Compounded Tirzepatide Safety Information

Compounded tirzepatide is a glucagon-like peptide-1 (GLP-1) receptor agonist that may be prescribed for chronic weight management when deemed medically appropriate by a licensed provider. This medication is prepared by licensed 503A compounding pharmacies and is not FDA-approved.

Important Notice: Elevate Health and Wellness LLC does not offer or distribute Zepbound®, Mounjaro®, or any branded tirzepatide medications. These are registered trademarks of Eli Lilly and Company. Elevate Health is not affiliated with Eli Lilly or any brand manufacturer. Our compounded tirzepatide products are independently compounded and prescribed only when clinically appropriate.

What is Compounded Tirzepatide?

Compounded tirzepatide may be prescribed for adults with:

• A BMI ≥30 kg/m2 (obesity), or
• A BMI ≥27 kg/m2 (overweight) with at least one weight-related comorbidity such as hypertension, type 2 diabetes, or dyslipidemia.

It is intended to be used in combination with a reduced-calorie diet and increased physical activity. All prescribing decisions are made after a medical evaluation.

Is It FDA Approved?

No. Compounded tirzepatide is not FDA-approved. It does not undergo FDA review for safety, efficacy, or manufacturing consistency. It is prepared in accordance with federal law under the guidance of a licensed provider for patients who may not have access to, or tolerate, FDA-approved alternatives.

Limitations of Use

• Do not use with other tirzepatide-containing or GLP-1 receptor agonist products.
• Not recommended for use in combination with weight loss supplements or medications without provider oversight.
• Safety in patients under 18, pregnant or breastfeeding individuals, or those with a history of pancreatitis has not been established

Safety Warnings

Thyroid C-Cell Tumors: In animal studies, tirzepatide caused thyroid tumors. The risk in humans is unknown. Do not use compounded tirzepatide if you or a family member has a history of medullary thyroid carcinoma (MTC) or MEN 2 syndrome.

Use Instructions

• Administer subcutaneously once per week in the thigh, upper arm, or abdomen
• Use the same day each week
• Rotate injection sites weekly

Drug Interactions

Tell your provider about all medications, including insulin, sulfonylureas, oral drugs, supplements, or birth control pills. Compounded tirzepatide slows gastric emptying, which can impact oral drug absorption.