Important information about compounded GLP-1 and GIP medicines

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The VitaVille offers compounded medicines that act like GLP-1 or GIP hormones. Examples include compounded versions of semaglutide-like or tirzepatide-like products.

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What “compounded” means

Compounded medicines are prepared for an individual patient based on a prescription from a licensed prescriber. They are not the same as FDA-approved products and they have not been reviewed by the FDA for safety, effectiveness, or quality. Ingredients, strength, and how the medicine is given may differ from brand-name drugs.

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How compounded products differ from FDA-approved semaglutide and tirzepatide

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• FDA-approved semaglutide and tirzepatide (examples: Wegovy, Ozempic, Zepbound, Mounjaro) are manufactured under FDA oversight and were tested for safety, effectiveness, and quality. Compounded versions are not FDA-approved. 

• Some compounded products may use different chemical forms, such as “salt” forms of semaglutide. These are not the same active ingredient as in approved drugs, and the FDA has said it does not have information showing these forms have the same properties.

• Because compounded drugs can come in different concentrations or delivery systems, dosing instructions may not match the FDA-approved labels. The FDA has received reports of dosing errors and overdoses with compounded semaglutide products. 

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Known and possible side effects

Side effects can be similar to the approved drugs in these classes and may include nausea, vomiting, diarrhea, constipation, stomach pain, headache, dizziness, and fatigue. More serious risks have been reported with GLP-1/GIP medicines, including gallbladder problems, pancreatitis, kidney problems, low blood sugar when used with insulin or certain diabetes medicines, and potential risk of thyroid C-cell tumors. Do not use if you have a personal or family history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia syndrome type 2 (MEN2). Ask your prescriber about your specific risks, medicines, and medical history.

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Effectiveness disclaimer

Because compounded GLP-1 and GIP products are not FDA-approved, their safety and effectiveness have not been reviewed by the FDA. Results can vary, and there is no FDA determination that a compounded product works the same as an approved drug. Use only under the guidance of a licensed prescriber. 

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Quality and sourcing

We source active ingredients from suppliers appropriate for compounding and prepare your medication in a facility that follows applicable federal and state standards for sterile and non-sterile compounding. Even so, compounded medicines do not go through FDA pre-market review. Be cautious about products sold online without a prescription or made by unknown sources; regulators have reported unapproved and sometimes contaminated or mislabeled “copycat” products sold outside traditional pharmacies.

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When compounded options are appropriate

Compounded therapy may be considered when a patient needs a specific strength, formulation, or ingredient combination not available in an approved product, and when a licensed prescriber determines it is medically necessary. Availability can also be affected by national supply conditions and current FDA policy. Ask us if you have questions about whether a compounded option is right for you at this time.

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How to use safely

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• Use exactly as prescribed. Do not change your dose without talking to your prescriber. Dosing errors have led to overdoses with compounded products. 

• Learn how to measure and inject your dose if your product is supplied in a vial or a device that differs from the branded pens.

• Tell your prescriber right away if you have severe stomach pain, persistent vomiting, a lump or swelling in your neck, trouble swallowing, hoarseness, or unexplained low blood sugar.

• If you are pregnant, planning to become pregnant, or breastfeeding, discuss risks and alternatives before starting.

 

Questions?

We are happy to review your prescription, explain how your medication was prepared, and discuss what to expect. Your health and safety are our top priorities.