GLP1 Informed Consent

INTRODUCTION

THIS INFORMED CONSENT FOR GLP-1/GIP RECEPTOR AGONIST MEDICATIONS (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").

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The purpose of this informed consent form is to give you written information regarding the risks, benefits, and alternatives with respect to compounded Semaglutide and Tirzepatide prescription medications for weight loss so that you can make a fully informed decision about whether to proceed with treatment. This material serves as a supplement to the discussion you have with your Superpower Healthcare Provider about the treatment. It is important that you fully understand this information, so please read this document thoroughly. If you have any questions regarding the procedure, ask your Superpower Healthcare Provider prior to signing the consent form.

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Your Superpower Healthcare Provider will perform an evaluation reviewing your medical history, any other medications and supplements you're taking, and other medical information to determine if Semaglutide or Tirzepatide are appropriate for you. These medications are intended to be used in combination with lifestyle change, nutrition, and physical activity for weight loss as recommended by your Superpower Healthcare Provider.

General Information and Background:

Glucagon-like peptide-1 (GLP-1) and Gastric inhibitory polypeptide (also known as glucose-dependent insulinotropic polypeptide) (GIP) and are the two primary hormones secreted from the intestines upon ingestion of glucose or nutrients to stimulate insulin secretion from pancreatic beta cells. GIP and GLP-1 then bind to their specific receptors which cause reactions thereby stimulating insulin secretion to move the glucose from the blood stream to the muscles and other cells where it can be used as well as having other effects throughout the body such as increasing fullness and satiety.

Semaglutide (GLP-1 Receptor Agonist) Medications:

Semaglutide is a GLP-1 receptor agonist, which means that works by mimicking GLP-1 that the body naturally produces. It docks in the same hormone receptors as the GLP-1 the body makes, causing the same reactions as the body's naturally produced GLP-1 (generally only be produced when someone eats a meal). Taking a GLP-1 receptor agonist helps prevent the liver from releasing too much sugar, thereby reducing blood sugar levels, and also promotes satiety—in other words, provokes a feeling of fullness. This happens because the drug slows down the digestive system, so you feel fuller for longer.

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Ozempic® is a brand name Semaglutide medication that has been approved by the FDA for blood sugar control in type 2 diabetics and is used off-label for weight loss. Wegovy® is another brand name Semaglutide medication that is FDA approved for weight loss along with diet and exercise.

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You should be aware that compounded Semaglutide (GLP-1 receptor agonist) products are not identical to the approved products Ozempic® and Wegovy®. Compounded GLP-1 agonists have not been evaluated for safety, quality and efficacy by the FDA. Compounded Semaglutide has not been approved by the FDA for weight loss or any other condition and is currently only available while the FDA approved versions are on the FDA shortage list. The Superpower Healthcare Providers generally prescribe Compounded Semaglutide due to the pricing and availability. By choosing to be prescribed Compounded Semaglutide, you understand that it is not FDA approved.

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The FDA doesn't consider Semaglutide Sodium to be the same ingredient as that in FDA approved drugs like Ozempic® and Wegovy®. Instead, the FDA states that the sodium version should not be used to make copies of the drugs in shortage and has "not been shown to be safe and effective." The Superpower Healthcare Providers prescribe Compounded Semaglutide products from a compounding pharmacy which states that they do not use the sodium form. If you see sodium on your prescription label, notify your Superpower Healthcare Provider immediately.

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Tirzepatide Medications:

Tirzepatide is both a GIP and GLP-1 receptor agonist. GIP and GLP-1 regulate gut hormones called incretins, which help our bodies know when we feel full and help prevent the liver from releasing too much sugar, thereby reducing blood sugar levels. The drug also slows down the digestive system, so you feel fuller longer.

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Mounjaro®, also known as Zepbound®, is the brand name patented version of Tirzepatide injectable that received FDA approval for obesity.

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You should be aware that compounded Tirzepatide (GIP and GLP-1 receptor agonist) products are not identical to the approved products Mounjaro® and Zepbound®. Compounded Tirzepatide-like products have not been evaluated for safety, quality and efficacy by the FDA. Compounded Tirzepatide has not been approved by the FDA for weight loss or any other condition and is currently only available while the FDA approved versions are on the FDA shortage list. The Superpower Healthcare Providers generally prescribe Compounded Tirzepatide due to cost and lack of availability of Mounjaro® and Zepbound®. By choosing to be prescribed Compounded Tirzepatide, you understand that it is not FDA approved.

