Semaglutide (Wegovy)
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Boxed warning
WARNING: RISK OF THYROID C-CELL TUMORS • 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 thyroid carcinoma (MTC), in humans as human relevance of semaglutide-induced rodent thyroid C-cell tumors has not been determined [see Warnings and Precautions ( 5.1 ), Nonclinical Toxicology ( 13.1 )] . • WEGOVY is contraindicated in patients with a personal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) [see Contraindications ( 4 )] .
Counsel patients regarding the potential risk for MTC with the use of WEGOVY and inform them of symptoms of thyroid tumors (e.g., a mass in the neck, dysphagia, dyspnea, persistent hoarseness). Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with WEGOVY [see Contraindications ( 4 ), Warnings and Precautions ( 5.1 )] . WARNING: RISK OF THYROID C-CELL TUMORS See full prescribing information for complete boxed warning. • In rodents, semaglutide causes thyroid C-cell tumors at clinically relevant exposures.
It is unknown whether WEGOVY causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans as the human relevance of semaglutide-induced rodent thyroid C-cell tumors has not been determined. ( 5.1 , 13.1 ) • WEGOVY is contraindicated in patients with a personal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Counsel patients regarding the potential risk of MTC and symptoms of thyroid tumors. ( 4 , 5.1 )
Dosing in kidney impairment
Acute Kidney Injury Due to Volume Depletion : Monitor renal function in patients reporting adverse reactions that could lead to volume depletion. When initiating WEGOVY, consider reducing the dose of concomitantly administered insulin or insulin secretagogue to reduce the risk of hypoglycemia [see Drug Interactions] . 5.5 Acute Kidney Injury Due to Volume Depletion There have been postmarketing reports of acute kidney injury, in some cases requiring hemodialysis, in patients treated with semaglutide [see Adverse Reactions] .
The majority of the reported events occurred in patients who experienced gastrointestinal adverse reactions leading to dehydration such as nausea, vomiting, or diarrhea [see Adverse Reactions] . Monitor renal function in patients reporting adverse reactions to WEGOVY that could lead to volume depletion, especially during dosage initiation and escalation of WEGOVY. 5.6 Severe Gastrointestinal Adverse Reactions Use of WEGOVY has been associated with gastrointestinal adverse reactions, sometimes severe [see Adverse Reactions] .
Preparation and administration
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Important Monitoring and Administration Instructions In patients with diabetes mellitus, monitor blood glucose prior to starting WEGOVY and during WEGOVY treatment [see Warnings and Precautions] . Administer WEGOVY in combination with a reduced-calorie diet and increased physical activity. WEGOVY Injection
Inform patients and their caregiver(s) which WEGOVY presentation (e.g., single-dose pen or syringe, or WEGOVY FlexTouch single-patient-use pen) they will receive and ensure they receive training appropriate for that specific presentation. If the prescribed WEGOVY presentation changes, ensure patients and caregivers receive appropriate training and instruct them to consult the Instructions for Use for the newly prescribed presentation.
Prior to initiation, train patients and their caregiver(s) on proper injection technique for the prescribed WEGOVY presentation [see Instructions for Use ] . After training, a patient may self-inject WEGOVY if the healthcare provider determines that it can be properly administered, except for the following: o WEGOVY FlexTouch is not recommended for self-administration by those who are visually impaired.
Visually inspect the WEGOVY injection prior to each administration. Only use if the solution is clear, colorless, and contains no particles.
Administer WEGOVY injection once weekly, on the same day each week, at any time of day, with or without meals.
Inject WEGOVY subcutaneously in the abdomen, thigh, or upper arm. The time of day and the injection site can be changed without the need for a dosage modification.
Rotate injection sites with each dose. WEGOVY Tablets
Take one WEGOVY tablet orally once daily on an empty stomach in the morning with water (up to 4 ounces). Do not take WEGOVY tablets with other liquids besides water [see Clinical Pharmacology] .
Swallow tablets whole. Do not split, crush, chew or dissolve in any solution.
Do not take more than one tablet per day.
After taking a WEGOVY tablet, wait at least 30 minutes before eating food, drinking beverages or taking other oral medications [see Clinical Pharmacology] .
Drug interactions
Check semaglutide (wegovy) against a medication listLabel text (3 paragraphs)
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 Clinical Pharmacology ( 12.3 )] . 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 with WEGOVY. Consider increased clinical or laboratory monitoring for medications that have a narrow therapeutic index or that require clinical monitoring.
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 )
Safety data
Reported adverse events (FAERS)
Liver injury (LiverTox)
LiverTox has no chapter for semaglutide (wegovy). Check the label's hepatic warnings.
Pregnancy and lactation
Pregnancy
8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to WEGOVY during pregnancy. Pregnant women exposed to WEGOVY and healthcare providers are encouraged to contact Novo Nordisk at 1-877-390-2760 or www.wegovypregnancyregistry.com. Risk Summary Based on animal reproduction studies, there may be potential risks to the fetus from exposure to semaglutide during pregnancy. Available pharmacovigilance data and data from clinical trials with WEGOVY use in pregnant patients are insufficient to establish a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes.
Weight loss offers no benefit to a pregnant patient and may cause fetal harm. When a pregnancy is recognized, advise the pregnant patient of the risk to a fetus. Discontinue WEGOVY in pregnant patients who are using it for weight reduction (see Clinical Considerations ). There may be risks to the mother and fetus related to underlying MASH with advanced liver fibrosis (see Clinical Considerations ). Whether WEGOVY treatment during pregnancy reduces these risks is unknown. WEGOVY for the treatment of MASH with advanced liver fibrosis should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
In pregnant rats administered semaglutide during organogenesis, embryofetal mortality, structural abnormalities and alterations to growth occurred at clinically relevant maternal exposures at the maximum recommended human dose (MRHD) of WEGOVY subcutaneous injection 7.2 mg/week, based on AUC. In pregnant rabbits and cynomolgus monkeys administered semaglutide during organogenesis, early pregnancy losses and structural abnormalities were observed in rabbits and monkeys at clinically relevant exposures. These findings coincided with a marked maternal body weight loss in both animal species (see Data ).
The background risk of major birth defects and miscarriage for the indicated populations are unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Disease-Associated Maternal and/or Embryo/fetal Risk: Appropriate weight gain based on pre-pregnancy weight is currently recommended for all pregnant patients, including those who already have overweight or obesity, because of the obligatory weight gain that occurs in maternal tissues during pregnancy. There may be risks to the mother and fetus related to MASH…
For breastfeeding, also see LactMed (National Library of Medicine), which summarizes milk levels and infant effects.
Supply and cost
Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
Price ladder
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