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SAFETY INFORMATION

Serious medicine deserves serious care.

Compounded GLP-1 medications are prescription treatments with a real mechanism and a real safety profile. Here is the plain-language version of what you should know, what to watch for, and what to do if something feels off.

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ABOUT COMPOUNDED MEDICATIONS

What it means when a medication is compounded.

A compounded medication is prepared by a state-licensed compounding pharmacy for an individual patient, pursuant to a prescription written by a licensed healthcare provider. It is prepared for you specifically, and only after an independent licensed provider has reviewed your health history and decided that treatment is appropriate.

Compounded is not a synonym for safer, gentler, or more effective. It describes how a medication is prepared, not how well it works. Compounded medications are not FDA-approved, and the FDA does not review individual compounded formulations for safety, effectiveness, or quality.

LuneRx is not a pharmacy and not a medical provider. The independent licensed providers we work with make every prescribing decision, and the state-licensed partner pharmacies that fill prescriptions operate under the oversight of state boards of pharmacy. Our role is the platform that connects you to both.

REQUIRED DISCLOSURES

Important FDA-related disclosures.

Compounded semaglutide and compounded tirzepatide are available only with a prescription. Whether treatment is appropriate for you is the decision of an independent licensed provider — no medication is dispensed without it.

  • The FDA does not review or approve compounded medications for safety, effectiveness, or quality.
  • Compounded medications are prepared by state-licensed pharmacies pursuant to a licensed provider's prescription and should only be used under medical supervision.
  • Compounded semaglutide and compounded tirzepatide are not the same as, and are not generic versions of, any FDA-approved medication, including Ozempic, Wegovy, Mounjaro, and Zepbound. They are different products and are not FDA-approved.
  • If you are pregnant, nursing, trying to conceive, or taking other medications or supplements, disclose everything during your consultation so the reviewing provider can screen appropriately.
SCREENING

Who should not use GLP-1 medications.

This list is not exhaustive, and it is not a substitute for a medical evaluation. The independent licensed provider who reviews your health history makes the final decision. GLP-1 medications are generally not appropriate if any of the following applies to you.

  • A personal or family history of medullary thyroid carcinoma (MTC).
  • A personal or family history of Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
  • Pregnancy, breastfeeding, or actively trying to conceive.
  • A history of pancreatitis.
  • Severe gastrointestinal disease, such as gastroparesis.
  • Significant kidney disease.
  • Whatever your history, disclose every medication and supplement you take to the reviewing provider — some combinations require closer screening.
WHAT TO EXPECT

Side effects, told plainly.

Most side effects appear during dose titration and settle as your body adjusts. The most common are nausea, constipation, fatigue, and heartburn. They are usually manageable — smaller meals, steady hydration, and a slower dose schedule all help, and the prescribing provider can adjust your plan if an effect persists.

Serious side effects are rare, but they are real. They include pancreatitis, gallbladder problems, allergic reactions, and changes in vision for people with diabetic retinopathy. Severe or persistent abdominal pain, pain that radiates to your back, vomiting that will not stop, yellowing of the skin or eyes, or a sudden change in vision are not symptoms to wait out.

If anything concerns you at any point, contact the prescribing provider. A small concern raised early is always better than a big one raised late.

IF SOMETHING FEELS OFF

What to do about a side effect or adverse event.

  1. Contact the prescribing provider first

    For anything uncomfortable but not urgent — persistent nausea, constipation, an injection-site issue — start with the provider who prescribed your medication. Many early side effects resolve with a dose adjustment or a change in schedule.

  2. Report to FDA MedWatch

    Adverse events connected to any medication can be reported directly to the FDA through the MedWatch program at https://www.fda.gov/safety/medwatch or by phone at 1-800-FDA-1088. Reporting strengthens the safety picture for everyone who uses these medications.

  3. Contact the dispensing pharmacy

    The state-licensed pharmacy that filled your prescription tracks batch-level and product-quality issues. Its contact information appears on your medication packaging. Prescriptions arranged through this platform are dispensed by Logos RX, 7543 W. Waters Ave, Tampa, FL 33615, reachable at 855-564-6779 or support@logosrx.com.

  4. For emergencies, act immediately

    For a severe allergic reaction, difficulty breathing, severe abdominal pain, or any symptom that feels like an emergency, call 911 or go to the nearest emergency room first. Everything else can wait until you are safe.

THE BOTTOM LINE

A prescription is required. Outcomes are never guaranteed.

Compounded semaglutide and compounded tirzepatide are prescription medications. Whether treatment is appropriate for you is always the decision of an independent licensed healthcare provider — never ours, and never yours alone. If a provider determines treatment is not appropriate, it will not be prescribed.

Compounded medications are not approved or evaluated by the FDA for safety, effectiveness, or quality. A licensed provider will determine whether treatment is appropriate for you.

No one can promise you a specific result, and we never will. Weight loss varies from person to person and depends on your health, your habits, and how your body responds to treatment. What you can expect from this platform is a careful process: honest screening, licensed professionals, and clear information at every step.

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