Consent To Treatment: Weight Loss

Effective Date: August 7, 2024

Informed Consent Instructions: This is an informed consent document to provide written information about the above named treatment regarding risks, benefits, and alternatives. It is important that you understand the information provided to you prior to proceeding with this treatment; please ask your healthcare professional any/all questions prior to signing this consent form.

I consent to treatment by Subito Health using Semaglutide (GLP-1 RA) or Tirzepatide (GIP/GLP-1 RA) injections for elective chronic weight management treatment. Treatment benefits will vary by individual, but may include: reduced appetite, feeling a sense of fullness for longer durations after eating (delayed gastric emptying), and increased fat-burning mechanisms which may result in weight loss. Additional therapeutic benefits related to weight management may include: improved blood sugar levels and reduced risk of adverse cardiovascular events.

Purpose of Treatment and General Information:

What is Semaglutide or Tirzepatide Weight Management Treatment: Semaglutide or Tirzepatide weight management injections are used for weight loss along with a diet and exercise plan. These injections are delivered beneath the surface of the skin (subcutaneously) for chronic weight management in adults with obesity (BMI >30) or
who are overweight (BMI >27) with at least one weight-related condition, including high blood pressure, diabetes type 2, and/or high cholesterol. Semaglutide mimics a glucagon-like peptide hormone called GLP-1, which slows the movement of food from the stomach into the small intestine, helping to reduce appetite and increase satiety after eating. Tirzepatide mimics both GIP and GLP-1 receptor agonist hormones, which trigger insulin creation, sensation of fullness, and appetite reduction. Additional treatment benefits associated with these weight loss injections may include: improved A1C and blood sugar levels by increasing insulin (a hormone that lowers blood sugar levels) and inhibiting glucagon (a hormone that raises blood sugar); improved blood pressure; reduced risk of major adverse cardiovascular events.

What to Expect During Treatment:

Your treatment provider wil begin with a consultation that includes blood draws to check lab values and will review your health and medication history to ensure you are a good candidate for weight loss injections. You will be counseled on nutrition and exercise recommendations to be used along with Semaglutide injections for chronic weight management, including reducing calories and increasing physical activity. You will be taught how to perform these injections at home just below the surface of the skin (subcutaneously) and will be prescribed a dosage that is adjusted for your individual needs, in accordance with your treatment plan. There is no downtime associated with this treatment. You may feel minor discomfort during the injection, similar to an insulin injection. Common side effects include: nausea, vomiting, diarrhea, indigestion, abdominal pain, constipation, fatigue, and dizziness. Multiple injections will be needed over the course of months to achieve desired results.

Dosing adjustments will be made by your treatment provider based on your body's response and any side effects you're experiencing. Treatment Regimen: Typical treatment regimen includes an initial series of weekly injections for 90 days, including monthly follow-ups and lab work. You will return to the office for follow-up visits and dose adjustments once per month until you've reached your weight loss goals. Maintenance: Once you have achieved your weight loss goal, you may be weaned down to lower dosing of Semaglutide or Tirzepatide at specified intervals and/or given a maintenance protocol. Maintenance injections may be necessary to maintain desired results. I understand the treatment goal is weight loss. I understand that repeated injections will be necessary in order to achieve desired results and that I will need to return to the office weekly for injections, as well as maintain regular follow-ups with my treatment provider.

Treatment Benefits:

Semaglutide and Tirzepatide injection benefits may include:

• Weight reduction and/or weight management 

• Improved blood sugar

• Reduced risk of adverse cardiovascular events related to obesity

Alternative Treatments:

Alternative forms of non-surgical and surgical treatment consist of: No treatment whatsoever, diet and lifestyle modifications, increased physical activity, other pharmaceutical weight management therapies, and bariatric surgery. Every procedure will involve a certain amount of risk. An individual’s choice to undergo a procedure is based on the comparison of the risk to the potential benefit. Although most patients do not experience adverse complications, you should discuss your concerns and potential risks with your treatment provider in order to make an informed decision.

