Warning: Risk of Thyroid C-Cell Tumors 

• In animal studies, Compounded tirzepatide caused thyroid tumors, including thyroid cancer. It is not confirmed if Compounded tirzepatide will cause thyroid tumors or a specific type of thyroid cancer known as medullary thyroid carcinoma (MTC) in humans. Notify your healthcare provider if you experience symptoms like a lump or swelling in your neck, hoarseness, difficulty swallowing, or shortness of breath, as these may be signs of thyroid cancer. 
• Compounded tirzepatide should not be used by individuals who have, or have family history of, medullary thyroid carcinoma (MTC) or who have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). 

FDA-Approved Use of Compounded tirzepatide 

• Compounded tirzepatide is prescribed for chronic weight management in adults alongside a reduced-calorie diet and increased physical activity. It is suitable for individuals with a body mass index (BMI) of: 
• 30 kg/m² or greater (obesity)  
• 27 kg/m² or greater (overweight) in the presence of at least one weight-related comorbid condition such as hypertension, dyslipidemia, type 2 diabetes mellitus, obstructive sleep apnea, or cardiovascular disease. 

Limitations of Use: 

• Do not use Compounded tirzepatide in combination with other tirzepatide-containing products or any other GLP-1 receptor agonist. 
• The safety and effectiveness of Compounded tirzepatide when used with other weight management products have not been established. 
• Compounded tirzepatide is not recommended for patients with a history of pancreatitis. 
• Who Should Not Use Compounded tirzepatide? 
• Anyone with a personal or family history of MTC, or who has MEN 2. 
• Individuals with known allergies to Compounded tirzepatide or its components. 
• Administration of Compounded tirzepatide 

Compounded tirzepatide is administered through a pre-filled injector pen as a subcutaneous injection in the stomach, thigh, or upper arm once a week. It can be taken with or without food. Your provider will guide you on the appropriate dosing regimen, which may involve dose adjustments every four weeks. 

Before Using Compounded tirzepatide: 

• Discuss all medications you are currently taking with your provider, including prescriptions, over-the-counter medications, vitamins, and supplements, especially: 
• Diabetes medications including insulin or sulfonylureas. 
• Oral medications, as Compounded tirzepatide may affect their absorption due to delayed gastric emptying. 
• Hormonal contraceptives, as Compounded tirzepatide may reduce their effectiveness. 

Pregnancy and Breastfeeding: 

• Compounded tirzepatide should not be used during pregnancy due to potential risks to the unborn baby based on animal studies. 
• The impact of Compounded tirzepatide on breast milk is unknown; discuss potential risks and benefits with your provider if you are breastfeeding or planning to breastfeed. 
• A pregnancy exposure registry monitors outcomes in women exposed to Compounded tirzepatide during pregnancy. 

Serious Side Effects to Monitor For: 

• Thyroid C-Cell Tumors: Symptoms include a lump or swelling in the neck, hoarseness, difficulty swallowing, or shortness of breath. 
• Severe Gastrointestinal Disease:  Compounded tirzepatide can cause severe gastrointestinal reactions; it is not recommended for patients with severe gastrointestinal conditions. 
• Acute Kidney Injury: Can occur due to dehydration from gastrointestinal side effects. 
• Acute Gallbladder Disease: Symptoms include upper stomach pain, jaundice, fever, or clay-colored stools. 
• Inflammation of the Pancreas (Acute Pancreatitis): Watch for severe abdominal pain that doesn’t go away. 
• Allergic Reactions: Symptoms include swelling of the face, lips, tongue, or throat, severe rash, or difficulty breathing. 
• Low Blood Sugar (Hypoglycemia): Especially in patients with type 2 diabetes using other glucose-lowering medications. 
• Suicidal Behavior and Ideation: Monitor for any new or worsening mental health changes. 

Common Side Effects of Compounded tirzepatide: 

• Nausea, diarrhea, vomiting, constipation, stomach pain, indigestion, injection site reactions, fatigue, allergic reactions, belching, hair loss, and gastroesophageal reflux disease (heartburn). 

Reporting Side Effects: 

• Report negative side effects of prescription products to the FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch. 

Note: 

• This information is not comprehensive. Please consult the full Prescribing Information for complete safety details.