Wegovy (Semaglutide) – Pharmaceutical Product Information

Product Description

Wegovy (Semaglutide) is a prescription medicine containing semaglutide, a glucagon-like peptide-1 (GLP-1) receptor agonist. It is used alongside a reduced-calorie diet and increased physical activity for chronic weight management in eligible patients.

Wegovy works by activating GLP-1 receptors involved in appetite regulation, food intake, blood glucose control, and gastrointestinal function. It is generally administered as a subcutaneous injection once weekly under the supervision of a qualified healthcare professional.

Important: Wegovy and Ozempic contain the same active ingredient, semaglutide, but they have different approved uses, dosing instructions, and product labeling.

What Is Wegovy?

Wegovy is an injectable prescription medicine used for long-term weight management in eligible individuals. It may help reduce appetite and food intake, supporting weight reduction when combined with appropriate dietary and physical activity changes.

Depending on the applicable regulatory approval, Wegovy may also be prescribed to reduce the risk of certain cardiovascular events in eligible adults with cardiovascular disease and overweight or obesity.

Wegovy should only be used under medical supervision and is not intended for self-medication.

Key Product Information

Mechanism of Action

Semaglutide imitates the activity of the naturally occurring GLP-1 hormone. It acts on GLP-1 receptors involved in appetite regulation, food intake, blood glucose management, and gastrointestinal function.

Its effects may include:

1. Appetite regulation: May reduce hunger and food cravings.

2. Reduced food intake: May support a reduction in daily calorie intake.

3. Delayed gastric emptying: Slows the movement of food from the stomach.

4. Blood glucose regulation: Supports glucose-dependent insulin secretion and may reduce glucagon release.

5. Weight management support: Helps eligible patients achieve and maintain weight reduction alongside lifestyle changes.

Treatment response varies between individuals and depends on several factors, including medical history, treatment adherence, and lifestyle.

Medical Uses

Wegovy may be prescribed for:

• Long-term weight management in adults with obesity.

• Weight management in adults with overweight and at least one weight-related medical condition.

• Weight management in eligible adolescents with obesity, according to applicable age and clinical criteria.

• Reducing the risk of certain major cardiovascular events in eligible adults with established cardiovascular disease and overweight or obesity.

• Other approved uses, depending on the country and regulatory authorization.

Wegovy is not intended to treat type 1 diabetes or diabetic ketoacidosis.

Eligibility for Weight Management

Treatment eligibility depends on factors such as body mass index, age, medical history, and associated health conditions.

Healthcare professionals may consider treatment for individuals who meet applicable criteria for obesity or overweight with weight-related medical conditions.

BMI thresholds, age requirements, and approved indications can vary between countries. A qualified healthcare professional should determine whether Wegovy is appropriate.

Potential Benefits

When appropriately prescribed, Wegovy may help with:

• Reduced appetite.

• Reduced calorie intake.

• Clinically meaningful weight reduction.

• Long-term weight maintenance.

• Improvement in certain weight-related health factors.

• Reduced risk of selected cardiovascular events in eligible patients.

• Improvement in certain blood glucose parameters in some individuals.

Results vary based on dosage, treatment duration, lifestyle, medical history, and individual response. Wegovy should not be used without appropriate medical assessment.

Dosage and Administration

Wegovy injection is generally administered subcutaneously once weekly. The dose is gradually increased to help the body adjust and reduce the likelihood of gastrointestinal side effects.

A commonly used U.S. injection titration schedule is:

The maintenance dose and available formulations may vary depending on the country, product, and medical indication.

Administration Precautions

• Use Wegovy exactly as prescribed.

• Inject the medicine into the abdomen, thigh, or upper arm as instructed.

• Administer the injection on the same day each week unless your healthcare professional advises otherwise.

• Do not increase or decrease the dose independently.

• Follow the official instructions for missed doses.

• Do not share injection pens between patients.

• Follow the manufacturer’s storage and handling instructions.

Dosage changes must be made only by a qualified healthcare professional.

Common Side Effects

Common adverse effects may include:

• Nausea

• Vomiting

• Diarrhea

• Constipation

• Abdominal pain

• Bloating

• Indigestion

• Headache

• Fatigue

• Reduced appetite

Gastrointestinal symptoms may be more noticeable during treatment initiation or dose escalation. Contact a healthcare professional if symptoms become severe, persistent, or interfere with food and fluid intake.

Serious Warnings and Risks

1. Thyroid C-Cell Tumors

Semaglutide caused thyroid C-cell tumors in animal studies. It is not known whether this effect occurs in humans.

