INFORMED CONSENT – PEPTIDES, WEIGHT LOSS MEDICATION & HORMONE THERAPY
Please read this carefully and ask any questions before signing.
Purpose of this Treatment
I understand that I am being offered one or more of the following therapies depending on my clinical assessment:
Peptide therapies
Weight loss medications
Hormone therapy
These treatments may aim to support weight management, hormonal balance, metabolic health, performance, recovery, longevity or symptom reduction, depending on my health needs.
I understand that treatment is individualised, and I may not receive all therapies listed above or requested in my consultation.
Unapproved Medicines Disclaimer
Unapproved medicines have not been evaluated by the TGA for safety, quality or effectiveness for the proposed use.
These products may have limited clinical evidence and short- or long-term risks may not be fully known.
Unapproved medicines are legally permitted when a registered Australian medical practitioner determines that the treatment is clinically justified and obtains my informed consent.
My prescribing practitioner has explained the reason these medicines are being recommended for me and why an approved option may not be suitable.
I may be receiving a compounded medicine, made specifically for me by a compounding pharmacy, which:
may vary in strength, potency or excipients compared to commercial products,
may not have undergone the same stability, shelf-life or batch-testing processes as ARTG-registered medicines.
I understand that adverse reactions, including serious reactions, can occur with unapproved or compounded products.
I understand that I must report any side effects or concerns immediately to my prescribing practitioner or seek urgent medical care if severe symptoms occur.
I understand that I may choose not to proceed with treatment and that I have been informed of appropriate alternatives.
I agree to participate in recommended monitoring, pathology tests and follow-up reviews, as this is essential for safe management when using unapproved medicines.
I acknowledge that the cost of unapproved medicines is not subsidised under the PBS and may vary.
By continuing with treatment, I confirm that:
I understand the regulatory status of the medicine(s) being prescribed to me.
I understand the risks, uncertainties, and evidence limitations.
I voluntarily consent to the use of unapproved and/or compounded medicines, as determined appropriate by my registered health practitioner.
Regulatory Status, Off-Label and Unapproved Use
I understand that some medicines used in my treatment may be:
Off-label (used outside their TGA-approved indication), and/or
Unapproved/compounded medicines supplied under TGA exemptions.
I have been explained and understand:
The regulatory status of my treatment
The known and potential risks
Any uncertainties or limitations in available evidence
I understand long-term data may be limited for some therapies.
Nature of the Treatment
I may receive therapies in injectable, oral, topical or other forms.
The dose, frequency and duration will be tailored to my needs.
I will receive instructions on:
Administration (including injection technique where relevant)
Storage
Sharps disposal (if applicable)
What to do if I miss a dose or experience a reaction
Benefits & Expected Outcomes
I understand that:
Outcomes cannot be guaranteed
Results vary between individuals
Benefits depend partly on lifestyle factors I control
Risks, Side Effects & Uncertainties
PEPTIDE THERAPY
Peptides may include compounds such as:
CJC-1295, Ipamorelin, Tesamorelin, BPC-157, AOD-9604, Melanotan, Thymosin fragments, and other compounded or unapproved peptides.
Common Side Effects
Injection site reactions (redness, swelling, tenderness, bruising)
Headache
Fatigue or low energy
Flushed or warm sensation
Water retention or bloating
Nausea or digestive upset
Mood changes or irritability
Vivid dreams or sleep pattern changes
Temporary changes in appetite
Joint pain or stiffness
Moderate Risks
Tingling or numbness in extremities
Joint swelling
Increased hunger (especially GH-related peptides)
Changes in blood pressure
Fluid retention
Elevated blood glucose or insulin resistance
Worsening of pre-existing hormone-sensitive conditions
Changes in cortisol rhythm
Injection-site infection (rare but possible)
Serious or Rare Risks
Allergic reactions, including anaphylaxis (rare)
Pituitary stimulation affecting hormone levels
Carpal tunnel–type symptoms
Elevated IGF-1 with potential long-term cancer-risk implications (theoretical but noted in literature)
Abnormal or rapid tissue growth (theoretical risk in unregulated GH-axis use)
Severe electrolyte imbalance
Worsening of undiagnosed cancers or tumours (theoretical GH/IGF axis risk)
Kidney or liver strain in susceptible individuals
Uncertainty Risks
Long-term safety data may be limited or unknown
Variability in potency or quality with compounded peptides
Off-label use means evidence quality may vary
HORMONE THERAPY
Includes:
Testosterone, thyroid hormones, progesterone, oestrogen, DHEA, pregnenolone, HRT, menopausal therapy, and androgen-optimisation therapies.
