Wegovy Prescribing Information, Explained Section by Section
The Wegovy label carries a boxed warning for thyroid c-cell tumors, 10 other warnings and 3 drug interaction lines. It is approved for 4 uses.
- Boxed warning
- Thyroid C-cell tumors
- Approved uses
- 4
- Warnings
- 10
- First approved
- 2021
Wegovy in brief
Its half-life is about 1 week: after 7 d, half is gone, and after five half-lives (35 d) about 3% is left.
In STEP 1 over 68 weeks, 14.9% of body weight came off, against 2.4% on placebo.
Monthly prices in US dollars, covering list price and self-pay offers, with each figure read from the maker's price page.
Sources: FDA label (DailyMed), healthsystemtracker.org, prnewswire.com 1 2.
The Wegovy boxed warning
Boxed warning: this drug caused thyroid C-cell tumors in rodents, and whether it causes them in people is not known. Do not use it if you have a history of medullary thyroid cancer (MTC) yourself or in your family. It is also not for people with MEN 2.
Words from the label
“In rodents, semaglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures. It is unknown whether WEGOVY causes thyroid C-cell tumors, including medullary”
Source: FDA label on DailyMed.
Indications
In adults with heart disease plus obesity or overweight, it lowers the risk of heart attack, stroke, or heart-related death (injection and tablets).
Words from the label
“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”
Source: FDA label on DailyMed.
This supports weight loss and long-term maintenance with diet and activity for adults and for children 12 and older who have obesity. It also applies to adults who have overweight and a weight-related condition.
Words from the label
“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”
Source: FDA label on DailyMed.
For adults, it treats MASH liver disease with no cirrhosis and moderate to advanced scarring (injection).
Words from the label
“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”
Source: FDA label on DailyMed.
The tablets are approved for weight loss and heart-risk reduction in adults.
Words from the label
“WEGOVY tablets are indicated in combination with a reduced calorie diet and increased physical activity:”
Source: FDA label on DailyMed.
Contraindications
Medullary thyroid cancer (MTC) in your own history or in a family member's, or MEN 2.
Words from the label
“personal or family history of MTC or in patients with MEN 2”
Source: FDA label on DailyMed.
A past serious allergic reaction to semaglutide or any ingredient in the product.
Words from the label
“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”
Source: FDA label on DailyMed.
Warnings and precautions
Thyroid C-cell tumors. Thyroid C-cell tumors were caused by it in rodents. Do not use it if you have had medullary thyroid cancer (MTC) or if a family member has. It is also not for people with MEN 2.
Words from the label
“In mice and rats, semaglutide caused a dose-dependent and treatment-duration-dependent increase in the incidence of thyroid C-cell tumors (adenomas and carcinomas) after lifetime exposure at”
Source: FDA label on DailyMed.
Pancreatitis. It can inflame the pancreas. Severe stomach pain that does not stop and sometimes reaches your back: stop taking it and seek care.
Words from the label
“Acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis, has been observed in patients treated with GLP-1 receptor agonists, including WEGOVY [see Adverse Reactions”
Source: FDA label on DailyMed.
Gallbladder disease. You may develop gallstones and inflammation of the gallbladder. Report belly pain in the upper right area, fever, or yellowing of the skin or eyes.
Words from the label
“Treatment with WEGOVY is associated with an increased occurrence of cholelithiasis and cholecystitis. The incidence of cholelithiasis and cholecystitis was higher in WEGOVY injection-treated pediatric”
Source: FDA label on DailyMed.
Low blood sugar. Combining it with insulin or a sulfonylurea raises the chance of low blood sugar, so those doses may need lowering.
Words from the label
“WEGOVY lowers blood glucose and can cause hypoglycemia.”
Source: FDA label on DailyMed.
Kidney injury from fluid loss. Fluid loss from vomiting or diarrhea can injure your kidneys. Report large amounts of fluid loss, and drink fluids.
Words from the label
“There have been postmarketing reports of acute kidney injury, in some cases requiring hemodialysis, in patients treated with semaglutide [see Adverse Reactions ( 6)]. The”
Source: FDA label on DailyMed.
Severe stomach and gut reactions. Stomach and gut side effects are common, and they can also be severe. People with severe gastroparesis are not advised to use this medicine.
Words from the label
“Use of WEGOVY has been associated with gastrointestinal adverse reactions, sometimes severe [see Adverse Reactions (6)]. In clinical trials for adults for weight reduction, severe”
Source: FDA label on DailyMed.
Serious allergic reactions. Reports list serious allergic reactions, including swelling affecting the face, lips or throat. If these problems happen, stop taking it and get help right away.
Words from the label
“Serious hypersensitivity reactions (e.g., anaphylaxis, angioedema) have been reported with WEGOVY. If hypersensitivity reactions occur, discontinue use of WEGOVY, treat promptly per standard of care,”
Source: FDA label on DailyMed.
Diabetic eye disease can get worse. People with type 2 diabetes may see diabetic eye disease worsen, especially when blood sugar falls fast. Eye checks matter if you already have it.
