Important Regulatory Note:
Compounded oral GLP-1 medications are not approved by the U.S. Food and Drug Administration (FDA). These formulations are prepared by licensed U.S. compounding pharmacies based on a healthcare provider’s prescription, typically when commercially available options are clinically unsuitable. These products have not undergone FDA review for safety, effectiveness, or quality assurance.

Intended Use:
Compounded oral GLP-1 medications may be prescribed for chronic weight management in adults with:

• A body mass index (BMI) ≥30 kg/m² (obesity), or
• A BMI ≥27 kg/m² (overweight) with one or more weight-related comorbidities (e.g., type 2 diabetes, high blood pressure, or high cholesterol).
  They should be used in combination with a reduced-calorie diet and increased physical activity.
  
  

Contraindications:
Do not use compounded oral GLP-1 medications if:

• You or a family member has a history of medullary thyroid carcinoma (MTC)
• You have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
• You have a known allergy to GLP-1 receptor agonists or to any ingredients in the compounded formulation
  
  

Warnings & Serious Risks:

• Thyroid tumors: Risk observed in animal studies; human relevance unknown.
• Pancreatitis: Discontinue and seek medical care if you experience severe or persistent abdominal pain.
• Gallbladder disease: Monitor for symptoms such as right upper abdominal pain, jaundice, or pale stools.
• Kidney issues: Dehydration from nausea, vomiting, or diarrhea may worsen kidney function.
• Hypoglycemia: May occur when used in combination with insulin or sulfonylureas.
• Vision changes: May exacerbate diabetic retinopathy in at-risk individuals.
• Mental health risks: Monitor for mood swings, depression, or suicidal thoughts.
• Gastrointestinal intolerance: Use caution if you have a history of severe GI conditions or gastroparesis.
  
  

Common Side Effects:

• Nausea
• Diarrhea
• Constipation
• Headache
• Abdominal discomfort
• Fatigue
• Indigestion
• Decreased appetite

These effects typically improve as your body adjusts to treatment.

Drug Interactions:
Compounded oral GLP-1 medications may:

• Delay gastric emptying and affect absorption of oral medications
• Require caution when taken with:
  • Oral contraceptives (use backup contraception as advised)
  • Medications with narrow therapeutic windows (e.g., warfarin)
  • Insulin or sulfonylureas (risk of hypoglycemia)

Always inform your provider of all medications, supplements, and herbs you are taking.

Pregnancy & Breastfeeding:

• Not recommended during pregnancy. Discontinue at least 2 months prior to planned conception.
• Unknown if active ingredients pass into breast milk. Avoid use while breastfeeding unless explicitly approved by your healthcare provider.

Administration:
Take exactly as prescribed by your healthcare provider. Do not crush or chew unless instructed. Some compounded oral GLP-1 medications may require specific timing relative to meals or hydration status—follow your provider’s or pharmacy’s guidance closely.

Storage:
Store in a cool, dry place at room temperature unless otherwise instructed. Protect from moisture and direct sunlight. Do not use past expiration date.

Emergency Situations:
Seek emergency care for signs of allergic reaction, severe vomiting, symptoms of pancreatitis, or significant mood changes. For life-threatening symptoms, call 911 immediately.

Disclaimer:
This information is intended for educational purposes only and does not replace professional medical advice. Compounded medications are prescribed off-label and are not FDA-evaluated. Speak with your licensed healthcare provider before starting or stopping any medication. Adverse effects can be reported to the FDA via 1-800-FDA-1088 or www.fda.gov/medwatch