Safety Information

Important Safety Information Regarding Compounded Tirzepatide
Compounded Medication Disclaimer
Compounded medications, including tirzepatide, are not approved by the U.S. Food and Drug Administration (FDA) and do not undergo the same clinical studies as FDA-approved drugs to evaluate safety or efficacy. Compounded medications may still be legally prescribed when determined appropriate by a licensed healthcare provider following a medical consultation.
Eligibility
You may qualify for treatment if:
- Your Body Mass Index (BMI) is 30 or higher, or
- Your BMI is 27 or higher with at least one weight-related condition such as high blood pressure, type 2 diabetes, high cholesterol, obstructive sleep apnea, or cardiovascular disease.
If your BMI is above 25, you may still be at risk for health issues and could qualify depending on your overall medical history. Eligibility is determined on a case-by-case basis. A licensed healthcare provider will carefully review your intake to confirm eligibility and ensure treatment is safe and appropriate for you.
Indication
Tirzepatide is a dual glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist used for chronic weight management in combination with a reduced-calorie diet and increased physical activity.
Contraindications
Do not use tirzepatide if:
- You or a family member has a history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
- You have had a severe allergic reaction to tirzepatide or any of its ingredients.
Warnings and Precautions
Serious side effects may occur with tirzepatide use, including:
- Thyroid Tumors: Risk of thyroid cancer. Report neck swelling, hoarseness, difficulty swallowing, or shortness of breath to your provider immediately.
- Gastroparesis (Stomach Paralysis): Symptoms include feeling full quickly, nausea, vomiting, or prolonged stomach discomfort.
- Pancreatitis: Severe abdominal pain, with or without vomiting, may indicate pancreatitis.
- Gallbladder Disease: Symptoms may include upper abdominal pain, jaundice, or clay-colored stools.
- Hypoglycemia: Low blood sugar, especially when used with insulin or sulfonylureas. Symptoms may include shakiness, sweating, confusion, or dizziness.
- Kidney Impairment: Dehydration caused by nausea or diarrhea may worsen kidney function.
- Severe Allergic Reactions: Seek immediate care if you experience swelling of the face or throat, difficulty breathing, rash, or rapid heartbeat.
- Mental Health Changes: New or worsening depression, mood changes, or suicidal thoughts must be reported to your provider immediately.
Precautions Before Use
Inform your healthcare provider if you:
- Have or have had pancreas or kidney problems.
- Have severe gastrointestinal issues such as gastroparesis.
- Are pregnant, planning to become pregnant, or breastfeeding. Tirzepatide is not recommended during pregnancy or breastfeeding.
- Are taking other medications, including prescriptions, over-the-counter drugs, vitamins, or supplements.
Administration
- Tirzepatide is administered once weekly by subcutaneous injection in the stomach, thigh, or upper arm.
- Follow dosing instructions provided by your healthcare provider.
- Do not adjust or discontinue tirzepatide without consulting your provider.
Mechanism of Action
Tirzepatide is a dual GIP and GLP-1 receptor agonist that mimics incretin hormones to regulate blood sugar, improve insulin secretion, and support appetite control.
Common Side Effects
The most common side effects include:
- Nausea, diarrhea, constipation, vomiting, indigestion, and abdominal pain.
This list does not include all possible side effects. Consult your healthcare provider regarding any adverse effects you may experience.
Important Notes
- Tirzepatide treatment should only be initiated and monitored by a licensed healthcare provider.
- If you experience a medical emergency, call 911 immediately.
- For additional safety information, contact FDA MedWatch at 1-800-FDA-1088 or visit www.fda.gov/medwatch.
Commitment to Safety
Yucca Health is committed to providing safe, transparent, and high-quality care. We encourage patients to discuss all concerns openly with their provider to ensure the best possible treatment outcomes.