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Important Safety Information (ISI) - Compounded GLP-1/GIP

Last updated: June 2, 2025

Compounded GLP-1/GIP is a dual-action injectable that combines glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonists. It may be prescribed off-label for weight management by a licensed healthcare provider through Belle when medically appropriate.

Please review the following Important Safety Information before beginning treatment. This is not a complete list of risks or side effects. Your provider will determine if compounded GLP-1/GIP is right for you based on your individual health needs.

Boxed Warning: Risk of Thyroid C-Cell Tumors

In rodent studies, GLP-1/GIP receptor agonists caused thyroid C-cell tumors. It is not known whether this risk occurs in humans. Compounded GLP-1/GIP 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).

Who Should Not Use Compounded GLP-1/GIP

Do not use compounded GLP-1/GIP if you:

  • Have a personal or family history of medullary thyroid carcinoma (MTC)
  • Have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
  • Have had a serious allergic reaction to compounded tirzepatide or any of its components
  • Are pregnant or planning to become pregnant

If you are breastfeeding or plan to breastfeed, speak with your provider before starting treatment.

Warnings and Precautions

Speak with your provider if you have or have had:

  • Pancreatitis
  • Gallbladder disease (e.g., gallstones)
  • Kidney disease or dehydration
  • Diabetic retinopathy
  • Liver disease
  • Depression or suicidal ideation
  • Gastrointestinal disorders (e.g., gastroparesis)

Compounded GLP-1/GIP slows gastric emptying and may affect the absorption of certain oral medications. Your provider may modify your medication regimen accordingly.

Common Side Effects

The most frequently reported side effects of compounded GLP-1/GIP include:

  • Nausea
  • Vomiting
  • Diarrhea
  • Constipation
  • Indigestion
  • Abdominal discomfort
  • Fatigue
  • Loss of appetite

These effects are generally mild and often decrease over time. If you experience persistent or severe symptoms, contact your provider.

Serious Side Effects

While uncommon, compounded GLP-1/GIP may cause serious adverse effects. Contact your provider immediately if you experience:

  • Severe abdominal pain (with or without vomiting), which may indicate pancreatitis
  • Signs of kidney issues such as decreased urination or swelling in the legs
  • Vision changes, especially if you have diabetic eye disease
  • Signs of an allergic reaction (rash, itching, swelling, trouble breathing)
  • Symptoms of low blood sugar, particularly when taken with other antidiabetic medications
  • Gallbladder inflammation or gallstones

Use and Administration

  • Use compounded GLP-1/GIP exactly as directed by your healthcare provider
  • Do not change your dose or dosing schedule without guidance
  • Continue to follow a provider-recommended diet and exercise plan
  • Attend regular check-ins to monitor your response and adjust your treatment as needed

Storage and Disposal

Follow the medication label or pharmacy instructions for proper storage. Keep out of reach of children and dispose of unused or expired medication safely.

Contact Your Provider

If you have questions about your treatment, side effects, or medication schedule, contact your healthcare provider directly. Do not stop or alter your treatment plan without medical supervision.