WEGOVY 2.27 mg/mL
semaglutide · INJECTION, SOLUTION · Novo Nordisk Pharmaceutical Industries, LP
WEGOVY is a injection, solution containing semaglutide at 2.27 mg/mL, taken subcutaneous. Manufactured by Novo Nordisk Pharmaceutical Industries, LP.
Key Facts
- Brand Name
- WEGOVY
- Generic Name
- semaglutide
- NDC Code (Product)
0169-1617- Manufacturer
- Novo Nordisk Pharmaceutical Industries, LP
- Strength
- 2.27 mg/mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- SUBCUTANEOUS
- Marketing Status
- Application #
- NDA215256
- Drug Class
- GLP-1 Receptor Agonist [EPC]
- Marketing Start
- 06/05/2021
Recall History
Cardinal Health Inc.
Temperature abuse: Wegovy product was potentially exposed to temperatures outside of the products labeled storage conditions due to a shipping error involving a Cardinal Health distribution center. More specifically, product was removed from refrigerated storage for an extended period of time and inappropriately released.
Novo Nordisk Inc.
Presence of Particulate Matter: Hair was found in a prefilled syringe
Novo Nordisk Inc.
Presence of Particulate Matter: Hair was found in a prefilled syringe
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE WEGOVY injection is indicated in combination with a reduced calorie diet and increased physical activity: • to reduce the risk of major adverse cardiovascular (CV) events (CV death, non-fatal myocardial infarction, or non-fatal stroke) in adults with established CV disease and either obesity or overweight. • to reduce excess body weight and maintain weight reduction long term in: o adults and pediatric patients aged 12 years and older with obesity. o adults with overweight in the presence of at least one weight-related comorbid condition. • for the treatment of noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH), formerly known as nonalcoholic steatohepatitis (NASH), with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis) in adults. This indication is approved under accelerated approval based on improvement of MASH and fibrosis [see Clinical Studies ( 14.4 )] . Continued approval for this indication may be contingent upon the verification and description of clinical benefit in a confirmatory trial. WEGOVY tablets are indicated in combination with a reduced calorie diet and increased physical activity: • to reduce …
Dosage & Administration
2 DOSAGE AND ADMINISTRATION In patients with diabetes, monitor blood glucose prior to starting and during WEGOVY treatment. ( 2.1 ) WEGOVY Injection • Administer WEGOVY injection once weekly as an adjunct to diet and increased physical activity, on the same day each week, at any time of day, with or without meals. ( 2.1 ) • Inject subcutaneously in the abdomen, thigh, or upper arm. ( 2.1 ) • Initiate at 0.25 mg once weekly for 4 weeks. Then follow the dosage escalation schedule in Table 1, titrating every 4 weeks to achieve the maintenance dosage. ( 2.2 ) • The usual recommended maintenance dosage of WEGOVY injection is 2.4 mg once weekly. Refer to the full PI for maintenance dosages based on the indication. ( 2.2 ) WEGOVY Tablets • Take WEGOVY tablets orally once-daily on an empty stomach in the morning with water (up to 4 ounces). Do not take with other liquids besides water. ( 2.1 ) • Swallow tablets whole. Do not split, crush, chew or dissolve. ( 2.1 ) • After taking WEGOVY tablet wait at least 30 minutes before eating food, drinking beverages or taking other oral medications. ( 2.1 ) • Initiate WEGOVY tablet with a dosage of 1.5 mg once daily for 30 days. Then follow the dosag…
Contraindications
4 CONTRAINDICATIONS WEGOVY is contraindicated in the following conditions: • a personal or family history of MTC or in patients with MEN 2 [see Warnings and Precautions ( 5.1 )] . • a prior serious hypersensitivity reaction to semaglutide or to any of the excipients in WEGOVY injection or WEGOVY tablet. Serious hypersensitivity reactions, including anaphylaxis and angioedema, have been reported with WEGOVY [see Warnings and Precautions ( 5.7 )] . • Personal or family history of MTC or in patients with MEN 2. ( 4 ) • Known hypersensitivity to semaglutide or any of the excipients in WEGOVY tablets or WEGOVY injection. ( 4 )
Drug Interactions
7 DRUG INTERACTIONS WEGOVY delays gastric emptying. May impact absorption of concomitantly administered oral medications. Consider increased clinical or laboratory monitoring when used concomitantly with other oral medications that have a narrow therapeutic index or that require clinical monitoring. ( 7.2 ) 7.1 Concomitant Use with Insulin or an Insulin Secretagogue (e.g., Sulfonylurea) WEGOVY lowers blood glucose and can cause hypoglycemia. The risk of hypoglycemia is increased when WEGOVY is used concomitantly with insulin or insulin secretagogues (e.g., sulfonylureas). The addition of WEGOVY in patients treated with insulin has not been evaluated. When initiating WEGOVY, consider reducing the dose of concomitantly administered insulin secretagogue or insulin to reduce the risk of hypoglycemia [see Warnings and Precautions ( 5.4 ), Adverse Reactions ( 6.1 )] . 7.2 Oral Medications WEGOVY causes a delay of gastric emptying and thereby has the potential to impact the absorption of concomitantly administered oral medications. In clinical pharmacology trials with semaglutide 1 mg once weekly injection, semaglutide did not affect the absorption of orally administered medications [see …
Adverse Reactions
6 ADVERSE REACTIONS The following serious adverse reactions are described below or elsewhere in the prescribing information: • Risk of Thyroid C-Cell Tumors [see Warnings and Precautions ( 5.1 )] • Acute Pancreatitis [see Warnings and Precautions ( 5.2 )] • Acute Gallbladder Disease [see Warnings and Precautions ( 5.3 )] • Hypoglycemia [see Warnings and Precautions ( 5.4 )] • Acute Kidney Injury Due to Volume Depletion [see Warnings and Precautions ( 5.5 )] • Severe Gastrointestinal Adverse Reactions [see Warnings and Precautions ( 5.6 )] • Hypersensitivity Reactions [see Warnings and Precautions ( 5.7 )] • Diabetic Retinopathy Complications in Patients with Type 2 Diabetes [see Warnings and Precautions ( 5.8 )] • Heart Rate Increase [see Warnings and Precautions ( 5.9 )] • Pulmonary Aspiration During General Anesthesia or Deep Sedation [see Warnings and Precautions ( 5.10 )] Most common adverse reactions (incidence ≥5%) in adults or pediatric patients aged 12 years and older are: nausea, diarrhea, vomiting, constipation, abdominal pain, dysesthesia, headache, fatigue, dyspepsia, dizziness, abdominal distension, eructation, hypoglycemia in patients with type 2 diabetes, flatulence,…
Frequently Asked Questions
What is WEGOVY used for?
WEGOVY contains semaglutide. It is a injection, solution taken subcutaneous. Consult your doctor for specific uses.
Is WEGOVY a controlled substance?
WEGOVY is not classified as a controlled substance by the DEA.
What is the generic name for WEGOVY?
The generic name for WEGOVY is semaglutide. There are 4 other brand versions of semaglutide.
What is the NDC code for WEGOVY 2.27 mg/mL?
The NDC (National Drug Code) for WEGOVY 2.27 mg/mL is 0169-1617, listed by Novo Nordisk Pharmaceutical Industries, LP.