Words from the label
“In a 2-year trial with semaglutide 0.5 mg and 1 mg once-weekly injection in adult patients with type 2 diabetes and high CV risk, diabetic”
Source: FDA label on DailyMed.
Faster heart rate. Can raise resting heart rate. Let your doctor know if your heart races or pounds while you are at rest.
Words from the label
“Treatment with WEGOVY was associated with increases in resting heart rate. Mean increases in resting heart rate of 1 to 4 beats per minute (bpm)”
Source: FDA label on DailyMed.
Food in the lungs during anesthesia or sedation. Food may stay in your stomach longer, which matters if you receive anesthesia or deep sedation. Tell your care team before you have any procedure.
Words from the label
“WEGOVY delays gastric emptying [see Clinical Pharmacology ( 12.2 )] . There have been rare postmarketing reports of pulmonary aspiration in patients receiving GLP-1 receptor”
Source: FDA label on DailyMed.
Source: FDA label on DailyMed.
Adverse reactions table
For each dose group, the table lists side effects that occurred most often in the label trials, with placebo results beside them.
| Side effect | Placebo | Wegovy 2.4 mg | More than placebo |
|---|---|---|---|
| Nausea | 16% | 44% | +28 points |
| Diarrhea | 16% | 30% | +14 points |
| Vomiting | 6% | 24% | +18 points |
| Constipation | 11% | 24% | +13 points |
| Abdominal Pain | 10% | 20% | +10 points |
| Headache | 10% | 14% | +4 points |
| Fatigue | 5% | 11% | +6 points |
| Dyspepsia | 3% | 9% | +6 points |
| Dizziness | 4% | 8% | +4 points |
| Abdominal Distension | 5% | 7% | +2 points |
| Eructation | Not reported | 7% | – |
| Hypoglycemia in T2DM | 2% | 6% | +4 points |
Source: Wegovy label (DailyMed).
Drug interactions
"Using it with insulin or a sulfonylurea such as glipizide or glimepiride raises the risk of low blood sugar. The doctor may lower those doses."
Words from the label
“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”
Source: FDA label on DailyMed.
It delays stomach emptying, and this can affect how your body absorbs other pills.
Words from the label
“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”
Source: FDA label on DailyMed.
One study found that Semaglutide tablets increased levothyroxine levels, so your thyroid levels may need to be checked.
Words from the label
“In a drug interaction study with the semaglutide tablet, levothyroxine exposure was increased 33% (90% CI: 1.25-1.42). Monitor the effects of oral medications concomitantly administered”
Source: FDA label on DailyMed.
Pregnancy and breastfeeding
During pregnancy, weight loss offers no benefit and may harm the baby. Stop taking it if you are pregnant, and at least 2 months before you try to conceive.
Words from the label
“Because of the potential for fetal harm, discontinue WEGOVY in patients at least 2 months before they plan to become pregnant to account for the”
Source: FDA label on DailyMed.
SNAC is in the tablets and is also found in breast milk. For the injection, it is not known whether it passes into breast milk.
Words from the label
“However, SNAC and/or its metabolites are present in human milk. Since the activity of enzymes involved in SNAC clearance may be lower in infants compared”
Source: FDA label on DailyMed.
Storage and patient counselling
Store pens in the fridge; if needed, they can stay out for up to 28 days. Keep tablets in the original bottle at room temperature.
Words from the label
“the pen can be kept from 8°C to 30°C (46°F to 86°F) up to 28”
Source: FDA label on DailyMed.
How other GLP-1 labels compare with this label
| Label | Boxed warning | Warnings | Interaction lines | Named beyond insulin and pills |
|---|---|---|---|---|
 Ozempic | Yes | 9 | 2 | Not listed |
| Wegovy | Yes | 10 | 3 | Levothyroxine |
 Rybelsus | Yes | 9 | 3 | Levothyroxine |
 Mounjaro | Yes | 9 | 4 | Birth control pills, Warfarin and narrow-range drugs |
 Zepbound | Yes | 9 | 4 | Birth control pills, Warfarin and narrow-range drugs |
 Foundayo | Yes | 9 | 6 | Birth control pills, Simvastatin, Strong CYP3A4 inhibitors, Strong CYP3A4 inducers |
 Trulicity | Yes | 9 | 3 | Warfarin and narrow-range drugs |
 Saxenda | Yes | 9 | 2 | Not listed |
 Victoza | Yes | 8 | 2 | Not listed |
| Byetta | No | 9 | 4 | Warfarin and narrow-range drugs, Birth control pills and antibiotics |
Label sources: Ozempic label (DailyMed), Wegovy label (DailyMed), Rybelsus label (DailyMed), Mounjaro label (DailyMed), Zepbound label (DailyMed), Foundayo label (DailyMed), Trulicity label (DailyMed), Saxenda label (DailyMed), Victoza label (DailyMed), Byetta label (DailyMed).
Read the full Wegovy label
The complete prescribing information is available at DailyMed, the National Library of Medicine label site.