Oral Semaglutide

WARNING: RISK OF THYROID C-CELL TUMORS
In animal studies, semaglutide and tirzepatide caused thyroid C-cell tumors. It is not known whether these medications cause thyroid tumors, including a type of thyroid cancer called medullary thyroid carcinoma (MTC), in people. Do not use these medications if you or any of your family members have ever had MTC, or if you have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Tell your provider right away if you develop a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath.

Do not use these medications if you:

• Have a personal or family history of MTC or MEN 2
• Have had a serious allergic reaction to semaglutide, tirzepatide, or any ingredient in the product
• Are pregnant, planning to become pregnant, or breastfeeding

Before starting treatment, tell your provider about all your medical conditions, including if you:

• Have or have had problems with your pancreas or kidneys
• Have or have had gallbladder problems
• Have type 2 diabetes, especially with a history of diabetic retinopathy (eye problems)
• Have severe stomach or digestive problems, including gastroparesis or trouble digesting food
• Have a history of depression, suicidal thoughts, or other mental health conditions
• Are scheduled for surgery or any procedure involving anesthesia or deep sedation
• Take any other medications, including other GLP-1 medicines, insulin or sulfonylureas, oral medications, or oral birth control
• Are pregnant, breastfeeding, or planning either

These medications may cause serious side effects, including:

• Possible thyroid tumors, including cancer (see warning above).
• Inflammation of the pancreas (pancreatitis). Stop use and call your provider for severe stomach-area pain that may spread to your back, with or without vomiting.
• Gallbladder problems, including gallstones — symptoms may include upper-stomach pain, fever, yellowing of the skin or eyes, or clay-colored stools.
• Low blood sugar (hypoglycemia), especially if used with insulin or a sulfonylurea. Symptoms may include dizziness, shakiness, sweating, confusion, or a fast heartbeat.
• Kidney problems (kidney failure). Nausea, vomiting, and diarrhea can cause dehydration, which may worsen kidney function. Stay hydrated.
• Serious allergic reactions. Stop use and get medical help for swelling of the face, lips, tongue, or throat, trouble breathing, severe rash or itching, or a fast heartbeat.
• Stomach and intestinal problems, sometimes severe, including a possible intestinal blockage (ileus).
• Diabetic retinopathy complications in people with type 2 diabetes.
• Food or liquid entering the lungs during surgery or procedures (pulmonary aspiration). Because these medications slow stomach emptying, tell your provider and anesthesia team well before any scheduled surgery or procedure.
• Depression or thoughts of suicide. Tell your provider about any new or worsening mood changes, depression, or suicidal thoughts.

For tirzepatide (Zepbound® and compounded tirzepatide): Tirzepatide may reduce the effectiveness of birth control pills. If you use oral contraceptives, talk to your provider about switching to a non-oral method or adding a barrier method for 4 weeks after you start and for 4 weeks after each dose increase.

Effect on other medications: Because these medications slow stomach emptying, they can affect how your body absorbs medications you take by mouth. Tell your provider about everything you take.

The most common side effects may include nausea, diarrhea, vomiting, constipation, stomach (abdominal) pain, indigestion, burping, fatigue, injection-site reactions, hair loss, and acid reflux. Nausea is most common when starting treatment or increasing your dose and usually lessens over time.

Pregnancy and breastfeeding: These medications may harm an unborn baby, and weight loss is not recommended during pregnancy. Do not use if you are pregnant or trying to become pregnant. Because semaglutide stays in the body for some time, your provider may advise stopping it at least 2 months before a planned pregnancy. Tell your provider right away if you become pregnant. It is not known whether these medications pass into breast milk — discuss breastfeeding with your provider.

About compounded medications: Compounded semaglutide and compounded tirzepatide are prepared by state-licensed compounding pharmacies. They are not FDA-approved, have not been evaluated by the FDA for safety, effectiveness, or quality, and are not generic, equivalent, or interchangeable versions of the branded medications. Because they are formulated using the GLP-1 active ingredients studied in those branded products, the safety considerations described here may apply. Ozempic® and Zepbound® are FDA-approved; compounded products are different from these branded medications.

About microdosing: “Microdosing” refers to using a lower dose than standard protocols. It is not an FDA-approved use or an officially recognized dosing standard. Any dose is determined solely by your licensed provider based on your health and goals.

General:

• These are prescription-only medications and should be used only if prescribed to you by a licensed provider after a medical evaluation. Never share your medication or injection device with another person, even if they have the same symptoms.
• Keep out of reach of children.
• This is not a complete list of side effects or safety information. For complete information, read the Medication Guide and Prescribing Information for the specific product you are prescribed, and talk with your provider or pharmacist.