GLP‑1 / GIP (Semaglutide / Tirzepatide) — Informed Consent (Wegovy/Ozempic + Mounjaro)

INFORMED CONSENT FOR GLP‑1 / GIP THERAPY (SEMAGLUTIDE / TIRZEPATIDE)

§1 PURPOSE, CONTEXT, AND SCOPE

§1.1 This document constitutes an informed consent agreement between the Patient identified herein (the “Patient”) and the Prescribing Physician acting on behalf of the Clinic. It is intended to document that the Patient has received, understood, and accepted comprehensive information regarding the proposed pharmacological use of a GLP‑1 receptor agonist and/or dual GLP‑1/GIP receptor agonist.

§1.3 Health optimization context: The Patient understands that the Clinic operates as a proactive health optimization / longevity practice. The Clinic is not an emergency provider. The Patient is responsible for maintaining an appropriate relationship with a primary care physician and/or relevant specialist(s) for diagnosis and management of disease, acute care, and emergencies.

§1.4 This consent is governed by the laws of Denmark and the European Union, including but not limited to the Danish Health Act (Sundhedsloven) and Regulation (EU) 2016/679 (General Data Protection Regulation).

§1.5 By signing this document, the Patient confirms they have had adequate time to read, consider, and ask questions, and that their questions have been answered to their satisfaction.

§3 MEDICATION, CLASS, AND DESCRIPTION OF TREATMENT

§3.1 GLP‑1 receptor agonists and dual GLP‑1/GIP receptor agonists are medicines that influence appetite regulation, gastric emptying, and metabolic signaling.

§3.3 Examples include (not exhaustive):

  • Semaglutide (Wegovy / Ozempic)
  • Tirzepatide (Mounjaro)

§3.4 The Patient understands that different brand products and dosing schedules exist. Dosing will be individualized and typically titrated gradually to improve tolerability.

§4 REGULATORY STATUS AND OFF‑LABEL USE

§4.1 The Patient understands that the medication prescribed is an industrially manufactured, EMA‑authorised medicine for specific indications.

§4.2 Depending on the Patient’s circumstances and the specific product, use may be within an authorised indication (e.g., weight management or glycaemic control) or may be outside the authorised indication (off‑label). The Patient understands the Prescribing Physician has explained the intended use in this Clinic setting.

§4.3 Health optimization framing: The Patient understands that prescribing primarily for “longevity,” “health optimization,” “metabolic flexibility,” or prevention/risk‑reduction is not itself an EMA‑approved indication, and that clinical outcomes (healthspan/lifespan) cannot be guaranteed.

§5 EXPECTED BENEFITS (NO GUARANTEE)

§5.1 Potential benefits may include:

  • Appetite regulation and improved satiety
  • Weight reduction and improved waist/visceral adiposity markers
  • Improvements in metabolic markers (e.g., glucose, insulin resistance surrogates, lipids) in some individuals
  • Improvements in cardiometabolic risk profile in some individuals

§5.2 The Patient understands that benefits are variable, not guaranteed, and depend on adherence, lifestyle, baseline risk, concurrent medications, and biological variability.

§6 MATERIAL RISKS, SIDE EFFECTS, AND WARNINGS

§6.1 The Patient understands that all medicines carry risks. The following risks are material and may be serious. This list is not exhaustive.

§6.2 Common / expected adverse effects may include:

  • Nausea, vomiting, diarrhea, constipation, abdominal discomfort, bloating
  • Reduced appetite, early satiety
  • Reflux/heartburn
  • Fatigue, headache
  • Injection‑site irritation (if injectable)

§6.3 Dehydration and electrolyte disturbances: Persistent vomiting/diarrhea can cause dehydration, dizziness, fainting, kidney injury, and electrolyte abnormalities. The Patient agrees to maintain hydration and seek care for persistent symptoms.

§6.4 Gallbladder and biliary disease: GLP‑1 based therapies can be associated with gallstones and gallbladder inflammation. The Patient must seek care for right upper abdominal pain, fever, jaundice, or persistent nausea/vomiting.

§6.5 Pancreatitis (rare, potentially serious): The Patient must seek urgent medical care for severe persistent abdominal pain (with or without vomiting).

§6.6 Severe gastrointestinal intolerance / gastroparesis‑like symptoms: These medicines can worsen delayed gastric emptying symptoms. The Patient understands that severe or persistent GI symptoms may require dose reduction or discontinuation.

