign="top" styleCode="Botrule Rrule">17 </td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule">Decreased Appetite </td><td align="center" valign="top" styleCode="Botrule Rrule">1 </td><td align="center" valign="top" styleCode="Botrule Rrule">5 </td><td align="center" valign="top" styleCode="Botrule Rrule">10 </td><td align="center" valign="top" styleCode="Botrule Rrule">11 </td></tr><tr><td align="left" valign="middle" styleCode="Botrule Lrule Rrule">Vomiting </td><td align="center" valign="top" styleCode="Botrule Rrule">2 </td><td align="center" valign="top" styleCode="Botrule Rrule">5 </td><td align="center" valign="top" styleCode="Botrule Rrule">5 </td><td align="center" valign="top" styleCode="Botrule Rrule">9 </td></tr><tr><td align="left" valign="middle" styleCode="Botrule Lrule Rrule">Constipation </td><td align="center" valign="top" styleCode="Botrule Rrule">1 </td><td align="center" valign="top" styleCode="Botrule Rrule">6 </td><td align="center" valign="top" styleCode="Botrule Rrule">6 </td><td align="center" valign="top" styleCode="Botrule Rrule">7 </td></tr><tr><td align="left" valign="middle" styleCode="Botrule Lrule Rrule">Dyspepsia </td><td align="center" valign="top" styleCode="Botrule Rrule">3 </td><td align="center" valign="top" styleCode="Botrule Rrule">8 </td><td align="center" valign="top" styleCode="Botrule Rrule">8 </td><td align="center" valign="top" styleCode="Botrule Rrule">5 </td></tr><tr><td align="left" valign="middle" styleCode="Botrule Lrule Rrule">Abdominal Pain </td><td align="center" valign="top" styleCode="Botrule Rrule">4 </td><td align="center" valign="top" styleCode="Botrule Rrule">6 </td><td align="center" valign="top" styleCode="Botrule Rrule">5 </td><td align="center" valign="top" styleCode="Botrule Rrule">5 </td></tr></tbody></table>

<table width="100%"><caption>Table 2: Hypoglycemia Adverse Reactions in Placebo-Controlled Trials in Adult Patients with Type 2 Diabetes Mellitus </caption><col width="32.320%" align="left"/><col width="16.660%" align="left"/><col width="16.680%" align="left"/><col width="16.680%" align="left"/><col width="17.660%" align="left"/><tfoot><tr><td colspan="5" align="left" valign="top"><paragraph>Note: Percentages reflect the number of patients who reported at least 1 episode of hypoglycemia in respective categories. </paragraph></td></tr><tr><td colspan="5" align="left" valign="top"><paragraph>* Reflects the study treatment period. Data include events occurring during 4 weeks of treatment-free safety follow up. Events after introduction of a new glucose-lowering treatment are excluded. </paragraph></td></tr><tr><td colspan="5" align="left" valign="top"><paragraph>** Episodes requiring the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. </paragraph></td></tr><tr><td colspan="5" align="left" valign="top"/></tr></tfoot><tbody><tr><td align="left" valign="top" styleCode="Toprule Botrule Lrule Rrule"/><td align="center" valign="top" styleCode="Toprule Botrule Rrule"><content styleCode="bold">Placebo </content> <content styleCode="bold">%</content></td><td align="center" valign="top" styleCode="Toprule Botrule Rrule"><content styleCode="bold">MOUNJARO 5 mg</content> <content styleCode="bold">%</content></td><td align="center" valign="top" styleCode="Toprule Botrule Rrule"><content styleCode="bold">MOUNJARO 10 mg</content> <content styleCode="bold">%</content></td><td align="center" valign="top" styleCode="Toprule Botrule Rrule"><content styleCode="bold">MOUNJARO 15 mg</content> <content styleCode="bold">%</content></td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule">Monotherapy </td><td align="center" valign="top" styleCode="Botrule Rrule"/><td align="center" valign="top" styleCode="Botrule Rrule"/><td align="center" valign="top" styleCode="Botrule Rrule"/><td align="center" valign="top" styleCode="Botrule Rrule"/></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule"> (40 weeks)* </td><td align="center" valign="top" styleCode="Botrule Rrule">N=115 </td><td align="center" valign="top" styleCode="Botrule Rrule">N=121 </td><td align="center" valign="top" styleCode="Botrule Rrule">N=119 </td><td align="center" valign="top" styleCode="Botrule Rrule">N=120 </td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule"> Blood glucose &lt;54 mg/dL </td><td align="center" valign="top" styleCode="Botrule Rrule">1 </td><td align="center" valign="top" styleCode="Botrule Rrule">0 </td><td align="center" valign="top" styleCode="Botrule Rrule">0 </td><td