Semaglutide Consent Form

Important Information Regarding Semaglutide Injection

The semaglutide provided by adoRN Esthetics has been sourced by a licenced compounding pharmacy with full faith in the safety and efficacy of the medication.

WARNING: RISK OF THYROID C-CELL TUMORS

- In rodents, semaglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures. It is unknown whether Semaglutide causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans as human relevance of semaglutide-induced rodent thyroid C-cell tumors has not been determined

- Semaglutide is contraindicated in patients with a personal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Counsel patients regarding the potential risk for MTC with the use of Semaglutide and inform them of symptoms of thyroid tumors (e.g. a mass in the neck, dysphagia, dyspnea, persistent hoarseness). Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with Semaglutide

Indications and Usage

Semaglutide injection 2.4 mg is indicated as an adjunct to a reduced calorie diet and increased physical activity for chronic weight management in:

- adults with an initial body mass index (BMI) of ≥30 kg/m2 (obesity) or ≥27 kg/m2 (overweight) in the presence of at least one weight-related comorbid condition (e.g., hypertension, type 2 diabetes mellitus, or dyslipidemia)

- pediatric patients aged 12 years and older with an initial BMI at the 95th percentile or greater standardized for age and sex (obesity)

Limitations of Use

- Semaglutide contains semaglutide and should not be coadministered with other semaglutide-containing products or with any GLP-1 receptor agonist

- The safety and effectiveness of Semaglutide in combination with other products intended for weight loss, including prescription drugs, over-the-counter drugs, and herbal preparations, have not been established

- Semaglutide has not been studied in patients with a history of pancreatitis

Important Safety Information

Contraindications
-Semaglutide is contraindicated in patients with a personal or family history of MTC or in patients with MEN 2, and in patients with a prior serious hypersensitivity reaction to semaglutide or to any of the excipients in Semaglutide. Serious hypersensitivity reactions, including anaphylaxis and angioedema have been reported with Semaglutide.

Warnings and Precautions

• Risk of Thyroid C-Cell Tumors: Patients should be further evaluated if serum calcitonin is measured and found to be elevated or thyroid nodules are noted on physical examination or neck imaging

• Acute Pancreatitis: Acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis, has been observed in patients treated with GLP-1 receptor agonists, including semaglutide. Acute pancreatitis was observed in patients treated with Semaglutide in clinical trials. Observe patients carefully for signs and symptoms of acute pancreatitis (including persistent severe abdominal pain, sometimes radiating to the back, and which may or may not be accompanied by vomiting). If acute pancreatitis is suspected, discontinue Semaglutide promptly, and if acute pancreatitis is confirmed, do not restart

• Acute Gallbladder Disease: Treatment with Semaglutide was associated with an increased occurrence of cholelithiasis and cholecystitis. The incidence of cholelithiasis and cholecystitis was higher in Semaglutide pediatric patients aged 12 years and older than in Semaglutide adults. In clinical trials in adult patients, cholelithiasis was reported by 1.6% of Semaglutide patients and 0.7% of placebo patients. Cholecystitis was reported by 0.6% of Semaglutide patients and 0.2% of placebo patients. In a clinical trial in pediatric patients aged 12 years and older, cholelithiasis was reported by 3.8% of Semaglutide patients and 0% placebo patients. Cholecystitis was reported by 0.8% of Semaglutide pediatric patients and 0% placebo patients. Substantial or rapid weight loss can increase the risk of cholelithiasis; however, the incidence of acute gallbladder disease was greater in Semaglutide patients than in placebo patients, even after accounting for the degree of weight loss. If cholelithiasis is suspected, gallbladder studies and appropriate clinical follow-up are indicated

• Hypoglycemia: Semaglutide lowers blood glucose and can cause hypoglycemia. In a trial of adult patients with type 2 diabetes, hypoglycemia was reported in 6.2% of Semaglutide patients versus 2.5% of placebo patients. Patients with type 2 diabetes taking Semaglutide with an insulin secretagogue (e.g. sulfonylurea) or insulin may have an increased risk of hypoglycemia, including severe hypoglycemia. Inform patients of the risk of hypoglycemia and educate them on the signs and symptoms. Monitor blood glucose in patients with type 2 diabetes

