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WEGOVY- semaglutide injection, solution

Buy Wegovy online

WEGOVY is a glucagon-like peptide-1 (GLP-1) receptor agonist used in conjunction with a reduced-calorie diet and increased physical activity for the following purposes:

  • To reduce the risk of major adverse cardiovascular events (such as cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke) in adults with established cardiovascular disease who are either obese or overweight.
  • To reduce excess body weight and maintain long-term weight reduction in:
    • Adults and pediatric patients aged 12 years and older with obesity.
    • Adults who are overweight with at least one weight-related comorbid condition.

Limitations of Use:

  • It is not recommended to use WEGOVY alongside other semaglutide-containing products or any other GLP-1 receptor agonists.

INDICATIONS AND USAGE

WEGOVY is indicated for use alongside a reduced-calorie diet and increased physical activity:

  • To reduce the risk of major adverse cardiovascular events (such as cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke) in adults with established cardiovascular disease who are either obese or overweight.
  • To reduce excess body weight and maintain long-term weight reduction in:
    • Adults and pediatric patients aged 12 years and older with obesity.
    • Adults who are overweight with at least one weight-related comorbid condition.

Limitations of Use:

  • WEGOVY contains semaglutide. It is not recommended to coadminister it with other semaglutide-containing products or any other GLP-1 receptor agonists

DESCRIPTION

WEGOVY (semaglutide) injection, for subcutaneous use, contains semaglutide, a human GLP-1 receptor agonist (or GLP-1 analog). The peptide backbone is produced through yeast fermentation. The primary protraction mechanism of semaglutide is albumin binding, facilitated by modifying the position 26 lysine with a hydrophilic spacer and a C18 fatty di-acid. Additionally, semaglutide is modified at position 8 to enhance stability against degradation by the enzyme dipeptidyl-peptidase 4 (DPP-4). A minor modification at position 34 ensures the attachment of only one fatty di-acid. The molecular formula is C187H291N45O59, and the molecular weight is 4113.58 g/mol.

INSTRUCTIONS FOR USE

Instructions for Use

WEGOVY® (semaglutide) injection

WEGOVY is available in five strengths. Before using your WEGOVY pen for the first time, consult your healthcare provider or caregiver about how to prepare and inject WEGOVY correctly.

Important Information

Read these Instructions for Use before starting WEGOVY. This information does not replace discussions with your healthcare provider about your medical condition or treatment.

  • Your WEGOVY pen is for single use only and is for subcutaneous (under the skin) injection.
  • The dose is pre-set on your pen.
  • The needle is covered and not visible.
  • Do not remove the pen cap until you are ready to inject.
  • Avoid touching or pressing on the needle cover to prevent needle stick injuries.
  • The injection starts when the needle cover is pressed firmly against your skin.
  • Do not remove the pen from your skin before the yellow bar in the pen window stops moving. Removing it too early or not pressing firmly enough may result in an incomplete dose.
  • If the yellow bar does not start moving or stops during the injection, contact your healthcare provider or Novo Nordisk at startWegovy.com or 1-833-934-6891.
  • The needle cover will lock when the pen is removed from your skin, and the injection cannot be restarted.
  • Individuals who are blind or have vision problems should not use the WEGOVY pen without assistance from a trained person.

Storage Instructions

  • Store the WEGOVY pen in the refrigerator between 36°F to 46°F (2°C to 8°C).
  • If needed, before removing the pen cap, WEGOVY can be stored at 46°F to 86°F (8°C to 30°C) in the original carton for up to 28 days.
  • Keep WEGOVY in the original carton to protect it from light.
  • Do not freeze.
  • Discard the pen if WEGOVY has been frozen, exposed to light, temperatures above 86°F (30°C), or has been out of the refrigerator for 28 days or longer.
  • Keep WEGOVY and all medicines out of the reach of children.

How to Use Your WEGOVY Pen

Do not use your WEGOVY pen without training from your healthcare provider. Ensure you or your caregiver know how to inject with the pen before starting treatment.

