Important Safety Information for Compounded GLP-1 (Semaglutide and Tirzepatide)

Overview
Compounded GLP-1 medications such as Semaglutide and Tirzepatide are prepared by U.S.-based, state-licensed 503A pharmacies to meet individual patient needs when commercially available products are not appropriate or available.

These compounded formulations are not FDA-approved, and the FDA does not evaluate compounded drugs for safety, effectiveness, or quality.

All compounded prescriptions must be used only under the supervision of a licensed healthcare provider.
Intended Use

Compounded Semaglutide or Tirzepatide may be prescribed by a licensed clinician as part of a personalized program designed to support metabolic health and weight management when clinically appropriate.
 Use of compounded GLP-1 medications for these purposes is considered off-label and should always occur under medical supervision.

Contraindications
 Do not use compounded GLP-1 medications 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 previous severe allergic reaction to GLP-1 receptor agonists
• Have severe gastrointestinal disease, such as gastroparesis
• Are pregnant or planning to become pregnant

Warnings and Precautions

• Thyroid C-cell tumors: Cases have been observed in studies of GLP-1 receptor agonists. Patients should report any neck mass, hoarseness, or difficulty swallowing.
• Pancreatitis: Discontinue and seek medical attention if you experience severe abdominal pain that may radiate to your back.
• Hypoglycemia: May occur when used with insulin or insulin-secretagogue medications; dose adjustments may be needed.
• Kidney function: Acute kidney injury has been reported; monitor renal function, particularly during dose changes.
• Gastrointestinal effects: Nausea, vomiting, diarrhea, or constipation may occur, especially during dose escalation.
• Allergic reactions: Rare but serious hypersensitivity reactions, including anaphylaxis and angioedema, have been reported. Stop therapy and seek immediate care if these occur.

Possible Side Effects
 The most commonly reported side effects include:

• Mild nausea or digestive discomfort
• Vomiting, diarrhea, or constipation
• Abdominal pain or bloating
• Fatigue or lightheadedness
• Mild injection-site redness or irritation

Most effects are temporary and lessen as your body adjusts. Report persistent or severe symptoms to your provider.

Medication Interactions
 Compounded GLP-1 medications may affect how other drugs are absorbed or tolerated. Tell your provider about all medicines and supplements you take, including:

• Insulin or oral diabetes medications
• Thyroid or steroid therapies
• Supplements marketed for metabolism or energy

Pregnancy and Breastfeeding
 Compounded GLP-1 medications should not be used during pregnancy. Their safety during pregnancy or lactation has not been established. Discuss contraception and treatment timing with your provider.

Monitoring and Follow-Up
Your provider will determine an appropriate dosing schedule and may recommend periodic check-ins or laboratory tests to monitor progress, side effects, and overall health.

Do not adjust your dose or discontinue therapy without consulting your provider.

Storage and Handling

• Store refrigerated at 2 – 8 °C (36 – 46 °F).
• Do not freeze. Keep away from direct light.
• Keep all medications out of reach of children and pets.
• Use only as directed and do not share your medication with others.

Disclaimer
This information is provided for educational purposes only and does not replace professional medical advice.
 Patients should consult a licensed healthcare provider to determine whether compounded GLP-1 therapy is appropriate for their individual health needs.

Compounded Semaglutide and Tirzepatide are not FDA-approved, and the FDA has not evaluated these products for safety, effectiveness, or quality.