Ozempic (Semaglutide) – Pharmaceutical Product Information

Product Description

Ozempic (Semaglutide) is a prescription medicine containing semaglutide, a glucagon-like peptide-1 (GLP-1) receptor agonist. It is used primarily alongside diet and exercise to improve blood glucose control in eligible adults with type 2 diabetes.

Ozempic works by helping regulate blood glucose, increasing glucose-dependent insulin secretion, reducing glucagon release, and slowing gastric emptying. It may also support weight reduction in some patients.

The medicine is administered as a subcutaneous injection, generally once weekly, under the direction of a qualified healthcare professional.

Key Product Information

What Is Ozempic?

Ozempic is a prescription medication containing semaglutide. It is used together with diet and exercise to improve blood glucose control in adults with type 2 diabetes.

In the current U.S. prescribing information, Ozempic is also indicated for reducing the risk of major cardiovascular events in certain adults with type 2 diabetes and established cardiovascular disease. It is also indicated for reducing specific kidney and cardiovascular risks in eligible adults with type 2 diabetes and chronic kidney disease. Approved indications may vary by country.

Mechanism of Action

Semaglutide mimics the activity of the naturally occurring GLP-1 hormone. It supports blood glucose regulation through several mechanisms:

• Increases insulin secretion when blood glucose levels are elevated.

• Reduces glucagon secretion in a glucose-dependent manner.

• Delays gastric emptying.

• May reduce appetite and food intake.

• Helps improve overall blood glucose control.

Ozempic is not intended for treating type 1 diabetes or diabetic ketoacidosis.

Medical Uses

Ozempic may be prescribed for:

• Improving blood glucose control in adults with type 2 diabetes.

• Supporting diabetes treatment alongside diet and exercise.

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

• Reducing certain kidney and cardiovascular risks in eligible adults with type 2 diabetes and chronic kidney disease, according to the applicable approved label.

Potential Benefits

Under medical supervision, Ozempic may help with:

• Improved blood glucose levels.

• Reduction in HbA1c.

• Improved glucose-dependent insulin response.

• Reduced risk of certain cardiovascular complications in eligible patients.

• Reduced risk of specific kidney-related outcomes in eligible patients.

• Weight reduction in some individuals as an associated treatment effect.

The response to treatment varies, and Ozempic should not be used solely for weight management unless its use is specifically authorized and prescribed for that purpose.

Dosage and Administration

Ozempic is administered by subcutaneous injection once weekly, with or without food.

The U.S. prescribing information specifies the following general adult titration schedule:

The starting dose is used for treatment initiation and is not intended to provide full glycemic control. Dosage changes must be made only by the prescribing healthcare professional.

If a dose is missed, the current U.S. label advises administering it within 5 days of the missed dose. Follow the product-specific instructions provided by your healthcare professional.

Common Side Effects

Common adverse effects may include:

• Nausea

• Vomiting

• Diarrhea

• Constipation

• Abdominal pain

• Reduced appetite

• Indigestion

Gastrointestinal symptoms may occur more frequently when treatment begins or when the dose is increased. Severe or persistent symptoms should be evaluated by a healthcare professional.

Serious Warnings and Risks

1. Thyroid C-Cell Tumors

Semaglutide caused thyroid C-cell tumors in animal studies. It is not known whether Ozempic causes these tumors in humans.

Ozempic is contraindicated in people with a personal or family history of medullary thyroid carcinoma or in people with Multiple Endocrine Neoplasia syndrome type 2.

2. Pancreatitis

Pancreatitis has been reported with GLP-1 receptor agonists. Seek urgent medical attention for severe, persistent abdominal pain, particularly if it radiates to the back or occurs with vomiting.

3. Diabetic Retinopathy Complications

Patients with a history of diabetic retinopathy may require monitoring because diabetic retinopathy complications have been reported. Report new or worsening vision changes promptly.

4. Hypoglycemia

The risk of low blood glucose may increase when Ozempic is used with insulin or insulin secretagogues, such as sulfonylureas.

