Ozempic®

Important Safety Information

Important Safety Information for Ozempic (semaglutide) injection

Caution: Risk of Thyroid C-Cell Tumors

In animal studies involving mice and rats, semaglutide (the active component in Ozempic and Wegovy) was associated with thyroid tumors, including thyroid cancer. It is uncertain whether Ozempic may lead to thyroid tumors or a specific thyroid cancer called medullary thyroid carcinoma (MTC) in humans. If you notice any neck lumps, swelling, hoarseness, difficulty swallowing, or shortness of breath, please inform your healthcare provider. These could be signs of thyroid cancer.

Do not use Ozempic if you or any family member has a history of medullary thyroid carcinoma (MTC) or a condition known as Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).

What is the FDA-approved use of Ozempic?

Ozempic is a glucagon-like peptide-1 (GLP-1) receptor agonist used for:

• Enhancing glycemic control in patients with type 2 diabetes mellitus, alongside diet and exercise.

• Reducing the risk of major cardiovascular events in patients with type 2 diabetes mellitus and established cardiovascular disease.

Limitations of Use:

• Ozempic has not been studied in patients with a history of pancreatitis.

• Ozempic is not intended for treating type 1 diabetes mellitus.

• Your HMR-affiliated provider may suggest Ozempic for chronic weight management (obesity or overweight).

Who should avoid Ozempic?

Do not use Ozempic if:

• You or any family member has a history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).

• You have known allergies to semaglutide (the active ingredient in Wegovy or Ozempic).

How should Ozempic be administered?

Ozempic can be taken with or without food. The pre-filled injector pen is self-administered as a subcutaneous injection in the stomach, thigh, or upper arm once a week on the same day each week.

Your HMR-affiliated provider will guide you on the treatment plan, which may include dose increases every four weeks.

Do not alter your dosing regimen or discontinue Ozempic without consulting your provider first.

What should I inform my HMR-affiliated provider before using Ozempic?

Ozempic can interact with certain medications. It's crucial to disclose all current medications, including prescription, over-the-counter drugs, vitamins, herbal supplements, and dietary supplements to your HMR-affiliated provider.

Some medications to be aware of include:

• Drugs for type 1 or type 2 diabetes, such as insulin or sulfonylureas (e.g., Amaryl or Glucotrol XL).

• Ozempic can delay gastric emptying, potentially affecting the absorption of orally taken medications. Your provider can advise on scheduling your medications.

Additionally, share your complete medical history with your provider, especially if you have a history of:

• Type 1 or type 2 diabetes

• Thyroid cancer

• Pancreatitis

• Kidney disease

• Diabetic retinopathy

• Depression

• Suicidal thoughts or behavior

Notify your provider if you are pregnant, planning to become pregnant, or breastfeeding.

If pregnant: Ozempic should not be used during pregnancy. Animal studies suggest potential risks to the unborn baby from Ozempic exposure during pregnancy. Weight loss during pregnancy is not beneficial and may harm the baby.

If of reproductive potential: Discontinue Ozempic at least two months before planned pregnancy, as the drug may persist in the bloodstream.

If breastfeeding: Ozempic was detected in the milk of lactating rats. Inform your provider if you are breastfeeding before starting Ozempic.

Pregnancy registry: A pregnancy exposure registry monitors outcomes in women exposed to semaglutide (the active ingredient in Ozempic and Ozempic) during pregnancy.

Pregnant women exposed to semaglutide and healthcare providers can contact Novo Nordisk at 1-800-727-6500.

Withholding or providing inaccurate health information to obtain treatment may lead to harm, including death.

What are the most serious side effects to monitor for while taking Ozempic?

If you experience a medical emergency, call 911 or seek immediate medical attention.

Serious side effects associated with Ozempic include:

• Thyroid C-Cell Tumors: While Ozempic's impact on human thyroid C-cell tumors remains uncertain, animal studies revealed an increase in thyroid C-cell tumors, including MTC. Ozempic is contraindicated for patients with a family history of MTC or MEN 2. Notify your provider if you notice neck lumps, swelling, hoarseness, difficulty swallowing, or shortness of breath, as these may indicate thyroid cancer.

• Acute Pancreatitis: Be vigilant for signs of acute pancreatitis, such as persistent severe abdominal pain, possibly radiating to the back, with or without vomiting.

• Diabetic Retinopathy Complications in Patients with Type 2 Diabetes: If you have type 2 diabetes, promptly inform your provider of any changes in vision.

• Never Share a Pen: Sharing Ozempic pens can lead to infections.

• Low Blood Sugar (Hypoglycemia): Ozempic can lower blood glucose, potentially causing low blood sugar in patients with type 2 diabetes using other glucose control medications. Monitor blood sugar levels and watch for signs of low blood sugar, including dizziness, blurred vision, mood changes, sweating, or rapid heartbeat.

• Acute Kidney Injury: In individuals with kidney issues, dehydration from diarrhea, nausea, and vomiting can worsen kidney problems. Ensure adequate hydration to reduce the risk of dehydration.

• Serious Allergic Reactions: Discontinue Ozempic immediately if you experience symptoms of a severe allergic reaction, such as facial swelling, severe rash, rapid heartbeat, breathing difficulties, or fainting.

• Acute Gallbladder Disease: Ozempic may lead to gallbladder problems, including gallstones. Some issues may require surgery. Inform your provider of upper stomach pain, yellowing of skin or eyes (jaundice), fever, or pale stools.

• Increase in Heart Rate: Notify your provider of a rapid resting heart rate.

• Suicidal Behavior and Ideation: Monitor your mental health for sudden changes in mood, behavior, thoughts, or feelings. If you experience new, worsening, or concerning mental changes, contact your healthcare provider promptly.

What are the most common side effects of Ozempic?

Common side effects of Ozempic include:

• Nausea

• Vomiting

• Diarrhea

• Stomach pain

• Constipation

If you experience adverse effects, please report them:

• Contact Novo Nordisk Inc. at 1-833-934-6891

• Contact FDA MedWatch at 1-800-FDA-1088 or visit www.fda.gov/medwatch

This information is not exhaustive. Refer to the full Prescribing Information for complete safety details.