Informed Consent to Participate in Treatment with GLP-1 Agonist

This consent form outlines the agreement between the patient and Aspire Medical Group regarding the use of compounded glucagon-like peptide-1 (GLP-1) receptor agonist medications as part of the patient’s weight management plan. It is crucial for patients to understand the benefits, risks, and responsibilities associated with GLP-1 agonists to ensure safe and effective treatment.

The following information aims to educate the patient on the risks associated with the use of GLP-1 agonists, facilitating understanding and consent to a treatment contract.This consent form is intended to serve as confirmation of informed consent for compounded glucagon-like peptide-1 receptor agonists Injections (Semaglutide or Tirzepatide), which are prescription medications used for weight loss.

GLP-1 (Glucagon-Like Peptide-1) is a hormone produced in the intestines in response to food intake. It plays a crucial role in regulating blood sugar levels by stimulating insulin secretion in a glucose-dependent manner (meaning it only increases insulin release when blood sugar levels are elevated). GLP-1 also suppresses glucagon secretion (a hormone that increases blood sugar levels) and slows down gastric emptying, which helps to control postprandial (after-meal) glucose levels.Mechanism of Action

GLP-1 receptor agonists bind to and activate GLP-1 receptors on pancreatic beta cells (which produce insulin) and other tissues involved in glucose metabolism. This activation leads to increased insulin secretion in response to meals, reduced glucagon secretion (which decreases glucose production by the liver), and slowed gastric emptying (which helps to prevent rapid rises in blood sugar after eating).

Clinical Use of GLP-1 Agonists

Clinical Use: GLP-1 receptor agonists are typically prescribed along with a reduced-calorie diet and increased physical activity to individuals with type 2 diabetes who have not achieved adequate blood sugar control with other oral medications. GLP-1 agonists, originally developed for the management of type 2 diabetes, have also been approved for weight management due to their beneficial effects on appetite control and metabolism.

Benefits of GLP-1 Agonists

• Effective in promoting weight loss by reducing appetite and increasing feelings of fullness.
• Helps improve blood sugar control by enhancing insulin secretion in response to meals.
• Lowers the risk of cardiovascular events, such as heart attack or stroke, in people with type 2 diabetes.
• May improve metabolic health by reducing inflammation and oxidative stress.
• Typically associated with a lower risk of hypoglycemia compared to other diabetes medications.

Mild side effects may include:

• Nausea: An initial side effect that often improves over time.
• Gastroesophageal Reflux Disease (GERD): Symptoms of acid reflux or heartburn.
• Vomiting: Occasional vomiting, especially early in treatment.
• Diarrhea: Less common but can occur.
• Constipation: Less common but can occur.
• Abdominal Distention: Feeling of bloating or fullness in the abdomen.
• Abdominal Pain: Discomfort or pain in the abdomen.
• Dyspepsia: General discomfort in the upper abdomen.
• Belching: Excessive air or gas in the stomach, leading to burping.
• Flatulence: Increased gas production and passing of gas.
• Headache: Mild to moderate headaches.
• Fatigue: Feelings of tiredness or lack of energy.
• Dizziness: Occasional dizziness or lightheadedness.
• Hypoglycemia: Less common than with other diabetes medications, but can occur, especially when combined with insulin or sulfonylureas.
• Injection Site Reactions: Mild reactions such as redness, bruising, swelling, or itching at the injection site. 

In rare cases, serious side effects may include:

• Allergic Reactions: Although rare, allergic reactions including serious hypersensitivity reactions (e.g., anaphylaxis) have been reported with GLP-1 agonists. Patients should seek immediate medical attention if they experience symptoms such as rash, itching, swelling, dizziness, or difficulty breathing.
• Pancreatitis: There is a rare but serious risk of pancreatitis (inflammation of the pancreas) associated with GLP-1 agonists. Symptoms of pancreatitis include severe abdominal pain that may radiate to the back, nausea, and vomiting. Patients should seek immediate medical attention if they experience these symptoms.
• Acute Kidney Injury: In rare cases, GLP-1 agonists have been associated with acute kidney injury. Patients should be monitored for signs of decreased kidney function, such as changes in urine output, swelling in the legs or ankles, and fatigue.
• Thyroid C-Cell Tumors: Studies in rodents have shown an increased risk of thyroid C-cell tumors with some GLP-1 agonists. While this risk has not been definitively established in humans, it is a concern that requires monitoring, particularly in individuals with a personal or family history of medullary thyroid carcinoma (MTC).
   

