IMPORTANT SAFETY INFORMATION

IF YOU ARE EXPERIENCING A MEDICAL EMERGENCY, CALL 911 OR GO TO YOUR NEAREST EMERGENCY ROOM IMMEDIATELY. DO NOT RELY ON THIS WEBSITE FOR EMERGENCY MEDICAL GUIDANCE.

Below is important safety information about medications, IV therapy, and peptide therapy services available through Evolve Your Bod. Please review this information carefully. If you have any questions, we encourage you to speak with your provider or a licensed healthcare professional before beginning any treatment.

This page is for informational and educational purposes only. It does not constitute medical advice, diagnosis, or treatment recommendations. Individual results and risks vary. Always consult with your healthcare provider regarding the appropriateness of any medication, therapy, or treatment for your specific health situation.

1. Compounded Medications and Formulations

Many of the medications and IV formulations provided through the Evolve Your Bod platform are compounded preparations produced by licensed compounding pharmacies. Compounded medications and formulations are created by combining, mixing, or altering ingredients to produce a customized preparation tailored to an individual patient’s needs.

Important information about compounded medications:

– Compounded medications are NOT FDA-approved. They have not undergone the same rigorous FDA approval process (including large-scale clinical trials) as commercially manufactured drugs.

– The safety, efficacy, potency, and purity of compounded medications may differ from commercially available, FDA-approved products.

– Compounded medications are produced in pharmacies that are licensed and regulated by state boards of pharmacy. Some compounding pharmacies may also be registered with the FDA as outsourcing facilities under Section 503B of the Federal Food, Drug, and Cosmetic Act.

– The decision to prescribe a compounded medication is made by your licensed healthcare provider based on your individual clinical needs. Discuss the potential benefits, risks, and alternatives with your provider.

– If you experience any adverse reaction to a compounded medication, contact your healthcare provider immediately. You or your provider may also report adverse events to the FDA’s MedWatch program at www.fda.gov/medwatch.

2. Medical Weight Management Medications

The following medications may be prescribed for medical weight management through Evolve Your Bod. Each link provides the FDA-approved prescribing information (label) for the commercially manufactured version of the active ingredient. If you receive a compounded version of any of these medications, the compounded formulation may differ from the FDA-approved product.

GLP-1 Receptor Agonists

Semaglutide (Active Ingredient in Wegovy® / Ozempic®)

Read the FDA Label: https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/215256s000lbl.pdf

Liraglutide (Active Ingredient in Saxenda®)

Read the FDA Label: https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206321orig1s000lbl.pdf

Tirzepatide (Active Ingredient in Mounjaro® / Zepbound®)

Read the FDA Label: https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215866s000lbl.pdf

Common risks and side effects of GLP-1 receptor agonists may include:

– Nausea, vomiting, diarrhea, constipation, and abdominal pain (most common, especially during dose escalation).

– Pancreatitis (inflammation of the pancreas) — seek immediate medical attention if you experience severe, persistent abdominal pain.

– Gallbladder problems, including gallstones and cholecystitis.

– Hypoglycemia (low blood sugar), especially when used with other diabetes medications.

– Kidney injury, particularly in patients who experience severe dehydration from nausea/vomiting/diarrhea.

– Thyroid C-cell tumors — semaglutide and liraglutide carry a boxed warning regarding thyroid C-cell tumors observed in rodent studies. These medications are contraindicated in patients with a personal or family history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).

– Allergic reactions, including anaphylaxis and angioedema.

– Injection site reactions (pain, redness, swelling).

– Suicidal ideation — the FDA has investigated reports of suicidal thoughts in patients taking GLP-1 medications. Report any changes in mood, behavior, or suicidal thoughts to your provider immediately.

Other Weight Management Medications

Phentermine (Active Ingredient in Adipex-P®)

Read the FDA Label: https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/085128s065lbl.pdf

Phentermine + Topiramate (Active Ingredient in Qsymia®)

Read the FDA Label: https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022580s000lbl.pdf

Naltrexone + Bupropion (Active Ingredient in Contrave®)

Read the FDA Label: https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/200063s000lbl.pdf

3. Hormone Replacement Therapy (HRT) Medications

The following medications may be prescribed for hormone optimization through Evolve Your Bod:

Testosterone Cypionate (Active Ingredient in Depo®-Testosterone)

Read the FDA Label: https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/085635s040lbl.pdf

Anastrozole (Active Ingredient in Arimidex®)

Read the FDA Label: https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020541s026lbl.pdf

Clomiphene Citrate (Active Ingredient in Clomid®)

Read the FDA Label: https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/016131s026lbl.pdf

Important safety considerations for hormone therapy:

– Testosterone therapy may increase the risk of cardiovascular events (heart attack, stroke), polycythemia (elevated red blood cell count), liver toxicity, mood changes, acne, and hair loss. Regular blood work monitoring is essential.

