CONSENT TO EXTREME WEIGHT LOSS & WELLNESS HEALTH TUTORIAL VIDEO FOR SUBCUTANEOUS INJECTION TRAINING AND GLP-1 DOSING INSTRUCTIONS

Updated September 20, 2024

`. PURPOSE: Extreme Weight Loss & Wellness has provided a subcutaneous injection training video for training of nonmedical personnel on how to perform self-injection of compound medication. This tutorial video is to be utilized to train patients on how to properly perform self-injection of subcutaneous medications provided by the Extreme Weight Loss & Wellness and prescribed during the Telehealth consultation.

2. NATURE OF SUBCUTANEOUS INJECTION TRAINING VIDEO AND EXTREME WEIGHT LOSS & WELLNESS CONSULTATION:
The Extreme Weight Loss & Wellness subcutaneous injection training video and consultation will provide:

3. Accurate instructions on supplies needed for self-injection which will be provided with your prescription

4. Information on what it means to perform a subcutaneous injection

5. Information and demonstration of how you can perform self-administered subcutaneous injection

6. Review of common issues that may occur during subcutaneous injection and how to manage them

7. Review of contraindications to (reasons not to use) subcutaneous injection

8. BENEFITS AND RISKS: Since we are not physically located in your community, the Extreme Weight Loss & Wellness Telehealth consultation and guidance on performing a self-injection are being provided to you using interactive video, audio, and telecommunications as well as recorded demonstrations. The Extreme Weight Loss & Wellness tutorial video on how to perform subcutaneous self-injection serves as the training video provided to the patient in order to train patients on how to perform self-injection of medications required to be delivered subcutaneously. While the benefit of this is being able to provide remote training without requiring the presence of a provider at a specific location, this does come with some potential risk. Risks of any injection include, but are not limited to: tingling or numbness, redness, swelling, pain, bruising, prolonged bleeding, skin irritation, skin infection at the site, or issues with the devices used for self-administration. Major but very rare complications include: allergic reactions including anaphylactic reaction and major adverse skin reactions/wound complications. Additional risks include but are not limited to taking the improper amount of medication (underdosing or overdosing) which may lead to limited effects of the medication and/or can cause serious and severe side effects including but not limited to nausea, vomiting, severe abdominal pain, pancreatitis, gastroparesis, liver injury, kidney injury, hypovolemic shock related to altered fluid status, and may result in adverse events serious enough to require hospitalization and emergent treatment. You can minimize the risks by carefully reviewing the Extreme Weight Loss & Wellness subcutaneous injection Tutorial as well as properly following the dosing directions located on your medical vial ship to you on behalf of Extreme Weight Loss & Wellness.

9. GLP-1 Contraindications, Side Effects and Potential Adverse Events: GLP-1 medications are known to cause potential side effects and adverse events related to their use. This risk is increased when dosing instructions are not performed appropriately. You are consenting to understand the potential risks of taking GLP-1 medications, including but not limited to the side effects listed for these medications. Prescribing Information including these materials is posted below and on the Extreme Weigh Loss & Wellness website at the following location and should be read and understood prior to initiating GLP-1 therapy: https://www.myextremeweightloss.com/important-glp-1-safety-information/

10. RIGHTS: You may withhold or withdraw consent to perform training for subcutaneous injection by not viewing the Extreme Weight Loss & Wellness subcutaneousinjection training video at any time before or during the consultation without affecting the right to future patient care or treatment. Extreme Weight Loss & Wellness subcutaneous Health providers retain the right to refuse prescribing subcutaneous injections if the training is not completed or if you are not following the training instructions. By not completing the subcutaneous injection training process, the patient increases all those risks of performing self-injection of subcutaneous medications listed above. This is not supported by our health provider as this increases your risk of potential harm if administering your medications incorrectly.

11. NO PROMISES OF RESULT: While Extreme Weight Loss & Wellness will try to give you his/her judgment as to what the patient can likely expect health-wise after the consultation and training video, because healthcare practice has unavoidable uncertainties, no promises of specific results or outcome can or will be made.

12. DISPUTES: Any dispute arising from an Extreme Weight Loss & Wellness Telehealth consultation will be resolved in the Jefferson Parish Court in Gretna, Louisiana and Louisiana law will apply.

13. WHAT ACCEPTING THIS CONSENT MEANS—YOUR ACCEPTANCE AND AGREEMENT:

Statement for the Patient. I have read and accept the terms of the Extreme Weight Loss & Wellness telehealth consultation, the Extreme Weight Loss & Wellness subcutaneous injection tutorial training video, and GLP-1 medication consent above (1 through 8) and understand the benefits and risks of the Extreme Weight Loss & Wellness Telehealth consultation, Extreme Weight Loss & Wellness subcutaneous injection training video, and usage of GLP-1 medications. I have had my questions about the service and the self-injection process answered. I confirm that no patient emergency condition is present and consent to participating in the Extreme Weight Loss & Wellness Telehealth consultation and subcutaneous injection training video as described in this consent.