Preparation

  1. Prepare for your injection:
    • Gather supplies: WEGOVY pen, alcohol swab or soap and water, gauze pad or cotton ball, sharps disposal container.
    • Wash your hands.
    • Check the WEGOVY pen:
      • Do not use if the pen appears used or broken.
      • Do not use if the medicine is not clear and colorless.
      • Do not use if the expiration date has passed.
      • Contact Novo Nordisk at 1-833-934-6891 if your pen fails any of these checks.
  1. Choose your injection site:
    • Your healthcare provider can help you select the best site.
    • You may inject into your upper leg, lower stomach (avoiding the area within 2 inches of your belly button), or upper arm.
    • Avoid areas where the skin is tender, bruised, red, or hard, or where there are scars or stretch marks.
    • Rotate injection sites within the same area weekly.
    • Clean the injection site with an alcohol swab or soap and water, then let it dry.

Injection

  1. Remove the pen cap:
    • Pull the pen cap straight off.
  1. Inject WEGOVY:
    • Press the pen firmly against your skin and keep applying pressure until the yellow bar stops moving.
    • You will hear two clicks during the injection:
      • Click 1: The injection starts.
      • Click 2: The injection is ongoing.
    • Refer to the "Troubleshooting" section if you encounter problems.

Disposal

  1. Dispose of the pen safely:
    • Dispose of the WEGOVY pen immediately after use in an FDA-cleared sharps disposal container.
    • If you do not have an FDA-cleared sharps disposal container, use a heavy-duty plastic container with a puncture-resistant lid that can be tightly closed, remains upright and stable during use, is leak-resistant, and is properly labeled.
    • Follow community guidelines for disposal when the container is almost full. Do not recycle the pen or disposal container or throw them in household trash.

Care for Your Pen

  • Protect your pen:
    • Do not drop or expose your pen to liquids.
    • If damaged, do not attempt to fix it. Use a new one.
    • Keep the pen cap on until ready to inject to maintain sterility.

If you have any questions about WEGOVY, visit startWegovy.com or call Novo Nordisk Inc. at 1-833-Wegovy-1.

 HOW SUPPLIED/STORAGE AND HANDLING

WEGOVY injection is a clear, colorless solution available in a pre-filled, disposable, single-dose pen injector with an integrated needle. It is supplied in cartons containing 4 pen injectors with the following packaging configurations:

Total Strength per Total Volume:

  • 0.25 mg/0.5 mL (NDC: 0169-4525-14)
  • 0.5 mg/0.5 mL (NDC: 0169-4505-14)
  • 1 mg/0.5 mL (NDC: 0169-4501-14)
  • 1.7 mg/0.75 mL (NDC: 0169-4517-14)
  • 2.4 mg/0.75 mL (NDC: 0169-4524-14)

Recommended Storage:

Store the WEGOVY single-dose pen in the refrigerator at 2°C to 8°C (36°F to 46°F). If needed, before cap removal, the pen can be kept at 8°C to 30°C (46°F to 86°F) for up to 28 days. Do not freeze. Protect WEGOVY from light and keep it in the original carton until administration. Discard the WEGOVY pen after use.

PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Medication Guide and Instructions for Use).

Risk of Thyroid C-cell Tumors:
Inform patients that semaglutide has caused thyroid C-cell tumors in rodents, and the relevance of this finding to humans is unknown. Counsel patients to report symptoms of thyroid tumors (such as a lump in the neck, hoarseness, difficulty swallowing, or shortness of breath) to their physician [see Boxed Warning and Warnings and Precautions (5.1)].

Acute Pancreatitis:
Inform patients about the potential risk of acute pancreatitis. Instruct them to discontinue WEGOVY immediately and contact their physician if they suspect pancreatitis (severe abdominal pain that may radiate to the back, with or without vomiting) [see Warnings and Precautions (5.2)].

Acute Gallbladder Disease:
Inform patients of the risk of acute gallbladder disease. Advise that significant or rapid weight loss can increase this risk, but gallbladder disease can also occur without such weight loss. Instruct patients to contact their healthcare provider if gallbladder disease is suspected for appropriate clinical follow-up [see Warnings and Precautions (5.3)].

Hypoglycemia:
Inform patients of the risk of hypoglycemia and educate them on its signs and symptoms. Advise diabetic patients on glycemic-lowering therapy that they may have an increased risk of hypoglycemia when using WEGOVY, and to report any signs or symptoms to their healthcare provider [see Warnings and Precautions (5.4)].

Dehydration and Renal Impairment:
Advise patients of the potential risk of dehydration due to gastrointestinal adverse reactions and the importance of maintaining hydration. Inform patients of the potential for worsening renal function, the signs and symptoms of renal impairment, and the possibility of dialysis if renal failure occurs [see Warnings and Precautions (5.5)].

