Fillable EntyvioConnect ENROLLMENT FORM Benets Investigation Start Program For (ENTYVIO)

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EntyvioConnect ENROLLMENT FORM Benets Investigation Start Program For (ENTYVIO)

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EntyvioConnect
Call 1-855-ENTYVIO
(1-855-368-9846)
with any questions
EntyvioConnect Patient Support Managers are
available Monday to Friday from 8 am to 8 pm ET
(except holidays).
ENROLL TODAY!
To enroll in EntyvioConnect, have your patients fill out the first and second pages
of the enrollment form, ensuring they sign both gray boxes.
Benefits Investigation
Support during the process of determining a
patient’s insurance benefits and eligibility for
certain EntyvioConnect services
Prior Authorization (PA) Support
Assistance in obtaining PA approval from the
patient’s insurance company to cover Entyvio
Denial and Appeal Support
Guidance to support an oce when appealing
any denied PA requests
Co-Pay Program
Allows commercially insured, eligible patients to
pay as little as $5 per dose*, up to a total benefit
of $20,000 per year
Start Program
New-to-Entyvio patients who have received a
denied PA from a commercial health plan are
eligible to receive Entyvio at no cost for up to
1 year while the appeals process is conducted
Bridge Program
Entyvio patients with a temporary loss or gap
in commercial coverage or authorization are
eligible to receive Entyvio at no cost for up to
6 months
Nurse Support
Enrolled patients will be paired with a Nurse
Educator to receive continued guidance
throughout their treatment on Entyvio. Our
nurses do not provide medical advice. Patients
can request Nurse Support when they sign up
on page 4
FAX completed forms to
1-877-488-6814
Please see Indications and Important Safety Information on page 7.
For your patients prescribed Entyvio, EntyvioConnect gives
access to the following programs:
ENROLLMENT FORM
* The EntyvioConnect Co-Pay Program (“Co-Pay Program”) provides financial support for commercially insured patients who qualify for the Co-Pay Program. The Co-Pay Program cannot be
used if patient is a beneficiary of, or any part of the prescription is covered by: 1) any federal-, state-, or government-funded healthcare program (Medicare, Medicare Advantage, Medicaid,
TRICARE, etc.), including a state pharmaceutical assistance program (the Federal Employees Health Benefit [FEHB] Program is not a government-funded healthcare program for the purpose
of this oer), 2) the Medicare Prescription Drug Program (Part D), or if patient is currently in the coverage gap, or 3) insurance that is paying the entire cost of the prescription. Patient may not
seek reimbursement from any other plan or program (Flexible Spending Account [FSA], Health Savings Account [HSA], Health Reimbursement Account [HRA], etc.) for any out-of-pocket costs
covered by the Co-Pay Program. Patient or healthcare provider may be required to submit an Explanation of Benefits (EOB) following each infusion to the Co-Pay Program. Takeda reserves
the right to change or end the Co-Pay Program at any time without notice, and other terms and conditions may apply. Oer not valid for patients under 18 years of age. Assistance under the
Co-Pay Program is not transferable. The Co-Pay Program only applies in the United States, including Puerto Rico and other U.S. territories, and does not apply where prohibited by law, taxed, or
restricted. This does not constitute health insurance. Void where use is prohibited by your insurance provider. If your insurance situation changes you must notify EntyvioConnect at
1-844-368-9846. This oer is not transferable and is limited to one oer per person and may not be combined with any other coupon, discount, prescription savings card, rebate, free trial,
patient assistance, or other oer. Not valid if reproduced.
See pages 5 and 6 for terms and conditions for EntyvioConnect and its programs and services.
DIAGNOSIS CODES
This guide is designed to support the reimbursement process for both providers and payers by providing
coding information for Entyvio. Providers are responsible for determining and submitting
the appropriate codes, charges, and modifiers for all medically appropriate services and products.
Please contact individual payers for current and specific coding, coverage, and payment policies.
The following coding information is intended as general information only. Please refer to your patient's payer's
policies for specific billing guidance.
