Compounded Tirzepatide — Important Safety Information
Risk of thyroid C-cell tumors, pancreatitis, hypoglycemia, and gastrointestinal effects. Not for pregnancy or MTC/MEN 2 history.
Compounded drugs are permitted to be prescribed under federal law, but are not FDA-approved and do not undergo FDA safety, effectiveness, or manufacturing review. Your EOS Health-affiliated provider may recommend this medication based on your individual medical evaluation.
Indications: Tirzepatide is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Contraindications
Tirzepatide is contraindicated in patients with a personal or family history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). It should not be used in patients with a history of severe gastrointestinal disease, including gastroparesis.
Warnings and Precautions
- Risk of Thyroid C-Cell Tumors: Cases of MTC have been reported in patients treated with GLP-1 receptor agonists, including tirzepatide. Patients should be assessed for risk factors prior to initiation and monitored for signs and symptoms of thyroid tumors.
- Pancreatitis: Acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis, has been reported with GLP-1 receptor agonists. Discontinue tirzepatide and seek medical attention if symptoms occur.
- Hypoglycemia with concomitant insulin or insulin secretagogues: Dose adjustments may be required.
- Acute Kidney Injury: Cases of acute renal failure and worsening chronic renal failure have been reported. Monitor renal function and exercise caution in patients with renal impairment.
- Hypersensitivity Reactions: Serious reactions, including anaphylaxis, angioedema, and urticaria, have been reported. Discontinue and initiate appropriate medical treatment.
- Gastrointestinal Adverse Reactions: Nausea, vomiting, diarrhea, and constipation may occur. These may decrease over time or with dose reduction.
Adverse Reactions
The most common adverse reactions (≥5%) associated with tirzepatide include nausea, vomiting, diarrhea, abdominal pain, and constipation.
Pregnancy and Lactation
Tirzepatide should not be used during pregnancy as it may cause fetal harm. It is unknown whether tirzepatide is excreted in human milk; caution should be exercised when administering to breastfeeding women.
Drug Interactions
Caution should be exercised when co-administering tirzepatide with other drugs that affect gastrointestinal motility or absorption, as well as drugs that may increase the risk of hypoglycemia.
Patient Counseling
Patients should be counseled on the risks and benefits of tirzepatide therapy, including the potential for gastrointestinal adverse reactions, hypoglycemia, and the importance of adherence to diet and exercise. Patients should also be educated on the signs and symptoms of thyroid tumors, pancreatitis, and hypersensitivity reactions.
You are encouraged to report negative side effects to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
This information is not comprehensive. Please reach out to your EOS Health-affiliated provider with any questions or concerns.