Superpower Health

Informed Consent for Growth Hormone Releasing Peptides (Injection and Troche)

Last Updated and Effective:
10.8.2024

INTRODUCTION

THIS INFORMED CONSENT (THE"CONSENT") FOR GROWTH HORMONE RELEASING HORMONE, SPECIFICALLY SERMORELIN, INJECTIONS AND/OR TROCHES (“GHRH” or “GHRH TREATMENT”) SETS FORTH THE TERMS AND POLICIES FOR THE CLINICAL SERVICES PROVIDED BY SUPERPOWER MEDICAL GROUP OF CA PC, A CALIFORNIA PROFESSIONAL MEDICAL CORPORATION, AND OTHER THIRD-PARTY MEDICAL GROUPS (COLLECTIVELY, 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 consent is to provide you with information about the risks, benefits, and safety considerations associated with GHRH Treatment in order for you to make an informed decision as to whether or not to proceed with treatment, as well as to obtain your agreement to adhere to the treatment protocol as prescribed by your Medical Group healthcare provider (“Healthcare Provider”). Please read this form carefully and ask any questions you have before signing.

GENERAL INFORMATION: SERMORELIN ACETATE | GHRH THERAPY

As with all therapies, there are potential benefits and risks.

Potential Benefits of GHRH:

Sermorelin is a Growth Hormone Releasing Hormone (GHRH) peptide. It triggers the pituitary gland in the brain to generate growth hormone, providing potential advantages for muscle growth, strength, exercise capacity, bone density, immune function, skin thickness, wound healing, metabolism, and overall health. However, your Medical Group health care provider cannot guarantee any health benefits or that there will be no harm from the use of GHRH.

  • OFF-LABEL USE OF FDA-APPROVED DRUGS
    • Sermorelin is approved by the FDA for treating growth hormone deficiencies in children and is also used off-label in adults. Sermorelin has not been approved by the FDA to for any other purpose or to treat any other medical disease, diagnosis or condition.
  • NEVER TAKE MORE THAN PRESCRIBED
    • It is not recommended to exceed the recommended dosage of GHRH prescribed by your Medical Group provider. Overdose will not provide better results. It will only increase the occurrence of side effects.
  • ADMINISTRATION:  
    • GHRH is  administered either via an oral lozenge called a troche that dissolves under the tongue near the delicate capillaries located there or an injection into the subcutaneous into the fat layer just below the skin. Please be informed that there are certain risks associated with injections.

Potential Risks and Side Effects of GHRH

By signing this form, you understand the possible risks associated with this GHRH Treatment. The following is a list of some common possible side effects of GHRH but there may be others:

  1. Water retention which may result in swelling of the hands and ankles (Continued fluid retention could lead to headaches and/or joint pain, and possibly carpal tunnel syndrome, increased blood pressure or insulin dependence); 
  2. Elevated blood pressure, which may be reversed with dose adjustment;
  3. An initial mild increase in fasting blood sugar (if you are diabetic);
  4. Parethesias (numbness and tingling in the hands) and/or Arthralgias (joint aching)
  5. Bruises at the injection site;
  6. Infection at the injection site if improper techniques are used;
  7. Clinical Tests have shown that increased blood-serum levels of Insulin-Like Growth Factor One (IGF-1), Human GrowthHormone, alkaline phosphatase, and inorganic mineral phosphorus can occur as a result of GHRH therapy;
  8. Taking glucocorticoid steroids in combination with GHRH may reduce the effectiveness of therapy;
  9. There is always the risk of allergic reaction. There have been no reported general allergic responses to GHRH. The most common reaction to GHRH is related to local irritation around the injection site, which occurs in around one of every six patients. This irritation is characterized by redness, pain, or swelling;
  10. Antibodies: A significant portion of GHRH Treatment patients develop antibodies against Growth Hormone Factor during atleast one point of therapy. There is no clear assessment of the significance of the presence of these antibodies, and the levels of these antibodies can change quickly from test to test. A positive result at one juncture regularly turns into a negative result after the next test. The production of these antibodies does not seem to have any adverse effect on the patient. Also, these antibodies do not seem to produce any change in the effectiveness of GHRP Treatment.