The following ICD-10-CM diagnosis codes may be appropriate to describe these disease states:
ICD-10-CM codes for ulcerative colitis
1
Code Description
K51.00 Ulcerative (chronic) pancolitis without complications
K51.20 Ulcerative (chronic) proctitis without complications
K51.30 Ulcerative (chronic) rectosigmoiditis without complications
K51.50 Left-sided colitis without complications
K51.80 Other ulcerative colitis without complications
K51.90 Ulcerative colitis, unspecified, without complications
ICD-10-CM codes for Crohn’s disease
1
Code Description
K50.00 Crohn’s disease of small intestine without complications
K50.10 Crohn’s disease of large intestine without complications
K50.80 Crohn’s disease of both small and large intestine without complications
K50.90 Crohn’s disease, unspecified, without complications
ICD-10-CM=International Classification of Diseases, Tenth Revision, Clinical Modification.
Please see Indications and Important Safety Information on page 7.
For complete Dosage and Administration, please see full Prescribing Information, including Medication Guide.
2
EntyvioConnect Enrollment and Prescription Form
FAX page 3 and page 4 to 1-877-488-6814
or call 1-855-ENTYVIO (1-855-368-9846)
Monday through Friday, from 8 am to 8 pm ET (except holidays)
Primary Insurance Plan  Plan Phone 
Subscriber Name 
Birth Date  Relationship to Patient 
Policy ID #  Group # 
PA Reference #
Secondary or Prescription Plan  Plan Phone 
Subscriber Name 
Birth Date  Relationship to Patient 
Policy ID #  Group #  OR
RxBIN  RxPCN  RxGroup 
Prescriber Name (First, Last) 
Practice/Facility Name 
Address 
City/State/ZIP 
Preferred Contact Name 
Oce Phone  Oce Fax 
Co-pay/Claims/AR Fax (if dierent from above)
Tax ID #  NPI # 
Treatment Provider Name (First, Last) 
Practice/Facility Name 
Address 
City/State/ZIP 
Oce Phone  Oce Fax 
Tax ID #  NPI # 
Preferred Contact Name 
Prior therapies
2
:
o Humira® (adalimumab) o 6-MP/azathioprine o Cimzia® (certolizumab pegol) o Remicade® (infliximab) o Cortcosteroids o Stelara® (ustekinumab)
o
Other
Please complete Entyvio prescription information. Attach your prescription if this form does not comply with state laws (NY and NJ).
PATIENT INFORMATION (COMPLETE AND SUBMIT PATIENT AUTHORIZATIONS ON PAGE 4)
1.
PATIENT INSURANCE INFORMATION (FAX A COPY OF BOTH SIDES OF THE PRIMARY AND/OR SECONDARY INSURANCE CARD[S])
2.
PRESCRIBER INFORMATION
3.
INFUSION SITE INFORMATION (REQUIRED IF DIFFERENT FROM PRESCRIBER)
4.
PATIENT CLINICAL INFORMATION AND PRIOR THERAPIES
5.
DOSAGE AND DIRECTIONS FOR USE (REQUIRED FOR SPECIALTY PHARMACY TRIAGE)
6.
Name (First, Middle Initial, Last) 
Address 
City/State/ZIP 
Legal Representative Name (if applicable) 
Birth Date (MM/DD/YYYY)  Gender o Male o Female
Email   Primary Phone 
Legal Representative Primary Phone (if applicable) 
o  Hospital
outpatient
o  Infusion
center
o  Non-prescribing
MD’s oce
o  Patient
home
o Other
ICD-10-CM Diagnosis Code(s)
Current Medications
Medication Allergies, if any
Please refer to the Entyvio Prescribing Information on how to reconstitute and
dilute Entyvio for intravenous (IV) infusion.
Do you intend to buy and bill? o Yes o No
Description of site of care for infusion
X
PRESCRIBER SIGNATURE (Dispense as written) DATE
X
PRESCRIBER SIGNATURE (Substitution permitted) DATE
PRESCRIBER SIGNATURE
By signing this form, I certify that therapy with Entyvio is medically necessary for the patient identified in this application (“Patient”). I have reviewed the current Entyvio Prescribing
Information and will be supervising Patient’s treatment. I have received from Patient, or his/her personal representative, the necessary authorization to release, in accordance with applicable
federal and state law regulations, referenced medical and/or other patient information relating to Entyvio therapy to Takeda Pharmaceuticals U.S.A., Inc., including its present and future
aliates, business partners, agents and contractors, for the purpose of seeking information related to coverage and/or assisting in initiating or continuing Entyvio therapy. I authorize
EntyvioConnect to transmit this prescription to the appropriate pharmacy designated by me, Patient (or his/her legal representative), or Patient’s plan. I agree that product provided through
the Program (if applicable) shall only be used for Patient, must not be resold, oered for sale or trade, or returned for credit, nor shall Patient nor any third-party payer, Medicare, or Medicaid
be charged for this product. I have read, understand, and agree to the applicable Terms and Conditions. I understand that I am under no obligation to prescribe or purchase Entyvio or any
other product manufactured by Takeda, and I certify I have received nothing of value from Takeda or its agents or representatives for prescribing a Takeda product.
