Important Safety Information for GLP-1 Microdose Therapy

Indications: GLP-1 microdose therapy is prescribed as part of a clinician-directed wellness plan to support appetite regulation, metabolic health, and glycemic control in appropriate adult patients. It is not intended to replace diet and exercise.

Contraindications: GLP-1 microdose therapy should not be used in patients with:

• A personal or family history of medullary thyroid carcinoma (MTC)
• Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
• A history of severe gastrointestinal disease, including gastroparesis
• Known hypersensitivity to GLP-1 receptor agonists or any component of the formulation

Warnings and Precautions:

Risk of Thyroid C-Cell Tumors:
GLP-1 receptor agonists have been associated with an increased risk of thyroid C-cell tumors in animal studies. While the relevance to humans is unknown, patients should be evaluated for thyroid-related risk factors prior to initiation and monitored for symptoms such as a neck mass, difficulty swallowing, or persistent hoarseness.

Pancreatitis:
Acute pancreatitis has been reported in patients receiving GLP-1 receptor agonists. Patients should be advised to discontinue therapy and seek medical attention if they experience persistent, severe abdominal pain that may radiate to the back, with or without vomiting.

Hypoglycemia with Concomitant Use of Insulin or Insulin Secretagogues:
The risk of hypoglycemia may be increased when GLP-1 therapy is used in combination with insulin or insulin secretagogues. Dose adjustments of concomitant medications may be necessary.

Acute Kidney Injury:
Cases of acute kidney injury and worsening of chronic renal failure have been reported, particularly in patients experiencing significant gastrointestinal side effects such as nausea, vomiting, or dehydration. Renal function should be monitored in patients with underlying kidney disease.

Hypersensitivity Reactions:
Serious hypersensitivity reactions, including anaphylaxis and angioedema, have been reported with GLP-1 receptor agonists. If a hypersensitivity reaction occurs, discontinue therapy immediately and seek medical care.

Gastrointestinal Adverse Reactions:
Common gastrointestinal side effects may include nausea, vomiting, diarrhea, constipation, and abdominal discomfort. These effects are often dose-related and may improve over time or with dose adjustments.

Adverse Reactions:
The most commonly reported adverse reactions with GLP-1 therapy include nausea, vomiting, diarrhea, constipation, abdominal pain, decreased appetite, and fatigue.

Pregnancy and Lactation:
GLP-1 microdose therapy should not be used during pregnancy due to potential risk to the fetus. It is unknown whether GLP-1 medications are excreted in human milk; caution should be exercised when administering to breastfeeding individuals.

Drug Interactions:
GLP-1 therapy may affect gastrointestinal motility and the absorption of oral medications. Caution should be used when co-administering medications that require rapid gastrointestinal absorption or those that increase the risk of hypoglycemia.

Patient Counseling Information:
Patients should be counseled on the potential risks and benefits of GLP-1 microdose therapy, including possible gastrointestinal side effects, the importance of hydration, adherence to prescribed dosing, and maintaining healthy dietary and lifestyle habits. Patients should also be educated on the signs and symptoms of thyroid tumors, pancreatitis, hypoglycemia, and hypersensitivity reactions.

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