Practice & Clinical Information

Patient Identification

1. Purpose, Scope & Voluntary Election — FDA-Approved GLP-1 Receptor Agonist Therapy

I, the undersigned patient, am voluntarily electing to receive an FDA-approved GLP-1 receptor agonist medication as part of an individualized clinical program designed by my treating provider. The medication will be dispensed through a licensed pharmacy in accordance with my prescription.

I understand the medication may be prescribed for an FDA-approved indication (e.g., type 2 diabetes mellitus, chronic weight management in eligible patients, cardiovascular risk reduction in select products) or for an off-label indication recognized by the practice of medicine. My provider has discussed which indication applies to me.

2. Regulatory Status, FDA-Approved Indications & Off-Label Use

I understand and acknowledge:

Initials ______ The medication I am receiving is an FDA-approved drug product for one or more specific indications. I have been informed of the indication for which my prescription is being written.

Initials ______ If my prescription is being written for an off-label indication (an indication other than the one approved by the FDA for this drug), I understand that off-label prescribing is a lawful and recognized component of the practice of medicine but does not carry FDA endorsement for that specific use.

Initials ______ FDA-approved drugs carry product labeling that includes Boxed Warnings, contraindications, warnings and precautions, adverse reactions, and dosing information. I have received or have been offered the official Medication Guide for my specific product, and I have been encouraged to read it.

Initials ______ This medication is being dispensed through a licensed pharmacy. Refills, dose escalations, and interruptions in supply may occur due to manufacturer back-orders or insurance authorization decisions; I will work with my provider and pharmacy on continuity of therapy.

Initials ______ This consent is companion to — not a substitute for — the FDA Medication Guide and the prescribing information distributed with the product.

3. Boxed Warnings & Major Safety Disclosures

Initials ______ I confirm I have no personal or family history of MTC or MEN-2.

3.1 Pancreatitis

Acute pancreatitis, including fatal cases, has been reported in patients on GLP-1 receptor agonists. I will discontinue the medication and seek immediate medical attention for severe, persistent abdominal pain (with or without vomiting), particularly pain that radiates to the back.

Initials ______ I understand the pancreatitis warning and the symptoms that require immediate evaluation.

3.2 Acute Kidney Injury

Acute kidney injury, sometimes requiring dialysis, has occurred — usually in the setting of nausea, vomiting, diarrhea, and dehydration. I will maintain adequate hydration and report persistent GI symptoms or decreased urine output.

Initials ______ I understand the kidney injury warning and the importance of hydration.

3.3 Diabetic Retinopathy Complications (Semaglutide)

Patients with type 2 diabetes and a history of diabetic retinopathy may experience worsening of retinopathy, particularly with rapid improvement in glucose control. I will continue routine eye examinations as advised.

Initials ______ I understand the retinopathy warning and will continue eye-care follow-up as directed.

3.4 Hypoglycemia

GLP-1 receptor agonists by themselves carry low intrinsic hypoglycemia risk. The risk increases significantly when used with insulin, sulfonylureas, or other glucose-lowering agents. My provider may adjust those concurrent medications.

Initials ______ I understand the hypoglycemia risk and will monitor glucose if I am also taking insulin or a sulfonylurea.

3.5 Severe Gastrointestinal Disease

Severe GI adverse reactions have been reported, including ileus and gastroparesis. Patients with pre-existing severe gastroparesis or significant GI motility disorders are not appropriate candidates.

Initials ______ I understand the severe GI disease warning.

3.6 Gallbladder Disease

Cholelithiasis and cholecystitis have been reported, particularly during rapid weight loss. I will report right-upper-quadrant pain, fever, or jaundice promptly.

3.7 Suicidal Behavior and Ideation

Post-marketing reports have prompted regulatory review of possible suicidal ideation in patients on GLP-1 receptor agonists. I will report new or worsening depression, mood changes, or thoughts of self-harm to my provider immediately and use 988 or the nearest emergency department for active suicidal thoughts.

Initials ______ I understand the suicidal-ideation safety signal and the escalation pathway.

3.8 Pregnancy & Reproductive Considerations

GLP-1 receptor agonists are not recommended during pregnancy. A washout period before attempting conception is typically advised — semaglutide is generally discontinued at least 2 months before a planned pregnancy due to its long half-life. Patients of reproductive potential should discuss reliable contraception with their provider before initiating therapy. Patients on combined oral contraceptives should be aware that significant GI effects may reduce contraceptive efficacy; barrier or non-oral contraception may be advised.

Initials ______ I understand the pregnancy considerations, washout requirement, and contraceptive guidance.

4. Surgery, Anesthesia & Procedural Considerations

Initials ______ I will inform every clinician who treats me — including surgeons, anesthesiologists, dentists, gastroenterologists, urgent-care providers, and emergency-department staff — that I am taking an FDA-approved GLP-1 receptor agonist.

Initials ______ I will notify the practice in advance of any planned procedure so a hold strategy can be developed.

5. Patient Health Disclosure & Eligibility Screening

I have truthfully disclosed each of the following to my provider, and I will report any change:

Eligibility Notes (Provider-Completed)

Initials ______ I have completed the disclosures above truthfully and will notify the practice of any changes.

