THIS INFORMED CONSENT (THE"CONSENT") FOR TESTOSTERONE REPLACEMENT THERAPY ORAL CAPSULES SOLD UNDER THE BRAND NAME KYZATREX® (“TRT CAPSULES”) SETS FORTH THE TERMS AND POLICIES FOR THE CLINICAL SERVICES PROVIDED BY SUPERPOWER MEDICAL GROUP OF CAPC, 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 taking oral TRT capsules 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.
Kyzatrex®(testosterone undecanoate), is an oral prescription testosterone for adult men who have low or no testosterone levels due to certain medical conditions.
Testosterone replacement therapy (TRT) is a treatment to replace the testosterone that’s been lost and get testosterone levels back to a normal range. The FDA approves testosterone therapy for men who lack or have low testosterone levels in conjunction with an associated medical condition. Other uses may be considered off label. The safety and efficacy of testosterone supplementation for off label use is not established. Many individuals have inadequate testosterone levels despite technically normalblood tests. In such cases, testosterone replacement therapy can be used to augment testosterone levels in a number of conditions where diminished hormone levels are evident. Lifestyle modifications such as diet and exercise, sufficient sleep, and stress reduction have also proven to improve overall health and hormone levels. Testosterone replacement therapy is used to treat symptoms or when lab tests suggest suboptimal hormone levels. In such case, testosterone replacement therapy is implemented to optimize testosterone levels in the blood, helping to reduce symptoms associated with lower levels. Potential benefits can include: increased energy, increased sex drive, increased bone density, weight loss, increased muscle mass, better sleep and decreased anxiety. However, no benefits are or lack of side effects are guaranteed.
TRT has traditionally consisted of testosterone patches, gels, subdermal pellets, and injections. Kyzatrex® is an oral capsule formulated to be easily absorbed and to bypass metabolism of your liver. That means it works efficiently, without causing liver damage. Injections and pellets can be painful, and gels and creams can be messy and have a risk that they can rub off on family members and pets.
Kyzatrex® should be taken with food. Absorption is not affected by alcohol consumption and not materially affected by fat content of food.
The Medical Group providers prescribe testosterone therapy only in appropriate cases. Nevertheless, in order to reduce uncertainties and potential risks, patients who are prescribed testosterone replacement must agree to have adequate lab testing and physical examination as recommended by their Medical Group provider. Testosterone refills will not be issued if the required testing and follow up reviews with your provider are not followed as prescribed.
As with all therapies, there are potential benefits and risks.
According to The Endocrine Society, testosterone therapy can improve sexual concerns, bone health, muscle and anemia (low red cells in the blood).Additional potential benefits, according to the published literature, include increase in skeletal muscle mass, strength and power, self-reported mobility, and some measures of physical function, as well as modest improvement in depressive symptoms, quality of life, and improved glucose tolerance in men with Type 2 diabetes.
The American College of Physicians states: “Evidence from 20 observational studies with a mean follow-up ranging from 0.73 to 10.3 years showed no increased risk for mortality, cardiovascular events, prostate cancer, or pulmonary embolism or deep venous thrombosis.”
The most extensive study to date examined prostate safety during testosterone replacement in men with hypogonadism (testosterone deficiency). The results were that there was not any statistical significance compared to men in the placebo group regarding an increased incidence of prostate cancer, acute urinary retention, invasive surgical procedures, prostate biopsy, and International Prostate Symptom Score.However, PSA levels did increase more in the testosterone group than in the placebo group.
A separate large study examined the cardiovascular safety of testosterone-replacement therapy in middle aged and older men between the ages of 45 to 80 years who had preexisting or a high risk of cardiovascular disease with hypogonadism(testosterone deficiency). Daily transdermal testosterone had less incidence of cardiovascular events compared to placebo.
While these studies showed a high degree of safety, side effects could still occur with long-term use. The most common side effect of TRT is high blood pressure. Other side effects may include: headache, joint or back pain, diarrhea, increased red blood cell count, anxiety, constipation, swelling of the legs, and increased prostate specific antigen (PSA) levels as well as those listed below.
The following is a list of some common possible side effects of TRT:
These are not all the possible side effects of TRT.
Testosterone containing medications are a controlled substance as designated by the DEA and should be stored in a safe and secure place to prevent unauthorized access and use. Keeping this medication in a locked box, locked cabinet, or safe is recommended. It is against federal regulation to sell, share, or distribute this prescription to anyone for whom it has not been prescribed.
There are often various options for treating the symptoms of declining testosterone levels as they develop with non-hormonal therapies such as herbal therapies, dietary supplements, and lifestyle modifications such as nutrition, physical exercise, weight loss, stress reduction etc.
You should not use testosterone replacement therapy if any of the following apply to you:
Kyzatrex® is not intended to be used for men who have low testosterone due to age. Use of Kyzatrex® for this purpose is not FDA approved.
Your Healthcare Provider will determine the appropriate dosage of based on laboratory testing and medical history. Kyzatrex® is supplied in 200 mg Capsules with the suggested dosing of200 mg twice a day or 400 mg twice a day based on your provider’s recommendations. Testosterone dosing should be tailored to each patient based on individual lab values and guided by the prescriber’s clinical expertise.This approach ensures that treatment is both safe and effective, addressing the unique needs and physiological responses of each patient.
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 receivingprescriptions, you will be required to complete laboratory testing beforeinitiating treatment, three months after starting treatment, and then annuallythereafter, unless otherwise indicated by your clinician in the event of a dosechange or the occurrence of side effects.
It is very important you follow your provider’s instructions. You agree not to change your dosing of testosterone to manipulate your hormone levels in order to increase the amount of testosterone prescribed to you.
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 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.
There are potential risks associated with the use of telehealth. These risks include, but may not be limited to:
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.
Please sign below to acknowledge your understanding and agreement of the following terms in order to proceed with treatment with Testosterone Replacement Therapy OralCapsules (Kyzatrex®) with a Medical Group Healthcare Provider via theSuperpower Platform:
BY SIGNING THIS INFORMED CONSENT,YOU ACKNOWLEDGE THAT YOU HAVE READ AND UNDERSTAND THE INFORMATION PROVIDEDABOUT TRT 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 TRT 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.
You acknowledge that there are no guarantees or assurances made with respect to the results of taking the TRT Capsules prescribed for you, and there are no guarantees that there will not be side effects and complications.
You understand that TRT 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 prescribingHealthcare Provider updated as to any changes in your health conditions and history during treatment with TRT, 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 TRT ORAL CAPSULES 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.
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 withTRT and elect and consent to proceed with treatment.
MEMBER NAME:___________________________
SIGNATURE:_____________________________
DATE:__________________________________
