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Important Safety Information (ISI) - Compounded GLP-1

Last updated: June 2, 2025

Compounded GLP-1 is a glucagon-like peptide-1 (GLP-1) receptor agonist that may be prescribed for chronic weight management and blood sugar control. Belle offers compounded GLP-1 through licensed healthcare providers when medically appropriate.

Please review the following important safety information before starting treatment. This is not a complete list of all possible risks and side effects. You should speak with your provider for personalized guidance.

Boxed Warning: Risk of Thyroid C-Cell Tumors

In animal studies, compounded semaglutide caused thyroid C-cell tumors. It is not known if this risk occurs in humans. However, compounded semaglutide should not be used 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).

Who Should Not Use Compounded GLP-1

Do not take compounded GLP-1 if you:

  • Have a personal or family history of MTC
  • Have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
  • Are allergic to compounded semaglutide or any of its ingredients
  • Are pregnant or planning to become pregnant

If you are breastfeeding, consult your provider before starting treatment.

Warnings and Precautions

Tell your provider if you have or have had:

  • A history of pancreatitis
  • Gallbladder problems (such as gallstones)
  • Kidney disease or dehydration
  • Diabetic retinopathy
  • Gastrointestinal disorders (such as gastroparesis)
  • Liver impairment
  • Depression or suicidal thoughts

Compounded GLP-1 slows gastric emptying, which may impact the absorption of oral medications. Your provider may adjust your medication schedule accordingly.

Common Side Effects

Compounded GLP-1 may cause the following side effects:

  • Nausea
  • Vomiting
  • Diarrhea
  • Constipation
  • Abdominal pain
  • Headache
  • Fatigue
  • Loss of appetite

These side effects are usually mild to moderate and tend to decrease over time. Notify your provider if symptoms persist or become severe.

Serious Side Effects

Although rare, serious side effects may include:

  • Pancreatitis (severe abdominal pain that may radiate to the back, with or without vomiting)
  • Kidney problems (due to dehydration from nausea, vomiting, or diarrhea)
  • Vision changes, particularly in individuals with diabetic retinopathy
  • Low blood sugar (especially if combined with other glucose-lowering drugs)
  • Gallbladder issues such as cholelithiasis or cholecystitis
  • Allergic reactions (rash, itching, difficulty breathing, or swelling of the face/lips)

If you experience any of these symptoms, seek medical attention immediately.

Medication Use

  • Take compounded GLP-1 exactly as prescribed by your provider.
  • Do not change your dose without medical guidance.
  • Continue to follow any dietary, exercise, and lifestyle recommendations provided by your care team.
  • Keep all appointments with your provider to monitor your progress and adjust treatment if needed.

Storage and Handling

Store compounded GLP-1 according to the instructions provided with your medication. Keep out of reach of children and dispose of any expired or unused medication safely.

Contact Your Provider

Always speak with your licensed provider if you have any questions or concerns about your treatment, side effects, or medication use. Do not start or stop Semaglutide without medical supervision.