INFORMED CONSENT FOR PEPTIDE THERAPY

I acknowledge that I have discussed peptide therapy with ICON ANTI-AGING AND AESTHETICS PLLC and understand the risks, benefits, and alternatives to this treatment.

The goal of peptide therapy is to help prevent, reduce, or control dysfunction associated with the aging process through hormonal balancing, oxidative stress control, and stimulation of the body’s innate repair systems. However, I understand that this treatment may be considered new, controversial, and not approved by the Food and Drug Administration (FDA) for certain uses.

Peptides Included in This Therapy
This consent covers the administration of the following peptides:

- CJC-1295/Ipamorelin – Growth hormone-releasing hormone analog and ghrelin secretagogue, increasing natural growth hormone levels and promoting repair processes.
- BPC-157 – A gastric-derived peptide that may aid in healing joint injuries, muscle sprains, and skin integrity.
- Sermorelin Acetate – A growth hormone-releasing peptide (GHRP) therapy that stimulates endogenous growth hormone production.
- Hexarelin – A growth hormone secretagogue with potential anabolic and regenerative properties.
- MOTS-c – A mitochondrial-derived peptide that may enhance metabolic function and energy regulation.
- NAD+ – A coenzyme involved in cellular energy production, DNA repair, and longevity.
- Tesamorelin – Used to promote fat loss and potentially support cognitive function.
- 5-Amino-1MQ – A peptide designed to regulate cellular metabolism and support weight loss.
- Dihexa – A cognitive-enhancing peptide with potential neuroprotective properties.
- Omberacetam – A nootropic peptide that may improve memory and focus.
- Thymosin Beta-4 (TB-4) / TB-500 – Peptides that may promote tissue repair and reduce inflammation.
- Omnitrope – A recombinant human growth hormone used in cases of growth hormone deficiency.
- Semaglutide, Tirzepatide, Retatrutide – GLP-1 receptor agonists that aid in weight management and glucose regulation.
- AOD-9604 – A peptide fragment of growth hormone with fat-burning potential.

Benefits and General Information

Peptide therapy may provide benefits such as:
- Increased muscle growth and fat loss
- Improved recovery from injuries
- Enhanced cognitive function and neuroprotection
- Hormonal optimization and metabolic balance
- Skin, hair, and wound healing support

Potential Risks and Side Effects

Although peptide therapy is generally well tolerated, potential risks include:

- Anaphylaxis – A severe, potentially life-threatening allergic reaction that may cause difficulty breathing, swelling, and low blood pressure. Immediate medical attention is required if symptoms occur.
- Allergic Reactions – Hives, itching, swelling, or severe anaphylaxis requiring emergency medical attention.
- Injection Site Reactions – Pain, redness, swelling, or bruising at the injection site.
- Hormonal Fluctuations – Possible changes in insulin, IGF-1 levels, and metabolism.
- Immune System Responses – Development of antibodies that may reduce effectiveness.
- Gastrointestinal Issues – Nausea, vomiting, diarrhea, or bloating (especially with GLP-1 receptor agonists like Semaglutide and Tirzepatide).
- Water Retention & Edema – May occur with growth hormone-related peptides.
- Unknown Long-Term Effects – Some peptides lack extensive human studies on long-term safety.

Specific Risks Associated with Certain Peptides:
- CJC-1295/Ipamorelin: Injection site redness, flushing, transient high blood sugar, development of antibodies, water retention. Not recommended for patients with known cancer.
- BPC-157: Injection site redness; oral formulation has no known side effects.
- GLP-1 Peptides (Semaglutide, Tirzepatide, Retatrutide): Risk of thyroid tumors in predisposed individuals, gastrointestinal issues.

Contraindications
Peptide therapy should not be used by individuals with:
- Active or suspected cancer
- Severe cardiovascular disease
- Pregnancy or breastfeeding
- Uncontrolled diabetes (for certain peptides)
- A history of severe allergic reactions or anaphylaxis to peptide therapy

Patient Responsibilities
I understand that:
- This therapy is elective and not guaranteed to produce specific results.
- I am responsible for following proper storage, administration, and dosing instructions.
- I will inform ICON ANTI-AGING AND AESTHETICS PLLC of any new medical conditions or medications.
- I will report any adverse reactions immediately.

No Guarantee of Results
While peptide therapy may offer potential benefits, I acknowledge that results vary and there is no guarantee of success.

Patient Acknowledgment and Consent

I confirm that:
- I have read and understood this Informed Consent for Peptide Therapy.
- I have discussed this treatment with my provider and have had the opportunity to ask questions.
- I acknowledge that some peptides included in this therapy are not FDA-approved.
- I understand the risks, benefits, and alternatives to peptide therapy.
- I accept the responsibility of undergoing this treatment at my own risk.