Possible Risks and Side Effects:
Possible side effects/risks of Semaglutide and Tirzepatide Weight Management Treatment may include:
1. General Side Effects: I understand there is a risk of discomfort, pinpoint bleeding, pain at the injection site, bruising, allergic reaction, damage to deeper structures, or gastrointestinal side effects that may occur.
2. Gastrointestinal Upset: The most common side effects of treatment include: Nausea, vomiting, diarrhea, constipation, indigestion, belching, feeling bloated, and abdominal pain. Slow titration of dosing adjustments may help prevent these side effects, or dosing adjustments may be required if side effects persist. Your treatment provider can provide you with medications and/or recommendations to help alleviate these side effects, including suggesting eating slowly, eating bland foods, avoiding greasy foods, and avoiding lying down immediately after eating.
3. Fatigue, Dizziness, and Headache: Some patients experience fatigue, dizziness, and/or headache, which may be a result of low blood sugar. If you experience these symptoms, please discuss this with your treatment provider.
4. Low Blood Sugar: There is an increased risk of low blood sugar (hypoglycemia), especially in patients with type 2 diabetes taking medications such as insulin or sulfonylureas. Symptoms may include: dizziness, headache, lightheadedness, rapid heartbeat, mood changes, irritability, weakness, shakiness, slurred speech, confusion, or hunger. Talk to your healthcare provider about how to recognize and treat low blood sugar. If you have diabetes type 2, you should check your blood sugar as directed.
5. Increased Heart Rate: You may experience an increased heart rate while at rest. Please contact your treatment provider if you experience your heart racing or if you feel a pounding sensation in your chest that lasts for several minutes or longer.
6. Allergic Reaction or Hypersensitivity: Although rare, allergic reactions or serious hypersensitivity may occur. Signs of allergic reaction may include: hives, difficulty breathing, swelling of your face, lips, tongue, or throat; additional
treatment may be necessary should an allergic reaction occur.
7. Runny Nose and Sore Throat: Common side effects include a runny nose and sore throat. Tell your treatment provider if these symptoms persist or become bothersome.

8. Bleeding/Bruising/Redness: It is possible to experience minor pinpoint bleeding during and after injection. Bruising in soft tissues may occur, as well as minor redness or swelling.
9. Infection: Although rare, if an infection occurs as a result of treatment at injection site, additional treatment including antibiotics or an additional procedure may be necessary.
10. Depression, Suicidal Thoughts, Mood Changes (Semaglutide): Some weight loss medications, including Semaglutide, may increase the risk of depression and/or suicidal ideations. Any new or worsening changes in mood, behaviors, thoughts, or feelings should be reported to your healthcare provider right away.
11. Pancreatitis: Inflammation of the pancreas (pancreatitis) may occur. If you experience persistent severe pain in your stomach, with or without vomiting, please contact your treatment provider right away.
12. Gallbladder Inflammation and/or Gallstones: You may experience gallbladder issues, including gallstones. Signs/symptoms of gallbladder inflammation and/or gallstones include: pain in your upper stomach, yellowing of skin and/or eyes, clay-colored stools, and fever. Please contact your treatment provider right away if you experience these symptoms. Some gallbladder issues may required additional treatment incurred at your expense, and which may include surgical intervention and/or hospitalization.
13. Gastrointestinal Blockage or Disease: Although rare, there is a risk of stomach blockage (known as a an ileus) resulting from decreased intestinal movement of food and fluids. Symptoms include persistent, unrelieved constipation, stomach cramping and swelling, loss of appetite, inability to pass gas, and vomiting. An ileus can be serious and life threatening if left untreated; treatment may include hospitalization and/or surgery incurred at your expense.
14. Dehydration and Acute Kidney Injury and/or Renal Impairment: There is a potential risk for dehydration leading to acute kidney injury and/or worsening renal impairment due to adverse gastrointestinal reactions (nausea, vomiting, diarrhea). It is important to drink adequate fluids to help reduce your risk of dehydration, which may cause kidney impairment.
15. Thyroid C-cell Tumors: There is a potential risk for thyroid C-cell tumors when taking Semaglutide. Please report any signs/symptoms of thyroid tumors to your treatment provider, including: persistent hoarseness, shortness of breath, mass in neck, and/or difficulty swallowing.
16. Changes in Vision: Patients with diabetic retinopathy may experience changes in vision while taking Semaglutide. This may be caused by a rapid improvement in glucose control, which could lead to temporary worsening of retinopathy, however, the effect of long-term glycemic control on diabetic retinopathy has not yet been studied. Please report any changes in vision to your treament provider.

