Peptide Therapy Clearances with Spakinect

Peptide Therapy Clearances with Spakinect

Peptide Therapy

Spakinect completes Good Faith Exams (GFEs) for the following Peptides:

  • Sermorelin

  • CJC-1295 / Ipamorelin

  • Tesamorelin

  • Hexarelin

  • PT-141 (Bremelanotide)

  • Pentadecapeptide (BPC-157)

  • GHK-Cu (Copper Peptide)

  • NAD

Important points to note

  1. At this time, our providers do not prescribe any medications. The prescription, administration instructions, dose, frequency, and route must come from the clinic's medical director/prescriber. 
  2. Clients should have a standard operating procedure (SOP) for peptide therapy established by the clinics's medical director. In addition, each patient should have an individualized order that should clearly outline all screening, dosing, and monitoring requirements and must be signed by the medical director or an on-site medical provider. 
  3. Spakinect recommends that patients be monitored through the entire course of treatment. 

FAQs

What is Peptide Therapy?

Peptide Therapy involves the use of short chains of amino acids that target specific physiological pathways to support health, recovery, and wellness. Clinical use includes treatment of growth hormone deficiency, age-related hormonal decline, metabolic dysfunction, tissue repair, immune support, cognitive optimization, gut healing, and sexual dysfunction.

Do you review labs or require labs for Peptide Therapy?

Currently, our providers do not review labs, but they will take into consideration any reported lab abnormalities during the medical history review. All required labs, monitoring, or diagnostic testing should be directed by your medical director and established within your clinic’s SOPs.

Spakinect recommends:

  1. The patient's recent applicable laboratory values should be evaluated prior to initiating treatment. 
  2. Re-evaluation and monitoring should occur throughout the treatment course. 
  3. Cardiac function (blood pressure and heart rate) should be monitored before treatment initiation and throughout therapy. 
  4. Therapy should be discontinued for any adverse reactions, with follow-up per clinic protocol. 

Additional screenings and follow-up requirements should be determined by the clinic’s medical director.

What does the peptide therapy screening process involve?

  1. Comprehensive review of medical history, medications, allergies, recent surgeries or procedures, and permanent implants. 
  2. Inquiry about relevant conditions such as cancer history, cardiovascular disease, uncontrolled hypertension, thyroid disorders, or endocrine dysfunction. 
  3. Follow up questions tailored to the peptide being considered and the patient's overall health status. 

*Our evaluation process is guided by product inserts, clinical manuals, and evidence-based practices.

How long is the peptide therapy GFE good for?

Peptide Therapy GFE approvals are valid for 12 months from the documented timestamp. If a patient’s medical status changes within this period, the GFE becomes null and void, and a new GFE must be completed prior to further administration.

Can Spakinect provide dosing or prescribing guidance?

All dosing, frequency, route of administration, and monitoring requirements must be outlined by your onsite medical director in your clinic’s SOPs and individualized patient orders.

Important notes to keep in mind

  1. Peptide therapies are considered wellness and optimization treatments; they are not intended to diagnose, treat, cure, or prevent any disease. 
  2. Some peptides may not yet have FDA clearance or approval. Individual results can vary from patient to patient. 
  3. For any off-label uses, dosing, or administration methods. Clinics must follow their medical director's established protocols and individualized patient orders, and screen patients carefully for clinical considerations before treatment. 

What additional considerations should we include in our clinic’s SOPs?

  • Initial and ongoing monitoring parameters (labs & vital signs)

  • Patient counseling on side effects, interactions, and contraindications

  • Frequency of follow-up visits

  • Criteria for discontinuation or referral to a specialist

Any other questions regarding Peptide Therapy or our GFEs? Please email clinicalsupport@spakinect.com for additional guidance.



    • Related Articles

    • Hormone Replacement Therapy (HRT)

      Important points to note: Spakinect completes GFEs for Hormone Replacement Therapy (HRT) for: Estrogen, Progesterone, and Testosterone Testosterone only At this time, our providers do not prescribe any medications. The prescription, administration ...
    • Wegovy (Semaglutide) clearances with Spakinect

      Any additional questions please email our clinical team at clinicalsupport@spakinect.com We have the ability to approve your patients for the use of semaglutide. But, we do have a couple of restrictions. At this time, Spakinect does not prescribe any ...
    • Spakinect Minor Policy

      For any minors (ages 13-17 years old) requesting aesthetic treatments, the minor’s parent and/or legal guardian must be physically present to provide consent for treatment during the Good Faith Evaluation (GFE) process. *Patients under the age of 13 ...
    • Spakinect Translator Policy

      For non-English speaking patients, there must be a guardian, friend/family member, staff member, or licensed interpreter physically present during the Good Faith Evaluation (GFE). The translator must obtain verbal consent to discuss the patient’s ...
    • Spakinect Client Portal Access Policy

      Requesting an invitation to the Spakinect Client Portal is a relatively short process that, once completed, will allow you to search, download, and save patient Good Faith Evaluations among many other things. It is an essential part of our program ...