Informed Consent for Compounded GLP-1 and GIP/GLP-1 Receptor Agonist Therapy
You are requesting treatment with a compounded GLP-1 receptor agonist or GIP/GLP-1 receptor agonist medication, such as semaglutide, tirzepatide, or liraglutide, as part of a medical weight management or obesity treatment plan. These medications work by mimicking incretin hormones that regulate appetite, slow gastric emptying, promote fullness, and improve metabolic health.
Compounded medications are custom-prepared by licensed pharmacists. These formulations may allow for alternative dosing schedules, titration strategies, dosing frequencies, routes of administration, or the addition of ingredients intended to improve tolerability or reduce side effects. Compounded medications are not reviewed or approved by the U.S. Food and Drug Administration (FDA) and are not subject to the same testing, clinical trials, or manufacturing oversight as FDA-approved brand-name products. As a result, compounded medications may differ from FDA-approved products in consistency, potency, efficacy, and safety.
Weight loss medications are typically prescribed for individuals who are obese, or for individuals who are overweight with related medical conditions. Use of these medications in individuals who are overweight without an associated medical condition is considered off-label, meaning the medication is prescribed in a manner not specifically approved by the FDA. Off-label prescribing is a common and accepted medical practice when clinically appropriate and based on medical judgment.
Potential benefits of treatment may include weight loss or weight management, improved blood glucose control, reduced cardiovascular risk, and overall improvement in metabolic health. While many patients tolerate these medications well, they may cause side effects and, in rare cases, serious adverse events including emergency room visits, hospitalization, or death. Common side effects include nausea, vomiting, diarrhea, constipation, decreased appetite, and indigestion. Serious or less common risks include pancreatitis, low blood sugar, gallbladder disease, kidney injury or worsening kidney function, allergic reactions, and gastrointestinal motility disorders such as gastroparesis.
These medications are not safe for use during pregnancy or while breastfeeding, as they may pose risks to a developing baby. The FDA advises the use of additional contraception because these medications may reduce the effectiveness of oral contraceptives. If you use oral birth control, you must continue it with a barrier method, such as condoms, for the first month after starting treatment and for one month after any dose increase. You may choose to switch to a non-oral contraceptive method, such as an intrauterine device or implant, prior to starting treatment. After stopping the medication, you should continue using effective contraception for at least two months to ensure the medication has fully cleared from your system before attempting to conceive.
Ongoing follow-up is required to monitor your response to treatment and to assess for side effects. Medication doses may be adjusted based on tolerability and clinical response.
I verify that I am the patient and that I have answered the questions asked in this intake form. I confirm that I have reviewed and understood all the questions asked of me. I attest that the answers and information I have provided in this questionnaire is true and complete to the best of my knowledge. I understand that it is critical to my health to share complete health information with my doctor. I will not hold the doctor or affiliated medical practice responsible for any oversights or omissions, whether intentional or not, in the information that I provided.
By proceeding with treatment, you acknowledge that compounded medications are not FDA-approved and may differ from FDA-approved products in safety and effectiveness. You understand the potential benefits, risks, side effects, and pregnancy-related precautions associated with GLP-1 and GIP/GLP-1 receptor agonist therapy, including possible off-label use, and agree to follow prescribed instructions, attend required follow-up, and promptly report any concerns or side effects.
