1) Purpose & program
I am being evaluated for treatment with a GLP‑1/GIP medicine (tirzepatide; brand examples include Zepbound® for weight management and Mounjaro® for type 2 diabetes). Treatment is combined with nutrition, activity, and lifestyle changes. I understand what the medication is for, how it is given (once‑weekly subcutaneous injection), typical dose escalation, and expected duration. I may decline or stop at any time before the dose is given.
2) Alternatives
Alternatives include FDA‑approved GLP‑1/other weight‑management options as appropriate, lifestyle therapy alone, or no treatment. I may discuss these and ask questions.
3) Major risks & important warnings (summary)
• Boxed warning/contraindication: Do not use if I or a family member has medullary thyroid carcinoma (MTC) or MEN2. Report neck lump, hoarseness, trouble swallowing/breathing.
• Gastrointestinal effects (nausea, vomiting, diarrhea, constipation), sometimes severe; not recommended in severe GI disease/gastroparesis. Report persistent/worsening symptoms.
• Pancreatitis: sudden, severe abdominal pain with/without back pain—stop medication and seek care.
• Gallbladder disease: right‑upper abdominal pain, fever, jaundice—seek evaluation.
• Acute kidney injury from dehydration—maintain fluids; seek care for reduced urination or leg swelling.
• Hypoglycemia if combined with insulin or sulfonylureas—doses of those medicines may need to be lowered; know signs/symptoms.
• Suicidal thoughts/mood changes—report immediately; medication may be stopped.
• Oral meds & birth control: Delayed gastric emptying may affect oral drugs; monitor narrow‑therapeutic‑index meds. Oral hormonal contraceptives can be less reliable after starting or increasing dose—use a non‑oral method or add a barrier for 4 weeks after initiation and after each dose increase.
• Before anesthesia/deep sedation: Tell procedural clinicians I’m on a GLP‑1; rare aspiration events have been reported.
4) Pregnancy & special populations
Tirzepatide may cause fetal harm; I will stop if pregnant or planning pregnancy and will discuss breastfeeding. This therapy is for adults.
5) Medication sources & compounding policy
Our practice primarily uses FDA‑approved products. Compounded tirzepatide will only be considered when medically necessary and not essentially a copy of an FDA‑approved drug, with the patient‑specific clinical difference documented on my prescription (e.g., excipient allergy or a medically necessary nonstandard strength for micro‑dosing). Cost/insurance coverage alone is not a valid reason for a compounded copy. If a compounded product is used, I understand it is not FDA‑approved; while the pharmacy performs quality testing (e.g., potency and sterility), FDA has warned about fraudulent/unsafe GLP‑1 products and dosing errors with compounded versions. I will only use medications dispensed through clinic‑approved, state‑licensed 503A pharmacies or FDA‑registered 503B outsourcing facilities. Our clinic does not prescribe semaglutide.
6) Responsibilities
I agree to: (a) provide complete medical history, medication list, allergies, and requested labs; (b) attend scheduled follow‑ups; (c) follow the dose‑escalation plan exactly and never change dose or frequency without prescriber approval; (d) if using a vial, measure doses exactly as trained; store and handle pen/vial as labeled; (e) report adverse effects immediately, including severe abdominal pain; persistent vomiting/diarrhea/dehydration; signs of gallbladder disease; new neck mass/hoarseness; allergic reaction; very low blood sugar; markedly decreased urination/leg swelling; new/worsening depression or suicidal thoughts; (f) use fiber/hydration or other prescriber‑recommended measures to mitigate constipation, and report constipation lasting more than 5 days or severe GI symptoms for medical review.
7) Benefits & expectations
Benefits may include weight loss, improved metabolic markers, and symptom improvement when combined with diet and activity. Results vary, and no outcome is guaranteed. I understand potential costs, that aesthetic/weight‑management services are not refundable once provided, and that insurance coverage is not accepted.
8) Acknowledgments (mark yes)