This list is not exhaustive of all possible risks associated with Semaglutide and Tirzepatide weight management treatment, as there are both known- and unknown- side effects and risks associated with any medication or treatment

Contraindications To Treatment:

Semaglutide and Tirzerpatide injections are contraindicated in those who:

• are pregnant or are breastfeeding

• have ever had Medullary Thyroid Cancer (MTC) (this includes a family history of MTC)

• have Multiple Endocrine Neoplasia Syndrome type 2 (MEN 2)

• have ever had a serious allergic reaction to Semaglutide or Tirzerpatide or any of the ingredients in Semaglutide or Tirzepatide, including compound formulations, which may include: vitamin b12 and/or vitamin b6

Please tell your treatment provider if you have any other medical conditions, including the following, as

Semaglutide or Tirzepatide injections may not be suitable for you:

• plan to become pregnant (you should stop Semaglutide and Tirzepatide 2 months prior to pregnancy)

• have, or have had, problems with your pancreas or kidneys

• have type 1 diabetes, type 2 diabetes, or a history of diabetic retinopathyare

• taking certain medications, including: sulfonylureas or insulin
  have, or have had, depression, mental health issues, and/or suicidal thoughts

Possible Medication Interactions and/or Reduced Effectiveness
Prescription and OTC Medication, Herbal and Nutritional Supplements, and Minerals: I understand that certain herbal products, medications, and supplements may affect the way Semaglutide or Tirzepatide works, resulting in reduced efficacy of treatment and/or additional side effects. Semaglutide and Tirzepatide slows stomach emptying and can affect absorption of oral medications medicines, which may affect the way certain medications work or the effectiveness of medications.

Liability Release Related to Adverse Effects

I assume full liability for any adverse effects that may result from the non-negligent administration of the proposed treatment. I waive any claim in law or equity for a redress of any grievance that I may have concerning- or resulting from- the treatment, except as that claim pertains to the negligent administration of this procedure.

Pregnancy Waiver:

I deny the possibility of being pregnant at this time. I understand that Semaglutide or Tirzepatide may harm an unborn baby and the safety of the use of Semaglutide or Tirzepatide during pregnancy and breastfeeding has not been studied. If I am unsure of pregnancy, I will request a pregnancy test prior to my treatment. I further acknowledge that I should stop using Semaglutide at least 2 months prior to becoming pregnant.

No Guarantee of Results:

In some situations, it may not be possible to achieve desired weight loss results. It is also possible that Semaglutide or Tirzepatide injections may fail to produce any reduction in weight. Should complications occur, additional- or other treatments may be necessary. Semaglutide and Tirzepatide injections are not a permanent solution for weight management, and must be maintained with lifestyle and diet modifications; you may also require maintenance injections to maintain desired weight. As a weight management treatment, it is recommended to allow at least 90 days of treatment to achieve results. Duration of results is unknown and not guaranteed.

Financial Responsibility: 

By signing below, I acknowledge that I understand the regular charge applies to all treatments. I understand- and agree- that all services rendered to me are charged directly to me and that I am personally responsible for payment. I acknowledge that most insurances do not cover the cost of weight loss injection treatment, and therefore, I am required to pay for services and medication out of pocket. In the event that I am not satisfied with my results, I agree not to seek a refund for Semaglutide or Tirzepatide treatment services rendered, as I am fully aware that there is no implied or explicit guarantee of results, as stated in the acknowledgement above. I further agree in the event of non-payment and/or reversal of payment via a credit card dispute that I initiate, I will bear the cost of collection fees, and/or court fees, and/or any reasonable legal fees resulting from such instance.

Semaglutide (GLP-1 RA) or Tirzepatide (GIP/GLP-1 RA)Weight Management Treatment Consent:
By signing below, I acknowledge and agree:

• I have fully disclosed on my client intake form and during consultation with treatment provider any and all medications, previous complications, planned or previous surgeries, sensitivities, allergies, or current conditions that may, or may not, affect my treatment.

• I have read the foregoing informed consent for Semaglutide or Tirzepatide Weight Management Treatment; I agree to the treatment and all known and unknown associated risks.

• I have received and will follow all aftercare instructions.

• I acknowledge that no guarantee has been given by anyone as to the results that may be obtained.

