Informed Consent for NAD+ Injections

INTRODUCTION

THIS INFORMED CONSENT FOR NAD+ INJECTIONS (THE "CONSENT") 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 (THE "MEDICAL GROUPS") THROUGH THE ONLINE TECHNOLOGY PLATFORM ("PLATFORM" OR "SUPERPOWER PLATFORM"),WHICH IS OWNED AND OPERATED BY SUPERPOWER HEALTH, INC.("SUPERPOWER").

This informed consent is for the use of nicotinamide adenine dinucleotide (NAD+)injections, a coenzyme involved in numerous cellular processes, for thepotential treatment of age-related conditions and overall wellness optimization. The purpose of this consent is to provide you with information about the risks, benefits, and safety considerations associated with NAD+injection 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

What is NAD+: NAD+, or nicotinamide adenine dinucleotide, is a critical coenzyme found in every cell in your body, and it is involved in hundreds of metabolic processes. But NAD+ levels decline with age. NAD+ has two general sets of reactions in the human body: helping turn nutrients into energy as a key player in metabolism and working as a helper molecule for proteins that regulate other cellular functions. Therefore, increasing NAD+ levels in the body can help with energy and potentially act as an anti-aging treatment.NAD+ precursors such as nicotinamide riboside (NR) and nicotinamide mononucleotide (NMN) can be taken orally, or NAD+ can be taken intravenously or via subcutaneous injection.

NAD+injections have emerged as a potential therapeutic strategy to replenish cellular NAD+ levels and combat age-related diseases. Injection delivery allows for higher bioavailability and potentially enhanced therapeutic effects compared to oral NAD+ precursors because the NAD+ goes directly into the tissue and bypasses the liver. NAD+ injections are not FDA approved.

RISKS AND SIDE EFFECTS

While robust clinical trials examining the efficacy and safety of NAD+ injections in humans are still limited, some potential mild and transient side effects may include:

• Fatigue
• Nausea  
• Headache
• Dizziness
• Mild injection site pain or bruising
• Flushing
• Dyspepsia
• Diarrhea

Serious adverse events appear rare based on available data, but could theoretically include:

• Allergic reactions
• Phlebitis at injection site
• Infection at injection site (anytime the skin is punctured, there is a risk of infection despite all precautionary measures)
• Hypotension
• Arrhythmia

CONTRAINDICATIONS

NAD+ injections may be contraindicated in the following situations:

• Allergy to NAD+ or any components of the injection
• Pregnancy and lactation (safety unknown)  
• Severe hepatic impairment(metabolism may be altered)
• Renal failure (excretion may be impaired)
• Cardiovascular disease (theoretical risk of systemic effects)
• Bleeding disorder
• Studies have shown that there is potential that higher levels of nicotinamide riboside could increase the risk of developing triple-negative breast cancer and may cause the cancer to metastasize to the brain. Therefore, you should NOT use NAD+ in any treatment if you have cancer or a history of cancer.

If any of these contraindications apply to you, inform your Healthcare Provider before starting treatment.

TREATMENT PROTOCOL

Your Healthcare Provider will determine the appropriate dosage of NAD+ injections based on your individual needs and medical history. The Superpower recommended starting dose for general health is:

Start 20mgNAD+ SC 1-3 times per week for the first week. Your Healthcare Provider may increase your injection dose by 20 mg every week as desired to a max dose of 100 mg NAD+ 1-3 times per week. Do not exceed more than 300 mg per week unless otherwise discussed with a Superpower Healthcare Provider.

Once astable well-tolerated dose is achieved, it can be continued long-term with periodic monitoring. The ideal duration of treatment is undefined. Clinical response, patient preference, and emerging research should guide maintenance therapy.

ALTERNATIVES

Use of NAD+ Injections is voluntary and elective. Potential Alternatives of NAD+ injections include but are not limited to: No treatment; Oral supplementation with NAD+ precursors; Intranasal NAD+; regular vigorous exercise may help maintain NAD+ levels with age; and dietary change (certain foods contain trace amounts of NAD+ precursors, such as small amount of NMN in vegetables such as broccoli, cucumber, and cabbage, as well as some fruit. NR is also found in foods, in particular milk, but the amounts are in the “low micromolar range” according to studies. This may help provide enough NAD+ for functioning, but not enough to replace what’s lost with age.)

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 customer 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 the Healthcare Provider;
• 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 for healthcare providers, you have to be physically present in the state in which your Healthcare Provider is licensed 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 TO THE 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 Healthcare Provider(s) via the Superpower 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 the Clinical 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 in order to proceed with treatment with NAD+ injection therapy 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 NAD+ INJECTION 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.

Use the NAD+injections exactly as directed by your Healthcare Provider. Do not use more of it, do not use it more often, and do not use it for a longer time than yourHealthcare Provider ordered.

NO GUARANTEES OR FDA APPROVAL:

You understand there is no guarantee that NAD+ injections will improve, reduce or eliminate any medical symptoms or conditions you have.You understand that there is no guarantee of any results including, without limitation, any increase in energy, anti-aging benefit or any other benefit from NAD+ injections and there are no refunds for NAD+ treatments.

You understand that the nature and purpose of NAD+ is still considered experimental and medically unnecessary and not the standard of medical care. You acknowledge that there are no guarantees there will not be side effects and complications. Additionally, you understand and acknowledge that theUnited States Food and Drug Administration (FDA) has not evaluated or approvedNAD+ to diagnose, treat, cure, or prevent any disease or medical condition.

COMPLETE MEDICAL HISTORY:

You understand that use of NAD+ injections 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 use of NAD+injections and you agree there shall be no liability on the part of the MedicalGroups, 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 NAD+ INJECTION TREATMENT 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 AGEOF 18.

By signing this Informed Consent to NAD+ Injection, I confirm and agree that: I have read this entire Informed Consent, 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 NAD+ Injections and elect and consent to proceed with treatment.

MEMBER NAME:___________________________
SIGNATURE:_____________________________
DATE:__________________________________

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