Telehealth informed consent

The purpose of this informed consent document is to provide you with written information about Peptide Therapy, and its risks, benefits, and alternative treatments, so that you can make an informed decision about whether to proceed with treatment. This material serves as a supplement to the discussion you have with your PeRx medical provider about the treatment. It is important that you fully understand this information, so please read this document thoroughly. If you have any questions regarding the treatment, ask your PeRx medical provider prior to signing the consent form.

Peptides are short-chain amino acids that occur naturally in the human body and play crucial roles in hormonal balance, immunity, cognitive function, digestion, and numerous other body processes. The body uses some peptides to signal protein production and others to transport nutrients between different body parts. There are yet other peptides whose function is to regulate enzyme action, thereby regulating various biological processes. While the body produces peptides naturally, factors such as age, lifestyle choices like smoking and drinking, stress, and poor diet can slow down their production. In turn, this jeopardizes their function, leading to faster aging, accumulation of body fat, lack of energy, and a decrease in muscle mass.

Many peptides are administered by subcutaneous injection. Either the peptide is administered by a medical provider, or a patient self-administers the injection using a tiny needle into the fat tissue. Because the needle is so small, the injection is generally less painful. Peptides can also come in the form of transdermal creams, nasal sprays, oral tablets, and capsules.

Because there are many different types of peptides, the potential benefits depend on the peptide used. Some of the possible benefits of Peptide Therapy, depending upon the peptide(s) used, include: prevention and reduction of symptoms associated with the aging process, hormonal balancing, enhancement of immunity, assistance with weight loss or muscle gain, and reduction of pain.

Injury & Tissue Repair: BPC-157, TB-500, BPC/TB-500 Combo, BPC Capsules, BPC/TB-500 Capsules

Muscle & Growth: CJC-1295/Ipamorelin, Sermorelin, Tesamorelin, Tesamorelin/Ipamorelin Combo

Metabolic & Fat Loss: AOD 9604, MOTS-C, AOD 9604/MOTS-C Combo

Intimacy & Sexual Health: PT-141 (Bremelanotide)

Neurological & Brain: Semax/Selank Combo, Pinealon/PE-22-28/Selank Combo, DSIP

Cosmetic & Skin: GHK-Cu, GHK-Cu/Epitalon Combo

Longevity & Immune: Thymosin Alpha-1, Epitalon, NAD+, Glutathione

It is important to note that while the US Food and Drug Administration (FDA) has approved some peptides for the treatment of certain medical conditions, the FDA has not approved many peptides offered by PeRx to treat, cure or prevent any disease. Unless the specific peptide is FDA-approved for a specific use, any potential benefits or statements about potential benefits have not been approved by the FDA. Peptides that are not FDA approved are used clinically under a medical provider's prescription and prepared by compounding pharmacies in compliance with state and federal laws.

The FDA has not approved most of the peptides offered by PeRx. FDA-approved peptides in our catalog include Sermorelin and PT-141 (bremelanotide). The FDA views unapproved peptides as experimental and considers them to have safety risks. Additionally, as of January 1, 2022, BPC-157 is also prohibited under the World Anti-Doping Agency (WADA) Prohibited List.

The FDA is constantly monitoring its position with respect to these substances. You can find out more about the FDA's list of safety risks for each peptide that is not FDA-approved at: https://www.fda.gov/drugs/human-drug-compounding/safety-risks-associated-certain-bulk-drug-substances-nominated-use-compounding

As with any treatment, peptides, whether taken orally, nasally, through a cream, or injection, can have risks and side effects, including but not limited to:

Temporary metabolic disturbances such as changes in blood sugar, changes in blood pressure leading to headache, lightheadedness or dizziness, increased thirst or hunger, flu-like symptoms, stomach upset, diarrhea or constipation, nausea, and vomiting.

Development of antibodies to the peptides. Fluid retention. Alteration in lipid profiles. Allergies, including life-threatening allergies to the peptides used.

Discomfort such as pain, redness, bruising, swelling, burning, stinging, bleeding and/or scar formation at the site of the injection; infection is always a potential risk when the skin is punctured even when sterile procedures are used. Injury to nerve and/or muscle at the site of the injection.