Common Side Effects
Acne or oilier skin
Fluid retention
Mood changes, irritability or anxiety
Breast tenderness
Libido changes (increase or decrease)
Weight fluctuations
Fatigue or sleep disruption
Moderate Risks
Blood pressure increases
Headaches or migraines
Hair thinning or increased body hair (androgenic effect)
Menstrual cycle irregularities (women)
Changes in cholesterol (HDL decrease, LDL increase)
Increased red blood cell count (erythrocytosis)
Swelling of hands or feet
Thyroid over- or under-replacement symptoms
Serious or Rare Risks
Blood clots (VTE risk, particularly with oestrogen therapy)
Cardiovascular events (heart attack, stroke) in high-risk individuals
Liver dysfunction (rare, more common with oral androgens)
Sleep apnoea worsening
Prostate enlargement or urinary symptoms (men)
Fertility suppression (men and women)
Endometrial or breast cancer risk considerations (women on HRT)
Severe mood disturbance or aggression (androgen-related)
Special Precautions
Not recommended during pregnancy or breastfeeding
Requires strict monitoring: bloods, haematology, hormones, liver function, lipids, BP
Dose adjustments often required
WEIGHT-LOSS MEDICATIONS
Includes:
GLP-1 agonists (Semaglutide, Tirzepatide, Liraglutide), compounded weight-loss formulations, Metformin (if used for weight), Phentermine derivatives, Naltrexone/Bupropion, and appetite-modulating compounds.
Common Side Effects
Moderate Risks
Severe gastrointestinal irritation
Gallbladder issues (sludge, gallstones)
Dehydration
Electrolyte imbalance
Hypoglycaemia (especially when combined with other glucose-lowering drugs)
Hair shedding (telogen effluvium from calorie deficit)
Muscle loss if protein intake is insufficient
Heart rate changes
Serious or Rare Risks
Pancreatitis (serious abdominal pain, vomiting)
Kidney injury from dehydration or reduced oral intake
Significant gastroparesis (delayed stomach emptying)
Bowel obstruction (rare but reported)
Severe allergic reactions
Thyroid C-cell tumours in animals (uncertain relevance in humans; listed by manufacturers)
Suicidal ideation (rare, associated with some weight-loss medications)
Cardiovascular strain (stimulant-based medications only)
Liver inflammation (rare)
Special Precautions
Should not be used in pregnancy
Must be used cautiously in patients with:
Requires regular clinical review
GLOBAL RISKS ACROSS ALL THREE CATEGORIES
Drug Interactions
Monitoring-Dependent Risks
Failure to complete bloods or follow-up increases risk of:
Lifestyle-Related Risks
Pregnancy & Fertility
Many peptides, hormones and weight-loss medications are not safe in pregnancy.
Some may reduce fertility or affect menstrual cycles and ovulation.
I understand there may be unknown or unforeseen risks, especially with newer or compounded therapies.
I agree to stop the medication and seek urgent medical attention if severe symptoms occur.
Alternatives to Treatment
Alternatives include:
Lifestyle-only interventions
Allied health or psychological support
Other standard pharmacological options
Not commencing treatment
I am informed of reasonable alternatives relevant to my situation.
Monitoring, Pathology & Follow-Up
I understand that safe treatment requires:
Baseline and follow-up blood tests
Periodic review of symptoms and side effects
Follow-up appointments as recommended
I agree to:
My practitioner may change or discontinue treatment if risks outweigh benefits.
Pregnancy, Breastfeeding & Fertility
I understand that many of these therapies are not recommended during pregnancy or breastfeeding.
I agree to notify the clinic immediately if:
Treatment may need to be paused or stopped.
Interaction with Other Medications & Conditions
I understand these therapies may interact with other medicines or supplements.
I agree to:
Disclose all medications, supplements and substances I take
Update the clinic if anything changes
Inform other healthcare providers involved in my care
Privacy, Confidentiality & Use of Data
My information is managed in accordance with the Privacy Act 1988 (Cth) and relevant state health records legislation.