IMPORTANT SAFETY INFORMATION FOR GLP-1 MEDICATIONS:

Novo Nordisk’s Wegovy® (semaglutide) and Mounjaro® (Tirzepatide) are FDA approved for weight loss. If your medical needs cannot be met by an FDA-approved drug, a compounded drug might be appropriate. However, compounded drugs pose a higher risk to patients than FDA-approved drugs because compounded drugs do not undergo FDA premarket review for safety, effectiveness, or quality. Compounded drugs should only be used to fulfill the needs of patients whose medical needs cannot be met by an FDA-approved drug. Your Extreme Weight Loss & Wellness Health provider will provide the recommend doses based on your medical evaluation.

Indications and Use:

Compounded Medications are a class of injectable prescription medicine that may help adults with obesity, or with excess weight (overweight) who also have weight-related medical problems, lose weight and keep it off. It should be used with a reduced-calorie diet and increased physical activity.

Compounded/GLP-1 Medication is a synthetic glucagon-like peptide-1 (GLP-1) receptor agonist used for chronic weight management, along with a reduced calorie diet and increased physical activity, for people with an initial body mass index (BMI) of:

· 30 kg/m2 or greater (obesity) or

· 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid condition (e.g., hypertension, type 2 diabetes mellitus, or dyslipidemia).

Compounded/GLP-1 Medication should not be used with other Compounded/GLP-1 receptor agonist-containing products or any GLP-1 receptor agonist medicines. It is not known if Compounded/GLP-1 medication is safe and effective when taken with other prescription, over-the-counter, or herbal weight loss products. It is not known if Compounded/GLP-1 medication can be used in people who have had pancreatitis. It is not known if GLP-1 medication is safe and effective for use in children under 18 years of age.

Important Safety Information for GLP-1 Medications

Warning: Risk of Thyroid C-Cell Tumors

· In studies with mice and rats, GLP-1 medication caused thyroid tumors, including thyroid cancer. It is not known if GLP-1 Medications will cause thyroid tumors or a type of thyroid cancer called medullary thyroid carcinoma (MTC) in people. Tell your provider if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. These may be symptoms of thyroid cancer.

· Do not use GLP-1 Medications if you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC) or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).

What is the FDA-approved use of GLP-1 Medications?

GLP-1 Medications are a class of medications that act as glucagon-like peptide-1 (GLP-1) receptor agonists for chronic weight management, along with a reduced calorie diet and increased physical activity, for people with an initial body mass index (BMI) of:

· 30 kg/m2 or greater (obesity) or

· 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid condition (e.g., hypertension, type 2 diabetes mellitus, or dyslipidemia).

Limitations of Use:

· GLP-1 Medications should not be used in combination with other semaglutide, tirzepatide, or liraglutide-containing products or any other GLP-1 receptor agonist

· The safety and efficacy of coadministration with other products for weight loss have not been established

· GLP-1 Medications has not been studied in patients with a history of pancreatitis

Who should not use GLP-1 Medications?

Do not use GLP-1 Medications if:

· You or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC) or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).

· You have a known allergic reaction to GLP-1 medication

How should GLP-1 medication be administered?

You can take GLP-1 medication with or without food. The pre-filled injector pen is self-administered as a subcutaneous injection in the stomach, thigh, or upper arm once a week on the same day every week. Your Extreme Weight Loss & Wellness provider will guide you on a treatment regimen that may include an increase in dose every four weeks.

You should not change your dosing regimen or stop taking GLP-1 medication as prescribed without discussing with your provider first.

What should I tell my Extreme Weight Loss & Wellness provider before using GLP-1 medication?

· GLP-1 medication has certain drug interactions. It’s important to tell your Extreme Weight Loss & Wellness provider all of the medications you are currently taking, including prescription, over-the-counter medications, vitamins, and herbal and dietary supplements.

Some medications to watch out for include:

· Medications used to treat type 1 or type 2 diabetes, including insulin or sulfonylureas (such as Amaryl or Glucotrol XL)

· GLP-1 medication causes a delay in gastric emptying, so it has the potential to impact the absorption of medications that are taken by mouth at the same time. Your provider can guide you on how to schedule your medications.

· Other GLP-1 medications, including Ozempic®, Saxenda®, Victoza®, Byetta®, or Bydureon®

· If you’re using other products for weight loss, including dietary supplements

It’s important to share your entire medical history with your provider. In particular, tell your provider if you have a past history of:

· Type 1 or type 2 diabetes

· Thyroid cancer

· Pancreatitis

· Kidney disease

· Diabetic retinopathy

· Depression

· Suicidal thoughts or behavior

Tell your provider if you are pregnant, planning to become pregnant, or breastfeeding.

· If you are pregnant: GLP-1 medication should not be used during pregnancy. Based on animal studies, there may be potential risks to an unborn baby from exposure to GLP-1 medication during pregnancy. There is no benefit to weight loss during pregnancy and it may cause harm to the unborn baby.

