Informed Consent Sermorelin

 


1. INTRODUCTION
I understand that I am being offered treatment with sermorelin, a synthetic peptide that acts as a growth hormone-releasing hormone (GHRH) analog, which stimulates the pituitary gland to produce and release endogenous growth hormone (GH).
I acknowledge that this therapy is being prescribed as part of a personalized treatment plan through Vybrant Health and Wellness.

2. OFF-LABEL USE DISCLOSURE
I understand that:

  • Sermorelin was previously approved by the U.S. Food and Drug Administration (FDA) for the evaluation of pituitary function and pediatric growth hormone deficiency.
  • Its use for adult hormone optimization, anti-aging, body composition improvement, sleep enhancement, or performance optimization is considered OFF-LABEL.
  • Off-label prescribing is a common and legally accepted medical practice when supported by clinical judgment and available evidence.

I acknowledge that the provider has explained the rationale for its use in my case.

3. COMPOUNDED MEDICATION DISCLOSURE
I understand that:

  • The sermorelin prescribed to me is compounded by a licensed U.S. compounding pharmacy.
  • Compounded medications are NOT FDA-approved.
  • Compounding is used when commercially available products do not meet patient-specific needs.
  • The pharmacy used is expected to follow applicable state and federal regulations; however, compounded medications are not reviewed by the FDA for safety, efficacy, or consistency in the same manner as FDA-approved drugs.


4. MECHANISM OF ACTION
Sermorelin works by stimulating the hypothalamic-pituitary axis to increase natural growth hormone secretion. This may lead to downstream increases in insulin-like growth factor-1 (IGF-1), which plays a role in metabolism, tissue repair, and body composition.

5. POTENTIAL BENEFITS
I understand that potential benefits are not guaranteed and may include:

  • Improved sleep quality
  • Increased energy and recovery
  • Improved body composition (fat reduction, lean mass support)
  • Enhanced exercise recovery
  • Support for skin health and tissue repair
  • Potential improvement in overall well-being

I understand that results vary significantly between individuals and depend on factors such as lifestyle, nutrition, sleep, and underlying medical conditions.

6. RISKS AND POTENTIAL SIDE EFFECTS
I understand that all medical treatments carry risks. Potential side effects of sermorelin may include, but are not limited to:
Common:

  • Injection site reactions (pain, redness, swelling)
  • Headache
  • Flushing
  • Dizziness

Hormonal/Metabolic:

  • Changes in IGF-1 levels
  • Water retention (edema)
  • Joint discomfort
  • Mild insulin resistance or changes in glucose metabolism

Less Common but Possible:

  • Nausea
  • Increased appetite
  • Carpal tunnel-like symptoms
  • Gynecomastia (rare, indirect hormonal effects)

Serious Risks (Rare):

  • Worsening of untreated endocrine disorders
  • Potential stimulation of pre-existing malignancy (theoretical risk due to IGF-1 signaling)
  • Increased intracranial pressure (very rare)

 

7. CONTRAINDICATIONS AND PRECAUTIONS
I understand that sermorelin may not be appropriate if I have:

  • Active or suspected cancer
  • Untreated or poorly controlled diabetes
  • Untreated sleep apnea
  • Significant pituitary or hypothalamic disorders
  • Pregnancy or breastfeeding

I agree to disclose all medical conditions honestly and understand that withholding information may increase my risk.

8. ALTERNATIVES TO TREATMENT
I understand that alternatives include:

  • No treatment
  • Lifestyle modification (nutrition, sleep, exercise optimization)
  • Other medical therapies (e.g., growth hormone therapy, if clinically indicated and appropriate)
  • Addressing underlying hormonal or metabolic conditions

I understand I am not obligated to proceed with sermorelin therapy.

9. MONITORING AND FOLLOW-UP
I understand that:

  • Ongoing monitoring is required to ensure safety and effectiveness.
  • This may include laboratory testing (e.g., IGF-1, glucose, A1c, metabolic panels).
  • Follow-up visits are necessary to assess response and adjust treatment.
  • Failure to complete recommended monitoring may result in discontinuation of therapy.


10. PATIENT RESPONSIBILITIES
I agree to:

  • Follow dosing and administration instructions as prescribed
  • Not adjust dosage without provider guidance
  • Report side effects promptly
  • Maintain recommended follow-up and lab testing
  • Not share medication with others


11. NO GUARANTEE OF RESULTS
I understand that:

  • No specific outcomes or results have been promised
  • Response to therapy varies widely
  • This therapy is part of a comprehensive plan and not a standalone solution


12. FINANCIAL RESPONSIBILITY
I understand that:

  • This treatment is elective and typically not covered by insurance
  • I am responsible for all associated costs, including medication, visits, and labs
  • Payment policies and subscription terms have been explained separately

 

13. INDEMNIFICATION AND HOLD HARMLESS AGREEMENT

To the fullest extent permitted by law, I agree to release, indemnify, defend, and hold harmless Vybrant Health and Wellness, its owners, providers, employees, contractors, and affiliated pharmacies from and against any and all claims, liabilities, damages, losses, costs, or expenses (including reasonable attorney’s fees) arising out of or related to:

My decision to undergo off-label sermorelin therapy
My failure to follow medical instructions, dosing, or monitoring recommendations
My failure to disclose accurate and complete medical history
Any adverse outcomes related to the use of compounded medications
Use of the medication outside of prescribed guidelines

I understand that:

This agreement does not waive liability for gross negligence or willful misconduct by the provider, where prohibited by law
I am voluntarily assuming the known and unknown risks associated with this therapy

14. VOLUNTARY CONSENT
I confirm that:

  • I have had the opportunity to ask questions and all questions have been answered to my satisfaction
  • I understand the risks, benefits, and alternatives
  • I voluntarily consent to the off-label use of sermorelin

 

15. RIGHT TO WITHDRAW
I understand that I may discontinue treatment at any time, but I should consult my provider before doing so.