align="center" valign="top" styleCode="Botrule Rrule">0 </td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule"> Severe hypoglycemia** </td><td align="center" valign="top" styleCode="Botrule Rrule">0 </td><td align="center" valign="top" styleCode="Botrule Rrule">0 </td><td align="center" valign="top" styleCode="Botrule Rrule">0 </td><td align="center" valign="top" styleCode="Botrule Rrule">0 </td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule">Add-on to Basal Insulin with or without Metformin </td><td align="center" valign="top" styleCode="Botrule Rrule"/><td align="center" valign="top" styleCode="Botrule Rrule"/><td align="center" valign="top" styleCode="Botrule Rrule"/><td align="center" valign="top" styleCode="Botrule Rrule"/></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule"> (40 weeks)* </td><td align="center" valign="top" styleCode="Botrule Rrule">N=120 </td><td align="center" valign="top" styleCode="Botrule Rrule">N=116 </td><td align="center" valign="top" styleCode="Botrule Rrule">N=119 </td><td align="center" valign="top" styleCode="Botrule Rrule">N=120 </td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule"> Blood glucose &lt;54 mg/dL </td><td align="center" valign="top" styleCode="Botrule Rrule">13 </td><td align="center" valign="top" styleCode="Botrule Rrule">16 </td><td align="center" valign="top" styleCode="Botrule Rrule">19 </td><td align="center" valign="top" styleCode="Botrule Rrule">14 </td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule"> Severe hypoglycemia** </td><td align="center" valign="top" styleCode="Botrule Rrule">0 </td><td align="center" valign="top" styleCode="Botrule Rrule">0 </td><td align="center" valign="top" styleCode="Botrule Rrule">2 </td><td align="center" valign="top" styleCode="Botrule Rrule">1 </td></tr></tbody></table>

<table width="100%"><caption>Table 3: Hypoglycemia Adverse Reactions in the 30 Week Trial of MOUNJARO Added to Metformin or Basal Insulin, or Both in Pediatric Patients 10 Years of Age and Older with Type 2 Diabetes Mellitus </caption><col width="61.460%" align="left"/><col width="10.097%" align="left"/><col width="14.221%" align="left"/><col width="14.221%" align="left"/><tfoot><tr><td colspan="4" align="left" valign="top"><paragraph>Note: Percentages reflect the number of patients who reported at least 1 episode of blood glucose &lt;54 mg/dL. </paragraph></td></tr><tr><td colspan="4" align="left" valign="top"><paragraph>^a Events after the introduction of a new glucose-lowering treatment are excluded. </paragraph></td></tr></tfoot><tbody><tr><td align="left" valign="top" styleCode="Toprule Botrule Lrule Rrule"/><td align="center" valign="top" styleCode="Toprule Botrule Rrule"><content styleCode="bold">Placebo</content> <content styleCode="bold">%</content></td><td align="center" valign="top" styleCode="Toprule Botrule Rrule"><content styleCode="bold">MOUNJARO</content> <content styleCode="bold">5 mg</content> <content styleCode="bold">%</content></td><td align="center" valign="top" styleCode="Toprule Botrule Rrule"><content styleCode="bold">MOUNJARO</content> <content styleCode="bold">10 mg</content> <content styleCode="bold">%</content></td></tr><tr><td align="left" valign="middle" styleCode="Botrule Lrule Rrule">Add on to basal insulin with or without metformin^a</td><td align="center" valign="middle" styleCode="Botrule Rrule">N=10 </td><td align="center" valign="middle" styleCode="Botrule Rrule">N=10 </td><td align="center" valign="middle" styleCode="Botrule Rrule">N=11 </td></tr><tr><td align="left" valign="middle" styleCode="Botrule Lrule Rrule"> Blood glucose &lt;54 mg/dL </td><td align="center" valign="middle" styleCode="Botrule Rrule">10 </td><td align="center" valign="middle" styleCode="Botrule Rrule">30 </td><td align="center" valign="middle" styleCode="Botrule Rrule">27 </td></tr><tr><td align="left" valign="middle" styleCode="Botrule Lrule Rrule">Add on to metformin alone^a</td><td align="center" valign="middle" styleCode="Botrule Rrule">N=24 </td><td align="center" valign="middle" styleCode="Botrule Rrule">N=22 </td><td align="center" valign="middle" styleCode="Botrule Rrule">N=22 </td></tr><tr><td align="left" valign="middle" styleCode="Botrule Lrule Rrule"> Blood glucose &lt;54 mg/dL </td><td align="center" valign="middle" styleCode="Botrule Rrule">4 </td><td align="center" valign="middle" styleCode="Botrule Rrule">9 </td><td align="center" valign="middle" styleCode="Botrule Rrule">9 </td></tr></tbody></table>