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Side Effects, Risks and Complications: Every treatment involves a certain amount of risk, and it is important that you understand these risks and the possible complications associated with use of Semaglutide and Tirzepatide. An individual's choice to take a medication is based on the comparison of the risk to potential benefit.

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The most common side effects from taking Semaglutide and Tirzepatide include, but are not limited to:

• Nausea, vomiting, diarrhea, constipation, abdominal pain, headache, fatigue, dyspepsia, dizziness, hypotension, abdominal distension (bloating), eructation (burping), hypoglycemia in patients with type 2 diabetes, flatulence (gas), gastroenteritis, gastroesophageal reflux disease, injection site reactions, allergic reactions, and hair loss. Your Healthcare Provider will work with you to limit and treat these side effects.
• You may also experience redness or pain at the injection sites if these drugs are administered via injection.
• Additionally, many individuals notice that their face may become excessively thin and their cheeks hollow looking due to rapid weight loss.

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Possible Drug Interactions:

• Anti-diabetic agents, specifically Insulin and Sulfonylureas (e.g., glyburide, gliclazide, glipizide, glibenclamide, tolbutamide and glimepiride) due to the increased risk of hypoglycemia since GIP and GLP-1 already lower blood sugar.
• Do not take with other GLP-1 agonist medications such as Adlyxin®, Byetta®, Bydureon®, Ozempic®, Rybelsus®, Trulicity®, Victoza®, Wegovy® (this is NOT an all-inclusive list).
• Semaglutide and Tirzepatide cause a delay in gastric emptying, so they have the potential to impact the absorption of medications that are taken by mouth at the same time. Your Superpower Healthcare Provider can guide you on how to schedule your medications.
• If you are taking Tirzepatide and using oral hormonal contraceptives (birth control), Tirzepatide may decrease the efficacy of your birth control, especially after the first dose. You should switch to a non-oral contraceptive method or add a barrier method of contraception for 4 weeks after starting Tirzepatide and for 4 weeks after each dose escalation until you reach a maintenance dose.

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Please tell your Superpower Healthcare Provider about any other medications in your routine, and especially any that you think may lower your blood sugar.

Potential Serious Side Effects and Complications include, but are not limited to:

• Gastroparesis and chronic gastrointestinal issues (constipation and/or diarrhea)
• Thyroid C-cell tumor and Medullary thyroid cancer
• Hypersensitivity reaction, Anaphylaxis and/or Angioedema
• Acute kidney injury and chronic renal failure exacerbation. In people who have kidney problems, diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration) which may cause kidney problems to get worse. It is important for you to drink plenty of water to help reduce your chance of dehydration.
• Cholelithiasis and Cholecystitis (Gallbladder problems)
• Diabetic Retinopathy Complications. Inform your Superpower Healthcare Provider if you experience any changes in vision while taking Semaglutide or Tirzepatide. Patients with a history of diabetic retinopathy should be monitored. In patients with type 2 diabetes, rapid improvement of glucose control has been associated with temporary worsening of diabetic retinopathy.
• Pancreatitis (be aware of: persistent severe abdominal pain, sometimes radiating to the back, and which may or may not be accompanied by vomiting)
• Heart Rate Increase. Monitor heart rate at regular intervals and tell your Superpower Healthcare Provider right away if you have a racing heartbeat while at rest.
• Suicidal Behavior and Ideation. Monitor for depression or suicidal thoughts. You should pay attention to any mental health changes, especially sudden changes in your mood, behaviors, thoughts, or feelings. Call your healthcare provider right away if you have any mental changes that are new, worse, or worry you.
• Pulmonary Aspiration During General Anesthesia or Deep Sedation. Semaglutide and Tirzepatide cause a delay in gastric emptying. There have been reports of pulmonary aspiration (when food or liquid from the stomach enters the lungs) in people taking GLP-1 medications while undergoing surgery requiring sedation, even when instructed to fast before the surgery. If you have a planned major surgery requiring sedation, reach out to your Superpower Healthcare Provider for instructions.

This is not a complete list of side effects and complications, and others may occur.