Side effects and risks may vary based on the type of peptide used and are often dose-related and possibly eliminated by adjusting the dosage.

CJC-1295/Ipamorelin: Compounded drugs containing CJC-1295 may pose risk for immunogenicity for certain routes of administration and may have complexities regarding peptide-related impurities and API characterization. FDA has identified serious adverse events associated with CJC-1295 including increased heart rate and systemic vasodilatory reaction. Available clinical data are limited. Compounded drugs containing Ipamorelin acetate may pose risk for immunogenicity for certain routes of administration due to the potential for aggregation or peptide-related impurities. Ipamorelin acetate also contains unnatural amino acids, which add to the complexity of peptide characterization. A study published in literature identified serious adverse events including death when ipamorelin was administered intravenously for improving gastric motility. The FDA has not identified safety-related information regarding ipamorelin acetate via certain other injectable routes of administration; thus, the FDA lacks sufficient information to know if it would cause harm if administered to humans via those routes.

BPC-157: Compounded drugs containing BPC-157 may pose risk for immunogenicity for certain routes of administration and may have complexities regarding peptide-related impurities and API characterization. FDA has identified no, or only limited, safety-related information for proposed routes of administration; thus, FDA lacks sufficient information to know whether the drug would cause harm when administered to humans.

TB-500 (Thymosin Beta-4): Compounded drugs containing Thymosin Beta-4 may pose risk for immunogenicity for certain routes of administration due to the potential for aggregation as well as peptide-related impurities. FDA has not identified any human exposure data for drug products containing Thymosin Beta-4. FDA lacks important information regarding any safety issues raised by this drug, including whether it would cause harm if administered to humans.

Sermorelin: Sermorelin is a synthetic (man-made) version of a naturally occurring substance that causes release of growth hormone from the pituitary gland in the brain, with the potential to help build lean muscle, reduce fat stores, and improve athletic performance and muscle recovery time. The most common side effects are pain, redness, or swelling at the place of injection.

Tesamorelin: Tesamorelin is a growth hormone-releasing factor analogue used to target visceral fat reduction through natural growth hormone stimulation. It may cause injection site reactions, nausea, joint pain, and peripheral edema. Patients with active malignancy or hypersensitivity to tesamorelin should not use this peptide.

GHK-Cu: Compounded injectable drugs containing GHK-Cu may pose risk for immunogenicity due to the potential for aggregation and peptide-related impurities. There are limited data in humans to inform safety-related considerations.

AOD 9604: Compounded drugs containing AOD-9604 may pose significant risk for immunogenicity for certain routes of administration and may have peptide-related impurities and API characterization concerns. FDA has identified no, or only limited, safety-related information for proposed routes of administration; thus, the FDA lacks sufficient information to know whether the drug would cause harm when administered to humans. FDA has also identified serious adverse events that may be associated with AOD-9604, though causality is not clear.

MOTS-C: MOTS-C is a mitochondria-derived peptide that acts as an exercise mimetic, affecting metabolism and insulin sensitivity. Human clinical data are limited, and compounded formulations may pose immunogenicity risk. The FDA lacks sufficient information to fully characterize its safety profile when administered to humans.

PT-141 (Bremelanotide): PT-141, also known as Bremelanotide, is a synthetic peptide subcutaneous injection used to treat sexual dysfunction in men and women. It works at the brain to increase sexual desire and is generally well tolerated if dosage instructions are followed, but can have side effects including, among others: increased blood pressure, darkening of the skin on the face, gums or breasts, nausea, vomiting, bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site; and feeling of warmth and redness of the face, neck, arms, and occasionally the upper chest.

Semax/Selank: Compounded drugs containing Semax (heptapeptide) or Selank acetate may pose risk for immunogenicity for certain routes of administration due to the potential for aggregation and peptide-related impurities. FDA has no, or limited, safety-related information for proposed routes of administration; thus, the FDA lacks sufficient information to know whether either drug would cause harm if administered to humans.

