Informed Consent for Injectable TB-500

INTRODUCTION

THIS INFORMED CONSENT FOR COMPOUNDED TB-500 INJECTABLE MEDICATION (THE "CONSENT") SETS FORTH INFORMATION REGARDING THE CLINICAL SERVICES PROVIDED BY SUPERPOWER MEDICAL GROUP OF CA PC, A CALIFORNIA PROFESSIONAL MEDICAL CORPORATION, AND OTHER THIRD-PARTY MEDICAL GROUPS (THE "MEDICAL GROUPS") THROUGH THE ONLINE TECHNOLOGY PLATFORM ("PLATFORM" OR "SUPERPOWER PLATFORM"), WHICH IS OWNED AND OPERATED BY SUPERPOWER HEALTH, INC. ("SUPERPOWER").

The purpose of this informed consent form is to give you written information about the potential benefits, risks, uncertainties, and alternatives associated with compounded TB-500 administered by subcutaneous injection, so that you can decide whether to proceed. This material supplements your discussion with your Superpower Healthcare Provider. Please read it thoroughly and ask any questions before signing or starting treatment.

Your Superpower Healthcare Provider will review your medical history, medications, supplements, any available laboratory results, and treatment goals to determine whether treatment may be appropriate. An in-person examination, additional testing, or specialist evaluation may be required. Completing an intake or signing this Consent does not guarantee a prescription.

General Information and Background

TB-500 is a synthetic, chemically modified seven-amino-acid fragment related to thymosin beta-4, a naturally occurring protein involved in cell movement and tissue-repair signaling. This Consent refers to the short N-acetylated fragment, sometimes identified as Ac-LKKTETQ. It does not refer to full-length, 43-amino-acid thymosin beta-4. Human studies of the full-length protein do not establish the safety or effectiveness of TB-500.

TB-500 is not FDA-approved for any medical condition. Its ability to heal injuries or wounds, reduce pain, improve recovery, or enhance physical performance has not been established in reliable human clinical trials.

Your Healthcare Provider may discuss treatment goals such as improvement in a specific symptom or physical function. These are goals, not proven benefits. You may experience no improvement, and your underlying condition may persist or worsen. Treatment must not delay appropriate diagnosis, wound care, rehabilitation, or other established care.

Compounded TB-500 Injectable Medication

This Consent covers standalone TB-500 administered into the fatty tissue beneath the skin. It does not cover injection into a vein, muscle, tendon, or joint, or combination products containing other peptides. Any different product or route requires a separate clinical discussion and appropriate consent.

There is no FDA-approved TB-500 product against which the compounded preparation can be considered an approved generic or equivalent. Compounded medications do not undergo FDA premarket review for safety, effectiveness, or quality. FDA has identified concerns about peptide-related impurities, aggregates, immune reactions, and the lack of human safety information for TB-500. FDA's Center for Drug Evaluation and Research recommended against including TB-500 on the list of substances that may be used in compounding. HHS has since adopted the interim policy described below, which does not resolve these safety questions.

Products described as "TB-500" may differ in their actual ingredient or chemical form. The HHS policy described below applies only to TB-500 acetate. The dispensing pharmacy must confirm that the product supplied matches the prescription. An unknown or unverified product is not covered by this Consent and must not be used.

A safe and effective human dose, maximum safe dose, and treatment duration have not been established. Prescribing schedules may reflect clinical convention rather than validated human dose-finding studies. Your prescribed dose, concentration, frequency, course length, and planned reassessment date will be provided separately.

HHS Enforcement Discretion Policy

TB-500 is not approved by FDA and is not authorized for sale. Compounded TB-500 is made available through the Platform solely in reliance on an interim enforcement discretion policy issued by the U.S. Department of Health and Human Services ("HHS") in October 2026. Under that policy, while FDA completes rulemaking on whether TB-500 may be used in compounding, HHS has stated that it does not intend to take enforcement action against a state-licensed pharmacy or licensed physician that compounds TB-500 acetate for an individual patient under a valid prescription, subject to conditions that include testing of the ingredient and reporting of serious adverse events. The policy reflects HHS's current enforcement intentions only. It is not an FDA approval or authorization, and it is not a finding that TB-500 is safe or effective.

HHS may revise or rescind the policy at any time, in whole or in part, including if a safety signal or product-quality issue arises. The policy will also be superseded by FDA's final rule, which may not permit TB-500 to be used in compounding. State laws may further limit availability. As a result, Superpower and the Medical Groups cannot guarantee continued availability of TB-500, and your treatment may need to stop before your planned course is complete, with little or no notice. A prescription or signed Consent does not guarantee that TB-500 can be lawfully compounded or dispensed to you.

