Important Regulatory Note:
Compounded sublingual GLP-1 medications are not approved by the U.S. Food and Drug Administration (FDA). They are formulated by licensed compounding pharmacies upon a healthcare provider’s prescription, typically when injectable or commercial oral options are not suitable. These products have not undergone FDA review for safety, effectiveness, or manufacturing quality.

Intended Use:
Sublingual GLP-1 medications may be prescribed for adults with:

• A body mass index (BMI) ≥30 kg/m² (obesity), or
• A BMI ≥27 kg/m² (overweight) with at least one weight-related comorbidity (e.g., type 2 diabetes, high blood pressure, or elevated cholesterol).
  They are used as part of a comprehensive weight management plan that includes a calorie-restricted diet and increased physical activity.
  
  

Contraindications:
Do not use sublingual GLP-1 if you:

• Have a personal or family history of medullary thyroid carcinoma (MTC)
• Have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
• Are allergic to GLP-1 receptor agonists or any ingredients in the sublingual formulation
  
  

Warnings & Serious Risks:

• Thyroid tumors: Risk observed in rodent studies. Human relevance is uncertain.
• Pancreatitis: Stop treatment and contact your provider immediately if you experience persistent, severe abdominal pain.
• Gallbladder issues: Watch for symptoms such as abdominal pain, jaundice, or pale stools.
• Kidney function decline: Vomiting or diarrhea may lead to dehydration and exacerbate kidney issues.
• Hypoglycemia: Especially in combination with insulin or sulfonylureas.
• Vision changes: Risk of worsening diabetic retinopathy in some individuals.
• Mood or behavioral changes: Monitor for depression, irritability, or suicidal thoughts.
• Severe gastrointestinal conditions: Use caution in individuals with conditions such as gastroparesis.
  
  

Common Side Effects:

• Nausea
• Diarrhea
• Constipation
• Headache
• Fatigue
• Decreased appetite
• Bloating or indigestion
• Mild taste disturbances or dry mouth (due to sublingual delivery)

Side effects are usually mild and improve over time.

Drug Interactions:

• May delay gastric emptying and affect the absorption of oral medications
• Use caution when combining with:
  • Oral contraceptives (backup contraception may be recommended)
  • Medications with narrow therapeutic windows
  • Insulin or sulfonylureas

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

Pregnancy & Breastfeeding:

• Not recommended for use during pregnancy. Discontinue at least 2 months before attempting to conceive.
• Unknown if the medication is excreted in breast milk. Use only with medical supervision if breastfeeding.
  
  

Administration:
Place the sublingual tablet under the tongue and allow it to dissolve completely without chewing or swallowing. Avoid eating or drinking for several minutes afterward unless directed otherwise. Follow your provider’s instructions carefully.

Storage:
Store at room temperature in a dry location. Avoid moisture, heat, and direct sunlight. Do not use past the expiration date.

Emergency Situations:
Seek immediate medical attention for signs of serious allergic reactions, severe gastrointestinal distress, or behavioral changes. In a medical emergency, call 911.

Disclaimer:
This information is provided for educational purposes only and is not a substitute for medical advice. Compounded sublingual GLP-1 medications are prescribed off-label and not evaluated by the FDA. Consult your licensed provider before making any changes to your treatment. Report any adverse reactions to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.