Consent for GLP-1 Treatment

If prescribed, your treatment may be compounded semaglutide (a GLP-1 receptor agonist) or compounded tirzepatide (a GIP and GLP-1 receptor agonist). These medicines act on hormones that regulate appetite and digestion. They slow stomach emptying, increase fullness, and reduce hunger. They are given as a once-weekly injection under the skin. Your Clinician starts with a low dose and may increase it gradually to reduce side effects.

Compounded medications are not FDA-approved. They are prepared by a state-licensed pharmacy for you based on a valid prescription, and have not been evaluated by the FDA for safety, effectiveness, or quality. They are not the same as, and are not generic versions of, FDA-approved Ozempic®, Wegovy®, Mounjaro®, or Zepbound®. Compounded products may differ from approved products in formulation, strength, or inactive ingredients, which are listed on your prescription label.

When combined with a reduced-calorie diet and increased physical activity, GLP-1 medications may help with weight loss and with blood sugar, blood pressure, and cholesterol. Results vary from person to person and are not guaranteed. Some people lose little or no weight. Weight is often regained after the medication is stopped.

Tell your Clinician, and do not take this medication, if any of these apply to you:

• You or a family member have had medullary thyroid carcinoma (MTC), or you have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2);
• You have had a serious allergic reaction to semaglutide, tirzepatide, or any ingredient in the product;
• You are pregnant, may be pregnant, are planning pregnancy, or are breastfeeding.

Also tell your Clinician if you have, or have had: pancreatitis; gallbladder disease; kidney problems; diabetic retinopathy or other eye disease; severe stomach or bowel problems, including gastroparesis; type 1 or type 2 diabetes; depression, suicidal thoughts, or an eating disorder; or upcoming surgery or a procedure requiring anesthesia or sedation.

Common: nausea, vomiting, diarrhea, constipation, stomach pain, indigestion, burping, bloating, decreased appetite, fatigue, headache, dizziness, injection-site reactions, and hair thinning. These are usually mild to moderate and often improve over time or with dose adjustment.

Serious, but less common:

• Possible thyroid tumors, including cancer. In studies in rodents, semaglutide and tirzepatide caused thyroid C-cell tumors. It is not known whether they cause these tumors, including MTC, in humans. Tell your Clinician right away about a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath.
• Pancreatitis: severe stomach pain that may spread to your back, with or without vomiting.
• Gallbladder problems, including gallstones: pain in the upper right stomach, fever, yellowing of the skin or eyes, or clay-colored stools.
• Low blood sugar (hypoglycemia), especially if you also take insulin or a sulfonylurea: shakiness, sweating, confusion, fast heartbeat, dizziness.
• Dehydration and kidney problems, especially with ongoing vomiting or diarrhea. Drink fluids and tell your care team if you cannot keep fluids down.
• Serious allergic reactions: swelling of the face, lips, tongue, or throat; trouble breathing or swallowing; severe rash; fainting.
• Changes in vision, including worsening diabetic retinopathy; sudden vision loss requires immediate care.
• Increased heart rate.
• Depression or suicidal thoughts. Watch for new or worsening mood changes. If you have thoughts of harming yourself, call or text 988 or call 911.
• Slowed stomach emptying and bowel blockage (ileus).
• Risk with anesthesia or sedation. Food may stay in your stomach longer, which can increase the risk of inhaling stomach contents during procedures. Tell every doctor or dentist planning a procedure that you take this medication.
• Loss of muscle mass with rapid weight loss; adequate protein and strength exercise are recommended.

This is not a complete list. Read the information provided with your medication and ask your Clinician about any concerns.

• Do not use these medications if you are pregnant or breastfeeding.
• Stop semaglutide at least 2 months before you plan to become pregnant, and tell your Clinician.
• Tirzepatide may make birth control pills less effective. If you use oral birth control, use a non-oral method or add a barrier method (such as condoms) for 4 weeks after starting tirzepatide and for 4 weeks after each dose increase.
• If you become pregnant during treatment, stop the medication and contact your Clinician.

These medications slow stomach emptying and may change how other oral medicines are absorbed. Tell your Clinician about every medicine and supplement you take, including insulin, sulfonylureas, other diabetes medicines, thyroid medicine, blood thinners, and birth control. Do not take more than one GLP-1 or other prescription weight-loss medication at the same time unless your Clinician approves.

• Check your dose every time. Compounded medication may come in a vial, and the dose may be measured in units on the syringe rather than milligrams. Dosing errors have caused serious side effects. Follow your written dosing instructions exactly, use the syringe provided, and contact your care team if anything is unclear.
• Inject once a week, on the same day, under the skin of the stomach, thigh, or upper arm. Rotate injection sites.
• Do not increase or change your dose unless your Clinician tells you to. If you miss a dose, follow your Clinician's instructions.
• Store medication as directed on the label (usually refrigerated, not frozen). Do not use medication that looks cloudy, discolored, or contains particles unless the label says this is expected.
• Never share needles or medication. Dispose of needles in a sharps container.
• Keep medication out of reach of children. It may not be shipped in child-resistant packaging.

Call 911 or go to the nearest emergency room for: severe stomach pain that does not go away; signs of a serious allergic reaction; trouble breathing; fainting; sudden vision loss; or thoughts of harming yourself.

Contact your care team promptly (care@medirx.org or your patient portal) for: vomiting or diarrhea that lasts more than a day, inability to keep fluids down, signs of low blood sugar, a neck lump or hoarseness, upper-right stomach pain, yellow skin or eyes, or any side effect that worries you.

You may also report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Alternatives include: diet, exercise, and behavioral programs without medication; FDA-approved brand-name medications (such as Wegovy® or Zepbound®), which may be available through your own doctor or pharmacy; other prescription weight-management medications; bariatric surgery or other procedures; and no treatment. You may discuss any of these with your Clinician or your primary care provider.

By checking the box at checkout, I confirm that:

1. I have read this consent and had the opportunity to ask questions, which my care team will answer before I start treatment if I ask.
2. All information I gave is true and complete, and I will update my care team about any change in my health, medications, or pregnancy status.
3. I understand that compounded medications are not FDA-approved and that results are not guaranteed.
4. I understand the risks described above and that other, unknown risks may exist.
5. I will use the medication only as prescribed, only for myself, and will follow the dosing and storage instructions.
6. I will not use another GLP-1 or prescription weight-loss medication at the same time without my Clinician's approval.
7. I will seek emergency care for serious symptoms and contact my care team about side effects.
8. I may stop treatment at any time, and I will tell my Clinician if I do.
9. My Clinician may adjust, pause, or stop my treatment based on my health and safety.