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Zepbound ™ (tirzepatide) injection
2.5 mg/ 5 mg/ 7.5 mg/ 10 mg/ 12.5 mg/ 15 mg
This information is provided in response to your request. Resources may contain information about doses, uses, formulations and populations different from product labeling. See Prescribing Information above, if applicable.
What is the incidence of pancreatitis associated with Zepbound™ (tirzepatide)?
In clinical studies, 0.2% of Zepbound-treated participants had acute pancreatitis versus 0.2% of placebo-treated participants.
See important safety information, including boxed warning, in the attached prescribing information.
Zepbound is a glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide‑1 (GLP‑1) receptor agonist indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index (BMI) of
- 30 kg/m2 or greater (obesity) or
- 27 kg/m2 or greater (overweight) with at least 1 weight-related comorbid condition (eg, hypertension, dyslipidemia, type 2 diabetes [T2D], obstructive sleep apnea, or cardiovascular disease).1
Prescribing Information Related to Pancreatitis
Acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis, has been observed in patients treated with GLP-1 receptor agonists or tirzepatide.1
In clinical trials of tirzepatide for a different indication, 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
In Zepbound clinical trials, 0.2% of tirzepatide-treated patients had acute pancreatitis confirmed by adjudication (0.14 patients per 100 years of exposure) versus 0.2% of placebo-treated patients (0.15 patients per 100 years of exposure).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
Warnings and Precautions
After initiation of tirzepatide, observe patients carefully for signs and symptoms of pancreatitis (including persistent severe abdominal pain, sometimes radiating to the back, which may or may not be accompanied by vomiting).1
If pancreatitis is suspected,
- discontinue tirzepatide, and
- initiate appropriate management.1
If the diagnosis of pancreatitis is confirmed, tirzepatide should not be restarted.1
Enclosed Prescribing Information
1Zepbound [package insert]. Indianapolis, IN: Eli Lilly and Company; 2023.
Date of Last Review: November 08, 2023