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Contraindications and Additional Information Regarding Potential Risks: DO NOT TAKE THIS MEDICATION IF ANY OF THE FOLLOWING APPLY TO YOU. 

• Semaglutide and Tirzepatide should not be used in combination with other GLP-1 receptor agonists or other products intended for weight loss, including prescription drugs, over-the-counter drugs, or herbal weight loss products. Therefore, you must not take any other weight loss drugs, including over-the-counter weight loss products, while taking Semaglutide or Tirzepatide unless prescribed or recommended by your Superpower Healthcare Provider or another healthcare provider who knows you are also taking Semaglutide or Tirzepatide.
• Semaglutide and Tirzepatide should not be used in patients with a personal or family history of Medullary Thyroid Carcinoma (Medullary Thyroid Cancer) or with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Semaglutide and Tirzepatide caused thyroid C-cell tumors occurring in rodents (with unknown risks in humans).
• Semaglutide and Tirzepatide should not be used in people with type-1 diabetes or in anyone who is taking insulin and sulfonylureas.
• You have had an allergic reaction to Semaglutide, Tirzepatide, or any other GLP-1 agonist such as Adlyxin®, Byetta®, Bydureon®, Ozempic®, Rybelsus®, Trulicity®, Victoza®, Wegovy®, etc. Stop using Semaglutide or Tirzepatide right away if you experience symptoms of a serious allergic reaction, including swelling of your face, lips, tongue or throat, severe rash or itching, very rapid heartbeat, problems breathing or swallowing, or fainting or feeling dizzy.
• Semaglutide and Tirzepatide also have warnings for the possibility of causing pancreatitis, gallbladder problems, hypoglycemia, acute kidney injury, diabetic retinopathy, increased heart rate, severe gastrointestinal disease, and suicidal behavior or thinking. Therefore, Semaglutide and Tirzepatide should either not be used or should be used with extreme caution in people with a history of chronic or pancreatitis, decreased kidney function, diabetic retinopathy, severe gastrointestinal disease, or history of suicidal ideation.
• Pregnancy and Breastfeeding: You should stop using Semaglutide and Tirzepatide at least two (2) months before you plan to get pregnant and should not use it while breastfeeding. If you are a woman, use adequate contraception to ensure you do not become pregnant while taking Semaglutide or Tirzepatide. Please tell your Superpower Healthcare Provider if you plan to become pregnant, and immediately contact your Superpower Healthcare Provider if you inadvertently become pregnant while taking Semaglutide or Tirzepatide. Based on animal studies, there may be potential risks to an unborn baby from exposure to these medications during pregnancy. There is no benefit to weight loss during pregnancy and it may cause harm to the unborn baby.
• Pregnancy Registry Information: There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to semaglutide and tirzepatide during pregnancy. Pregnant women exposed to these medications and healthcare providers are encouraged to report exposures:

For Semaglutide: Contact Novo Nordisk at 1-877-390-2760 or [www.wegovypregnancyregistry.com](http://www.wegovypregnancyregistry.com)

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For Tirzepatide: Contact Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979)

Please note that the above list is not complete, and it describes the most common side effects and risks. Symptoms may be worse after there has been a change in your medication dose or when first starting the medication.

If you are experiencing a medical emergency, call 911 or seek immediate medical attention.

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Contact your Superpower Healthcare Provider or urgent care immediately if you experience any of the following while taking Semaglutide or Tirzepatide: vision changes; unusual mood changes, thoughts about hurting yourself; pounding heartbeats or fluttering in your chest; a light-headed feeling, like you might pass out; signs of a thyroid tumor (swelling or a lump in your neck, trouble swallowing, a hoarse voice, feeling short of breath); symptoms of pancreatitis (severe persistent pain in your upper stomach spreading to your back, nausea with or without vomiting, fast heart rate); gallbladder problems (upper stomach pain, fever, clay-colored stools, jaundice or yellowing of the skin or eyes); low blood sugar (headache, hunger, weakness, sweating, confusion, irritability, dizziness, fast heart rate, or feeling jittery); kidney problems (swelling, urinating less, feeling tired or short of breath); severe allergic reactions (swelling of your face, lips, tongue or throat, severe rash or itching, very rapid heartbeat, problems breathing or swallowing, or fainting or feeling dizzy); or stomach flu symptoms (stomach cramps, vomiting, loss of appetite, diarrhea that may be watery or bloody).

