Book NowIndications and Usage:Tirzepatide is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Warnings and Precautions:
- Pancreatitis: There have been post-marketing reports of acute pancreatitis in patients treated with tirzepatide. Inform patients of the symptoms of acute pancreatitis, such as severe abdominal pain that may radiate to the back, and discontinue tirzepatide immediately if pancreatitis is suspected.
- Hypoglycemia: When tirzepatide is used with an insulin secretagogue (e.g., sulfonylurea) or insulin, the risk of hypoglycemia may be increased. Consider lowering the dose of the insulin secretagogue or insulin to reduce this risk.
- Gastrointestinal Adverse Reactions: Tirzepatide may cause gastrointestinal side effects, including nausea, vomiting, diarrhea, and abdominal pain. These reactions are usually mild to moderate but can be severe. To minimize these effects, tirzepatide should be introduced gradually.
- Renal Impairment: Tirzepatide should be used with caution in patients with renal impairment. Gastrointestinal adverse reactions may lead to dehydration, which could worsen renal function.
- Hypersensitivity Reactions: Hypersensitivity reactions, including anaphylaxis and angioedema, have been reported in patients treated with tirzepatide. Discontinue tirzepatide if a serious hypersensitivity reaction occurs and initiate appropriate treatment.
- Thyroid C-cell Tumors: In animal studies, tirzepatide caused an increase in thyroid C-cell tumors. It is unknown whether tirzepatide causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans. Tirzepatide is contraindicated in patients with a personal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
Contraindications:
- Personal or family history of MTC or MEN 2.
- History of serious hypersensitivity reactions to tirzepatide or any of its components.
Common Side Effects:
The most common side effects of tirzepatide include:
- Nausea
- Diarrhea
- Vomiting
- Constipation
- Abdominal pain
- Decreased appetite
Dosing Information:
- Tirzepatide is administered once weekly, with or without food.
- Dose adjustments may be necessary based on the patient’s response and tolerability.
Patient Counseling Information:
- Advise patients on the symptoms of pancreatitis, hypoglycemia, and severe gastrointestinal issues, and instruct them to seek medical attention if these occur.
- Instruct patients to report any unusual lumps or swelling in the neck, hoarseness, or difficulty swallowing, as these may be signs of thyroid tumors.
Clinical Trials Information:
- In clinical trials, tirzepatide was shown to improve glycemic control and reduce body weight in adults with type 2 diabetes. However, these benefits must be weighed against the potential risks outlined above.
Reporting Adverse Events:
- Patients and healthcare providers are encouraged to report any adverse reactions or side effects to the FDA MedWatch program at www.fda.gov/medwatch or by calling 1-800-FDA-1088.
For more detailed information, please refer to the full prescribing information.