Pinealon/PE-22-28: These neuroprotective peptides have limited human clinical data. Compounded formulations may carry risk for immunogenicity and peptide-related impurities. The FDA lacks sufficient information to fully evaluate their safety when administered to humans.

DSIP (Delta Sleep Inducing Peptide): Compounded drugs containing emideltide (DSIP) may pose risk for immunogenicity for certain routes of administration and may have complexities regarding peptide-related impurities and API characterization. FDA has not identified safety-related information regarding emideltide for the proposed route of administration; thus, FDA lacks sufficient information to know whether the drug would cause harm if administered to humans.

Thymosin Alpha-1: Compounded drugs containing Thymosin Alpha-1 may pose significant risk for immunogenicity for certain routes of administration and may have complexities regarding peptide-related impurities and API characterization. The safety-related information available is inadequate for FDA to sufficiently understand the extent of any safety issues raised by the proposed compounded product.

Epitalon: Epitalon is a synthetic tetrapeptide that may activate telomerase to protect DNA and slow cellular aging. Human clinical data are limited and largely based on non-U.S. research. Compounded formulations may carry immunogenicity risk. The FDA lacks sufficient information to evaluate its safety when administered to humans.

NAD+: NAD+ (Nicotinamide Adenine Dinucleotide) is a coenzyme involved in cellular energy production and DNA repair. When administered intravenously or via injection, it may cause flushing, nausea, chest tightness, or rapid heart rate. Patients should inform their provider of any cardiac history prior to use.

Glutathione: Glutathione is the body's master antioxidant and is involved in detoxification and immune support. When administered via injection, side effects may include injection site reactions, nausea, and in rare cases, allergic reactions. Intravenous formulations carry additional risk and should be administered under close medical supervision.

Peptide Therapy is contraindicated during pregnancy and breastfeeding. Some peptides are contraindicated for those with a history of cancer or other medical conditions. A thorough and accurate health history is essential for your PeRx medical provider to prescribe the most beneficial and least harmful treatment for you.

This is an elective treatment. There is always the option of addressing symptoms with other therapies, and your PeRx medical provider will discuss these alternative options with you. For example, declining hormone levels and age-related conditions or muscle loss can be treated as they develop with bioidentical hormone replacement therapy and non-hormonal therapies such as herbal therapies, supplements, and lifestyle modifications.

I am aware that unforeseeable complications could occur, and I do not expect the PeRx medical providers to anticipate all possible complications.

I understand that each patient responds differently to treatments. I understand there is no guarantee, implied or stated, that the Peptide Therapy administered will improve, reduce, or eliminate any medical symptoms or conditions that I have, or that it will be free of side effects or risk.

I also understand that certain forms of Peptide Therapy may be considered unproven and experimental. Additionally, I understand and acknowledge that the United States Food and Drug Administration (FDA) has not evaluated or approved all forms of peptide therapy to diagnose, treat, cure, or prevent any disease. I understand that if I choose to use a peptide that has not been approved by the FDA, I will be using a product that has been developed for research purposes only.

I understand that for my safety, it is extremely important that I follow the instructions I receive with respect to dosing and administration and that I do not take more than prescribed or take additional medications while using peptides prescribed to me.

I understand that Peptide Therapy may be contraindicated if I have certain medical conditions, allergies, and/or if I take certain medications. I have disclosed and will truthfully and accurately disclose all personal medical information to the PeRx medical providers, including but not limited to: all of my health conditions; my use of all medications (both prescription and over-the-counter), herbs, vitamins, and other supplements; and all known allergies to drugs or other substances. I understand that failure to do so may negatively affect my treatment outcome and the safety of the Peptide Therapy, and there shall be no liability on the part of PeRx or the PeRx medical providers should I fail to do so.

By signing below, I confirm and agree that I have read this entire Informed Consent for Peptide Therapy, or someone has read it to me, and I understand and agree to the information herein. The nature of the therapy, and the potential risks, benefits, and alternatives have been explained to me, and I have had the opportunity to ask questions. All of my questions have been answered to my satisfaction. I hereby freely and voluntarily accept all risks associated with Peptide Therapy and elect and consent to proceed with treatment with PeRx.