This is not an all-inclusive list. There may be other risks or side effects unknown. By agreeing to undergo this therapy you are accepting these risks and freely agree to participate in GHRH Treatment.

Sermorelin/GHRH And Abuse:

There is no evidence to suggest that the use of GHRH for any period will result in any sort of dependency or proclivity toward abuse. The general pharmacology of GHRH does not produce any addictive effect, and clinical trials have produced no evidence of such an effect.

Available alternatives to GHRH:

  • Leaving the hormone levels as they are and doing nothing. Risks of this approach may include, but are not limited to, experiencing symptoms of growth hormone deficiency and an increased risk for aging-related diseases or dysfunction resulting from declining growth hormone levels. This alternative may result in the need to treat diseases or dysfunction associated with declining growth hormone levels as they appear clinically.
  • Treating the symptoms of declining growth hormone levels as they develop with non-hormonal therapies including dietary and herbal supplements, lifestyle changes (sleep, stress, environment), and nutrition. Risks may include but are not limited to: increased risk for aging-related diseases resulting from declining hormone levels.

Contraindications:

You should not use GHRH therapy if any of the following apply to you:

  • These drugs should not be used inpatients with known cancer. Human Growth Hormone can affect cell metabolism and cell growth. For example, if a patient had an underlying and/or undetected cancerous growth prior to undergoing hormone therapy, the administration Sermorelin or other hormones could possibly induce further growth of the underlying cancer. Some studies contradict this theory, but results are unknown. Therefore, HGH is contraindicated when there is any evidence of neoplastic (cancer) activity. HGH should be discontinued if there is evidence of tumor growth.
  • Proliferative diabetic retinopathy;
  • Pulmonary fibrosis;  
  • Recent coronary angioplasty;
  • Intracranial lesions must be inactive and anti-tumor therapy complete prior to institution of therapy;
  • It should not be initiated to treat patients with acute critical illness due to complications following open heart or abdominal surgery, multiple accidental traumas, or to patients having acute respiratory failure.
  • Caution is required when HGH is administered to patients with diabetes mellitus, as insulin dosage may need to be adjusted.
  • GHRH should NOT be administered to women who are pregnant or nursing. It is unknown if the GHRH affects the fetus or is produced in the month’s milk. There are many medications that are released by the mother in the nursing process, and for this reason mothers and physicians should exercise caution when using GHRH while breastfeeding.

TREATMENT PROTOCOL COMPLIANCE

Your Healthcare Provider will determine the appropriate dosage of based on laboratory testing and medical history.

Once your hormone levels and symptoms are optimized, you will be placed on a maintenance dose. Most men are on the protocol for at least 6-12 months and many continue for multiple years.

In order to continue receiving prescriptions, you will be required to complete laboratory testing before initiating treatment, three months after starting treatment, and then annually thereafter, unless otherwise indicated by your clinician in the event of a dose change or the occurrence of side effects.

It is very important you follow your provider’s instructions. You agree not to change your dosing of GHRH to manipulate your hormone levels to increase the amount of GHRH/Sermorelin prescribed to you.

You agree to comply with the proposed treatment and therapy as prescribed, including the fact that you maybe responsible for injecting the GHRH prescribed to you, and consent to periodic monitoring when requested, which may include:

  • Laboratory monitoring of blood o rurine chemistries and hormone levels
  • Regular screening evaluations

Your prescription may be terminated if lab testing and screening evaluations are not conducted as prescribed.

SHARPS DISPOSAL INFORMATION

If your provider approves home usage, the patient should use SHARPS containers meant for the proper disposal of used needles and syringes accumulated as a result of GHRH injections. These containers are puncture resistant and are a necessary safety measure to protect both patient and anyone who may encounter the used needles and syringes. It is vital that you understand importance of proper needle disposal and of the dangers of reusing syringes and needles as well.

