Important Safety Information

Compounded semaglutide and compounded tirzepatide

Semaglutide is a GLP-1 receptor agonist and tirzepatide is a dual GIP/GLP-1 receptor agonist. Both are prescription injections used, where a licensed clinician decides it is appropriate, alongside a reduced-calorie diet and increased physical activity for weight management.

Compounded semaglutide and tirzepatide are prepared by state-licensed compounding pharmacies. Compounded drugs are not FDA-approved and are not reviewed by the FDA for safety, effectiveness or quality. Treatment requires an online evaluation with an independent licensed healthcare provider, who decides whether it is appropriate for you; not everyone is approved.

Do not use if

• You or a family member have ever 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 of the ingredients.

Before you start

Before starting, tell your clinician if you have or have had pancreatitis (inflammation of the pancreas), kidney, liver or pancreas problems, thyroid tumors, gallbladder problems, diabetic retinopathy, severe stomach or digestion problems, depression or thoughts of suicide, or if you are pregnant, breastfeeding, or planning to become pregnant (these medications should be stopped before a planned pregnancy; your clinician will advise when), or if you are taking insulin, a sulfonylurea, or any other medications. Tirzepatide may make birth control pills less effective; use a non-oral method, or add a barrier method, for 4 weeks after starting and for 4 weeks after each dose increase.

Possible serious side effects

• In studies in rodents, semaglutide and tirzepatide caused thyroid C-cell tumors. It is not known whether they cause thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in people.
• Inflammation of the pancreas (pancreatitis). Stop using and call your clinician right away if you have severe pain in your stomach area that will not go away, with or without vomiting. The pain may be felt from your stomach area to your back.
• Gallbladder problems, including gallstones. Symptoms can include pain in your upper 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. Signs include dizziness, shakiness, sweating, confusion, headache, fast heartbeat and irritability.
• Kidney problems, including kidney failure. Diarrhea, nausea and vomiting can cause dehydration, which may make kidney problems worse. Drink plenty of fluids.
• Serious allergic reactions. Stop using and get medical help right away if you have swelling of the face, lips, tongue or throat, trouble breathing or swallowing, a severe rash or itching, fainting, or a very fast heartbeat.
• Increased heart rate. Tell your clinician if you feel your heart racing or pounding in your chest for several minutes while at rest.
• Changes in vision in people with type 2 diabetes. Tell your clinician if you notice changes in your vision.
• Depression or thoughts of suicide. Pay attention to changes in your mood, behavior, thoughts or feelings, and call your clinician right away if they are new, worse, or worry you.
• Food or liquid getting into the lungs during surgery or procedures that use anesthesia or deep sedation. Tell all your clinicians that you use this medication before any procedure.

Most common side effects

Nausea, vomiting, diarrhea, constipation, indigestion, mild stomach (abdominal) pain, and fatigue. These are usually mild but tell your clinician if they persist or worsen.

This is not a complete list of possible side effects. Call your clinician for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.