3
Please see Indications and Important Safety Information on page 7.
For complete Dosage and Administration, please see full Prescribing Information,
including Medication Guide.
ENTYVIO IV PRESCRIPTION INFORMATION (COMPLETE THIS SECTION)
Dose Dispense Description
Initiation
o Week 0: Infusion 300 mg IV 1 vial 14-day supply; 1 prescription, no refill
o Week 2: Infusion 300 mg IV 1 vial 30-day supply; 1 prescription, no refill
o Week 6: Infusion 300 mg IV 1 vial 30-day supply; 1 prescription, no refill
Maintenance
o Infusion 300 mg IV 1 vial 60-day supply; 1 prescription, 6 refills
By signing the Patient Authorization section on the second page of this EntyvioConnect Enrollment Form,
I authorize my physician, health insurance, and pharmacy providers (including any specialty pharmacy
that receives my prescription) to disclose my protected health information, including, but not limited to,
information relating to my medical condition, treatment, care management, and health insurance, as well
as all information provided on this form (“Protected Health Information”), to Takeda Pharmaceuticals U.S.A.,
Inc. and its present or future aliates, including the aliates and service providers that work on Takeda’s
behalf in connection with the EntyvioConnect Patient Support Program (the “Companies”). The Companies
will use my Protected Health Information for the purpose of facilitating the provision of the EntyvioCon nect
Patient Support Program products, supplies, or services as selected by me or my physician and may
include (but not be limited to) verification of insurance benefits and drug coverage, prior authorization
education, financial assistance with co-pays, patient assistance programs, and other related programs.
Specifically, I authorize the Companies to 1) receive, use, and disclose my Protected Health Information in
order to enroll me in EntyvioConnect and contact me, and/or the person legally authorized to sign on my
behalf, about EntyvioCon nect; 2) provide me, and/or the person legally authorized to sign on my behalf,
with educational materials, information, and services related to EntyvioConnect; 3) verify, investigate, and
provide information about my coverage for Entyvio, including but not limited to communicating with my
insurer, specialty pharmacies, and others involved in processing my pharmacy claims to verify my coverage;
4) coordinate prescription fulfillment; and 5) use my information to conduct internal analyses.
I understand that employees of the Companies only use my Protected Health Information for the purposes
described herein, to administer the Entyvio Connect Patient Support Program or as otherwise required
or allowed under the law, unless information that specifically identifies me is removed. Further, I understand
that my healthcare provider may receive financial remuneration from Takeda Pharmaceuticals U.S.A.
for marketing services. I understand that Protected Health Information disclosed under this Authorization
may no longer be protected by federal privacy law. I understand that I am entitled to a copy of this
Authorization. I understand that I may cancel this Authorization and that instructions for doing so are
contained in Takeda’s Website Privacy Notice available at www.takeda.com/privacy-notice/. I understand
that such cancellation will not apply to any information already used or disclosed through this Authorization.
This Authorization will expire within five (5) years from the date it is signed and provided on the first page
of this enrollment form, unless a shorter period is provided for by state law. I understand that I may refuse
to sign this Authorization and that refusing to sign this Authorization will not change the way my physician,
health insurance, and pharmacy providers treat me. I also understand that if I do not sign this Authorization,
I will not be able to receive EntyvioCon nect Patient Support Program products, supplies, or services.
PATIENT HIPAA AUTHORIZATION
8.
EntyvioConnect Enrollment and Prescription Form
FAX page 3 and page 4 to 1-877-488-6814
or call 1-855-ENTYVIO (1-855-368-9846)
Monday through Friday, from 8 am to 8 pm ET (except holidays)
PATIENT INFORMATION AND AUTHORIZATION
7.
Name (First, Middle Initial, Last) 
Email 
Mobile Phone   Alternate Phone 
Birth Date (MM/DD/YYYY)  Gender o Male o Female
Okay to leave a message about the status of my enrollment or prescription? o Yes o No
Patient Authorization I have read, understand, and agree to the release of my protected health information as described above.