· If you are a female or male of reproductive potential: Discontinue GLP-1 medication at least 2 months before a planned pregnancy since the drug can stay in the bloodstream for a long time.

· If you are breastfeeding: GLP-1 medication was found in the milk of lactating rats. Tell your Extreme Weight Loss & Wellness provider if you are breastfeeding before you start GLP-1 medication.

What are the most serious side effects that I or a caregiver should monitor for when taking GLP-1 medication?

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

These serious side effects can occur with GLP-1 medication. You or a caregiver should carefully monitor for these side effects, especially in the beginning of treatment and with dose changes.

· Thyroid C-Cell Tumors: In mice and rats, GLP-1 medication caused an increase in thyroid C-cell tumors, including medullary thyroid carcinoma (MTC). It is unknown whether GLP-1 medication causes thyroid C-cell tumors in humans. There were cases of MTC reported in patients who took liraglutide (the active ingredient in Victoza and Saxenda) after the drug was put on the market. GLP-1 medication is contraindicated in patients with a family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Tell your provider if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. These may be symptoms of thyroid cancer.

· Inflammation of Pancreas (Acute Pancreatitis): Monitor for signs of acute pancreatitis, including severe abdominal pain that does not go away, sometimes radiating to the back, with or without vomiting.

· Acute Gallbladder Disease: GLP-1 medication may cause gallbladder problems, including gallstones. Some gallbladder problems require surgery. Tell your provider right away if you have pain in your upper stomach, yellowing of skin or eyes (jaundice), fever, or clay-colored stools.

· Low Blood Sugar (hypoglycemia): GLP-1 medication lowers blood glucose. It can cause too low blood sugar in patients with type 2 diabetes who also take another glucose control medication. Monitor your blood sugar and watch out for signs of too low blood sugar such as dizziness, blurred vision, mood changes, sweating, or fast heartbeat.

· Acute Kidney Injury: 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.

· Serious Allergic Reactions: Stop using GLP-1 medication 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.

· Diabetic Retinopathy Complications in Patients with Type 2 Diabetes: If you have type 2 diabetes, tell your provider right away if you experience changes in vision.

· Increase in Heart Rate: Tell your provider right away if you have a racing heartbeat while at rest.

· Suicidal Behavior and Ideation: 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.

· Never Share a Pen: Pen-sharing poses a risk of infection.

What are the most common side effects of GLP-1 medication?

· Nausea

· Diarrhea

· Vomiting

· Constipation

· Stomach pain

· Indigestion

· Injection site reactions

· Feeling tired

· Allergic reactions

· Belching

· Hair loss

· Gastroesophageal reflux disease (heartburn)

Before using Compound GLP-1 medication

· Your healthcare provider should show you how to use GLP-1 Medications before you use it for the first time.

· Tell your healthcare provider if you are taking medicines to treat diabetes including insulin or sulfonylureas which could increase your risk of low blood sugar. Talk to your healthcare provider about low blood sugar levels and how to manage them.

· If you take birth control pills by mouth, talk to your healthcare provider before you use GLP-1 Medications. Birth control pills may not work as well while using GLP-1 Medications.

Your healthcare provider may recommend another type of birth control for 4 weeks after you start GLP-1 Medications and for 4 weeks after each increase in your dose of GLP-1 Medications.

Review these questions with your healthcare provider:

· Do you have other medical conditions, including problems with your pancreas or kidneys, or severe problems with your stomach, such as slowed emptying of your stomach (gastroparesis) or problems digesting food?

· Do you take diabetes medicines, such as insulin or sulfonylureas?

· Do you have a history of diabetic retinopathy?

· Do you take any other prescription medicines or over-the-counter drugs, vitamins, or herbal supplements?

· Are you pregnant, plan to become pregnant, breastfeeding, or plan to breastfeed? GLP-1 Medications may harm your unborn baby. Tell your healthcare provider if you become pregnant while using GLP-1 Medications. It is not known if GLP-1 Medications passes into your breast milk. You should talk with your healthcare provider about the best way to feed your baby while using GLP-1 Medications.

How to take

· Read the Instructions for Use that come with your GLP-1 Medications.

· Use GLP-1 Medications exactly as your healthcare provider says.

· GLP-1 Medications are injected under the skin (subcutaneously) of your stomach (abdomen), thigh, or upper arm.

· Use GLP-1 Medications as instructed by your medical provider

· Change (rotate) your injection site with each weekly injection. Do not use the same site for each injection.

· If you take too much of your GLP-1 Medication, call your healthcare provider, seek medical advice promptly, or contact a Poison Center expert right away at 1-800-222-1222.

Learn more

This summary provides basic information about GLP-1 Medications but does not include all information known about this medicine. Read the information that comes with your prescription each time your prescription is filled. This information does not take the place of talking with your healthcare provider. Be sure to talk to your healthcare provider about GLP-1 Medications and how to take them. Your healthcare provider is the best person to help you decide if GLP-1 Medications is right for you.