See Important Safety Information, including Boxed Warning, about:
Last Updated: August, 2024
Important Safety Info for GLP-1s
See Important Safety Information, including Boxed Warning, about:
Important Safety Information for GLP-1 Medications
Wegovy (semaglutide) Injection
See Important Safety Information, including Boxed Warning, below:
Warning: Risk of Thyroid C-Cell Tumors
In animal studies involving mice and rats, semaglutide, the active ingredient in Wegovy and Ozempic, was associated with thyroid tumors, including thyroid cancer. It is unknown whether Wegovy may cause thyroid tumors or medullary thyroid carcinoma (MTC) in humans. If you notice a lump or swelling in your neck, hoarseness, difficulty swallowing, or shortness of breath, contact your healthcare provider immediately as these may be symptoms of thyroid cancer.
Wegovy should not be used if you or any family members have a history of MTC or if you have a condition known as Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
Thyroid C-Cell Tumors
Semaglutide has been shown to cause an increase in thyroid C-cell tumors in mice and rats, including MTC. While it is unknown if Wegovy causes these tumors in humans, cases of MTC have been reported in patients using liraglutide (another GLP-1 medication). Wegovy is contraindicated in patients with a personal or family history of MTC or MEN 2. Report any neck lumps, swelling, hoarseness, trouble swallowing, or shortness of breath to your provider.
FDA-Approved Use of Wegovy
Wegovy is a GLP-1 receptor agonist approved for chronic weight management, to be used alongside a reduced-calorie diet and increased physical activity. It is intended for individuals with an initial body mass index (BMI) of:
- 30 kg/m² or greater (obesity)
- 27 kg/m² or greater (overweight) with at least one weight-related condition (e.g., hypertension, type 2 diabetes, dyslipidemia)
Limitations of Use:
- Wegovy should not be combined with other semaglutide-containing products or GLP-1 receptor agonists.
- The safety and efficacy of combining Wegovy with other weight loss products have not been established.
- Wegovy has not been studied in patients with a history of pancreatitis.
Who Should Not Use Wegovy? Do not use Wegovy if you:
- Have a history of MTC or MEN 2.
- Are allergic to semaglutide or any components of Wegovy.
Administration of Wegovy
Wegovy is administered once weekly via a pre-filled injector pen as a subcutaneous injection into the abdomen, thigh, or upper arm, with or without food. Your provider will guide you on a dosing regimen that may include dose increases every four weeks. Do not change your dosing or stop taking Wegovy without consulting your provider.
Before Using Wegovy, Tell Your Provider:
Wegovy can interact with other medications. Inform your provider about all the medications you are taking, including:
- Medications for type 1 or type 2 diabetes, including insulin or sulfonylureas (e.g., Amaryl, Glucotrol XL)
- Other GLP-1 medications like Ozempic, Saxenda, Victoza, Byetta, or Bydureon
- Weight loss products, including dietary supplements
- Prescription and over-the-counter medications, vitamins, and herbal supplements
Provide a full medical history, including:
- Diabetes (type 1 or type 2)
- Thyroid cancer
- Pancreatitis
- Kidney disease
- Depression
- Diabetic retinopathy
- Suicidal thoughts or behavior
Pregnancy and Breastfeeding:
- Pregnancy: Wegovy should not be used during pregnancy due to potential risks to the unborn baby. Discontinue Wegovy at least 2 months before a planned pregnancy.
- Breastfeeding: Inform your provider if you are breastfeeding. Semaglutide was found in the milk of lactating rats, and its presence in human milk is unknown.
Pregnancy Registry:
A registry monitors pregnancy outcomes in women exposed to semaglutide during pregnancy. Pregnant women and healthcare providers are encouraged to contact Novo Nordisk at 1-800-727-6500.
Serious Side Effects to Monitor: If you experience any of the following, seek immediate medical attention:
- Thyroid C-Cell Tumors: Watch for neck lumps, swelling, hoarseness, difficulty swallowing, or shortness of breath.
- Pancreatitis: Severe abdominal pain that may radiate to the back, with or without vomiting.
- Gallbladder Disease: Upper stomach pain, jaundice, fever, or clay-colored stools.
- Hypoglycemia: Dizziness, blurred vision, mood changes, sweating, or fast heartbeat.
- Acute Kidney Injury: Symptoms of dehydration, such as severe diarrhea, nausea, or vomiting.
- Serious Allergic Reactions: Swelling of the face, lips, tongue, or throat, severe rash, rapid heartbeat, breathing problems, or fainting.
- Diabetic Retinopathy: Changes in vision.
- Increased Heart Rate: Racing heartbeat at rest.
- Suicidal Behavior: Sudden changes in mood, behavior, thoughts, or feelings.
Common Side Effects:
These may include nausea, diarrhea, vomiting, constipation, abdominal pain, headache, fatigue, dyspepsia, dizziness, abdominal distension, eructation, hypoglycemia in patients with type 2 diabetes, flatulence, gastroenteritis, and gastroesophageal reflux disease.
Important Note:
Providing incomplete or inaccurate health information to obtain treatment may result in serious harm, including death in some cases.
Reporting Side Effects:
Contact Novo Nordisk at 1-833-934-6891 or the FDA MedWatch at 1-800-FDA-1088 or visit www.fda.gov/medwatch.