X
PATIENT SIGNATURE/LEGAL REPRESENTATIVE SIGNATURE (Indicate relationship) DATE
Patient Support Program Enrollment
I have read, understand, and agree to the use of my personal information for the purposes described on page 5, section 9.
X
PATIENT SIGNATURE/LEGAL REPRESENTATIVE SIGNATURE (Indicate relationship) DATE
o  Check this box if you wish to opt-in
for EntyvioConnect Nurse Support
o  Check this box if you wish to enroll
in text message communication, as
described on page 6, section 14
4
PATIENT COPY
By signing the Patient Authorization section on the second page of this EntyvioConnect Enrollment Form,
I authorize my physician, health insurance, and pharmacy providers (including any specialty pharmacy that
receives my prescription) to disclose my protected health information, including, but not limited to, information
relating to my medical condition, treatment, care management, and health insurance, as well as all information
provided on this form (“Protected Health Information”), to Takeda Pharmaceuticals U.S.A., Inc. and its present
or future aliates, including the aliates and service providers that work on Takeda’s behalf in connection
with the EntyvioConnect Patient Support Program (the “Companies”). The Companies will use my Protected
Health Information for the purpose of facilitating the provision of the EntyvioConnec t Patient Support Program
products, supplies, or services as selected by me or my physician and may include (but not be limited to)
verification of insurance benefits and drug coverage, prior authorization education, financial assistance with
co-pays, patient assistance programs, and other related programs. Specifically, I authorize the Companies
to 1) receive, use, and disclose my Protected Health Information in order to enroll me in EntyvioConnect and
contact me, and/or the person legally authorized to sign on my behalf, about EntyvioConnect; 2) provide
me, and/or the person legally authorized to sign on my behalf, with educational materials, information,
and services related to EntyvioConnect; 3) verify, investigate, and provide information about my coverage
for Entyvio, including but not limited to communicating with my insurer, specialty pharmacies, and others
involved in processing my pharmacy claims to verify my coverage; 4) coordinate prescription fulfillment;
and 5) use my information to conduct internal analyses.
I understand that employees of the Companies only use my Protected Health Information for the purposes
described herein, to administer the EntyvioConnect Patient Support Program or as otherwise required or
allowed under the law, unless information that specifically identifies me is removed. Further, I understand that
my healthcare provider may receive financial remuneration from Takeda Pharmaceuticals U.S.A. for marketing
services. I understand that Protected Health Information disclosed under this Authorization may no longer be
protected by federal privacy law. I understand that I am entitled to a copy of this Authorization. I understand
that I may cancel this Authorization and that instructions for doing so are contained in Takeda’s Website
Privacy Notice available at www.takeda.com/privacy-notice/. I understand that such cancellation will not apply
to any information already used or disclosed through this Authorization. This Authorization will expire within
five (5) years from the date it is signed and provided on the first page of this enrollment form, unless a shorter
period is provided for by state law. I understand that I may refuse to sign this Authorization and that refusing
to sign this Authorization will not change the way my physician, health insurance, and pharmacy providers
treat me. I also understand that if I do not sign this Authorization, I will not be able to receive E ntyvioConnect
Patient Support Program products, supplies, or services.
PATIENT HIPAA AUTHORIZATION
10.
PATIENT SUPPORT PROGRAM ENROLLMENT
9.
Enroll me in the Entyv ioCon nect Patient Support Program (the “Program”). I have read and understand the applicable terms and conditions.
I certify that all the information provided on this form is accurate and complete, and I agree to notify the Program immediately if my medical
or prescription drug coverage changes in any way. I understand that Takeda and its business partners will use my personal information to enroll
me in the Program, provide the support I am asking for, and oer related services to me. I authorize Takeda, its aliates and business partners to
use my personal information to provide me with information and oers related to Entyvio, the diseases and the conditions it treats, and related
treatment options. In addition to information about Entyvio and related health conditions, I understand this may include information about clinical
trials and market research opportunities, and other support services or programs Takeda may in the future develop for patients. I also authorize
Takeda to use my de-identified information to help Takeda improve and develop products, services, materials, and programs or for health economic
outcomes and market research. I understand that I may revoke my permission at any time. To learn how Takeda will use and protect my personal
information, I acknowledge that I have reviewed Takeda’s Privacy Notice (www.takeda.com/privacy-notice/).