• I consent to the collection of photo(s) and video(s) of the treatment to be performed, including appropriate portions of my body for: medical documentation, insurance documentation, and/or educational and training purposes. I understand that efforts will be made to conceal my identity, but in some circumstances the photographs may portray features that will make my identity recognizable.

• For women of childbearing age: by signing below I confirm that I am not pregnant and do not intend to become pregnant anytime during the course of this treatment and that I am not breastfeeding. Furthermore, I agree to keep my treatment provider informed should I become pregnant during the course of this treatment.

• It has been explained to me in a way that I understand:

• There may be alternative procedures or methods or treatments.

• There are risks, known and unknown, to the procedure or treatment proposed.

• I have had ample opportunity to ask any questions regarding Semaglutide or Tirzepatide Weight Management Treatment benefits, side effects and after care, and all of my questions have been answered to my satisfaction. I believe I have adequate knowledge to understand the nature and risk of the treatment to which I am consenting.

• By signing below, I am consenting to undergo this, and any subsequent Semaglutide or Tirzepatide Weight Management Treatment for 365 days from the date below, with all aforementioned understood by me. I release the overseeing clinic physician, the person performing the Semaglutide or Tirzepatide Weight Management Treatment,
  and the clinic facility from liability associated with treatment.

Acknowledgement of Off-Label Use:

I understand Tirzepatide is currently approved by the Food and Drug Administration for the intended purpose of type 2 diabetes management. Regardless, I choose to receive Tirzepatide subcutaneous injections for the purpose of weight management and I am willing to accept the potential risks, side effects- both known and unknown- that my treatment provider has discussed with me. I further acknowledge that there may be unknown risks, side effects, and outcomes not listed above in the "Known Risks and Side Effects" section and that long-term effects and risks of Tirzepatide for weight management may not be known.

Consent to Off-Label Use Treatment:

I understand that Tirzepatide is not currently a standard form of treatment for weight loss management. I hereby confirm that the nature and purpose of the aforementioned treatment may be considered medically unnecessary and/or experimental and not a currently indicated treatment for the purpose I am seeking.

The risks involved with this treatment and the possibilities of complications have been explained to me. I fully understand that the treatment to be provided may be considered experimental and unproven by scientific testing and peer-reviewed publication.

By signing below, I am consenting to undergo off-label use Tirzepatide treatments, with all aforementioned understood by me. I hereby release the overseeing clinic physician, the person performing the treatment, and the clinic facility from liability associated with treatment.

Treatment Liability Waiver:

I acknowledge that elective supplementation therapies, including, but not limited to Semaglutide or Tirzepatide Weight Management Treatment, may be considered medically unnecessary. It may or may not mitigate, alleviate, or cure the condition for which it has been prescribed. This treatment has been recommended to me in the belief that it is of potential benefit and its use will quite probably improve the condition for which I am under treatment for. Based on the risks and potential benefits of this proposed treatment, I have elected to receive this proposed treatment by providers and staff at Subito Health.

I understand that I may suspend or terminate my treatment at anytime by informing my medical provider. I assume full liability for any adverse effects that may result from the non-negligent administration of the proposed treatment. I waive any claim in law or equity for redress of any grievance that I may have concerning or resulting from the procedure, except as that claim pertains to negligent administration of this procedure. The risks involved and the possibilities of complications have been explained to me. I fully understand and confirm that the nature and purpose of the aforementioned treatment to be provided may be considered unproven by scientific testing and peer reviewed publications and therefore may be considered medically unnecessary or not currently indicated.

Therefore, in consideration for any treatment received, I agree to unconditionally defend, hold harmless and release from any and all liability the company and the individual that provided my treatment, the insured, and any additional insured’s, as well as any officers, directors, or employees of the above companies for any condition or result, known or unknown, that may arise as a consequence of any treatment that I receive.

I understand and agree that any legal action of any kind related to any treatment I receive will be limited to binding arbitration using a single arbitrator agreed to by both parties.

Covid-19 and Communicable Diseases:
Acceptance of Risk; Release; Indemnification. I am fully aware that there are a number of risks associated with me entering on the Subito Health property during the COVID-19 pandemic under the circumstances of receiving treatments, including without limitation: (a) I could contract COVID-19 or other diseases such as the flu or legionnaires disease which could result in a serious medical condition requiring medical treatment in a hospital or could possibly lead to death; and (b) I will be subject to normal risks associated with general exposure to viruses and other communicable diseases.