Safety Information for Compounded Tirzepatide

Important Notice:
Compounded tirzepatide is a customized medication prepared by a compounding pharmacy based on a healthcare provider’s prescription. Unlike the FDA-approved version of tirzepatide (e.g., Mounjaro®), compounded tirzepatide has not been reviewed or approved by the FDA for safety, effectiveness, or quality. The formulation, concentration, and dosage may vary, and individual responses to compounded medications can differ.

Before Using Compounded Tirzepatide, Tell Your Healthcare Provider If You Have:

1. Medical Conditions:

   • History of pancreatitis: Tirzepatide has been associated with a risk of pancreatitis (inflammation of the pancreas). If you have a history of pancreatitis, your healthcare provider may recommend against using compounded tirzepatide.
   • Diabetic retinopathy: Tirzepatide may affect the eyes in patients with diabetic retinopathy, potentially worsening the condition. Notify your healthcare provider if you have or have had diabetic eye disease.
   • Kidney or liver problems: Compounded tirzepatide may impact kidney function, particularly in individuals with existing kidney disease. Regular kidney function tests may be necessary.
   • Gastrointestinal (GI) issues: Tirzepatide can slow gastric emptying, which may lead to nausea, vomiting, and other GI symptoms. If you have a history of gastroparesis or other GI disorders, discuss this with your healthcare provider before using this medication.

2. Allergies:

   • Hypersensitivity: Do not use compounded tirzepatide if you are allergic to tirzepatide or any of its ingredients. Symptoms of an allergic reaction may include rash, itching, swelling, or difficulty breathing.

3. Pregnancy and Breastfeeding:

   • Pregnancy: Compounded tirzepatide is not recommended during pregnancy, as its effects on the fetus are unknown. If you are pregnant or planning to become pregnant, discuss alternative treatments with your healthcare provider.
   • Breastfeeding: It is not known whether tirzepatide passes into breast milk. Consult your healthcare provider before using this medication while breastfeeding.

4. Other Medications:

   • Drug Interactions: Compounded tirzepatide may interact with other medications, including insulin and oral diabetes medications. Inform your healthcare provider of all medications, supplements, or herbal products you are currently taking.

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Administration and Dosage

• Injection: Compounded tirzepatide is administered subcutaneously (under the skin), typically once a week. Your healthcare provider will instruct you on the proper technique for injection and rotating injection sites to minimize discomfort or irritation.
• Storage: Store compounded tirzepatide in the refrigerator (36°F to 46°F or 2°C to 8°C). Do not freeze. Keep it out of reach of children and pets.
• Disposal: Use a proper sharps container to dispose of used needles and syringes.

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Potential Side Effects

Common side effects of compounded tirzepatide may include:

• Gastrointestinal symptoms: nausea, vomiting, diarrhea, constipation, stomach pain, and bloating. These symptoms are most common at the beginning of treatment and may improve over time.
• Low blood sugar (hypoglycemia): Tirzepatide can increase the risk of hypoglycemia, especially when used in combination with other diabetes medications (e.g., insulin or sulfonylureas). Symptoms of hypoglycemia include sweating, shaking, dizziness, or confusion.
• Injection site reactions: Redness, swelling, or irritation at the injection site may occur. Rotate injection sites to help reduce these reactions.
• Fatigue and headache: Some people may feel unusually tired or experience headaches.

Less common but more serious side effects include:

• Pancreatitis (inflammation of the pancreas): Seek immediate medical attention if you experience severe abdominal pain, nausea, or vomiting, as these may be signs of pancreatitis.
• Thyroid tumors: There have been reports of thyroid tumors in animal studies with similar GLP-1 receptor agonists. Although the risk to humans is unclear, tirzepatide should be avoided in individuals with a personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN 2).
• Kidney problems: Tirzepatide may affect kidney function, especially in individuals with pre-existing kidney conditions. Symptoms of kidney issues include swelling of the legs or ankles, changes in urination, or unusual fatigue.

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When to Seek Immediate Medical Attention

• Severe abdominal pain, nausea, vomiting, or loss of appetite, which may indicate pancreatitis.
• Signs of an allergic reaction, such as difficulty breathing, swelling of the face or throat, rash, or itching.
• Signs of kidney problems, such as swelling in the legs or ankles, changes in urination, or fatigue.

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Additional Considerations

• Monitoring: Your healthcare provider may recommend regular monitoring of blood sugar levels, kidney function, and thyroid function while using compounded tirzepatide. Regular follow-up visits are important to assess the effectiveness and safety of the treatment.
• Lifestyle Modifications: For optimal results, compounded tirzepatide should be used as part of a comprehensive weight management or diabetes care program, including dietary changes, exercise, and weight loss. Your healthcare provider will provide guidance on these aspects.

Compounded tirzepatide is not FDA-approved, and its safety, efficacy, and quality have not been evaluated by regulatory authorities. Always consult your healthcare provider to ensure that compounded tirzepatide is appropriate for your specific needs. Follow your healthcare provider’s instructions for safe use.

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This safety information is designed to provide essential details on the risks and precautions associated with compounded tirzepatide. Individuals should have a thorough discussion with their healthcare providers to ensure the medication is appropriate for their individual needs and health conditions.