START PROGRAM TERMS AND CONDITIONS
11.
The Start Program provides Entyvio at no cost to eligible new-to-therapy patients who have received a prior authorization denial from their
commercial payer. Patients eligible for federal or state healthcare programs (Medicare, Medicaid, TRICARE, etc) are ineligible. Patients must have
a valid prescription for Entyvio that is consistent with Entyvio’s label. The Start Program provides Entyvio at no cost to eligible patients for up
to one year. If a patient enrolled in the Start Program is still appealing coverage at one year, the patient may be eligible for additional Entyvio
under the Start Program. Patients must submit evidence of prior authorization denial from their commercial payer and other required documents.
There is no purchase obligation by virtue of a patient’s participation in the Start Program. Free product provided through the Start Program is
only available through the Start Program’s contracted non-commercial specialty pharmacy. No claim for reimbursement for product dispensed
through the Start Program may be submitted to any third-party payer. Benefits provided under the Start Program are not transferable. The Start
Program is a one-time oer per patient. Eligibility will be determined on a case-by-case basis. Takeda reserves the right to change or end the
Start Program at any time, and other terms and conditions may apply.
5
PATIENT COPY (CONTINUED)
CO-PAY PROGRAM TERMS AND CONDITIONS
13.
The EntyvioConnect Co-Pay Program (“Co-Pay Program”) provides financial support for commercially insured patients who qualify for the
Co-Pay Program. The Co-Pay Program cannot be used if patient is a beneficiary of, or any part of the prescription is covered by: 1) any federal-,
state-, or government-funded healthcare program (Medicare, Medicare Advantage, Medicaid, TRICARE, etc.), including a state pharmaceutical
assistance program (the Federal Employees Health Benefit [FEHB] Program is not a government-funded healthcare program for the purpose of
this oer), 2) the Medicare Prescription Drug Program (Part D), or if patient is currently in the coverage gap, or 3) insurance that is paying the
entire cost of the prescription. Patient may not seek reimbursement from any other plan or program (Flexible Spending Account [FSA], Health
Savings Account [HSA], Health Reimbursement Account [HRA], etc.) for any out-of-pocket costs covered by the Co-Pay Program. Patient or
healthcare provider may be required to submit an Explanation of Benefits (EOB) following each infusion to the Co-Pay Program. Takeda reserves
the right to change or end the Co-Pay Program at any time without notice, and other terms and conditions may apply. Oer not valid for patients
under 18 years of age. Assistance under the Co-Pay Program is not transferable. The Co-Pay Program only applies in the United States, including
Puerto Rico and other U.S. territories, and does not apply where prohibited by law, taxed, or restricted. This does not constitute health insurance.
Void where use is prohibited by your insurance provider. If your insurance situation changes you must notify EntyvioConnect at 1-844-368-9846.
This oer is not transferable and is limited to one oer per person and may not be combined with any other coupon, discount, prescription
savings card, rebate, free trial, patient assistance, or other oer. Not valid if reproduced.
BRIDGE PROGRAM TERMS AND CONDITIONS
12.
The Bridge Program provides continuity of care when an eligible Entyvio patient experiences a loss of or gap in commercial insurance coverage or
authorization. The Bridge Program provides up to 6 months of product at no cost to enrolled patients while they obtain commercial coverage for
Entyvio. Patients must be currently receiving Entyvio therapy and experiencing a gap in or loss of commercial coverage. The Bridge Program is not
available to patients who are eligible for federal or state healthcare programs (Medicare, Medicaid, TRICARE, etc). Patients who have not yet received
their first dose of Entyvio are not eligible. There is no purchase obligation by virtue of a patient’s participation in the Bridge Program. Free
product provided through the Bridge Program is only available through the Bridge Program’s contracted non-commercial specialty pharmacy.
No claim for reimbursement for product dispensed through the Bridge Program may be submitted to any third-party payer. Benefits provided
under the Bridge Program are not transferable. The Bridge Program is a one-time oer per patient. Eligibility will be determined on a case-by-case
basis. Takeda reserves the right to change or end the Bridge Program at any time, and other terms and conditions may apply.
By agreeing to these EntyvioConnect (the “Program”) text message terms and conditions, you agree to receive text messages on your mobile
device subject to the Terms & Conditions described below. You also consent to receive autodialed and/or pre-recorded calls and/or text
messages from or on behalf of the Program at the telephone number provided above. You understand that this consent is not a condition of
purchase or use of the Program or of any Takeda product or service.