Hypersensitivity Reactions:
Inform patients that serious hypersensitivity reactions have been reported postmarketing with semaglutide. Advise them on the symptoms of such reactions and instruct them to stop taking WEGOVY and seek medical advice promptly if these occur [see Warnings and Precautions (5.6)].

Diabetic Retinopathy Complications in Patients with Type 2 Diabetes:
Inform patients with type 2 diabetes to contact their physician if they experience changes in vision during treatment with WEGOVY [see Warnings and Precautions (5.7)].

Heart Rate Increase:
Instruct patients to inform their healthcare provider if they experience palpitations or a racing heartbeat while at rest during WEGOVY treatment [see Warnings and Precautions (5.8)].

Suicidal Behavior and Ideation:
Advise patients to report any emergence or worsening of depression, suicidal thoughts or behavior, or unusual changes in mood or behavior. Inform them to stop taking WEGOVY if they experience suicidal thoughts or behaviors [see Warnings and Precautions (5.9)].

Pregnancy:
Inform patients that WEGOVY may cause fetal harm. Advise them to inform their healthcare provider of any known or suspected pregnancy. Patients exposed to WEGOVY during pregnancy should contact Novo Nordisk at 1-877-390-2760 or www.wegovypregnancyregistry.com [see Use in Specific Populations (8.1)].

Manufactured by:
Novo Nordisk A/S
DK-2880 Bagsvaerd
Denmark

For additional information about WEGOVY, contact:
Novo Nordisk Inc.
800 Scudders Mill Road
Plainsboro, NJ 08536
1-833-934-6891

Version: 4
WEGOVY® is a registered trademark of Novo Nordisk A/S.

PATENT INFORMATION:
http://www.novonordisk-us.com/products/product-patents.html

© 2024 Novo Nordisk

WARNINGS AND PRECAUTIONS

  • Acute Pancreatitis: Has occurred in clinical trials. Discontinue promptly if pancreatitis is suspected. Do not restart if pancreatitis is confirmed.
  • Acute Gallbladder Disease: Has occurred in clinical trials. If cholelithiasis is suspected, conduct gallbladder studies and ensure clinical follow-up.
  • Hypoglycemia: The concurrent use of insulin or an insulin secretagogue may increase the risk of hypoglycemia, including severe cases. Reducing the dose of insulin or insulin secretagogue may be necessary. Inform all patients of the risk of hypoglycemia and educate them on its signs and symptoms.
  • Acute Kidney Injury: Has occurred. Monitor renal function when initiating or escalating doses of WEGOVY in patients reporting severe adverse gastrointestinal reactions or in those with renal impairment experiencing severe gastrointestinal reactions.
  • Hypersensitivity Reactions: Anaphylactic reactions and angioedema have been reported postmarketing. Discontinue WEGOVY if suspected and promptly seek medical advice.
  • Diabetic Retinopathy Complications in Patients with Type 2 Diabetes: Has been reported in trials with semaglutide. Patients with a history of diabetic retinopathy should be monitored.
  • Heart Rate Increase: Monitor heart rate at regular intervals.
  • Suicidal Behavior and Ideation: Monitor for depression or suicidal thoughts. Discontinue WEGOVY if symptoms develop.

 

DOSAGE AND ADMINISTRATION

  • Administer WEGOVY once weekly as an adjunct to diet and increased physical activity. It should be taken on the same day each week, at any time of day, with or without meals.
  • Inject subcutaneously in the abdomen, thigh, or upper arm.
  • For patients with type 2 diabetes, monitor blood glucose levels before starting and during WEGOVY treatment.
  • Begin with a dosage of 0.25 mg once weekly for 4 weeks. Then, follow the dosage escalation schedule, increasing every 4 weeks to reach the maintenance dosage.
  • The maintenance dosage of WEGOVY in adults is either 2.4 mg (recommended) or 1.7 mg once weekly.
  • The maintenance dosage of WEGOVY in pediatric patients aged 12 years and older is 2.4 mg once weekly.

 

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.

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. 

The highlights above do not include all or the complete information needed to use Ozempic safely and effectively. See full prescribing information for Wegovy

Additional information at https://dailymed.nlm.nih.gov