6. Administration, Dose Escalation, Storage & Pen Handling

6.1 Pre-Filled Pen Devices

FDA-approved injectable GLP-1 receptor agonists are typically supplied in pre-filled pen-injector devices. These devices have specific instructions for activation, needle attachment, dose-dial selection, injection technique, and disposal. The Manufacturer Instructions for Use included with the device are the authoritative reference for handling, and patients should review them at every refill in case of changes.

• Use a NEW pen-needle for each injection; never re-use a needle.

• Inspect the medication for clarity and absence of particles before each use; discard if cloudy or discolored.

• Rotate injection sites — typical sites are abdomen (avoid 2 inches around navel), upper outer thigh, or upper outer arm.

• Hold the pen in place for the full count specified by the manufacturer (commonly 6–10 seconds) after pressing the dose button to ensure complete delivery.

• Dispose of pen-needles immediately into an FDA-cleared sharps container; do not place sharps in household trash or recycling.

• Discard the pen device per the manufacturer's beyond-use guidance (e.g., many products are discarded 28–56 days after first use, even if medication remains).

6.2 Oral Semaglutide (Rybelsus®) — Special Administration

• Take in the morning on an empty stomach with no more than 4 ounces of plain water — at least 30 minutes before the first food, beverage, or other oral medication of the day.

• Swallow the tablet whole — do not split, crush, or chew.

• Other oral medications taken too close to the dose may have altered absorption.

6.3 Dose Escalation

FDA-approved GLP-1 receptor agonists are typically initiated at a low dose and titrated upward over weeks to months to reduce GI side effects. I will follow the escalation schedule provided by my provider and will not advance my dose ahead of schedule.

Initials ______ I will follow the dose-escalation schedule exactly as written by my provider.

Initials ______ I will not double a missed dose; I will follow the manufacturer's missed-dose guidance for my specific product or contact the practice.

6.4 Storage

7. Common Adverse Effects, Tolerability & What to Expect

7.1 Most Common Adverse Effects (Especially During Initiation and Dose Escalation)

• Nausea — particularly with the first dose at each new strength

• Vomiting

• Diarrhea or constipation

• Abdominal pain or dyspepsia

• Decreased appetite (a therapeutic effect, but can be excessive)

• Injection-site reactions — pain, redness, itching, or small nodule

• Headache

• Fatigue

• Dizziness

7.2 Tolerability Strategies

• Eat smaller, more frequent meals.

• Avoid large, high-fat, or greasy meals.

• Stop eating when full — do not push past satiety.

• Maintain hydration with water and electrolytes.

• Maintain adequate protein intake to preserve lean mass.

• Consider a brief dose-hold or extended titration interval if GI effects are intolerable; coordinate with your provider before adjusting.

7.3 Less Common but Important Effects (Contact Provider)

• Persistent vomiting, dehydration, or inability to keep fluids down

• Significant weight loss exceeding the planned trajectory

• Loss of lean body mass or muscle weakness

• Hair shedding (often related to rapid weight loss; usually self-limited)

• Mood changes, sleep changes, or new psychiatric symptoms

• Persistent constipation requiring intervention

• Gallbladder symptoms (RUQ pain, fever, jaundice)

• Eye changes, especially in patients with diabetic retinopathy

• Cardiovascular symptoms — palpitations, chest discomfort

8. Voluntary Election, Acknowledgments & Signatures

Please initial each statement to confirm your understanding:

Initials ______ I have read this FDA-Approved GLP-1 Receptor Agonist Consent in its entirety or had it read to me, and the language used is one I understand.

Initials ______ I have had the opportunity to ask questions, and my questions have been answered to my satisfaction.

Initials ______ I understand my prescription is for an FDA-approved branded or generic GLP-1 receptor agonist, dispensed through a licensed pharmacy.

Initials ______ I understand and accept the Boxed Warnings and major safety disclosures, including thyroid C-cell tumor risk, pancreatitis, acute kidney injury, retinopathy, hypoglycemia (when combined with insulin or sulfonylureas), severe GI events, gallbladder disease, suicidal behavior signal, and pregnancy considerations.

Initials ______ I understand the surgical / anesthesia consideration and will notify all procedural teams in advance.

Initials ______ I will follow only the dose-escalation, administration, and missed-dose instructions provided by my treating provider and the FDA Medication Guide.

Initials ______ I will report adverse effects promptly and seek emergency care for red-flag symptoms.

Initials ______ I am 18 years of age or older (or the age of consent for this product per labeling) and competent to give informed consent.

Initials ______ My election to use this medication is voluntary, and I assume the risks set out in this document and the FDA-approved labeling.

Patient — by signing below, I confirm I have read, understood, and voluntarily agreed to all terms of this FDA-Approved GLP-1 Receptor Agonist Therapy Consent.

Provider — by signing below, I confirm that the patient was screened for contraindications and Boxed Warning conditions, was determined an appropriate candidate per FDA-approved or recognized off-label indication, was provided the FDA Medication Guide for the specific product, was instructed in pen-device or oral administration as appropriate, and had questions answered.