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

The use of tirzepatide in patients undergoing surgical procedures or hospitalization has not been evaluated.

Tirzepatide delays gastric emptying. There have been rare postmarketing reports of pulmonary aspiration in patients receiving glucagon-like peptide-1 (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.1 

Available data are insufficient to inform recommendations to mitigate the risk of pulmonary aspiration during general anesthesia or deep sedation in patients taking tirzepatide, including whether modifying preoperative fasting recommendations or temporarily discontinuing tirzepatide 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 tirzepatide.1

Health care providers should use patient medical records and their clinical judgement to make a treatment recommendation. The additional considerations below may be helpful to determine what is best for their patient (Pharmacokinetics and Pharmacodynamics, Drug Interactions, Warnings and Precautions).

Administer tirzepatide

• once weekly
• any time of day, and
• with or without food.1

Tirzepatide should be injected subcutaneously in the abdomen, thigh, or upper arm.1

Following subcutaneous administration, the time to maximum plasma concentration of tirzepatide ranges from 8 to 72 hours.1

Steady-state plasma tirzepatide concentrations were achieved following 4 weeks of once-weekly administration.1

Tirzepatide is highly bound to plasma albumin (99%).1

The elimination half-life of tirzepatide is approximately 5 days.1

For full information on pharmacokinetics, please refer to the enclosed prescribing information.1 

Because tirzepatide delays gastric emptying, it could potentially impact the absorption of concomitantly administered oral medications. The impact of tirzepatide on gastric emptying was greatest after a single dose of 5 mg and diminished after subsequent doses.1

Patients on oral medications dependent on threshold concentrations for efficacy and those with a narrow therapeutic index (eg, warfarin) should be monitored when concomitantly administered with tirzepatide.1

In vitro studies of tirzepatide showed low potential to inhibit or induce CYP enzymes, and to inhibit drug transporters.1

Following first dose of tirzepatide 5 mg, acetaminophen maximum concentration (C_max) was reduced by 50% and the median peak plasma concentration (t_max) occurred 1 hour later. After coadministration at week 4, there was no meaningful impact on acetaminophen C_max and t_max. Overall acetaminophen exposure (AUC_0-24h) was not influenced.1

For full information on drug interactions, please refer to the enclosed prescribing information.1 

Tirzepatide should not be used in patients with a

• personal or family history of medullary thyroid carcinoma (MTC) or in patients with multiple endocrine neoplasia syndrome type 2 (MEN 2), or
• known serious hypersensitivity to tirzepatide or any of the excipients in tirzepatide.1 

Serious hypersensitivity reactions, including anaphylaxis and angioedema, have been reported with tirzepatide.1

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

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 tirzepatideand initiate appropriate management.1

There have been postmarketing reports of acute kidney injury, in some cases requiring hemodialysis, in patients treated with GLP-1 receptor agonist or tirzepatide.1

The majority of the reported events occurred in patients who experienced gastrointestinal adverse reactions leading to dehydration, such as 

• nausea
• vomiting, or
• diarrhea.1

Monitor renal function in patients reporting adverse reactions to tirzepatide that could lead to volume depletion, especially during dosage initiation and escalation of tirzepatide.1

Use of tirzepatide has been associated with gastrointestinal adverse reactions, sometimes severe. In the pool of placebo-controlled trials, severe gastrointestinal adverse reactions occurred more frequently among patients receiving tirzepatide (5 mg 1.3%, 10 mg 0.4%, 15 mg 1.2%) than placebo (0.9%).1 

Tirzepatide is not recommended in patients with severe gastroparesis.1

For full information on precautions, please refer to the enclosed prescribing information.1 

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