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").
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.
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.
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 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.
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.
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.
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.
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.
Mounjaro®, also known as Zepbound®, is the brand name patented version of Tirzepatide injectable that received FDA approval for obesity.
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.
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.
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). Please tell your Superpower Healthcare Provider about any other medications in your routine, and especially any that you think may lower your blood sugar.
This is not a complete list of side effects and complications, and others may occur.
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.
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 (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; or stomach flu symptoms--stomach cramps, vomiting, loss of appetite, diarrhea (may be watery or bloody).
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.
BY CLICKING "I AGREE" OR OTHERWISE INDICATING YOUR ACCEPTANCE, YOU ARE PROVIDING YOUR INFORMED CONSENT TO RECEIVE GLP-1/GIP RECEPTOR AGONIST 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 AGE OF 18.
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.
MEMBER NAME:___________________________
SIGNATURE:_____________________________
DATE:__________________________________