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Alternatives: Alternatives to Semaglutide and Tirzepatide for weight loss and blood sugar management include diet and exercise, other diabetic drugs, weight loss surgery, and natural herbal supplements. Other diabetic drugs, weight loss surgery and supplements also have potential benefits and risks to be discussed with your Superpower Healthcare Provider.

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Medical History Disclosure Requirements:

It is important to share your entire medical history with Superpower.

In particular, disclose to Superpower if you have or had a past history of:

• Type 1 or type 2 diabetes
• Thyroid cancer
• Gastrointestinal disease (especially severe gastrointestinal disease)
• Pancreatitis
• Kidney disease
• Diabetic retinopathy
• Depression
• Suicidal thoughts or behavior

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Withholding or providing inaccurate information about your health and medical history in order to obtain treatment may result in harm, including, in some cases, death.

By joining a Superpower GLP-1 plan, you acknowledge your understanding and agreement to proceed with treatment using Compounded Semaglutide or Tirzepatide, as prescribed by a Superpower Healthcare Provider.

• I have read and understand all of the above statements and have been informed of potential side effects and risks that may be associated with the use of Compounded Semaglutide and Tirzepatide prescriptions. I fully understand what I am signing and hereby request and consent to treatment using Compounded Semaglutide or Tirzepatide as prescribed to me by my Superpower Healthcare Provider. I understand that other treatment alternatives are available for weight loss and blood sugar management.
• NO GUARANTEES: I acknowledge that there are no guarantees or assurances made with respect to weight loss or any results of taking the Compounded Semaglutide or Tirzepatide prescribed for me, and I understand that it works best when combined with diet and exercise.
• NO FDA APPROVAL FOR COMPOUNDED MEDICATIONS: I understand that compounded Semaglutide and compounded Tirzepatide are not approved by the FDA for any purpose and are formulated and used on a research basis only.
• NO REFUNDS: I understand that results may vary, and I understand that there are no refunds. I understand that my prescription is in my individual name and cannot be returned.
• Complete Medical History: I understand that Semaglutide and Tirzepatide may be inappropriate and unsafe if I have certain health conditions, allergies, or take certain medications or supplements, whether prescribed or over-the-counter. For this and other reasons, I understand that it is vital that I truthfully and accurately disclose all health information requested by my Superpower Healthcare Provider including allergies, medications I am taking (both prescription and over the counter), medical/surgical/social/family history, and pertinent lab results, and keep my Superpower Healthcare Provider updated as to any changes in my health conditions and history during treatment with Semaglutide and Tirzepatide, and there shall be no liability on the part of Superpower, a Medical Group or my Superpower Healthcare Provider if I fail to do so. I understand that if I become pregnant or start trying for pregnancy, I must stop this medication.

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Directions for use and Following Instructions:

• I understand that I will be in charge of storing and administering the medication prescribed to me. I will follow and comply with the recommended instructions, doses and methods of administration and understand this is very important for the safety of the treatment. I understand that failure to comply with the dosage and administration instructions could alter the weight loss results and the safety of treatment.
• I will not adjust my medications up or down without prior instruction to do so.
• I will not share needles, syringes, or pens with anyone, as sharing poses a risk of infection.
• I will dispose of needles safely.
• I agree that I will not use any medications after the Beyond Usage Date (BUD).

CERTIFICATION OF CONSENT TO PROCEED WITH TREATMENT:

BY JOINING A SUPERPOWER GLP-1 PLAN, YOU PROVIDE YOUR INFORMED CONSENT TO RECEIVE GLP-1/GIP RECEPTOR AGONIST TREATMENT. YOU CERTIFY THAT YOU ARE AT LEAST 18 YEARS OF AGE AND ARE NOT CONSENTING ON BEHALF OF A MINOR, AS THIS SERVICE IS STRICTLY FOR ADULTS

I have read this entire Informed Consent, and I understand and agree to the information herein. 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 Compounded Semaglutide and/or Tirzepatide and a prescribed healthy diet for the purpose of losing weight and elect and consent to proceed with treatment.

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MEMBER NAME:___________________________

SIGNATURE:_____________________________

DATE:__________________________________

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