Important Safety Information for Tirzepatide

Indications:
Tirzepatide is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

It is not approved by the U.S. Food and Drug Administration (FDA) for weight loss. Licensed clinicians may, at their discretion, prescribe Tirzepatide off-label for metabolic or weight-related care when clinically appropriate.

Contraindications:
Tirzepatide is contraindicated 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).
 It should not be used in patients with a history of severe gastrointestinal disease, including gastroparesis.

Do not use Tirzepatide in patients with a known hypersensitivity to the medication or any of its components.

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. The relevance of these findings to humans has not been determined. Patients should be evaluated for risk factors prior to starting therapy and monitored for signs or symptoms of thyroid tumors (such as a neck mass, difficulty swallowing, or persistent hoarseness).

Pancreatitis:
 Acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis, has been reported in patients treated with GLP-1 receptor agonists. Patients should be informed of the possible symptoms of pancreatitis (such as severe abdominal pain that may radiate to the back, with or without vomiting) and instructed to stop using Tirzepatide and seek immediate medical attention if they occur.

Hypoglycemia with Concomitant Use of Insulin or Insulin Secretagogues:
 The risk of hypoglycemia is increased when Tirzepatide is used in combination with insulin or insulin secretagogues (for example, sulfonylureas). A reduction in the dose of these agents may be required to lower the risk of low blood sugar.

Acute Kidney Injury:
 Cases of acute renal failure and worsening of chronic renal failure have been reported in patients receiving GLP-1 receptor agonists. Renal function should be monitored in patients who experience nausea, vomiting, or dehydration, particularly those with pre-existing kidney disease.

Hypersensitivity Reactions:
 Serious hypersensitivity reactions — including anaphylaxis (severe allergic reaction), angioedema (swelling of the face, lips, or throat), and urticaria (hives) — have been reported in patients using Tirzepatide. If a hypersensitivity reaction occurs, discontinue Tirzepatide immediately and initiate appropriate medical treatment.

Gastrointestinal Adverse Reactions:
Nausea, vomiting, diarrhea, and constipation are among the most common side effects of Tirzepatide. These reactions are generally mild to moderate, tend to decrease over time, and may be managed by adjusting the dosage. Caution is advised in patients with severe gastrointestinal disease.

Adverse Reactions:
 The most commonly reported 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 recommended to discontinue Tirzepatide at least two months before a planned pregnancy.

It is unknown whether Tirzepatide is excreted in human milk. Use caution when administering Tirzepatide to breastfeeding individuals, and discuss potential risks and benefits with a qualified healthcare provider.

Drug Interactions:
Caution should be exercised when Tirzepatide is co-administered with medications that affect gastrointestinal motility or absorption, or those that may increase the risk of hypoglycemia. Patients should be closely monitored when starting or adjusting such therapies.

Patient Counseling Information:
Patients should be advised on the potential risks and benefits of Tirzepatide therapy, including possible gastrointestinal reactions, hypoglycemia (particularly when combined with insulin or insulin secretagogues), and the importance of maintaining a balanced diet and regular exercise routine.

Patients should be instructed to recognize and report any symptoms of thyroid tumors, pancreatitis, or allergic reactions promptly. Regular follow-up with a healthcare provider is recommended to monitor progress and manage side effects.

Note:
This information is provided for educational purposes only and does not replace professional medical advice. Patients should consult a licensed healthcare provider to determine whether Tirzepatide therapy is appropriate for their individual circumstances.

Compounded Tirzepatide is not FDA-approved, and the FDA has not evaluated compounded medications for safety, effectiveness, or quality.