Information may be shared with my GP, specialists, pharmacies, other clinics and practitioners working with Hydralyfe, nurses, staff or pathology providers when necessary for my care.
De-identified data may be used for quality improvement and clinical governance.
Indemnity, Patient Responsibility & Acknowledgement Clause
I acknowledge and agree that:
I am responsible for following all medical instructions, including dosage, administration, storage and disposal.
I am responsible for attending required reviews and pathology monitoring.
I will inform the clinic promptly of any adverse symptoms, new diagnoses, medication changes or health events.
I will not alter doses, frequency or administration without medical advice.
I understand that failure to follow medical guidance may increase my risk of harm.
Indemnity Statement :
I agree to indemnify and hold harmless the clinic, its practitioners and staff from liability that arises as a result of:
My failure to provide accurate, complete and truthful medical information
My failure to disclose medications, supplements, recreational substances, allergies or medical conditions
My failure to follow medical instructions, including dosage, administration, storage or safety protocols
Any modification of treatment, including changing doses or stopping/starting medicines without medical advice
My failure to complete recommended monitoring, pathology, reviews or follow-up appointments
Misuse, abuse, diversion or sharing of prescribed medications
My decision to continue treatment against medical advice
My failure to seek urgent medical care when experiencing adverse symptoms
Any harm arising from co-existing conditions, medications or behaviours I did not disclose
Any harm arising from lifestyle choices (e.g., alcohol, supplements, exercise, caloric restriction) that compound medication effects
My improper storage, handling or disposal of medications or sharps
Any adverse event resulting from third-party compounding, manufacturing variability, or issues outside the Clinic’s control
Misinterpretation or misuse of educational or written information provided by the Clinic
I acknowledge that I am choosing to undertake treatment that may involve off-label, unapproved and compounded medicines, and I accept full responsibility for complying with all medical instructions, safety requirements, monitoring, pathology, and follow-up.
I agree to indemnify, defend and hold harmless the clinic, its directors, employees, contractors, nurses, doctors, allied health professionals and affiliated service providers (“the Clinic”) from any claim, loss, injury, cost, damage or liability that arises directly or indirectly from the treatment.
This indemnity applies to:
Economic, physical, psychological or reputational harm
Losses suffered by me or third parties
Claims made against the Clinic by me or on my behalf
I acknowledge and understand that the use of peptide therapies, hormone treatments and weight-loss medications—including those prescribed off-label, unapproved, or compounded—carries inherent, known, foreseeable, and potentially unknown risks.
By proceeding with treatment, I voluntarily and knowingly assume all risks associated with these therapies, including but not limited to:
Known and expected side effects
Potential complications
Rare or serious adverse events
Risks associated with unapproved, off-label or compounded medicines
Risks related to my personal health conditions
Risks arising from medication interactions
Risks associated with injections, devices, sharps and storage
Risks associated with treatment failure or suboptimal response
Risks that may not yet be fully understood due to limited long-term data
I understand that:
No treatment outcome can ever be guaranteed.
Some risks may be unpredictable or not fully established in current medical literature.
My individual response may differ significantly from expected outcomes.
Off-label and unapproved medicines may not have been evaluated by the TGA for safety, quality or effectiveness.
Compounded medicines may vary in potency, formulation, stability or excipients.
I further acknowledge that:
The safe use of these therapies depends on my compliance with monitoring, pathology, follow-up and medical instructions.
The risk of adverse events significantly increases if I fail to follow the treatment plan as directed.
I am responsible for promptly reporting any adverse symptoms, side effects, changes in health status, or medication changes.
I may request additional information at any time and may withdraw from treatment at any time.
By signing , I confirm that:
I have been informed of the nature, benefits, alternatives and risks of treatment.
I have had the opportunity to ask questions and receive answers.
I freely and voluntarily assume all risks associated with these therapies to the fullest extent permitted by Australian law.
I understand that this clause is intended to demonstrate my acceptance of the inherent risks of treatment
Voluntary Consent
By signing this form, I confirm that:
I have read and understood this document
My questions have been answered
I understand the nature, risks, benefits, uncertainties and alternatives
I understand that some therapies may involve off-label or unapproved medicines
I may withdraw my consent at any time
I agree to the monitoring, follow-up and safety requirements
I give my informed consent for the above therapies as clinically recommended