Important Safety Information Regarding Compounded Tirzepatide Products

Please note: Compounded medications, including tirzepatide, are not FDA-approved and do not undergo the same clinical studies as FDA-approved medications to evaluate safety and efficacy. However, they may still be legally prescribed. Based on your medical consultation, a healthcare provider at Yucca Health may determine that compounded tirzepatide is appropriate for you.

Tirzepatide is a glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist used for chronic weight management. It is prescribed in combination with a reduced-calorie diet and increased physical activity for individuals with:

• BMI ≥30 (obesity)
• BMI ≥27 (overweight) with at least one weight-related condition (e.g., hypertension, type 2 diabetes, dyslipidemia, obstructive sleep apnea, or cardiovascular disease).

Consult your healthcare provider to determine if tirzepatide is right for you.

Warnings and Precautions

Serious Side Effects:
Tirzepatide may cause the following serious side effects:

1. Thyroid Tumors: Potential risk of thyroid cancer. Contact your healthcare provider immediately if you experience neck swelling, hoarseness, difficulty swallowing, or shortness of breath.
2. Gastroparesis (stomach paralysis): Symptoms include feeling full quickly, nausea, vomiting, or prolonged stomach discomfort.
3. Pancreatitis: Severe abdominal pain (with or without vomiting). Seek medical attention if symptoms occur.
4. Gallbladder Problems: Pain in the upper abdomen, jaundice, or clay-colored stools may indicate gallstones.
5. Low Blood Sugar (Hypoglycemia): More likely when combined with insulin or sulfonylureas. Symptoms include dizziness, sweating, confusion, and shakiness.
6. Kidney Problems: Dehydration from nausea or diarrhea may worsen kidney function.
7. Severe Allergic Reactions: Symptoms include swelling of the face or throat, difficulty breathing, rash, or rapid heartbeat.
8. Mental Health Changes: New or worsening depression, suicidal thoughts, or mood changes should be reported immediately.

Who Should Not Use Tirzepatide

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 serious allergic reaction to tirzepatide.

Inform Your Provider of These Conditions

Before starting tirzepatide, discuss with your healthcare provider if you:

• Have or had pancreas or kidney problems.
• Have severe gastrointestinal issues like gastroparesis.
• Are pregnant, planning to become pregnant, or breastfeeding.
• Take medications for diabetes or any other condition.

Administration and Use

• Tirzepatide is administered once weekly via subcutaneous injection in the stomach, thigh, or upper arm.
• Always follow the dosage and regimen instructions provided by your healthcare provider.
• Do not adjust or discontinue tirzepatide without consulting your provider.

Mechanism of Action

Tirzepatide activates GIP and GLP-1 receptors, mimicking incretin hormones that regulate blood sugar and improve insulin release after meals.

Common Side Effects

The most common side effects include nausea, diarrhea, constipation, vomiting, indigestion, and abdominal pain. These are not all the possible side effects. Speak with your provider about any concerns.

Important Note

If you experience a medical emergency, call 911 or seek immediate medical care.

For further safety information, contact FDA MedWatch at 1-800-FDA-1088 or visit www.fda.gov/medwatch.

Yucca Health is committed to transparency and providing you with the highest-quality care throughout your journey.