– Testosterone is a Schedule III controlled substance under federal law. It must be prescribed and administered in accordance with DEA and state regulations.

– Hormone therapy requires ongoing medical supervision and periodic laboratory monitoring to assess hormone levels, liver function, lipid panels, and hematocrit.

– Women receiving hormone therapy should discuss the risks of breast cancer, blood clots, and cardiovascular events with their provider.

– Compounded hormone preparations may differ in dosing, delivery method, and bioavailability from commercially manufactured products.

4. Insomnia Medications

The following medications may be prescribed for insomnia through Evolve Your Bod:

Hydroxyzine Pamoate (Active Ingredient in Vistaril®)

Read the FDA Label: https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022411s008lbl.pdf

Trazodone (Active Ingredient in Oleptro®)

Read the FDA Label: https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020541s026lbl.pdf

Mirtazapine (Active Ingredient in Remeron®)

Read the FDA Label: https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020415s023s024.pdf

Zolpidem (Active Ingredient in Ambien®)

Read the FDA Label: https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019908s027lbl.pdf

Safety note: Trazodone and mirtazapine carry a boxed warning regarding increased risk of suicidal thoughts and behavior in children, adolescents, and young adults. Report any changes in mood, behavior, or suicidal thoughts to your provider immediately.

5. Peptide Therapy

Evolve Your Bod may offer peptide therapy services for athletic recovery, anti-aging, metabolic optimization, cognitive enhancement, and other wellness applications. Peptide therapies are administered under the direction of a licensed healthcare provider.

Important safety information about peptide therapy:

– Peptide therapies used in integrative and functional medicine contexts are generally compounded preparations. They are NOT FDA-approved for the specific indications for which they may be prescribed through Evolve Your Bod.

– The safety and efficacy of compounded peptides have not been established through FDA-approved clinical trials for the specific uses being recommended.

– Some peptides that were previously available from compounding pharmacies have been placed on the FDA’s “category 2” list of substances that may not be compounded under Section 503A or 503B. Your provider will prescribe only peptides that are legally available for compounding at the time of your treatment.

– Common side effects of peptide therapy may include injection site reactions (redness, swelling, pain), headache, nausea, flushing, dizziness, fatigue, and changes in appetite or sleep patterns. Side effects vary by peptide.

– Allergic reactions, including serious allergic reactions, are possible with any injectable therapy.

– Peptide therapy requires ongoing medical supervision. Do not self-adjust doses or frequency without consulting your provider.

– Discuss the potential benefits, risks, alternatives, and limitations of peptide therapy with your provider before beginning treatment.

– Report any adverse reactions to your provider immediately. You or your provider may also report adverse events to the FDA’s MedWatch program.

6. IV Therapy

IV therapy services are available through Evolve Your Bod’s Hybrid (Consult + IV) and Mobile IV care models. IV therapy involves the administration of fluids, vitamins, minerals, medications, or other therapeutic formulations directly into your bloodstream through a needle or catheter inserted into a vein. All IV therapy is ordered by a licensed physician and administered by a licensed clinical professional (registered nurse or higher-level licensee).

Important safety information about IV therapy:

Risks and Potential Complications

– Pain, bruising, swelling, or discomfort at the insertion site.

– Infiltration — IV fluid leaking into the surrounding tissue, causing swelling and discomfort.

– Extravasation — irritating or vesicant substances leaking into surrounding tissue, potentially causing tissue damage.

– Phlebitis — inflammation of the vein, which may cause redness, warmth, and tenderness along the vein.

– Infection at the insertion site or, in rare cases, systemic infection (sepsis).

– Allergic or adverse reactions to IV formulations, including anaphylaxis (a severe, life-threatening allergic reaction) in rare cases.

– Air embolism — air entering the bloodstream, which can be life-threatening in rare cases.