Side Effects, Risks, and Complications

Every treatment involves risk. For TB-500, adequate human safety data are lacking, so the frequency and full range of side effects are unknown. It is not possible to provide a reliable list of "common" TB-500 side effects or estimate the likelihood of serious harm. An absence of reported problems does not establish safety.

Possible Injection Effects and Symptoms to Report

• Injections can cause pain, burning, redness, itching, swelling, bruising, bleeding, or a lump at the injection site. Poor technique can cause infection or tissue injury.
• Report new headache, unusual fatigue, flu-like symptoms, nausea, dizziness, rash, or any other new symptoms after treatment. These are symptoms to monitor; they are not established common effects of TB-500.
• Report any new lump or unexplained swelling, changing skin lesion, or darkening of the skin or gums. Pigment changes have been reported with a combination containing TB-500 and another peptide, but the responsible ingredient and relevance to standalone TB-500 are uncertain.

Tell your Healthcare Provider about new symptoms even if you are unsure they are related. Do not assume that an adverse symptom means treatment is working.

Possible Drug Interactions

Formal human interaction studies are lacking. TB-500 may interact with prescription medications, nonprescription products, supplements, or other peptides in ways that are not yet understood.

• Disclose all cancer treatments, including hormone-blocking treatments, immunotherapy, chemotherapy, and radiation treatment, as well as immunosuppressive medications. Any personal history of cancer excludes participation in this treatment program. Use of immunosuppressive medication requires clinical review.
• Tell your Healthcare Provider about anticoagulants or antiplatelet medications, such as warfarin, apixaban, rivaroxaban, aspirin, or clopidogrel. These medicines can increase bruising or bleeding from injections; a specific TB-500 interaction has not been established.
• Do not stop or change established treatment, add another peptide, or combine products without review by a clinician who knows everything you are taking. Safety of TB-500 combinations has not been established.

Potential Serious Side Effects and Complications

• Severe allergic reactions. TB-500 or another ingredient could cause a serious reaction, including anaphylaxis, with swelling, difficulty breathing, or collapse. The frequency is unknown.
• Immune reactions. Your immune system may react to the peptide, impurities, or aggregates in the preparation. Possible consequences include hypersensitivity or antibody formation. The likelihood and long-term significance are uncertain, and routine laboratory testing cannot rule them out.
• Infection and product-quality problems. Contamination, an incorrect ingredient or concentration, improper storage, or dosing errors may cause serious injury. Injection-related infection can progress to an abscess or bloodstream infection. Serious infections and severe allergic reactions can be life-threatening.
• Uncertain effects on abnormal tissue growth. Research involving related thymosin beta-4 pathways raises questions about cell movement, blood-vessel formation, and existing cancers. Much of that evidence concerns the full-length protein rather than TB-500. Whether TB-500 could affect an existing cancer or increase cancer risk is unknown; adequate cancer-safety studies are lacking. This is an unresolved concern, not proof that TB-500 causes cancer.
• Other unknown harms. Effects on organ function, fertility, pregnancy, and long-term or repeated exposure have not been adequately characterized. Unexpected reactions, including serious or lasting harm, may occur. There is no established safe exposure threshold or laboratory test that excludes these risks.
• Delayed care or reinjury. Symptom improvement does not prove that an injury or wound has healed. Delaying diagnosis, neglecting wound care, increasing activity too quickly, or substituting TB-500 for recommended treatment can worsen your condition.

This is not a complete list of possible risks or complications. Following instructions and completing monitoring cannot eliminate all risks.

Contraindications and Additional Information Regarding Potential Risks

Because TB-500 has no FDA-approved prescribing information, there is no established label-based list of contraindications. The following are precautionary exclusions and requirements for this treatment program.

Do Not Start or Continue Treatment if Any of the Following Apply

• You are under 18 years of age.
• You are pregnant, breastfeeding, or attempting to conceive.
• You have a known allergy to TB-500 or an ingredient in the dispensed preparation, or have had a serious reaction to a previous dose.
• You have any personal history of cancer, regardless of cancer type, stage, or time since diagnosis or treatment. You must also not start or continue treatment if cancer is suspected, including a new finding being evaluated for possible cancer.
• You cannot verify the medication, concentration, dose, or instructions, or you cannot administer and store it safely.

Pregnancy, breastfeeding, and fertility: Effects on fertility, an unborn baby, and a breastfed infant are not adequately known. If you could become pregnant, discuss effective contraception with your Healthcare Provider. Stop treatment and contact your Healthcare Provider promptly if you become pregnant or decide to attempt conception. No evidence-based preconception washout period has been established.

Before treatment, disclose precancerous changes, liver or kidney disease, diabetes, bleeding disorders, immune-system conditions, active infection, and planned surgery or procedures. These may require additional evaluation, coordination with another clinician, or deferral of treatment. Do not inject through infected, inflamed, damaged, or otherwise abnormal skin.

