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Brand Name
Entyvio
Generic Name
Vedolizumab
View Brand Information FDA approval date: May 20, 2014
Classification: Integrin Receptor Antagonist
Form: Injection
What is Entyvio (Vedolizumab)?
ENTYVIO is indicated in adults for the treatment of: moderately to severely active ulcerative colitis. moderately to severely active Crohn's disease. ENTYVIO is an integrin receptor antagonist indicated in adults for the treatment of: moderately to severely active ulcerative colitis. moderately to severely active Crohn's disease.
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An Open-Label, Phase 4 Study to Evaluate the Efficacy and Safety of Dual Targeted Therapy With Vedolizumab Intravenous (IV) and Adalimumab Subcutaneous (SC) or Vedolizumab IV and Ustekinumab IV/SC in Moderate to Severe Crohn's Disease (CD)
Summary: The main aim of this study is to learn about the effect of treatment with vedolizumab IV (vedolizumab) together with adalimumab or vedolizumab (VDZ) together with ustekinumab (UST) in adults with moderate to severe Crohn's Disease, and the effect of treatment with vedolizumab alone, after the dual targeted treatment. The study is conducted in two parts. In Part A, participants will receive the dua...
RRA-18896: An Observational Study to Assess the Long-term Safety of Ustekinumab Versus Other Biologic Therapies Among Patients With Crohn's Disease: A New-User Cohort Study Using the Department of Defense Electronic Health Records Database
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VERIFY: Vedolizumab for the Prevention of Immune Checkpoint Inhibitor Related Diarrhea or Colitis in Patients With Cancer: A Randomized, Double-Blinded, Placebo Controlled Trial
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Brand Information
Entyvio (vedolizumab)
1INDICATIONS AND USAGE
ENTYVIO is indicated in adults for the treatment of:
- moderately to severely active ulcerative colitis (UC).
- moderately to severely active Crohn's disease (CD).
2CONTRAINDICATIONS
ENTYVIO is contraindicated in patients who have had a known serious or severe hypersensitivity reaction to ENTYVIO or any of its excipients (such as dyspnea, bronchospasm, urticaria, flushing, rash and increased heart rate)
3ADVERSE REACTIONS
The following topics are also discussed in detail in the Warnings and Precautions section:
- Infusion-Related Reactions and Hypersensitivity Reactions
- Infections
- Progressive Multifocal Leukoencephalopathy
- Liver Injury
3.1Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The data described below reflect exposure to intravenous ENTYVIO in 3,326 patients and healthy volunteers in clinical trials, including 1,396 exposed for greater than one year, and 835 exposed for greater than two years.
3.2Postmarketing Experience
The following adverse reactions have been identified during post-approval use of ENTYVIO. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Immune system disorders: Anaphylaxis [see
Gastrointestinal system disorders: Acute pancreatitis.
Respiratory, thoracic, and mediastinal disorders: Interstitial lung disease, pneumonitis.
4DESCRIPTION
Vedolizumab, an integrin receptor antagonist, is a humanized IgG
5PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Medication Guide and Instructions for Use).
6INSTRUCTIONS FOR USE
ENTYVIO® (en ti' vee oh) PEN
Single-dose prefilled pen
Single-dose prefilled pen
This Instructions for Use contains information on how to inject ENTYVIO.
Your ENTYVIO single-dose prefilled pen
Storing ENTYVIO
- Store your prefilled pen in the refrigerator between 36°F to 46°F (2°C to 8°C).
- Your prefilled pen can be left in its box at room temperature up to 77°F (25°C) for up to 7 days (for example, when traveling).
- Do not freeze the prefilled pen.
- Do not leave the prefilled pen in direct sunlight.
- Throw away the prefilled pen in a FDA-cleared sharps disposal container if it has been left out of the refrigerator for more than 7 days, frozen, or left in direct sunlight. See
- Always keep ENTYVIO PENs, the sharps disposal container, and all medicines out of the reach of children.
This Instructions for Use has been approved by the U.S. Food and Drug Administration.
7INSTRUCTIONS FOR USE
ENTYVIO (en ti' vee oh)
Single-dose prefilled syringe
Single-dose prefilled syringe
This Instructions for Use contains information on how to inject ENTYVIO.
Your ENTYVIO single-dose prefilled syringe
Storing ENTYVIO
- Store your prefilled syringe in the refrigerator between 36°F to 46°F (2°C to 8°C).
- Your prefilled syringe can be left in its box at room temperature up to 77°F (25°C) for up to 7 days (for example, when traveling).
- Do not freeze the prefilled syringe.
- Do not leave the prefilled syringe in direct sunlight.
- Throw away the prefilled syringe in a FDA-cleared sharps disposal container if it has been left out of the refrigerator for more than 7 days, frozen, or left in direct sunlight. See
- Always keep ENTYVIO prefilled syringes, the sharps disposal container, and all medicines out of the reach of children.
This Instructions for Use has been approved by the U.S. Food and Drug Administration.
8PRINCIPAL DISPLAY PANEL - 300 mg Vial Label
NDC 64764-300-20 Rx only
Entyvio
vedolizumab
300 mg per vial*
vedolizumab
300 mg per vial*
For Intravenous Use Only
Must be reconstituted
Single-Dose Vial - Discard Unused
9PRINCIPAL DISPLAY PANEL - 300 mg Vial Carton
NDC 64764-300-20 Rx only
Entyvio
vedolizumab
300 mg per vial*
vedolizumab
300 mg per vial*
ATTENTION: Each patient is required to
For Intravenous Use Only
Must be reconstituted and diluted prior
Single-Dose Vial - Discard Unused Portion
Takeda
10PRINCIPAL DISPLAY PANEL - 108 mg/0.68 mL Pen Tray Carton
NDC 64764-108-21 Rx only
ENTYVIO
(vedolizumab)
injection
(vedolizumab)
injection
108 mg/0.68 mL
For Subcutaneous Use Only
1 Single-Dose Prefilled Pen
ATTENTION PHARMACIST: Each
11PRINCIPAL DISPLAY PANEL - 108 mg/0.68 mL Syringe Tray Carton
NDC 64764-107-11 Rx only
ENTYVIO
(vedolizumab)
injection
(vedolizumab)
injection
108 mg/0.68 mL
For Subcutaneous Use Only
1 Single-Dose Prefilled Syringe
ATTENTION PHARMACIST: Each patient