This consent form is provided for informational purposes and does not substitute for medical or legal advice. Patients should consult with their provider to discuss individual risks and benefits before starting peptide therapy.

Informed Consent for Compounded Semaglutide, retatutride and tirzepatide Treatment
Purpose of Treatment:
Semaglutide, retatutride and tirzepatide are glucagon-like peptide-1 (GLP-1) receptor agonists prescribed to assist with weight management in adults with a body mass index (BMI) outside the healthy range. These medications work by mimicking hormones that regulate appetite and insulin secretion.
Contraindications:
You should not take GLP-1 agonist medications if:
- You have a personal or family history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN-2).
- You are pregnant, planning to become pregnant, or are breastfeeding.
- You have a history of pancreatitis.
- You have severe gastrointestinal disease.
- You have a known allergy to retatutride, semaglutide, tirzepatide, or any components of the formulation.

Potential Risks and Side Effects:

1. Common Side Effects:
- Nausea
- Vomiting
- Diarrhea
- Constipation
- Abdominal pain
- Headache
- Fatigue
- Dizziness
- Indigestion
- Bloating
- Belching
- Injection site reactions (e.g., itching, burning, or thickening of the skin)

2. Serious Side Effects:
- Pancreatitis: Inflammation of the pancreas presenting as severe abdominal pain, which may radiate to the back, possibly accompanied by vomiting.
- Gallbladder Issues: Including gallstones and inflammation, with symptoms like upper stomach pain, yellowing of the skin or eyes, clay-colored stools, and fever.
- Hypoglycemia: Low blood sugar, especially in patients with type 2 diabetes on insulin or sulfonylureas, manifesting as dizziness, headache, rapid heartbeat, mood changes, weakness, shakiness, slurred speech, confusion, or hunger.
- Kidney Problems: Dehydration from gastrointestinal side effects can lead to acute kidney injury or worsening of chronic kidney disease.
- Thyroid C-Cell Tumors: There is a potential risk for thyroid tumors; symptoms include a mass in the neck, difficulty swallowing, hoarseness, or shortness of breath.
- Allergic Reactions: Such as rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, and trouble breathing.
- Increased Heart Rate: Some patients may experience an elevated heart rate while at rest.
- Vision Changes: Particularly in patients with diabetic retinopathy, there may be a risk of worsening vision.

Warnings and Precautions:

- Medication Interactions: Inform your healthcare provider about all medications, including over-the-counter drugs, vitamins, and supplements, as GLP-1 agonists can affect the absorption and effectiveness of other medications.
- Proper Administration: Ensure you understand the correct dosing and administration techniques to avoid dosing errors, which have been linked to adverse events, including hospitalizations.

Disclosure of Non-FDA Approved or Off-Label Use
Certain treatments, medications, or devices offered at our practice may be used “off-label” or may not be approved by the U.S. Food and Drug Administration (FDA) for the specific indication being treated. This means the use may be experimental, based on clinical judgment, current research, and best practice recommendations, but not formally approved by the FDA for this particular purpose.
By signing this consent, you acknowledge the following:
Non-FDA Approval: You understand that the drug, device, or treatment may not be approved by the FDA for the specific condition or indication for which it is being used.
Experimental Nature: You are aware that the intervention may be considered investigational or experimental, and not all risks or benefits are fully known.
Risks and Benefits: You have been informed of the known and potential risks, side effects, and possible benefits—both short-term and long-term—of the treatment.
Alternative Options: You have been advised of alternative FDA-approved treatments or therapies, and you understand that you are free to pursue those options instead.
Voluntary Consent: Your participation is entirely voluntary. You may decline or withdraw from the proposed treatment at any time without affecting your access to other care or incurring any penalty.
Confidentiality: Your medical information and data will be protected in accordance with HIPAA and applicable privacy laws.
Questions and Contact: You may contact our medical team at any time with questions or in the event of adverse effects. If the intervention is part of a research study, the study has been reviewed and approved by an Institutional Review Board (IRB), and IRB contact information will be provided upon request.
Device Use (if applicable): In cases involving the use of non-approved medical devices, efforts are made to obtain manufacturer authorization and, when appropriate, an independent physician review.
You have had the opportunity to ask questions and fully understand the nature, risks, and alternatives of the treatment offered.

Patient Acknowledgment:

I have read and understand the information provided above regarding the treatment with compounded semaglutide, retatutride and tirzepatide. I have discussed any concerns with my healthcare provider and have had all my questions answered to my satisfaction. I understand the potential risks and benefits associated with this treatment and agree to proceed.