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

2. Pancreatitis

Pancreatitis has been reported with GLP-1 receptor agonists.

Seek urgent medical attention if severe or persistent abdominal pain occurs, especially if the pain radiates to the back or is accompanied by vomiting.

3. Gallbladder Disease

Gallstones and gallbladder inflammation may occur during treatment.

Contact a healthcare professional if you experience:

• Persistent upper abdominal pain.

• Fever.

• Vomiting.

• Yellowing of the skin or eyes.

• Unusual abdominal tenderness.

4. Acute Kidney Injury

Vomiting and diarrhea can cause dehydration, which may contribute to kidney problems. Medical assessment may be necessary if severe gastrointestinal symptoms develop.

5. Severe Gastrointestinal Reactions

Wegovy may cause gastrointestinal adverse reactions. Patients with severe gastrointestinal disease or gastroparesis should discuss treatment suitability with their healthcare provider.

6. Increased Heart Rate

An increase in resting heart rate may occur in some patients. Inform your healthcare professional if you experience persistent palpitations or a noticeably rapid heartbeat.

7. Serious Allergic Reactions

Serious hypersensitivity reactions, including anaphylaxis and angioedema, have been reported.

Seek emergency medical care if symptoms such as the following develop:

• Difficulty breathing.

• Facial, lip, or throat swelling.

• Severe rash.

• Faintness.

• Sudden dizziness associated with an allergic reaction.

8. Diabetic Retinopathy

Patients with diabetes and a history of diabetic retinopathy may require monitoring. Report new or worsening vision changes to a healthcare professional.

9. Aspiration During Anesthesia

Wegovy may delay gastric emptying and may increase the risk of pulmonary aspiration during general anesthesia or deep sedation.

Inform the surgical and anesthesia team about Wegovy use before a planned procedure.

Drug Interactions

Wegovy may affect the absorption of oral medicines because it can delay gastric emptying.

Inform your healthcare provider if you use:

• Insulin.

• Sulfonylureas.

• Other diabetes medicines.

• Oral medicines with a narrow therapeutic index.

• Other semaglutide-containing products.

• Other GLP-1 receptor agonists.

• Medicines that may increase the risk of dehydration or hypoglycemia.

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

Contraindications and Precautions

Wegovy is contraindicated in individuals 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 the product’s ingredients.

Inform your healthcare provider if you have:

• A history of pancreatitis.

• Diabetic retinopathy.

• Severe gastrointestinal disease.

• Kidney disease.

• Gallbladder problems.

• A planned surgery or procedure involving anesthesia.

• Pregnancy, planned pregnancy, or breastfeeding.

• A history of significant nutritional or eating-related difficulties.

Semaglutide has a prolonged elimination period. Patients planning pregnancy should discuss treatment discontinuation with their healthcare professional. The U.S. product information advises stopping Wegovy at least 2 months before a planned pregnancy.

Storage Information

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

General storage precautions include:

• Keep the medicine within the recommended temperature range.

• Protect it from excessive heat and direct sunlight.

• Do not freeze the medicine.

• Do not use a product that has been frozen or improperly stored.

• Keep the medicine out of children’s reach.

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

• Do not share injection pens between patients.

Always follow the storage requirements supplied with the specific product.

Frequently Asked Questions

1. What is Wegovy used for?

Wegovy is used alongside a reduced-calorie diet and increased physical activity for long-term weight management in eligible patients. It may also be used for certain cardiovascular risk-reduction indications.

2. What is the active ingredient in Wegovy?

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

3. How often is Wegovy administered?

Wegovy injection is generally administered once weekly by subcutaneous injection.

4. Can Wegovy cause nausea?

Yes. Nausea is a commonly reported side effect. Vomiting, diarrhea, constipation, and abdominal discomfort may also occur.

5. Is Wegovy the same as Ozempic?

Both Wegovy and Ozempic contain semaglutide, but they have different approved indications, dosing instructions, and product labeling. They should not be combined unless specifically directed by a healthcare professional.

6. Can Wegovy be used with insulin?

Patients with diabetes may require careful medical monitoring when using medicines that affect blood glucose. Combining Wegovy with insulin or certain other diabetes medicines may increase the risk of hypoglycemia.

7. Who should not use Wegovy?

Individuals with a personal or family history of medullary thyroid carcinoma, MEN 2, or serious hypersensitivity to semaglutide or its ingredients should not use Wegovy. Other medical conditions require individual assessment.

8. Is Wegovy a prescription medicine?

Yes. Wegovy is a prescription medicine and should be used under qualified medical supervision.