Competitive sports: TB-500 is prohibited at all times under the World Anti-Doping Agency Prohibited List, including during and outside competition. A prescription does not automatically exempt you from anti-doping rules. Tell your Healthcare Provider if you participate in a sport or competition subject to testing; use may affect eligibility and result in sanctions.

When to Seek Medical Attention

Stop using the medication and call 911 or seek emergency care immediately for difficulty breathing; swelling of the face, lips, tongue, or throat; collapse or fainting; chest pain; sudden weakness or difficulty speaking; or severe or uncontrolled bleeding. Do not wait for a message through the Platform.

Hold further doses and seek prompt medical assessment for a spreading, hot, painful, or draining injection site; fever or chills; a significant rash; unexplained swelling; a new lump or suspicious skin change; unexpected darkening of the skin or gums; or persistent, substantial illness after dosing. Report unexplained weight loss or persistent night sweats. Severe or rapidly worsening symptoms require emergency care.

For other new or persistent symptoms, contact your Healthcare Provider before your next dose. Do not restart after a suspected serious reaction unless specifically instructed following evaluation.

Under the HHS policy, the compounding pharmacy must report serious adverse events and product-quality issues to FDA and applicable state authorities. You may also report side effects directly to FDA's MedWatch program at www.fda.gov/medwatch or 1-800-FDA-1088.

Alternatives

You may choose not to use TB-500 or may defer treatment while pursuing further evaluation. Depending on your diagnosis, alternatives may include physical therapy, activity modification, supervised rehabilitation, appropriate pain-management medications, established wound-care treatments, specialist assessment, or surgery when indicated. Wounds may require assessment of infection, blood supply, diabetes management, or other causes of poor healing. Participation in a properly authorized clinical trial may be an option if one is available and you qualify.

Your Healthcare Provider should discuss the expected benefits and risks of alternatives relevant to your condition. TB-500 should not replace treatment known to be effective for a diagnosed condition.

Medical History Disclosure Requirements

Provide a complete and accurate medical history, including:

• Current symptoms, diagnosis, injuries or wounds, prior investigations, surgeries, and treatments tried.
• Allergies and previous reactions to medicines, injections, preservatives, or other ingredients.
• Any personal history of cancer, regardless of cancer type, stage, or time since diagnosis or treatment; precancerous changes, new lumps, unexplained weight loss, relevant family history, and any cancer-directed treatment.
• Liver or kidney disease, diabetes, bleeding disorders, immune conditions, and infections.
• Pregnancy, breastfeeding, conception plans, and planned procedures.
• All medications, supplements, hormones, and peptides, including products obtained outside Superpower.
• Competitive sport participation and applicable anti-doping requirements.

Keep your Healthcare Provider informed of changes throughout treatment. Withholding or providing inaccurate information can lead to inappropriate treatment and serious harm.

Follow-up and Monitoring

Your treatment plan will identify a symptom or functional goal, a reassessment date, and reasons to stop. The protocol includes an asynchronous (online) check-in approximately 2 weeks after starting treatment, followed by asynchronous check-ins every 4 weeks thereafter. Your Healthcare Provider may request an earlier or additional assessment if needed. Continuing beyond the initial course is a separate decision that requires a review of your symptoms, any side effects, and the remaining uncertainties. Feeling better does not establish that continued treatment is safe.

Treatment may begin before laboratory testing is completed if your Healthcare Provider determines that starting treatment is appropriate. Required laboratory testing must be completed no later than day 60 after starting treatment. Your Healthcare Provider may require testing before treatment or sooner than day 60 if clinically indicated. Monitoring laboratory tests may be requested every 6 months, or at other times as needed, at your Healthcare Provider's discretion. Laboratory results provide information about your general health and may identify reasons to change or stop treatment. Keep age- and risk-appropriate cancer screening current as recommended by your usual clinician. Screening cannot reliably exclude every existing cancer or predict whether TB-500 could affect abnormal tissue growth.

There is no validated laboratory test or monitoring panel that establishes TB-500 safety or confirms that it is working. Normal results do not rule out immune reactions or long-term harm. Complete the monitoring requested by your Healthcare Provider. Treatment may be held or stopped for adverse effects, significant laboratory changes, a new medical concern, missing monitoring, an unverified product or dose, or lack of meaningful benefit at the planned reassessment. Do not extend a course or increase the dose because improvement has not occurred.

