zepbound®

Prescribing information and black box warning

WARNING: RISK OF THYROID C-CELL TUMORS

• In animal studies, tirzepatide caused thyroid C-cell tumors. It is unknown if Zepbound® causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans.

• Zepbound® is contraindicated in patients with a personal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).

• Advise patients to report any symptoms of thyroid tumors, such as a lump in the neck, difficulty swallowing, hoarseness, or shortness of breath.

Contraindications:

• Personal or family history of MTC or MEN 2.

• Known serious hypersensitivity to tirzepatide or any of its components.

Warnings and Precautions:

• Pancreatitis: Acute pancreatitis has been reported. Monitor for signs and symptoms; discontinue if pancreatitis is suspected.

• Hypoglycemia: When used with insulin or insulin secretagogues, the risk of hypoglycemia increases. Monitor blood glucose levels and consider dose adjustments.

• Renal Impairment: Monitor renal function in patients reporting severe adverse gastrointestinal reactions.

• Hypersensitivity Reactions: Serious hypersensitivity reactions, including anaphylaxis and angioedema, have been reported. Discontinue if a serious reaction occurs and treat promptly.

• Acute Gallbladder Disease: Gallbladder-related events, such as cholelithiasis, have been reported. Monitor patients for signs and symptoms of gallbladder disease.

Adverse Reactions:

• The most common adverse reactions (≥5%) include nausea, diarrhea, vomiting, constipation, abdominal pain, and decreased appetite.

Drug Interactions:

• Zepbound® delays gastric emptying, which may impact the absorption of oral medications. Monitor the effects of concomitant oral medications.

Use in Specific Populations:

• Pregnancy: Limited data; use only if the potential benefit justifies the potential risk to the fetus.

• Lactation: There are no data on the presence of tirzepatide in human milk; consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for Zepbound®.

• Pediatric Use: Safety and effectiveness have not been established in pediatric patients.

• Geriatric Use: No overall differences in safety or effectiveness were observed between elderly and younger patients, but greater sensitivity in some older individuals cannot be ruled out.

Administration:

• Administer Zepbound® once weekly, at any time of day, with or without meals.

• Inject subcutaneously in the abdomen, thigh, or upper arm. Rotate injection sites with each dose.

Patient Counseling Information:

• Advise patients to read the Medication Guide before starting Zepbound® and each time the prescription is renewed.

• Instruct patients on proper injection technique and the importance of rotating injection sites.

• Inform patients about the potential risks and benefits of Zepbound®.

• Encourage patients to report any adverse reactions or concerns promptly.

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