5. Acute Kidney Injury

Vomiting and diarrhea can cause fluid loss and dehydration, which may contribute to kidney problems. Medical assessment may be needed if severe gastrointestinal symptoms occur.

6. Severe Gastrointestinal Reactions

Ozempic may cause gastrointestinal adverse reactions, including potentially severe symptoms. It is not recommended for patients with severe gastroparesis according to the U.S. prescribing information.

7. Gallbladder Disease

Gallstones and gallbladder inflammation may occur. Seek medical assessment for persistent upper abdominal pain, fever, jaundice, or other concerning symptoms.

8. Serious Allergic Reactions

Serious hypersensitivity reactions, including anaphylaxis and angioedema, have been reported. Emergency medical care is necessary if breathing difficulty, facial swelling, or severe allergic symptoms develop.

9. Surgical and Anesthesia Considerations

Ozempic may delay gastric emptying, and pulmonary aspiration has been reported during general anesthesia or deep sedation. Patients should inform their healthcare team about Ozempic use before planned procedures.

Drug Interactions

Ozempic may interact with certain medicines or affect the absorption of oral medicines because it delays gastric emptying.

Inform your healthcare professional if you use:

• Insulin

• Sulfonylureas

• Other diabetes medicines

• Oral medicines with a narrow therapeutic index

• Other semaglutide-containing products

• Other GLP-1 receptor agonists

Do not combine Ozempic with another semaglutide-containing product or GLP-1 receptor agonist unless specifically instructed by a qualified healthcare professional.

Contraindications and Precautions

Ozempic is contraindicated in patients with:

• A personal or family history of medullary thyroid carcinoma.

• Multiple Endocrine Neoplasia syndrome type 2.

• A serious hypersensitivity reaction to semaglutide or any of its ingredients.

Inform your healthcare provider if you have:

• A history of pancreatitis.

• Diabetic retinopathy.

• Severe gastrointestinal disease or gastroparesis.

• Kidney disease.

• Gallbladder problems.

• A planned surgery or procedure involving anesthesia.

• Pregnancy, planned pregnancy, or breastfeeding.

The U.S. label advises discontinuing Ozempic at least 2 months before a planned pregnancy because semaglutide has a prolonged elimination period.

Storage Information

Store Ozempic according to the manufacturer’s instructions and the product packaging.

General storage precautions include:

• Keep the product within the recommended temperature range.

• Protect it from excessive heat and direct sunlight.

• Do not freeze the medicine.

• Do not use the product if it has been frozen or improperly stored.

• Keep it away from children.

• Do not use the medicine if its appearance does not meet the official product instructions.

• Never share an Ozempic injection pen between patients, even if the needle is changed.

Always follow the storage requirements for the specific product and packaging.

Frequently Asked Questions

1. What is Ozempic used for?

Ozempic is used with diet and exercise to improve blood glucose control in adults with type 2 diabetes.

2. What is the active ingredient in Ozempic?

The active ingredient is semaglutide, a GLP-1 receptor agonist.

3. How often is Ozempic administered?

Ozempic is generally administered once weekly by subcutaneous injection.

4. Can Ozempic cause nausea?

Yes. Nausea is one of the commonly reported side effects. Vomiting, diarrhea, constipation, and abdominal pain may also occur.

5. Is Ozempic a weight-loss medicine?

Ozempic is primarily indicated for specific type 2 diabetes-related uses. Semaglutide products may have separate regulatory approvals for weight management, depending on the product and country.

6. Can Ozempic be used with insulin?

It may be used with insulin in selected patients under medical supervision. Combining these medicines can increase the risk of hypoglycemia.

7. Who should not use Ozempic?

People with a personal or family history of medullary thyroid carcinoma, MEN 2, or serious hypersensitivity to semaglutide or its ingredients should not use Ozempic. A healthcare professional must assess other medical risks.

8. Is Ozempic available without a prescription?

Ozempic is a prescription medicine. Availability and dispensing requirements depend on the laws and regulations of the relevant country.