– Fluid overload or electrolyte imbalance, which may cause swelling, shortness of breath, or cardiac complications.

– Hematoma — blood pooling under the skin near the insertion site.

– Nerve injury at or near the insertion site.

– Vasovagal response — fainting, lightheadedness, or a drop in blood pressure during or after the procedure.

IV Formulations and Compounding

– IV formulations administered through Evolve may include compounded preparations that are NOT FDA-approved. Their safety, efficacy, potency, and sterility may differ from commercially manufactured IV products.

– Common IV therapy formulations may include saline, vitamins (such as B-complex, vitamin C, and B12), minerals (such as magnesium and zinc), NAD+, glutathione, amino acids, and other therapeutic agents as ordered by your physician.

– The specific formulation, ingredients, and dosage of your IV therapy will be determined by your physician based on your clinical needs and health history.

Contraindications

IV therapy may not be appropriate for all patients. Conditions that may affect your eligibility for IV therapy include, but are not limited to:

– Known allergy to any component of the IV formulation.

– Congestive heart failure or fluid-restricted conditions.

– Severe kidney disease or renal failure.

– Uncontrolled hypertension.

– Active infection at the proposed insertion site.

– Coagulopathy or anticoagulant therapy (may increase bleeding/bruising risk).

– Pregnancy or breastfeeding (some IV formulations may not be appropriate).

Your provider will review your medical history, allergies, and current medications before ordering IV therapy. You are responsible for disclosing all relevant health information to your provider and the administering nurse.

When to Seek Emergency Care During or After IV Therapy

Call 911 or go to the nearest emergency room immediately if you experience any of the following during or after IV therapy:

– Difficulty breathing, shortness of breath, or wheezing.

– Swelling of the face, lips, tongue, or throat.

– Chest pain or chest tightness.

– Rapid or irregular heartbeat.

– Severe dizziness, fainting, or loss of consciousness.

– Severe swelling, redness, or pain at or near the IV site that worsens rapidly.

– High fever, chills, or signs of infection following the IV session.

– Seizures.

– Any other symptoms that feel severe or life-threatening.

7. Other Medications and Supplements

The following additional medications or supplements may be prescribed or recommended through Evolve Your Bod:

Cyanocobalamin (Vitamin B12)

Read the FDA Label: https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/080737Orig1s040lbl.pdf

Additional medications may be prescribed by your provider based on your individual clinical needs. If a medication you are prescribed is not listed on this page, ask your provider for the FDA prescribing information or relevant safety data.

8. General Safety Guidance

For all treatments coordinated through Evolve Your Bod:

– Always disclose your complete medical history, current medications (including over-the-counter drugs and supplements), allergies, and any known adverse reactions to your healthcare provider before beginning any treatment.

– Follow your provider’s dosing instructions exactly. Do not adjust doses, frequency, or duration of any medication or therapy without consulting your provider.

– Attend all recommended follow-up appointments and complete any required laboratory monitoring (blood work) as directed by your provider.

– Store medications as directed on the label. Some medications, including compounded injectable medications and peptides, may require refrigeration.

– Keep all medications out of the reach of children. Not all prescriptions are dispensed in child-resistant packaging.

– Do not share your prescription medications with anyone else. Medications are prescribed based on your individual health profile and may be harmful to others.

– Report any side effects, adverse reactions, or unexpected symptoms to your healthcare provider promptly.

– If you experience a severe or life-threatening reaction to any medication or treatment, call 911 or go to the nearest emergency room immediately.

9. Reporting Adverse Events

If you experience a side effect or adverse event from any medication, IV formulation, or therapy received through Evolve Your Bod, please take the following steps:

– Contact your healthcare provider immediately.

– If the reaction is severe or life-threatening, call 911.

– Report the adverse event to Evolve Your Bod at info@evolveyourbod.com or 866-301-3141.

– You or your provider may also report adverse events directly to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program: online at www.fda.gov/medwatch, by phone at 1-800-FDA-1088, or by mail using FDA Form 3500 (available at www.fda.gov/medwatch/getforms.htm).

10. Contact Information

For questions about the safety information on this page, or to discuss the risks and benefits of any treatment with a member of our team, please contact:

Evolve Your Bod (AA Health Solutions, LLC)

5521 Bellaire Drive South, Suite 200, Fort Worth, TX 76109

Email: info@evolveyourbod.com | Phone: 866-301-3141