Tirzepatide (Mounjaro®)

Safety information from the label

This is not a complete list. Read the package insert and talk to your doctor and pharmacist.

From the Mounjaro® label

• Most common adverse reactions (reported in 5% or more of patients treated with Mounjaro): nausea, diarrhea, decreased appetite, vomiting, constipation, dyspepsia, and abdominal pain.
• Patients taking tirzepatide together with an insulin secretagogue (for example a sulfonylurea) or insulin may have a higher risk of hypoglycemia, including severe hypoglycemia.

From the Zepbound® label (also tirzepatide)

• Boxed warning: in rats, tirzepatide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures. It is unknown whether it causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans. It is contraindicated in patients with a personal or family history of MTC or with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
• Treatment with tirzepatide and GLP-1 receptor agonists is associated with more cases of acute gallbladder disease.
• Acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis, has been seen in patients treated with GLP-1 receptor agonists or tirzepatide.
• Tirzepatide may make oral hormonal contraceptives less effective. The label advises users to switch to a non-oral method, or add a barrier method, for 4 weeks after starting and for 4 weeks after each dose increase.
• Serious hypersensitivity reactions (for example anaphylaxis and angioedema) have been reported after marketing. In patients with type 2 diabetes, temporary worsening of diabetic retinopathy has been reported with rapid improvement in glucose control. Rare reports of pulmonary aspiration have occurred in patients on GLP-1 receptor agonists undergoing elective surgery or procedures under general anesthesia or deep sedation.

How it is used

• Mounjaro label: "Administer once weekly at any time of day, with or without meals. Inject subcutaneously in the abdomen, thigh, or have another person inject in the back of the upper arm. Rotate injection sites with each dose."
• The Medication Guide warns: "Do not share your MOUNJARO KwikPen or needles with other people, even if the needle has been changed. You may give other people a serious infection, or get a serious infection from them."

Sources