WildBerryMD – Informed Consent and Acknowledgment of Risk for Compounded GLP-1/GIP (Tirzepatide) Telehealth Treatment

Please read this document carefully. By signing below, you acknowledge that you have read, understood, and voluntarily agree to the information contained in this informed consent regarding treatment with compounded GLP-1/GIP (tirzepatide) prescribed through WildBerryMD via telehealth.

What Is Compounded GLP-1/GIP (Tirzepatide) Therapy?

GLP-1 (glucagon-like peptide-1) and GIP (glucose-dependent insulinotropic polypeptide) are naturally occurring hormones involved in regulating appetite, blood sugar, and digestion. Tirzepatide is a dual GLP-1/GIP receptor agonist that mimics the activity of these hormones and may help reduce appetite, slow stomach emptying, improve feelings of fullness, and support weight management when used in combination with appropriate nutrition, physical activity, and other lifestyle modifications.

At WildBerryMD, your compounded tirzepatide medication may include either cyanocobalamin (vitamin B12) or L-carnitine, depending on the formulation prescribed by your treating clinician and prepared by the compounding pharmacy.

Vitamin B12 is an essential vitamin involved in normal red blood cell formation, neurologic function, and energy metabolism. L-carnitine is a naturally occurring compound involved in fatty acid transport and cellular energy metabolism. These ingredients are included as part of the individualized compounded formulation. Individual benefits from these ingredients have not been established for every patient.

WildBerryMD utilizes an individualized dose-adjustment protocol. Your dosage may be adjusted based upon your clinical response, tolerability, medical history, and concurrent medications.

Instructions and Lifestyle Guidelines

To help optimize treatment and reduce side effects, I agree to:

• Follow a healthy, balanced eating plan emphasizing lean protein, vegetables, fiber, and whole foods.
• Eat slowly and stop eating when comfortably full.
• Drink at least 62 ounces of water daily unless otherwise instructed.
• Limit fried, greasy, processed, sugary, spicy, or high-fat foods if they worsen gastrointestinal symptoms.
• Limit or avoid alcohol, which may increase the risk of dehydration and low blood sugar.
• Participate in regular physical activity as recommended by my healthcare provider.
• Understand that long-term weight management requires ongoing lifestyle changes and that discontinuing treatment may result in increased appetite, return of cravings, and weight regain.

Contraindications – Inform Your Provider Before Starting Treatment

This medication may not be appropriate if you:

• Have an allergy or hypersensitivity to tirzepatide, GLP-1 medications, GIP medications, vitamin B12, L-carnitine, or any ingredient in the compounded formulation.
• Are pregnant, breastfeeding, or planning to become pregnant.
• Have a personal or family history of medullary thyroid carcinoma (MTC).
• Have Multiple Endocrine Neoplasia Syndrome Type 2 (MEN2).
• Have a history of pancreatitis.
• Have severe gastroparesis or significant stomach-emptying disorders.
• Have bowel obstruction or ileus.
• Have significant gallbladder disease.
• Have severe kidney disease.
• Have Type 1 diabetes.
• Use insulin or sulfonylurea medications unless specifically approved by your treating clinician.
• Have diabetic retinopathy or significant vision disease.
• Have uncontrolled psychiatric illness or suicidal thoughts.
• Are scheduled for surgery or procedures requiring anesthesia. You should notify your surgeon and anesthesia provider that you are taking tirzepatide, as temporary interruption of treatment may be recommended.

Possible Risks and Side Effects

This list is not all-inclusive.

Potential side effects include:

• Nausea
• Vomiting
• Diarrhea
• Constipation
• Heartburn
• Indigestion
• Belching
• Bloating
• Abdominal pain
• Fatigue
• Headache
• Dizziness
• Low blood sugar (especially when combined with insulin or sulfonylureas)
• Elevated heart rate
• Injection site redness, bruising, swelling, discomfort, or infection
• Temporary hair thinning or hair loss (alopecia), which may occur during treatment and may be related to rapid weight loss, nutritional changes, physiologic stress, or other factors
• Allergic reactions, including severe allergic reactions requiring emergency medical attention
• Pancreatitis
• Gallstones or gallbladder inflammation
• Delayed stomach emptying (gastroparesis)
• Severe constipation
• Ileus or bowel obstruction
• Kidney injury, particularly due to dehydration
• Worsening diabetic retinopathy
• Rare non-arteritic anterior ischemic optic neuropathy (NAION) resulting in sudden vision changes or vision loss
• Rare blood clots, including deep vein thrombosis (DVT) or pulmonary embolism (PE)

Thyroid Tumor Warning

In animal studies, medications in this class caused thyroid C-cell tumors. It is unknown whether this risk applies to humans. If thyroid C-cell tumors occur, they may develop into thyroid cancer, including medullary thyroid carcinoma (MTC). Contact your healthcare provider immediately if you experience:

• A lump or swelling in your neck
• Persistent hoarseness
• Difficulty swallowing
• Shortness of breath

Seek emergency medical care immediately if you experience severe abdominal pain, persistent vomiting, swelling of the face or throat, difficulty breathing, chest pain, sudden vision loss, or signs of severe dehydration.

