Prescription Drug Information: WEGOVY

WEGOVY- semaglutide injection, solution
Novo Nordisk

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) and 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) and Warnings and Precautions (5.1)].

1 INDICATIONS AND USAGE

WEGOVY is indicated as an adjunct to a reduced calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index (BMI) of [see Dosage and Administration (2.1)]:

30 kg/m2 or greater (obesity) or
27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid condition (e.g., hypertension, type 2 diabetes mellitus, or dyslipidemia)

Limitation of Use

WEGOVY contains semaglutide and should not be coadministered with other semaglutide-containing products or with any other GLP-1 receptor agonist.
The safety and effectiveness of WEGOVY in combination with other products intended for weight loss, including prescription drugs, over-the-counter drugs, and herbal preparations, have not been established.
WEGOVY has not been studied in patients with a history of pancreatitis [see Warnings and Precautions (5.2)].

2 DOSAGE AND ADMINISTRATION

2.1 Patient Selection

Select patients for WEGOVY treatment as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management based on their BMI. BMI is calculated by dividing weight (in kilograms) by height (in meters) squared. A chart for determining BMI based on height and weight is provided in Table 1.

Table 1. BMI Conversion Chart
Table 1
(click image for full-size original)

2.2 Important Administration Instructions

Prior to initiation of WEGOVY, train patients on proper injection technique. Refer to the accompanying Instructions for Use for complete administration instructions with illustrations.
Inspect WEGOVY visually prior to each injection. Only use if solution is clear, colorless, and contains no particles.
Administer WEGOVY once weekly, on the same day each week, at any time of day, with or without meals.
Administer WEGOVY subcutaneously in the abdomen, thigh, or upper arm. The time of day and the injection site can be changed without dose adjustment.
If one dose is missed and the next scheduled dose is more than 2 days away (48 hours), administer WEGOVY as soon as possible. If one dose is missed and the next scheduled dose is less than 2 days away (48 hours), do not administer the dose. Resume dosing on the regularly scheduled day of the week.
If more than 2 consecutive doses are missed, resume dosing as scheduled or, if needed, reinitiate WEGOVY and follow the dose escalation schedule, which may reduce the occurrence of gastrointestinal symptoms associated with reinitiation of treatment.

2.3 Recommended Dosage

Initiate WEGOVY with a dose of 0.25 mg injected subcutaneously once-weekly and follow the dose escalation schedule in Table 2 to minimize gastrointestinal adverse reactions [see Adverse Reactions (6.1)].

Table 2. Dose Escalation Schedule

Weeks

Weekly Dose

1 through 4

0.25 mg

Dose escalation

5 through 8

0.5 mg

9 through 12

1 mg

13 through 16

1.7 mg

Week 17 and onward

2.4 mg

Maintenance dose

If patients do not tolerate a dose during dose escalation, consider delaying dose escalation for 4 weeks.
The maintenance dose of WEGOVY is 2.4 mg injected subcutaneously once-weekly.
If patients do not tolerate the maintenance 2.4 mg once-weekly dose, the dose can be temporarily decreased to 1.7 mg once-weekly, for a maximum of 4 weeks. After 4 weeks, increase WEGOVY to the maintenance 2.4 mg once-weekly. Discontinue WEGOVY if the patient cannot tolerate the 2.4 mg dose.
In patients with type 2 diabetes, monitor blood glucose prior to starting WEGOVY and during WEGOVY treatment.

3 DOSAGE FORMS AND STRENGTHS

Injection: clear, colorless solution available in 5 pre-filled, disposable, single-dose pens:

Dose per Injection

Total Strength per Total Volume

0.25 mg

0.25 mg / 0.5 mL

0.5 mg

0.5 mg / 0.5 mL

1 mg

1 mg / 0.5 mL

1.7 mg

1.7 mg / 0.75 mL

2.4 mg

2.4 mg / 0.75 mL

4 CONTRAINDICATIONS

WEGOVY is contraindicated in the following conditions:

A personal or family history of medullary thyroid carcinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) [see Warnings and Precautions (5.1)].
A prior serious hypersensitivity reaction to semaglutide or to any of the excipients in WEGOVY. Serious hypersensitivity reactions, including anaphylaxis and angioedema, have been reported with semaglutide [see Warnings and Precautions (5.6)].

5 WARNINGS AND PRECAUTIONS

5.1 Risk of Thyroid C-Cell Tumors

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 clinically relevant plasma exposures [see Nonclinical Toxicology (13.1)]. 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.

Cases of MTC in patients treated with liraglutide, another GLP-1 receptor agonist, have been reported in the postmarketing period; the data in these reports are insufficient to establish or exclude a causal relationship between MTC and GLP-1 receptor agonist use in humans.

WEGOVY is contraindicated in patients with a personal or family history of MTC or in patients with MEN 2. 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. Such monitoring may increase the risk of unnecessary procedures, due to the low test specificity for serum calcitonin and a high background incidence of thyroid disease. Significantly elevated serum calcitonin value may indicate MTC and patients with MTC usually have calcitonin values greater than 50 ng/L. If serum calcitonin is measured and found to be elevated, the patient should be further evaluated. Patients with thyroid nodules noted on physical examination or neck imaging should also be further evaluated.

5.2 Acute Pancreatitis

Acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis, has been observed in patients treated with GLP-1 receptor agonists, including semaglutide. Acute pancreatitis was observed in patients treated with WEGOVY in clinical trials [see Adverse Reactions (6)]. After initiation of WEGOVY, observe patients carefully for signs and symptoms of acute pancreatitis (including persistent severe abdominal pain, sometimes radiating to the back, and which may or may not be accompanied by vomiting). If acute pancreatitis is suspected, WEGOVY should promptly be discontinued and appropriate management should be initiated. If acute pancreatitis is confirmed, WEGOVY should not be restarted.

WEGOVY has not been studied in patients with a history of pancreatitis. It is unknown if patients with a history of pancreatitis are at higher risk for development of pancreatitis on WEGOVY.

RxDrugLabels.com provides trustworthy package insert and label information about marketed prescription drugs as submitted by manufacturers to the U.S. Food and Drug Administration. Package information is not reviewed or updated separately by RxDrugLabels.com. Every individual prescription drug label and package insert entry contains a unique identifier which can be used to secure further details directly from the U.S. National Institutes of Health and/or the FDA.

Medication Sections

Medication Information by RSS

As a leading independent provider of trustworthy medication information, we source our database directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. RxDrugLabels.com provides the full prescription-only subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2021. All Rights Reserved.