Entyvio works through a gut-selective MOA by specifically binding to the α4β7 integrin and blocking its interaction with MAdCAM-1, which is mainly expressed on gut endothelial cells.1-7
Remission was evaluated at Week 52.1 Individual results may vary.
In a single‑arm, open label extension study 2243 patients received Entyvio with a median exposure of 1072 days (range 1 to 3412 days).8-10
For adult patients with moderately to severely active UC or CD when other therapies have not worked well enough or cannot be tolerated.
Only Entyvio (vedolizumab) Combines
Gut Selectivity2-7
Entyvio helps address inflammation where it occurs—the gut.1
Entyvio specifically binds to the α4β7 integrin and blocks the interaction between the α4β7 integrin and MAdCAM-1, which is mainly expressed on the GI tract endothelial cells.
Clinical trials evaluated safety in more than 3300 patients (UC and CD).1 A separate open-label study of up to 7 years demonstrated consistent results across safety parameters.8-10*
*In a single-arm, open label extension study of 2243 patients who received Entyvio with a median exposure of 1072 days (range 1 to 3412 days).8-10
Entyvio is the most prescribed biologicfor UC and CD new start patients16‡
‡Based on an analysis of data in SHA database comparing patient counts on a quarterly basis from December 2019 to August 2020, with "new starts" defined as "bio-naïve" plus "switch" patients. "Bio-naïve" is defined as any patient with UC or CD who had no UC or CD biologic drug claims for the past 3 years. "Switch" is defined as any patient who previously used a different UC or CD biologic drug and switched to their current therapy in the past 3 years.
Reaching new milestones for patients and physicians
1
More than 192k UC and CD patients have used Entyvio in the US since launch17§
2
Over 25k physicians have prescribed Entyvio in the US since launch18§
3
87% of commercially insured patients have first-line biologic unrestricted commercial coverage for Entyvio19||
§This information is derived from Symphony database of Entyvio medical and pharmacy claims from June 2014 to preliminary August 2020.
||First-line/unrestricted coverage refers to patients with no prior biologic use. Data regarding historical first-line/unrestricted commercial coverage for Entyvio are derived from Managed Markets Insights & Technology (MMIT) and contracted plans from the FY2019 Entyvio Payer Tracker, September 2016 to October 2018. Current first-line/unrestricted commercial coverage for Entyvio as of October 2020 is derived only from the MMIT data.
Important Safety Information
ENTYVIO (vedolizumab) for injection is contraindicated in patients who have had a known serious or severe hypersensitivity reaction to ENTYVIO or any of its excipients.
Infusion-related reactions and hypersensitivity reactions including anaphylaxis, dyspnea, bronchospasm, urticaria, flushing, rash, and increased blood pressure and heart rate have been reported. These reactions may occur with the first or subsequent infusions and may vary in their time of onset from during infusion or up to several hours post-infusion. If anaphylaxis or other serious infusion-related or hypersensitivity reactions occur, discontinue administration of ENTYVIO immediately and initiate appropriate treatment.
Patients treated with ENTYVIO are at increased risk for developing infections. Serious infections have been reported in patients treated with ENTYVIO, including anal abscess, sepsis (some fatal), tuberculosis, salmonella sepsis, Listeria meningitis, giardiasis, and cytomegaloviral colitis. ENTYVIO is not recommended in patients with active, severe infections until the infections are controlled. Consider withholding ENTYVIO in patients who develop a severe infection while on treatment with ENTYVIO. Exercise caution in patients with a history of recurring severe infections. Consider screening for tuberculosis (TB) according to the local practice.
Progressive multifocal leukoencephalopathy (PML), a rare and often fatal opportunistic infection of the central nervous system (CNS), has been reported with systemic immunosuppressants, including another integrin receptor antagonist. PML is caused by the John Cunningham (JC) virus and typically only occurs in patients who are immunocompromised. One case of PML in an ENTYVIO-treated patient with multiple contributory factors has been reported in the post marketing setting (e.g., human immunodeficiency virus [HIV] infection with a CD4 count of 300 cells/mm3 and prior and concomitant immunosuppression). Although unlikely, a risk of PML cannot be ruled out. Monitor patients for any new or worsening neurological signs or symptoms. Typical signs and symptoms associated with PML are diverse, progress over days to weeks, and include progressive weakness on one side of the body or clumsiness of limbs, disturbance of vision, and changes in thinking, memory, and orientation leading to confusion and personality changes. If PML is suspected, withhold dosing with ENTYVIO and refer to a neurologist; if confirmed, discontinue ENTYVIO dosing permanently.
There have been reports of elevations of transaminase and/or bilirubin in patients receiving ENTYVIO. ENTYVIO should be discontinued in patients with jaundice or other evidence of significant liver injury.
Prior to initiating treatment with ENTYVIO, all patients should be brought up to date with all immunizations according to current immunization guidelines. Patients receiving ENTYVIO may receive non-live vaccines and may receive live vaccines if the benefits outweigh the risks.
Most common adverse reactions (incidence ≥3% and ≥1% higher than placebo): nasopharyngitis, headache, arthralgia, nausea, pyrexia, upper respiratory tract infection, fatigue, cough, bronchitis, influenza, back pain, rash, pruritus, sinusitis, oropharyngeal pain, and pain in extremities.