Semaglutide (Wegovy®) is approved by the FDA for chronic weight management in pediatric patients aged 12 years and older with obesity. This approval provides an additional option for managing pediatric obesity, but it should be used as part of a comprehensive treatment plan under medical supervision.

In clinical studies, adverse reactions with semaglutide (Wegovy®) in pediatric patients aged 12 years and older were similar to those reported in adults. Pediatric patients 12 years and older treated with semaglutide (Wegovy®) had greater incidences of cholelithiasis (gallstones), cholecystitis (inflammation of the gallbladder), hypotension, rash, and urticaria (hives from an allergic reaction to medication) compared to adults treated with semaglutide (Wegovy®).

• You have a personal or family history of Thyroid C-Cell Tumors, including Medullary Thyroid Carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN-2).
• You are allergic to Semaglutide, Tirzepatide, BPC-157, SGLT2 Inhibitors, or any other GLP-1 Agonist.
• You are a Type 1 Diabetic.
• You have diabetes and are taking other blood sugar-lowering medications without first consulting your PCP or endocrinologist and licensed Aspire Medical Group clinician.
• You have a history of pancreatitis.
• You have a history of gallbladder disease.
• You have kidney disease or are on dialysis.
• You are pregnant, plan to become pregnant, or are breastfeeding.
• You have other concerning allergies.
• You are taking any other GLP-1 agonist medication.
• You have a history of diabetic retinopathy or diabetes.

 Your treatment plan includes ongoing one-on-one support throughout the entire process. Patients are weighed in the office monthly. Individual dosing will be adjusted as tolerated. Patients must comply with periodic lab monitoring as requested by their licensed Aspire Medical Group clinician in order to continue treatment to ensure safety and track progress. 

Medical History
Before using this medication, provide your complete medical history and a list of current medications to your licensed Aspire Medical Group clinician. Specifically, inform your clinician about any medications that may lower your blood sugar.

Drug Interactions
GLP-1 medications may delay gastric emptying, affecting the absorption of other oral medications. Monitor and report concerning side effects to your clinician.
Please inform your Aspire Medical Group clinician about any medications you are currently taking that may about any medications that may affect blood sugar levels.

Possible drug interactions with GLP-1 agonists include insulin and sulfonylureas due to the increased risk of hypoglycemia (low blood sugar) and corticosteroids due to increased risk of hyperglycemia (high blood sugar) which may necessitate the need for dose adjustment.

• I certify that I have read the contents of this form in its entirety. I have had the opportunity to ask questions and have had my questions answered. Ample opportunity has been offered to me to ask questions and seek clarification of anything unclear to me. I fully understand the contents of this form and have no further questions.
• I have informed my licensed Aspire Medical Group clinician of all medical conditions, any known allergies to drugs or other substances, and any past adverse reactions I’ve experienced. I have informed my provider of all medications (including prescription drugs, over-the-counter medications, vitamins, and supplements) I am currently taking.
• I understand this medication must be self-injected in the subcutaneous tissues once weekly.
• I understand this medication must be kept refrigerated.
• I will not share this medication (or needles) with others and agree to dispose of needles safely.
• I will inform my provider if I become pregnant or am breastfeeding.
• I will notify my provider if I experience side effects or if I am having trouble with administration. Your licensed Aspire Medical Group clinician can provide guidance on managing side effects and adjusting treatment plans if needed.
• I understand this prescription comes from a compounding pharmacy and is not FDA approved. I have been informed that the manufacturing facility is FDA monitored and the medication is third-party tested.
• I am aware of the possible side effects. I understand this medication could be harmful if taken inappropriately and should be used only as prescribed.
• I acknowledge that no guarantees have been made to me concerning my results.
• I consent to the use of GLP-1 agonists and I understand that my treatment with such medications will be governed by this agreement. I understand and accept the risks, conditions, and terms of the proposed treatment as presented. 
• I release Aspire Medical Group from any and all liability related to my receipt of compounded semaglutide.
• I am signing this form voluntarily, and I have full right and power to be bound by this agreement. I understand and will abide by this policy. By signing this form, I voluntarily give my consent for treatment and accept the associated risks.

By providing my electronic signature below, I agree to the terms and conditions outlined in this agreement. I agree to the use of electronic records and signatures. I acknowledge that I have read the related consumer disclosure.

The parties acknowledge and agree that this financial agreement form may be executed by electronic signature, which shall be considered as an original signature for all purposes and shall have the same force and effect as an original signature. Without limitation, “electronic signature” shall include faxed versions of an original signature or electronically scanned and transmitted versions (e.g., via PDF) of an original signature.