• Acute Kidney Injury: There have been postmarketing reports of acute kidney injury and worsening of chronic renal failure, which in some cases required hemodialysis, in patients treated with semaglutide. Patients with renal impairment may be at a greater risk of acute kidney injury, but some events have been reported in patients without known underlying renal disease. A majority of the events occurred in patients who experienced nausea, vomiting, or diarrhea, leading to volume depletion. Monitor renal function when initiating or escalating doses of Semaglutide in patients reporting severe adverse gastrointestinal reactions and in patients with renal impairment reporting any adverse reactions that could lead to volume depletion

• Hypersensitivity Reactions: Serious hypersensitivity reactions (e.g., anaphylaxis, angioedema) have been reported with Semaglutide. If hypersensitivity reactions occur, discontinue use of Semaglutide, treat promptly per standard of care, and monitor until signs and symptoms resolve. Use caution in a patient with a history of anaphylaxis or angioedema with another GLP-1 receptor agonist

• Diabetic Retinopathy Complications in Patients with Type 2 Diabetes: In a trial of adult patients with type 2 diabetes, diabetic retinopathy was reported by 4.0% of Semaglutide patients and 2.7% of placebo patients. Rapid improvement in glucose control has been associated with a temporary worsening of diabetic retinopathy. Patients with a history of diabetic retinopathy should be monitored for progression of diabetic retinopathy

• Heart Rate Increase: Mean increases in resting heart rate of 1 to 4 beats per minute (bpm) were observed in Semaglutide adult patients compared to placebo in clinical trials. More Semaglutide adult patients compared with placebo had maximum changes from baseline of 10 to 19 bpm (41% versus 34%) and 20 bpm or more (26% versus 16%). In a clinical trial in pediatric patients aged 12 years and older with normal baseline heart rate, more patients treated with Semaglutide compared to placebo had maximum changes in heart rate of 20 bpm or more (54% versus 39%). Monitor heart rate at regular intervals and instruct patients to report palpitations or feelings of a racing heartbeat while at rest. If patients experience a sustained increase in resting heart rate, discontinue Semaglutide

• Suicidal Behavior and Ideation: Suicidal behavior and ideation have been reported in clinical trials with other weight management products. Monitor patients for depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior. Discontinue Semaglutide in patients who experience suicidal thoughts or behaviors and avoid in patients with a history of suicidal attempts or active suicidal ideation

Adverse Reactions

Most common adverse reactions (incidence ≥5%) are: nausea, diarrhea, vomiting, constipation, abdominal pain, headache, fatigue, dyspepsia, dizziness, abdominal distention, eructation, hypoglycemia in patients with type 2 diabetes, flatulence, gastroenteritis, gastroesophageal reflux disease, and nasopharyngitis

Drug Interactions

- The addition of Semaglutide in patients treated with insulin has not been evaluated. When initiating Semaglutide, consider reducing the dose of concomitantly administered insulin secretagogues (such as sulfonylureas) or insulin to reduce the risk of hypoglycemia.

- Semaglutide causes a delay of gastric emptying and has the potential to impact the absorption of concomitantly administered oral medications. Monitor the effects of oral medications concomitantly administered with Semaglutide.

Use in Specific Populations

- Pregnancy: May cause fetal harm. When pregnancy is recognized, discontinue Semaglutide. Discontinue Semaglutide in patients at least 2 months before a planned pregnancy.

- Pediatric: Adverse reactions with Semaglutide in pediatric patients aged 12 years and older were similar to those reported in adults. Pediatric patients ≥12 years of age treated with Semaglutide had greater incidences of cholelithiasis, cholecystitis, hypotension, rash, and urticaria compared to adults treated with Semaglutide.

Compounded semaglutide drugs have not individually been reviewed by the FDA for safety, effectiveness and quality; there are other FDA-approved semaglutide medicines are available.

The following conditions make Semaglutide unsafe.

• hypersensitivity to drug or ingredient

• pregnancy

• medullary thyroid CA hx

• medullary thyroid CA family hx

• multiple endocrine neoplasia syndrome type 2

• suicidality hx

• suicidal ideation

I attest that I have not of the conditions listed in the previous paragraph.
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I ACKNOWLEDGE RECEIVING AND READING A COMPLETED COPY OF THIS AGREEMENT BEFORE SIGNING.
I UNDERSTAND AND AGREE TO THE TERMS AND CONDITIONS OUTLINED IN THIS AGREEMENT AND HOLD adoRN Esthetics AND ITS MEDICAL PRACTITIONERS HARMLESS FOR ANY SIDE EFFECTS OR INJURY CAUSED BY THIS MEDICATION.

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