USE OF TELEHEALTH

You understand that all Clinical Services will be provided via telehealth. Telehealth involves the delivery of healthcare services using electronic communications, information technology or other means between a healthcare provider and a patient who are not in the same physical location. Telehealth may be used for diagnosis, treatment, follow-up and/or patient education, and may include, but is not limited to, one or more of the following:

  • electronic transmission of client medical records, photo images, personal health information or other data between a patient and a provider;
  • interactions between a patient and provider via audio, video and/or data communications (such as messaging or email communications);
  • use of output data from medical devices, sound and video files.
  • Alternative methods of care may be available to you, such as in-person services, and you may choose an alternative at any time.

Electronic systems used will incorporate network and software security protocols to protect the confidentiality of customer identification and imaging data and will include measures to safeguard the data and to ensure its integrity against intentional or unintentional corruption.

EXPECTED BENEFITS OF TELEHEALTH:  

  • Improved access to care by enabling a patient to remain at a remote site while consulting with practitioners at distant/other sites.
  • More efficient client evaluation and management.
  • Obtaining expertise of a distant specialist.

POSSIBLE RISKS OF TELEHEALTH

There are potential risks associated with the use of telehealth. These risks include, but may not be limited to:

  • There is the potential that conditions that could be diagnosed with an in-person visit may go undetected in a remote encounter especially because a full physical exam cannot be performed.
  • In rare cases, information transmitted may not be sufficient (e.g. poor resolution of images) to allow for appropriate decision making by your Healthcare Provider on the Superpower Platform;
  • Delays in evaluation and treatment could occur due to deficiencies or failures of the equipment;
  • In very rare instances, security protocols could fail, causing a breach of privacy of personal health information;
  • In rare cases, a lack of access to complete health records may result in interactions or allergic reactions or other judgment errors.

Due to state licensure requirements of healthcare providers, you must physically be in the state that your Medical Group Healthcare Provider is licensed in during your telehealth visit. By agreeing to this Consent, you are confirming that you will only opt in to care when you are in your state of residence or in one of our locations. Furthermore, you are confirming that your state of residence is one in which the Medical Groups are licensed to treat.

PLEASE NOTE: THE MEDICAL GROUPS DO NOT ADDRESS MEDICAL EMERGENCIES. IF YOU BELIEVE YOU ARE EXPERIENCING A MEDICAL EMERGENCY, ARE CONSIDERING HARMING YOURSELF OR OTHERS, OR ARE OTHERWISE IN IMMINENT DANGER, YOU SHOULD DIAL 9-1-1 AND/OR GO TOTHE NEAREST EMERGENCY ROOM.

You should seek emergency help or follow-up care when recommended by any healthcare provider or when otherwise needed. You should never discontinue medications or stop a course of treatment without first contacting your primary care provider or other medical professionals for advice. You should not delay treatment or advice from your primary care provider or other medical professionals based on information provided by the Medical Group Healthcare Providers via theSuperpower Platform.

All laws and protections for in-person medical care also apply to telehealth care. This includes confidentiality of information, access to medical records, and sharing of information that could identify you personally. You may decide that you do not want to use theClinical Services at any time, seek treatment elsewhere and/or with in-person offerings.  

INFORMED CONSENT & ADHERENCE TO TREATMENT PLAN

Please sign below to acknowledge your understanding and agreement of the following terms to proceed with treatment with GHRH/Sermorelin Treatment with a MedicalGroup Healthcare Provider via the Superpower Platform:

BY SIGNING THIS INFORMED CONSENT,YOU ACKNOWLEDGE THAT YOU HAVE READ AND UNDERSTAND THE INFORMATION PROVIDED ABOUT GHRH TREATMENT, INCLUDING THE RISKS, BENEFITS, AND SAFETY CONSIDERATIONS.YOU AGREE TO ADHERE TO THE TREATMENT PROTOCOL AS PRESCRIBED BY YOUR HEALTHCARE PROVIDER AND TO REPORT ANY SEVERE SIDE EFFECTS OR CONCERNS TO YOUR HEALTHCARE PROVIDER PROMPTLY.