§6.7 Hypoglycaemia risk in combination therapy: These medicines alone typically have low hypoglycaemia risk; however, risk increases if combined with insulin and/or sulfonylureas or other glucose‑lowering therapies. Medication adjustments may be required.

§6.8 Thyroid C‑cell tumor warning (class warning): The Patient understands that some GLP‑1 receptor agonists carry warnings based on animal studies. The Patient must inform the Clinic of any personal/family history of medullary thyroid carcinoma (MTC) or MEN2, and report neck mass, hoarseness, dysphagia, or persistent throat symptoms.

§6.9 Peri‑procedural / anesthesia risk (important): Because these medicines can slow gastric emptying, there may be increased risk of regurgitation/aspiration during sedation or anesthesia. The Patient agrees to inform any treating clinicians/anesthetists and follow pre‑procedure instructions, including temporary holding of medication when advised.

§6.10 Rare vision event (NAION) — seek urgent care for sudden vision changes: The Patient understands that a very rare condition called non‑arteritic anterior ischaemic optic neuropathy (NAION) (sudden, painless loss of vision or visual‑field defect) has been reported in association with GLP‑1 based therapies in some post‑marketing reports and observational research. A causal relationship has not been definitively established. Nevertheless, because the consequence can be serious, the Patient agrees to stop the medication and seek urgent ophthalmologic/emergency evaluation if they develop sudden vision loss, new blind spots, or other acute visual changes.

§6.11 Allergic reactions: Rare allergic reactions can occur. The Patient must seek urgent care for swelling of face/tongue/throat, difficulty breathing, or widespread rash.

§7 CONTRAINDICATIONS AND PRECAUTIONS

§7.1 The Patient must disclose all relevant medical history including:

  • History of pancreatitis
  • Severe gastrointestinal disease (including severe reflux, suspected gastroparesis)
  • Gallbladder disease
  • Kidney disease or risk of dehydration
  • Personal/family history of MTC or MEN2
  • Eating disorders or significant psychiatric history that may affect adherence/safety

§7.2 The Prescribing Physician may decline to prescribe or may discontinue therapy if safety concerns arise.

§9 MONITORING, FOLLOW‑UP, AND SAFETY COMMUNICATION

§9.1 The Patient agrees to follow‑up as advised, which may include monitoring of weight, symptoms, blood pressure, and selected laboratory markers where appropriate.

§9.2 The Patient agrees to promptly report adverse effects, including persistent vomiting/diarrhea, severe abdominal pain, jaundice, signs of dehydration, or concerning symptoms.

§9.3 The Patient understands that dose changes are individualized and may require pausing, reducing, or discontinuing therapy based on tolerability and safety.

§10 ALTERNATIVES TO TREATMENT

§10.1 Alternatives may include:

  • Lifestyle interventions (nutrition, activity, sleep optimization, alcohol reduction)
  • Other pharmacotherapy where appropriate
  • Specialist referral
  • No pharmacological treatment

§10.2 The Patient understands they may decline treatment or stop treatment at any time.

§12 LIMITATION OF LIABILITY / NO GUARANTEE

§12.1 The Patient understands that medicine is not an exact science and no outcomes can be guaranteed.

§12.2 The Patient understands that adverse effects may occur despite appropriate prescribing and monitoring.

§12.3 Nothing in this consent excludes liability that cannot be excluded under applicable Danish law.

§13 WITHDRAWAL OF CONSENT

§13.1 The Patient may withdraw consent at any time by contacting the Clinic. The Prescribing Physician will provide guidance on safe discontinuation where applicable.

§14 DATA PROTECTION AND RECORDKEEPING

§14.1 The Patient’s personal data and health information will be processed in accordance with GDPR and applicable Danish law.

§14.2 This consent may be retained as part of the Patient’s medical record.

§15 ACKNOWLEDGMENTS AND DECLARATIONS

By consenting, the Patient confirms the following:

  • I have read this consent document in its entirety, or it has been read to me, and I understand its contents.
  • I understand the medication prescribed (the prescribed medication) and the general purpose of GLP‑1/GIP therapy.
  • I understand that benefits are variable and not guaranteed.
  • I understand the material risks, including dehydration, gallbladder disease, pancreatitis (rare), severe GI effects, anesthesia/aspiration considerations, and rare vision events (including NAION).
  • I have disclosed all relevant medical history and current medications to the Clinic.
  • I understand I must seek urgent/emergency care for severe symptoms and that the Clinic is not an emergency service.
  • I have had the opportunity to ask questions and my questions were answered.
  • I voluntarily consent to commence or continue treatment with the prescribed medication under the regimen agreed with my clinician.