Medication Interactions

Inform your provider of all prescription medications, over-the-counter medications, vitamins, and supplements.

Do not combine this medication with:

• Other GLP-1 or GLP-1/GIP medications (unless specifically directed)
• Insulin or sulfonylureas without provider supervision
• Prescription or OTC appetite suppressants without approval

Because tirzepatide slows stomach emptying, it may affect the absorption of certain oral medications.

No Guarantee of Results

Individual results vary.

WildBerryMD does not guarantee weight loss or any specific medical outcome. Maintaining weight loss typically requires continued lifestyle changes, and discontinuing treatment may result in weight regain.

Alternatives

Alternatives include:

• No treatment
• Lifestyle modification
• Nutrition counseling
• Exercise programs
• FDA-approved commercially available medications
• Bariatric surgery
• Other medically appropriate weight management options

Financial Responsibility

I understand that:

• WildBerryMD does not bill insurance for this program.
• All services are self-pay.
• Payment is due before services are rendered.
• Programs, services, consultations, and compounded medications are non-refundable and non-exchangeable.

Self-Administration, Storage, and Disposal

I understand and agree that:

• I have been instructed on how to properly administer my injections.
• I understand how to safely self-administer this medication.
• I will only use this medication for myself.
• I will not share, sell, or transfer this medication to another person.
• I will administer the medication exactly as prescribed.
• I will refrigerate the medication unless otherwise instructed by the dispensing pharmacy.
• I will not freeze the medication.
• I will keep the medication out of reach of children and pets.
• I will never reuse needles or syringes.
• I will properly dispose of used sharps in accordance with Arizona disposal recommendations using a puncture-resistant sharps container.

Compounded Medication Disclosure

I understand that my medication is a compounded prescription medication prepared by a licensed 503A compounding pharmacy pursuant to an individual prescription.

I understand that compounded medications:

• Are not FDA-approved drug products.
• Have not been reviewed by the FDA for safety, effectiveness, or manufacturing consistency before dispensing.
• Are prepared to meet individual patient needs.
• May include vitamin B12 or L-carnitine depending on the prescribed formulation.
• Are not interchangeable with FDA-approved medications such as Zepbound®, Mounjaro®, Ozempic®, or Wegovy®.

Telehealth Acknowledgment

I understand that:

• My evaluation and treatment are being provided through telehealth.
• Telehealth has limitations because no in-person physical examination is performed.
• Clinical decisions are based on the information I provide.
• Providing incomplete or inaccurate information may affect medical decision-making.
• WildBerryMD does not provide primary care or emergency medical services.
• I agree to maintain an ongoing relationship with a primary care provider.
• In the event of a medical emergency, I will call 911 or seek emergency medical care immediately.

Patient Responsibilities

I agree to:

• Provide accurate and complete medical information.
• Report changes in my health history.
• Report medication changes.
• Notify WildBerryMD if I become pregnant.
• Notify WildBerryMD of hospitalizations or serious medical conditions.
• Promptly report side effects or adverse reactions.
• Follow all dosing and follow-up instructions.

Off-Label and Regulatory Disclosure

I understand that:

• Compounded tirzepatide (with vitamin B12 or L-carnitine, when included) is a compounded prescription medication and is not an FDA-approved drug product.
• It is prepared by a licensed 503A compounding pharmacy pursuant to a valid prescription.
• It is not interchangeable with FDA-approved products.
• Delivery generally requires approximately 7–10 business days, but delays may occur.
• WildBerryMD may change compounding pharmacy partners as needed.

Assumption of Risk

I understand that all medical treatment involves inherent risks. I voluntarily choose to participate in this elective treatment program and knowingly accept the known and unknown risks associated with compounded tirzepatide therapy.

Limitation of Liability

To the fullest extent permitted by applicable law, I agree that WildBerryMD, its owners, healthcare professionals, employees, contractors, and agents shall not be liable for claims arising from my failure to follow medical instructions, failure to disclose accurate medical information, misuse of prescribed medication, or failure to seek appropriate medical care. Nothing in this agreement limits liability for gross negligence, willful misconduct, or any liability that cannot legally be waived.

Severability

If any provision of this agreement is determined to be unenforceable, the remaining provisions shall remain in full force and effect.

Entire Agreement

This consent constitutes the entire understanding regarding this treatment and supersedes prior verbal or written statements relating to this therapy.

Patient Acknowledgment and Consent

By signing below, I acknowledge and agree that:

• I have read and understand this informed consent.
• I have had the opportunity to ask questions and have received satisfactory answers.
• I understand the potential risks, benefits, alternatives, and limitations of treatment.
• I understand that individual results are not guaranteed.
• I understand that this medication is compounded and is not an FDA-approved drug product.
• I understand that my compounded formulation may contain vitamin B12 or L-carnitine.
• I understand how to properly administer this medication.
• I will only use this medication for myself.
• I understand that all fees are self-pay and that medications, services, and programs are non-refundable and non-exchangeable.
• I voluntarily consent to receive compounded GLP-1/GIP (tirzepatide) therapy through WildBerryMD.
• I understand that my electronic signature has the same legal effect as my handwritten signature.