Important Safety Information for Semaglutide (semaglutide) Injection
Warning: Potential Risk of Thyroid C-Cell Tumors
In laboratory studies involving rodents, semaglutide—the active component in Semaglutide and Ozempic—was linked to the development of thyroid tumors, including thyroid cancer. It is unknown whether Semaglutide poses the same risk to humans. If you notice a lump or swelling in your neck, experience hoarseness, difficulty swallowing, or shortness of breath, consult your healthcare provider immediately, as these may be signs of thyroid cancer.
Who Should Not Use Semaglutide?
Avoid using Semaglutide if:
You or a family member have ever been diagnosed with medullary thyroid carcinoma (MTC), a form of thyroid cancer.
You have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2), a disorder affecting the endocrine system.
You have a known allergy to semaglutide (the active ingredient in Semaglutide and Ozempic).
FDA-Approved Uses for Semaglutide
Semaglutide is approved to aid in weight reduction and long-term weight management when combined with a reduced-calorie diet and increased physical activity. It is prescribed for individuals with:
A body mass index (BMI) of 30 kg/m2 or greater (classified as obesity), or
A BMI of 27 kg/m2 or greater (classified as overweight) with at least one related condition such as high blood pressure, type 2 diabetes, or high cholesterol.
Additionally, Semaglutide is used to lower the risk of major cardiovascular events—such as heart attack, stroke, or cardiovascular-related death—in adults who have known heart disease and are classified as overweight or obese.
Limitations of Use
Semaglutide should not be taken alongside other medications containing semaglutide or any other GLP-1 receptor agonists.
Administration Guidelines
Semaglutide is a once-weekly injection that can be administered with or without food.
The pre-filled pen should be injected subcutaneously in the stomach, thigh, or upper arm on the same day each week.
Your MWLCOA-affiliated healthcare provider may adjust your dosage over time.
Never change your dosage or discontinue use without consulting your provider.
What to Discuss with Your MWLCOA Provider
Inform your provider about all medications and supplements you take, including prescription drugs, over-the-counter medications, vitamins, and herbal products. Specific medications that may interact with Semaglutide include:
Diabetes medications, including insulin and sulfonylureas (such as Amaryl or Glucotrol XL)
Other GLP-1 receptor agonists, including Ozempic, Saxenda, Victoza, Byetta, or Bydureon
Weight loss medications and dietary supplements
Share your full medical history, especially if you have a history of:
Type 1 or type 2 diabetes
Thyroid cancer
Pancreatitis
Kidney disease
Diabetic retinopathy
Depression or suicidal thoughts
Pregnancy and Breastfeeding Considerations
Pregnancy: Semaglutide should not be used during pregnancy due to potential risks to the unborn baby. There is no benefit to weight loss during pregnancy, and it may be harmful.
Reproductive Planning: If you are planning to conceive, discontinue Semaglutide at least two months before pregnancy, as the drug remains in the bloodstream for an extended period.
Breastfeeding: Semaglutide has been detected in the milk of lactating rats. Consult your provider before using Semaglutide if you are nursing.
Pregnant individuals exposed to Semaglutide can enroll in a pregnancy exposure registry to monitor potential effects. To participate, contact Novo Nordisk at 1-877-390-2760 or visit http://www.wegovypregnancyregistry.com.
Serious Side Effects to Monitor
Seek immediate medical attention if you experience any of the following:
Thyroid C-Cell Tumors: Watch for lumps, swelling, hoarseness, difficulty swallowing, or shortness of breath.
Pancreatitis: Severe, persistent abdominal pain that may radiate to the back, with or without vomiting.
Gallbladder Issues: Symptoms such as upper stomach pain, yellowing of the skin or eyes, fever, or pale-colored stools may indicate gallbladder disease.
Hypoglycemia (Low Blood Sugar): Symptoms include dizziness, blurred vision, mood changes, sweating, and rapid heartbeat.
Acute Kidney Injury: Dehydration from diarrhea, nausea, or vomiting can worsen kidney conditions. Drink plenty of fluids to stay hydrated.
Severe Allergic Reactions: Seek emergency care if you develop swelling of the face, lips, tongue, or throat, severe rash or itching, rapid heartbeat, breathing difficulty, or dizziness.
Diabetic Retinopathy: Report any changes in vision to your provider.
Increased Heart Rate: Inform your provider if you experience a rapid heartbeat while at rest.
Suicidal Thoughts or Behavior: If you experience changes in mood, behavior, or thoughts of self-harm, seek medical advice immediately.
Pen Sharing Risks: Never share your Semaglutide pen, as this can spread infections.
Common Side Effects
Nausea
Diarrhea
Vomiting
Constipation
Abdominal pain
Headache
Fatigue
Indigestion
Dizziness
Abdominal bloating
Belching
Low blood sugar (in patients with type 2 diabetes)
Flatulence
Gastroenteritis
Acid reflux
Reporting Adverse Effects
If you experience negative side effects, contact:
Novo Nordisk Inc.: 1-833-934-6891
FDA MedWatch: 1-800-FDA-1088 or visit http://www.fda.gov/medwatch
This summary does not cover all safety information. Please consult the full Prescribing Information for complete details.
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