Ozempic®

Important Safety Information Regarding Compounded Semaglutide Products

Please be aware that compounded drugs are not FDA-approved and do not undergo clinical studies to evaluate for safety and efficacy, similar to FDA-approved commercially available products. Compounded products may still be legally prescribed, and your healthcare provider may issue you a prescription for compounded semaglutide based on your medical consultation. Semaglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist used for chronic weight management, along with a reduced calorie diet and increased physical activity, for people with an initial body mass index (BMI) of: 30 kg/m2 or greater (obesity) or 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid condition (e.g., hypertension, type 2 diabetes mellitus, or dyslipidemia).

Speak with your healthcare provider to see if semaglutide may be right for you.

Semaglutide may cause serious side effects, including: Possible thyroid tumors, including cancer. Tell your healthcare provider if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. These may be symptoms of thyroid cancer. In studies with rodents, semaglutide caused thyroid tumors, including thyroid cancer. It is not known if semaglutide will cause thyroid tumors or a type of thyroid cancer called medullary thyroid carcinoma (MTC) in humans.

Who should not use semaglutide:

1. Do not use semaglutide if you or any family member has ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC) or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
2. Do not use semaglutide if you have had a serious allergic reaction to semaglutide in the past.
3. Before starting semaglutide, tell your healthcare provider if you have any other medical conditions, including if you:

• Have or have had problems with your pancreas or kidneys.
• Have a history of diabetic retinopathy (an eye problem related to diabetes).
• Are pregnant or plan to become pregnant. Semaglutide should not be used during pregnancy and there may be potential risks to an unborn baby from exposure to semaglutide during pregnancy. You should stop using semaglutide for at least 2 months before you plan to become pregnant.
• Are breastfeeding or plan to breastfeed. It is not known if semaglutide passes into your breast milk.
• Have or have had depression, suicidal thoughts, or mental health issues.

Tell your healthcare provider about all the medicines you take. This includes prescription medications, over-the-counter medicines, vitamins, and herbal supplements. Semaglutide may affect the way some medicines work, and some medicines may affect the way semaglutide works.

1. Serious side effects can occur with semaglutide. You or a caregiver should carefully monitor for these side effects, especially in the beginning of treatment and with dosage changes. Semaglutide may cause serious side effects, including: Thyroid C-Cell Tumors. Tell your healthcare provider if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. These may be symptoms of thyroid cancer. In studies with rodents, semaglutide caused thyroid tumors, including thyroid cancer. It is not known if semaglutide will cause thyroid tumors or a type of thyroid cancer called medullary thyroid carcinoma (MTC) in humans.
2. Paralysis of the stomach (gastroparesis). The symptoms of gastroparesis may include feeling full shortly after starting a meal, feeling full long after eating a meal, nausea, and vomiting. Contact your healthcare provider if you experience any of these symptoms.
3. Inflammation of your pancreas (pancreatitis). Stop using semaglutide and contact your healthcare provider immediately if you have severe pain in your stomach area (abdomen) that will not go away, with or without vomiting.
4. Gallbladder problems. Semaglutide may cause gallbladder problems, including gallstones. Some gallstones may need surgery. Contact your healthcare provider if you have symptoms, such as pain in your upper stomach (abdomen), fever, yellowing of the skin or eyes (jaundice), or clay-colored stools.
5. Increased risk of low blood sugar (hypoglycemia) in patients with type 2 diabetes. Signs and symptoms of low blood sugar may include dizziness or light-headedness, blurred vision, anxiety, irritability or mood changes, sweating, slurred speech, hunger, confusion or drowsiness, shakiness, weakness, headache, fast heartbeat, or feeling jittery. Talk to your healthcare provider about how to recognize and treat low blood sugar and check your blood sugar before you start and while you take semaglutide.
6. Kidney problems (kidney failure). In people who have kidney problems, diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration), which may cause kidney problems to get worse. It is important for you to drink fluids to help reduce your chance of dehydration.
7. Serious allergic reactions. Stop using semaglutide and seek medical attention if you have any symptoms of a serious allergic reaction, including swelling of your face, lips, tongue, or throat; problems breathing or swallowing; severe rash or itching; fainting or feeling dizzy; or very rapid heartbeat.
8. Change in vision in people with type 2 diabetes. Tell your healthcare provider if you have changes in vision with semaglutide.
9. Increased heart rate. Semaglutide may increase your heart rate while you are at rest. Talk to your healthcare provider if you feel your heart racing or pounding.
10. Depression or thoughts of suicide. You should pay attention to any mental changes, especially sudden changes in your mood, behaviors, thoughts, or feelings. Contact your healthcare provider immediately if you have any mental changes that are new, worse, or worry you.

The most common side effects of semaglutide may include: nausea, diarrhea, vomiting, constipation, stomach (abdomen) pain, headache, tiredness (fatigue), upset stomach, dizziness, feeling bloated, belching, gas, stomach flu, heartburn, and runny nose or sore throat.

If you are experiencing a medical emergency, call 911 or seek immediate medical attention. You are encouraged to report negative side effects of prescription products: Contact FDA MedWatch at 1-800-FDA-1088 or visit www.fda.gov/medwatch

Semaglutide administration. Semaglutide can be taken with or without food. The medication is self-administered as a subcutaneous injection in the stomach, thigh, or upper arm once a week on the same day every week. For detailed instructions on how to administer your dose, please speak with your healthcare provider. They will guide you on a treatment regimen and explain to self-administer the medication. You should not change your dosing regimen or stop taking semaglutide as prescribed without first discussing with your healthcare provider.

This information is not comprehensive. Please discuss with your healthcare provider any questions or concerns you have regarding semaglutide.

Important Safety Information Mechanism of Action: Semaglutide is a synthetic glucagon-like peptide-1 (GLP-1) receptor agonist that belongs to a class of drugs called incretin mimetics. Incretins are a type of hormone that stimulate a decrease in blood glucose levels, such as GLP-1 that binds to and activates the GLP-1 receptor. GLP-1 works to regulate ones appetite and caloric intake, and the GLP-1 receptor is present in several areas of your body, including areas in your brain responsible for appetite regulation. Semaglutide, as an agonist, binds to the GLP-1 receptor and works to lower blood glucose by stimulating insulin secretion and to inhibit glucagon release.

Adverse Reactions: Semaglutide is associated with GI adverse reactions, including nausea, diarrhea, vomiting, constipation, abdominal pain, dyspepsia, abdominal distention, eructation, flatulence, gastroenteritis, and gastroesophageal reflux disease. It has also been associated with causing headache, fatigue, dizziness, and hypoglycemia in patients with type 2 diabetes. Please discuss with your physician the contraindications and other warning and precautions before starting Semaglutide.

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