Medication Safety Information

All clinical services available through the AvataCore platform are provided exclusively by independent licensed healthcare providers who are not employees or agents of AvataCore. Clinical operations are facilitated through the OpenLoop Health network and its affiliated provider network.

All medical decisions — including assessment of eligibility for treatment, diagnosis, treatment planning, dosage determination, and issuance of prescriptions — are made solely by independent licensed healthcare providers exercising their independent clinical judgment. AvataCore makes no guarantee that enrollment will result in a prescription being issued.

Pharmacy fulfillment services are provided by independent, state-licensed 503B sterile compounding pharmacies. AvataCore does not own, operate, or control any pharmacy.

AvataCore references certain FDA-approved branded medications for informational and educational purposes only. The following trademarks belong to their respective pharmaceutical manufacturers. AvataCore is not affiliated with, endorsed by, or sponsored by any of these companies:

References to branded medications on this platform are made solely to provide educational context about the drug classes and active pharmaceutical ingredients involved in treatment programs. AvataCore does not sell, distribute, or represent branded versions of these medications unless explicitly stated and prescribed by a licensed provider.

The medications available through the AvataCore platform belong to a class of drugs that act on hormone receptor pathways involved in blood sugar regulation and appetite control. This information is provided for educational purposes only and does not constitute medical advice.

GLP-1 Receptor Agonists (e.g., Semaglutide)

Glucagon-like peptide-1 (GLP-1) receptor agonists mimic the GLP-1 hormone naturally produced in the gut. They work by stimulating insulin secretion in response to meals, suppressing glucagon release, slowing gastric emptying, and reducing appetite signals in the brain. Semaglutide is an FDA-approved GLP-1 receptor agonist used for glycemic control in type 2 diabetes and chronic weight management in eligible adults.

GIP/GLP-1 Dual Receptor Agonists (e.g., Tirzepatide)

Glucose-dependent insulinotropic polypeptide (GIP) and GLP-1 dual receptor agonists act on both hormone pathways simultaneously. Tirzepatide is an FDA-approved dual agonist used for glycemic control in type 2 diabetes and chronic weight management in eligible adults. The dual mechanism of action may produce different effects compared to GLP-1-only agonists.

Educational Note: The information above is general in nature. Individual treatment decisions, including drug selection, dosage, and titration schedule, are made exclusively by licensed healthcare providers based on your personal medical history, current health status, and clinical judgment. Do not interpret this information as a recommendation for any specific treatment.

You are required to provide your complete and accurate medical history during the clinical intake process. Withholding relevant medical information can result in serious harm, clinical errors, or prescribing of medications that are contraindicated for your condition. You must disclose to your provider any personal or family history of the following conditions:

This list is not exhaustive. Disclose all current medications (including over-the-counter drugs, supplements, and herbal products), allergies, and your full medical history to your provider. Your provider may ask for additional information based on your responses.

GLP-1 and GIP/GLP-1 dual receptor agonist medications are associated with a range of side effects. The following information is provided for educational purposes. Your licensed provider will discuss side effects specific to your prescribed medication and dosage.

Most Common Side Effects

These side effects are frequently reported and are often most pronounced during dose escalation periods:

Serious Side Effects — Seek Immediate Medical Attention

Not all side effects are listed here. Refer to the patient information provided with your medication and consult your licensed provider if you have concerns about any symptoms you experience.

In addition to the general risks associated with GLP-1 and GIP/GLP-1 dual agonist medications, compounded formulations carry specific risks that distinguish them from FDA-approved commercially manufactured drugs:

• Variability in Quality and Potency: Although 503B outsourcing facilities are subject to CGMP standards, compounded medications may exhibit greater variability in potency, sterility, and ingredient concentration compared to FDA-approved manufactured products. Quality can vary between batches or between compounding facilities.
• Different Inactive Ingredients: Compounded formulations may contain different inactive ingredients, preservatives, buffers, or excipients than commercially available branded medications. These differences can affect drug stability, absorption, tolerability, and the risk of allergic reactions.
• Limited Long-Term Clinical Data: The long-term safety and efficacy data available for compounded GLP-1 formulations is limited compared to FDA-approved products that have undergone extensive clinical trials. Long-term outcomes specific to compounded formulations have not been independently established.
• Not Bioequivalence-Tested: Compounded medications have not undergone formal bioequivalence testing to confirm they produce the same clinical effect as their branded counterparts at equivalent doses. Clinical response may differ from published studies on branded products.
• Regulatory Uncertainty: The legal availability of compounded versions of specific GLP-1 medications is contingent on FDA shortage designations. Changes in regulatory status can affect availability with limited advance notice.

Compounded medications serve an important role in healthcare when commercially manufactured alternatives are unavailable, inaccessible, or clinically unsuitable for a specific patient. Your licensed provider may determine that a compounded formulation is clinically appropriate in the following circumstances:

• FDA Drug Shortage: When an FDA-approved brand-name version of a medication is on the FDA Drug Shortage List and is unavailable or in limited supply, licensed compounding pharmacies may legally prepare compounded versions of that drug to meet patient need. Semaglutide and tirzepatide have been on the FDA shortage list; availability of compounded versions is subject to current shortage status.
• Allergy to Inactive Ingredients: When a patient has a documented allergy or intolerance to an inactive ingredient (excipient) present in the commercially available formulation, a compounded version without that ingredient may be clinically necessary.
• Specific Dosage Forms Required: When a patient requires a dosage form, concentration, or delivery mechanism that is not commercially available — such as specific titration doses not offered in manufactured products — a compounded formulation may be prepared to meet that clinical need.
• Cost and Access Barriers: When commercially manufactured alternatives are cost-prohibitive or otherwise inaccessible, compounded options may provide a clinically reasonable alternative at the discretion of the prescribing provider.

Provider Determination: Whether a compounded medication is appropriate for you is a clinical decision made exclusively by your licensed healthcare provider. AvataCore does not make this determination. Your provider will discuss the clinical rationale for prescribing a compounded formulation and will document the medical necessity as required by applicable law.

AvataCore is a technology platform and is not equipped to respond to medical emergencies or mental health crises. If you are experiencing a medical emergency or mental health crisis, contact emergency services or a crisis line immediately.