Acknowledgment and Agreement to Proceed

By signing this Consent, I acknowledge the following:

• Understanding and voluntary choice: I have read and understood this information, had the opportunity to discuss my circumstances and alternatives with my Healthcare Provider, and received answers to my questions. I voluntarily consent to the proposed treatment if my Healthcare Provider determines it is appropriate and it can be lawfully provided.
• No FDA approval: I understand that TB-500 and the compounded injectable product are not FDA-approved for any condition. This involves an unapproved drug substance, rather than simply a different use of an FDA-approved drug.
• Enforcement discretion and availability: I understand that TB-500 is not authorized for sale, that it is provided solely in reliance on an interim HHS enforcement discretion policy that may be revised or rescinded at any time, and that continued availability is not guaranteed.
• Limited evidence and unknown risks: I understand that the potential benefits are unproven, a safe and effective dose and duration are not established, and serious or long-term risks may be unknown.
• No guarantees: No specific symptom improvement, healing, recovery time, or other result has been promised. I understand that feeling better does not prove tissue healing or make return to activity safe.
• Complete medical history: I will accurately disclose my complete medical history, including any personal history of cancer, and all products I use, and promptly report changes, symptoms, pregnancy, or plans to conceive.
• Monitoring and reassessment: I agree to complete required laboratory testing no later than day 60 after starting treatment, or earlier if directed by my Healthcare Provider, and to complete requested follow-up and monitoring tests. I understand that my Healthcare Provider may request monitoring laboratory tests every 6 months or as needed at their discretion, and that continued treatment depends on clinical reassessment, including whether there is meaningful benefit.
• Financial terms: Prescription charges, cancellation, returns, and refunds, including if TB-500 becomes unavailable, are governed by the applicable terms disclosed separately. Signing this medical Consent does not itself change those terms.
• Right to decline or stop: I may decline treatment or withdraw consent for future treatment and discuss alternatives with my Healthcare Provider. Signing this Consent does not waive my legal rights or release any party from responsibility for negligent care.

Directions for Use and Following Instructions

• I will follow the written prescription and dispensing pharmacy instructions for the exact product supplied. I will confirm the medication name, ingredients, concentration, dose, injection volume, frequency, and route before the first dose and whenever the prescription or vial changes.
• I will use only TB-500 dispensed under my prescription by a licensed pharmacy. I will not substitute or combine it with products labeled "research use only" or "not for human use," or with TB-500 obtained from any other source.
• I understand that milligrams, micrograms, milliliters, and syringe "units" are not interchangeable. Syringe markings measure volume, and the amount of medication at a given marking depends on the concentration. I will not calculate or guess a dose from another product's instructions or an online example.
• I will administer this treatment only by the prescribed subcutaneous route after receiving instructions. I will not inject it into a vein, muscle, tendon, joint, or directly into an injury.
• I will not change the dose, frequency, course length, or formulation without instruction. If I miss a dose, I will follow the provided instructions or contact my Healthcare Provider or pharmacist; I will not double the next dose.
• I will wash my hands, prepare a clean area, use the instructed skin and vial-cleaning technique, rotate approved injection sites, and use a new sterile needle and syringe for each injection. I will never reuse or share injection equipment, vials, or medication. I will not sell or give my medication to anyone else.
• I will not mix TB-500 with other medications or add a diluent unless the dispensing pharmacy specifically directs me to do so and supplies clear preparation instructions.
• I will follow the pharmacy's storage, handling, transport, and preparation instructions and keep the medication out of reach of children and pets. I will use the earlier applicable discard deadline, including the labeled beyond-use date or any shorter period after puncture or reconstitution. I will not assume a universal 28-day rule applies.
• I will not use a damaged, expired, improperly stored, unexpectedly discolored, cloudy, or visibly contaminated product. I will contact the pharmacy if I am uncertain about its appearance, storage, or shipping conditions before injecting it.
• I will dispose of used needles and syringes in an appropriate sharps container and follow local disposal instructions.
• If I inject the wrong amount or product, I will seek immediate advice from my Healthcare Provider, pharmacist, or Poison Control at 1-800-222-1222. I will seek emergency care for severe symptoms.

CERTIFICATION OF CONSENT TO PROCEED WITH TREATMENT

BY SIGNING BELOW, I PROVIDE MY INFORMED CONSENT TO THE PROPOSED TREATMENT WITH COMPOUNDED TB-500 BY SUBCUTANEOUS INJECTION. I CERTIFY THAT I AM AT LEAST 18 YEARS OF AGE AND AM CONSENTING FOR MYSELF.

I have read this entire Informed Consent, or it has been explained to me in a language I understand. The proposed treatment, uncertainties, potential benefits, risks, and alternatives have been explained to me. I have had the opportunity to ask questions and have received answers satisfactory to me. I understand that I may request a copy of this Consent and withdraw consent for future treatment. I voluntarily elect to proceed, subject to my Healthcare Provider's assessment and applicable prescribing and dispensing requirements. If I accept this Consent electronically, including by checking a box, my electronic acceptance has the same effect as my handwritten signature.

MEMBER NAME: __________________________________________________

SIGNATURE: ______________________________________________________

DATE: ___________________________________________________________