See important safety information, including boxed warning, in the attached prescribing information.

Acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis, has been observed in patients treated with glucagon-like peptide-1 (GLP-1) receptor agonists.1

Tirzepatide 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 tirzepatide.1

After initiation of tirzepatide, observe patients carefully for signs and symptoms of pancreatitis (including persistent severe abdominal pain sometimes radiating to the back and which may or may not be accompanied by vomiting).1

If pancreatitis is suspected,

• discontinue tirzepatide, and
• initiate appropriate management.1

In tirzepatide clinical studies in adults with type 2 diabetes (T2D), 14 events 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 patients (0.11 patients per 100 years of exposure).1

The preferred terms pancreatitis and pancreatitis acute have been very rarely reported in the Global Patient Safety (GPS) spontaneous database.2

Very rarely is defined as an adverse event that has been reported at an estimated rate of <0.01% according to the GPS database.2

These data do not represent the rate of occurrence of an adverse event in the treated population; they merely represent the rate of reporting of a particular adverse event to the company.2

Spontaneous reporting of adverse events can be highly variable and is not controlled clinical information on which to base an assessment of whether a particular drug product caused an event.2

Spontaneous reporting is also limited in usage due to a bias in reporting, including

• incomplete information concerning the patient as with an unknown medical history
• unknown concomitant medications and disease states, and
• under reporting.2

The GPS database may also include reports of adverse events for products that may be available from Eli Lilly and Company and from other manufacturers. Although verification of product manufacturer is sought, this verification is not always obtainable. The default for these cases is to include them in the GPS database.2

Due to the dynamic nature of the GPS database, this information is valid for data received through May 13, 2024.2

MOUNJARO® (tirzepatide) injection, for subcutaneous use, Lilly