Indications
Adult Ulcerative Colitis (UC)
ENTYVIO (vedolizumab) is indicated in adults for the treatment of moderately to severely active UC.
Adult Crohn's Disease (CD)
ENTYVIO (vedolizumab) is indicated in adults for the treatment of moderately to severely active CD.
Loftus EV, Feagan BG, Panaccione R, et al; for the GEMINI LTS study team. Aliment Pharmacol Ther. 2020;00:1-13.
Data on file. MLN0002, Final CSR C13008, July 2018. Takeda Pharmaceuticals USA, Inc.
Data on file. Internal communication, October 2020. Takeda Pharmaceuticals USA, Inc.
Data on file. MLN0002, Final CSR C13006, September 2012. Takeda Pharmaceuticals USA, Inc.
Data on file. MLN0002, Final CSR C13007, October 2012. Takeda Pharmaceuticals USA, Inc.
Sands BE, Peyrin-Biroulet L, Loftus EV Jr, et al. N Engl J Med. 2019;381(13):1215-1226.
Data on file. DDW Abstract 416a, May 2019. Takeda Pharmaceuticals USA, Inc.
Data on file. DDW Oral Presentation 416a, May 2019. Takeda Pharmaceuticals USA, Inc.
Data on file. Entyvio Prescriber Count for New Start Patients - Supporting Data & Methodology Overview, October 2020. Takeda Pharmaceuticals USA, Inc.
Data on file. Entyvio Patient Counts - Supporting Data & Methodology Overview, October 2020. Takeda Pharmaceuticals USA, Inc.
Data on file. Entyvio Prescriber Counts - Supporting Data & Methodology Overview, October 2020. Takeda Pharmaceuticals USA, Inc.
Data on file. Entyvio Reimbursement and Access Analytics Report, October 2020. Takeda Pharmaceuticals USA, Inc.
Important Safety Information
ENTYVIO (vedolizumab) for injection is contraindicated in patients who have had a known serious or severe hypersensitivity reaction to ENTYVIO or any of its excipients.
Infusion-related reactions and hypersensitivity reactions including anaphylaxis, dyspnea, bronchospasm, urticaria, flushing, rash, and increased blood pressure and heart rate have been reported. These reactions may occur with the first or subsequent infusions and may vary in their time of onset from during infusion or up to several hours post-infusion. If anaphylaxis or other serious infusion-related or hypersensitivity reactions occur, discontinue administration of ENTYVIO immediately and initiate appropriate treatment.
Patients treated with ENTYVIO are at increased risk for developing infections. Serious infections have been reported in patients treated with ENTYVIO, including anal abscess, sepsis (some fatal), tuberculosis, salmonella sepsis, Listeria meningitis, giardiasis, and cytomegaloviral colitis. ENTYVIO is not recommended in patients with active, severe infections until the infections are controlled. Consider withholding ENTYVIO in patients who develop a severe infection while on treatment with ENTYVIO. Exercise caution in patients with a history of recurring severe infections. Consider screening for tuberculosis (TB) according to the local practice.
Progressive multifocal leukoencephalopathy (PML), a rare and often fatal opportunistic infection of the central nervous system (CNS), has been reported with systemic immunosuppressants, including another integrin receptor antagonist. PML is caused by the John Cunningham (JC) virus and typically only occurs in patients who are immunocompromised. One case of PML in an ENTYVIO-treated patient with multiple contributory factors has been reported in the post marketing setting (e.g., human immunodeficiency virus [HIV] infection with a CD4 count of 300 cells/mm3 and prior and concomitant immunosuppression). Although unlikely, a risk of PML cannot be ruled out. Monitor patients for any new or worsening neurological signs or symptoms. Typical signs and symptoms associated with PML are diverse, progress over days to weeks, and include progressive weakness on one side of the body or clumsiness of limbs, disturbance of vision, and changes in thinking, memory, and orientation leading to confusion and personality changes. If PML is suspected, withhold dosing with ENTYVIO and refer to a neurologist; if confirmed, discontinue ENTYVIO dosing permanently.
There have been reports of elevations of transaminase and/or bilirubin in patients receiving ENTYVIO. ENTYVIO should be discontinued in patients with jaundice or other evidence of significant liver injury.
Prior to initiating treatment with ENTYVIO, all patients should be brought up to date with all immunizations according to current immunization guidelines. Patients receiving ENTYVIO may receive non-live vaccines and may receive live vaccines if the benefits outweigh the risks.
Most common adverse reactions (incidence ≥3% and ≥1% higher than placebo): nasopharyngitis, headache, arthralgia, nausea, pyrexia, upper respiratory tract infection, fatigue, cough, bronchitis, influenza, back pain, rash, pruritus, sinusitis, oropharyngeal pain, and pain in extremities.
Indications
Adult Ulcerative Colitis (UC)
ENTYVIO (vedolizumab) is indicated in adults for the treatment of moderately to severely active UC.
Adult Crohn's Disease (CD)
ENTYVIO (vedolizumab) is indicated in adults for the treatment of moderately to severely active CD.
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