Is there a pregnancy exposure registry for ENTYVIO?

Yes, there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ENTYVIO during pregnancy. For more information, you can call 1-877-TAKEDA-7 (1-877-825-3327).

What are the risks associated with inflammatory bowel disease (IBD) in pregnancy?

Published data suggest that the risk of adverse pregnancy outcomes in women with IBD is associated with increased disease activity. Adverse pregnancy outcomes include preterm delivery (before 37 weeks of gestation), low birth weight (less than 2,500 g) infants, and small for gestational age at birth.

Can ENTYVIO affect immune responses in newborns and infants?

ENTYVIO administered during pregnancy could affect immune responses in the in utero-exposed newborn and infant. The clinical significance of low levels of ENTYVIO in utero-exposed infants is unknown. The safety of administering live or live-attenuated vaccines in exposed infants is also unknown.

Is ENTYVIO safe for use in pediatric patients?

Safety and effectiveness of ENTYVIO in pediatric patients have not been established.

Is ENTYVIO safe for use in geriatric patients?

Clinical trials of ENTYVIO did not include sufficient numbers of subjects aged 65 and over.

Entyvio Prescribing & Dosing Schedule

Dosage & Administration

Important Administration Information

* Before initiating ENTYVIO, update immunizations according to current immunization guidelines.
* Intravenous Administration: ENTYVIO should be administered intravenously by a healthcare provider.
* Subcutaneous Injection: ENTYVIO prefilled syringe and ENTYVIO PEN are intended for subcutaneous use. A patient may self-inject or caregiver may inject after proper training on correct subcutaneous injection technique.

Recommended Dosage

* Week 0: 300 mg infused intravenously over approximately 30 minutes.
* Week 2: 300 mg infused intravenously over approximately 30 minutes.
* Week 6: Patients may remain on ENTYVIO intravenous therapy or switch to subcutaneous injection after receiving two ENTYVIO intravenous doses administered at Week 0 and Week 2.
* Intravenous Infusion: 300 mg infused over approximately 30 minutes and then every eight weeks thereafter.
* Subcutaneous Injection: 108 mg subcutaneously once every two weeks.

* Discontinue ENTYVIO in patients who do not show evidence of therapeutic benefit by Week 14.
* Patients currently receiving and responding to ENTYVIO intravenous therapy after Week 6 may also be switched to subcutaneous injection. Administer the first subcutaneous dose in place of the next scheduled intravenous infusion and every two weeks thereafter.

Preparation and Administration Instructions:

* See full prescribing information for complete information on reconstitution, dilution, administration, and storage.

Get Your Patient on Entyvio

See your patient's specific prior authorization requirements including coverage restrictions and step therapies

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Entyvio Prescribing Information

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Entyvio Prior Authorization Resources

Most recent state uniform prior authorization forms

Verified: Sep 24, 2024Arizona - Uniform Prior Authorization Form

Verified: Sep 24, 2024Colorado - Uniform Prior Authorization Form

Verified: Sep 24, 2024Hawaii - Uniform Prior Authorization Form

Verified: Sep 24, 2024Illinois - Uniform Prior Authorization Form

Verified: Sep 24, 2024Indiana - Uniform Prior Authorization Form

Verified: Sep 24, 2024Louisiana - Uniform Prior Authorization Form

Verified: Sep 24, 2024Minnesota - Uniform Prior Authorization Form

Verified: Sep 24, 2024New Hampshire - Uniform Prior Authorization Form

Verified: Sep 24, 2024New Mexico - Uniform Prior Authorization Form

Verified: Sep 24, 2024Oregon - Uniform Prior Authorization Form

Verified: Sep 24, 2024Texas - Uniform Prior Authorization Form

Verified: Oct 05, 2024Washington - Uniform Prior Authorization Form

Verified: Oct 05, 2024Wisconsin - Uniform Prior Authorization Form

Appeal Letter For Rejected Claim

Coverage Authorization Appeals

Complete Letter of Medical Necessity

Benefits investigation

Entyvio Connect Enrollment Form

Reimbursement help (FRM)

Receive Assistance from an FRM Regarding Reimbursement Information

Entyvio Financial Assistance Options

Copay savings program

Entyvio Connect Enrollment Form

Enroll in Patient Savings Program

Co-Pay Claim Form

Learn More

Overview

Reduce patient OOP costs for drug (and occasionally for drug administration/infusion costs or drug-related test costs)

Patient benefit

A portion (or all) of patient OOP (deductible, copay), typically up to monthly and/or annual max

Patient eligibility

Patient must enroll or activate (may permit HCPs to enroll on patient’s behalf for HCP-administered drugs)
Generally, must have commercial insurance (rarely, may permit uninsured patients to use)
May never be used with government insurance

How to sign up

Cards may be downloadable digital cards or hard copies
Some pharmacos offer debit cards with pre-loaded copay benefit
Typically, available through multiple channels (e.g., rep to HCP to patient; pharmacy to patient; patient via website, Hub live agent, or copay vendor (live agent or IVR); patient and HCP via Hub enrollment form)
Some HCP-administered product programs permit HCPs to enroll on a patient’s behalf through via Hub form

Bridge program

Entyvio Connect Enrollment Form

Start Program [Awaiting Approval]

Bridge Program [Temporary loss or gap in coverage]

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Overview

Provide patient immediate access to therapy during an insurance delay (typically new starts; some may cover change in insurance)
Limited time/ fill (typically 7-30 days; some may offer additional fill for continued delay up to certain limit)

Patient benefit

100% free (outside of insurance)

Patient eligibility

HCP must enroll patient
May be limited to commercially insured patients (i.e., no government beneficiaries); some programs may allow government beneficiaries

How to sign up

Typically HCP assisted enrollment (via form)

Foundation programs

Patient Assistance Application Form

Learn More

Overview

Charitable 501(c)(3) organizations provide direct cost-sharing and other support (e.g., travel, counseling) through disease-state funds to indigent patients on first-come first-served basis
These organizations may receive financial contributions from drug manaufacturers for particular disease-state funds that cannot provide funds directly to patients - the foundation must be independent/unaligned

Patient benefit

Patients apply for grants that cover a portion (or all) of their out-of-pocket costs (deductibles and copays) until the grant is exhausted

Patient eligibility

Patients must apply and meet eligibility criteria including income level (typically a multiple of federal poverty line), specific diagnosis, insurance status, etc.

How to sign up

Patients submit proof of out-of-pocket drug costs to charities for reimbursement

Entyvio PubMed™ News

Entyvio Patient Education

To share resource; ask patient to:

1.Pull out phone

2.Open camera

3.Scan QR code with camera

4.Tap link