Participants will receive an average of 5 text messages each month while enrolled in the Program. Such messages may be nonmarketing
messages related to the Patient Support Program.
There is no fee payable to Takeda to receive text messages; however, your carrier’s message and data rates may apply.
You represent that you are the account holder for the mobile telephone number(s) that you provide to opt into the Program. You are
responsible for notifying Takeda immediately if you change your mobile telephone number. You may notify Takeda of a number change by
calling 1-855-ENTYVIO.
Data obtained from you in connection with your registration for, and use of, this SMS service may include your phone number and/or email
address, related carrier information, and elements of pharmacy claim information and will be used to administer this Program and to provide
Program benefits such as information about your prescription, refill reminders, as well as Program updates and alerts.
Takeda will not be liable for any delays in the receipt of any SMS messages as delivery is subject to eective transmission from your
network operator.
This Program is valid with most major US carriers, including Verizon Wireless, Sprint, Nextel, Boost Mobile, T-Mobile®, AT&T, Alltel, ACS Wireless,
Bluegrass Cellular, Carolina West Wireless, CellCom, Cellular One of East Central Illinois (ECIT), Cincinnati Bell, Cricket, C-Spire Wireless, Duet IP
(AKA Max/Benton/Albany), Element Mobile, Epic Touch, GCI Communications, Golden State, Hawkeye (Chat Mobility), Hawkeye (NW Missouri
Cellular), Illinois Valley Cellular (IVC), Inland Cellular, iWireless, Keystone Wireless (Immix/PC Management), MetroPCS, MobiPCS, Mosaic, MTPCS/
Cellular One (Cellone Nation), Nex-Tech Wireless, nTelos, Panhandle Telecommunications, Pioneer, Plateau, Revol Wireless, Rina-Custer, Rina-All
West, Rina-Cambridge Telecom Coop, Rina-Eagle Valley Comm, Rina-Farmers Mutual Telephone Co, Rina-Nucla Nutria Telephone Co, Rina-
Silver Star, Rina-South Central Comm, Rina-Syringa, Rina-UBET, Rina-Manti, Simmetry, South Canaan/CellularOne of NEPA, Thumb Cellular,
Union Wireless, United Wireless, U.S. Cellular, Viaero Wireless, Virgin Mobile, and West Central Wireless (includes Five Star Wireless).
Takeda may be required to contact the user if an adverse event is reported.
You agree to indemnify Takeda and any third parties texting on its behalf in full for all claims, expenses, and damages related to or caused, in
whole or in part, by your failure to immediately notify us if you change your telephone number, including but not limited to all claims, expenses,
and damages related to or arising under the Telephone Consumer Protection Act.
Takeda reserves the right to rescind, revoke, or amend the Program without notice at any time.
You can unsubscribe from this Program by texting STOP. For questions about this Program, text HELP or contact the customer support center
at 1-855-ENTYVIO.
TEXT MESSAGING
14.
6
For appropriate adult patients with moderate to severe ulcerative colitis or Crohn's disease when other therapies have not worked well
enough or cannot be tolerated.
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/mm
3
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.
Please see full Prescribing Information, including Medication Guide.
INDICATIONS
Adult Ulcerative Colitis
ENTYVIO (vedolizumab) is indicated in adults for the treatment of moderately to severely active UC.
Adult Crohn’s Disease
ENTYVIO (vedolizumab) is indicated in adults for the treatment of moderately to severely active CD.
References: 1. Centers for Medicare & Medicaid Services. 2020 ICD-10-CM. https://www.cms.gov/Medicare/Coding/ICD10/2020-ICD-10-CM. Accessed March 23, 2020.
2. Entyvio (vedolizumab) prescribing information. Takeda Pharmaceuticals.
ENTYVIO is a trademark of Millennium Pharmaceuticals, Inc., registered with the U.S. Patent and Trademark Oce and is used under license
by Takeda Pharmaceuticals America, Inc.
©2020 Takeda Pharmaceuticals U.S.A., Inc., Lexington, MA 02421. All rights reserved. US-VED-0219v2.0 07/20
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EntyvioConnect ENROLLMENT FORM Benets Investigation Start Program For (ENTYVIO)

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Completed 17 July 2021

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