Warning: Risk of Thyroid C-Cell Tumors

Studies in rodents have shown that semaglutide can lead to thyroid tumors, including thyroid cancer. It is unknown if semaglutide can cause thyroid tumors or medullary thyroid carcinoma (MTC) in humans. Notify your healthcare provider if you experience symptoms such as a new lump or swelling in your neck, hoarseness, difficulty swallowing, or shortness of breath, as these could indicate thyroid cancer.

Who Should Avoid Using Semaglutide

Do not use semaglutide if you or your family members have a history of medullary thyroid carcinoma (MTC) or if you have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Additionally, avoid compounded semaglutide if you have had a previous allergic reaction to a semaglutide product.

Semaglutide should not be used during pregnancy or breastfeeding, due to potential fetal harm. Discontinue semaglutide at least two months before planning to conceive.

Semaglutide should not be used with other products containing semaglutide or any other GLP-1 receptor agonists, and it has not been studied in patients with a history of pancreatitis.

Uses of Semaglutide

Compounded semaglutide is legally permitted under federal law but has not been FDA-approved and does not undergo review for safety, effectiveness, or manufacturing standards.

Semaglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist prescribed for weight management (in conjunction with a reduced calorie diet and exercise) in adults with a body mass index (BMI) of:

• 30 kg/m2 or more (obesity)

• 27 kg/m2 or more (overweight) with at least one weight-related medical condition (such as high blood pressure, type 2 diabetes mellitus, or high cholesterol)

Healthcare providers may prescribe specific doses of compounded semaglutide based on your medical assessment.

Before using Semaglutide, tell your healthcare provider about

All of your medical conditions. Provide your complete medical history, particularly if you are pregnant or planning to become pregnant, are breastfeeding or planning to breastfeed, have any planned surgeries or procedures, or if you have a history of diabetes, thyroid cancer, pancreatitis, ileus, kidney disease, gallstones, diabetic eye disease, depression, or suicidal thoughts.

All medications you are taking. Semaglutide causes a delay in stomach emptying, which can impact the absorption of some medications in the stomach. Inform your healthcare provider about all prescriptions, over-the-counter medications, vitamins, and herbal supplements you take, especially any diabetes treatments such as insulin or sulfonylureas.

Semaglutide may cause serious side effects, including:

• Potential thyroid tumors, including cancer. Notify your healthcare provider if you notice a new lump or swelling in your neck, experience hoarseness, difficulty swallowing, or shortness of breath. These symptoms may indicate thyroid cancer.

• Inflammation of the pancreas (acute pancreatitis). Stop using semaglutide and contact your healthcare provider immediately if you experience severe, persistent abdominal pain with or without vomiting, often radiating to the back.

• Serious allergic reactions. Stop semaglutide use immediately and seek medical assistance if you experience symptoms like swelling of the face, lips, tongue, or throat; shortness of breath, wheezing or swallowing difficulties; severe rash or itching; fainting or dizziness; or rapid resting heartbeat.

• Kidney problems (kidney failure). In individuals with existing kidney issues, dehydration from diarrhea, nausea, or vomiting may worsen kidney function. It is extremely important to maintain adequate fluid intake to reduce dehydration risk.

• Gallbladder problems. Some individuals using semaglutide have reported gallbladder issues, including gallstones, which may require surgery. Notify your healthcare provider right away if you experience symptoms such as upper abdominal pain, fever, yellowing of the skin or eyes, or pale-colored stools.

• Vision changes. Notify your healthcare provider if you notice changes in your vision while using semaglutide, particularly if you have type 2 diabetes.

• Low blood sugar (hypoglycemia). Your risk of hypoglycemia may increase if you use semaglutide with other medications that lower blood sugar, such as sulfonylureas or insulin. Symptoms may include dizziness, blurred vision, anxiety, sweating, confusion, shakiness, weakness, headache, rapid heartbeat, and jitteriness.

• Suicidal thoughts or behavior. Notify your healthcare provider if you experience sudden changes in your mental health or suicidal thoughts.

• Infection. Do not reuse needles or share your prescription medication or multi dose vial with others, even when using a different needle for injection and following proper injection technique. Doing so could lead to serious infections.

• Food or liquid getting to the lungs during surgery. Notify your healthcare provider that you are taking compounded semaglutide before you are scheduled to have surgery or other procedures.

Common side effects of semaglutide may include nausea, diarrhea, vomiting, constipation, abdominal pain, headache, fatigue, upset stomach, heartburn, bloating, gas, belching, dizziness, and low blood sugar (specifically in people with type 2 diabetes).

If you experience side effects from prescription medications, please report them to FDA MedWatch at 1-800-FDA-1088 or visit www.fda.gov/medwatch.

Wegovy® and Ozempic® are registered trademarks of Novo Nordisk A/S. Novo Nordisk is a registered trademark of Novo Nordisk A/S.