Take your medication exactly as directed and written on your prescription label. By FDA law, this medication is not for resale, nor can it be returned for refund. Do not let anyone else take your medication. This medication is intended for use solely by the person for whom it is prescribed and should not be shared with any other individuals.Please follow the directions of your prescribing Healthcare Provider and on your prescription label carefully. If you need further explanation or have questions, please ask your prescribing Healthcare Provider to explain any part you do not understand.

You understand that the HealthcareProvider prescribing GHRH holds a professional license issued by the professional licensing board or agency in the state where they practice. You can report a complaint relating to the care provided by contacting the appropriate state professional licensing board.

NO GUARANTEES:

You acknowledge that there are no guarantees or assurances made with respect to the results of using the GHRH Treatment prescribed for you, and there are no guarantees that there will not be side effects and complications.

COMPLETE MEDICAL HISTORY:

You understand that GHRH Treatment may be inappropriate and unsafe if you have certain health conditions, allergies, or take certain medications or supplements, whether prescribed or over-the-counter. For this and other reasons, you understand that it is vital that you truthfully and accurately disclose all health information requested by your prescribing Healthcare Provider including allergies, medications you are taking (both prescription and over the counter), medical/surgical/social/family history, and pertinent lab results, and keep your Medical Group prescribing Healthcare Provider updated as to any changes in your health conditions and history during treatment with GHRH, and you agree there shall be no liability on the part of the Medical Groups, the Healthcare Providers or Superpower if you fail to do so.

CERTIFICATION OF CONSENT TO PROCEED WITH TREATMENT:

BY CLICKING "I AGREE" OR OTHERWISE INDICATING YOUR ACCEPTANCE, YOU ARE PROVIDING YOUR INFORMED CONSENT TO RECEIVE GHRH(SERMORELIN) TREATMENT EITHER VIA INJECTION OR ORAL TROCHE THROUGH THIS SERVICE. YOU CERTIFY THAT YOU ARE NOT CONSENTING ON BEHALF OF A MINOR CHILD, AS THIS SERVICE DOES NOT PROVIDE TREATMENT TO INDIVIDUALS UNDER THE AGE OF 18.

  • By signing, I hereby confirm and attest that I am not under the jurisdiction of any governing body which prohibits the use of hormone and/or human growth hormone replacement therapy, such as sports organizations, competitive athletic/bodybuilding organizations, Olympic sports teams, or the like.
  • I have completely disclosed my medical history, including prescription and non-prescription medications that I am currently taking or plan to take during my treatment, as well as any other over-the-counter medications, recreational drugs or social substances, herbs, extracts and other dietary supplements to you. I agree to comply with the recommendations regarding the continuation or discontinuation of these preparations.
  • I understand that I will be responsible for injecting and/or administering any GHRH prescribed to me. I agree to conform and comply with the recommended doses and methods of     administration. I also agree to comply with any requests for initial and subsequent blood tests, as required, to monitor my hormone levels.
  • I acknowledge that there are no guarantees relating to the effectiveness of GHRH and there are NO refunds.
  • I confirm and agree that: I have read this entire InformedConsent, and I understand and agree to the information herein. I understand this is an elective treatment. The nature of the therapy, and the potential risks, benefits and alternatives have been explained to me, and I have had the opportunity to ask questions, and all my questions have been answered to my satisfaction. I hereby freely and voluntarily accept all risks associated with GHRHTreatment and elect and consent to proceed with treatment.

MEMBER NAME:___________________________

SIGNATURE:_____________________________

DATE:__________________________________