For adults with moderately to severely active ulcerative colitis (UC) or Crohn’s disease.

NOW APPROVED The ENTYVIO® Pen for Crohn's Disease.

Adults with Crohn’s or UC
can be prescribed
the ENTYVIO Pen for
maintenance therapy

ENTYVIO® Pen packaging.

Key Resources

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ENTYVIO Pen?

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about ENTYVIO Pen
Approval for Crohn’s

FAQs

When will the ENTYVIO Pen be available for Crohn’s disease?

The ENTYVIO Pen is now available to be prescribed as maintenance therapy for adults with moderate to severe Crohn's or UC.

Will the ENTYVIO Pen for subcutaneous (SC) injection have the same indications as the approved intravenous (IV) formulation?

Yes, the ENTYVIO Pen is approved for the treatment of adults with moderate to severe Crohn's or UC.

Patients may switch to ENTYVIO SC after 2 or more doses of ENTYVIO IV. Please see Full Prescribing Information for more information.

Will the ENTYVIO subcutaneous formulation (via the ENTYVIO Pen) replace IV for Crohn’s?

No, ENTYVIO IV will continue to be available for patients with Crohn's or UC. ENTYVIO SC and ENTYVIO IV are both approved for use as maintenance therapy, providing physicians and patients with greater flexibility on route of administration options. Patients responding to ENTYVIO IV after Week 6 may be switched to ENTYVIO SC.

Why is Takeda launching a subcutaneous administration of ENTYVIO for Crohn’s?

Living with Crohn’s disease can be a lifelong journey, and the needs and preferences of adult patients living with moderately to severely active Crohn’s vary. The availability of the ENTYVIO Pen for Crohn's or UC gives patients and their healthcare providers added flexibility to choose a route of administration for maintenance therapy—intravenous infusion or a single-dose subcutaneous injection pen.

Can current Crohn’s patients transition from ENTYVIO IV to ENTYVIO subcutaneous?

Yes. 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.1

What is the dosing for ENTYVIO subcutaneous for Crohn's and UC? Is it the same dosage amount as ENTYVIO IV?

Dosing remains the same for both Crohn's and UC. The recommended dose for ENTYVIO SC maintenance therapy is 108 mg, administered once every 2 weeks after at least 2 IV induction doses.1 The first SC maintenance dose should be administered in place of the next scheduled IV infusion and every 2 weeks thereafter. The SC dosing is different from the currently approved IV dosing, which is 300 mg IV every 8 weeks for maintenance therapy.1

Please refer to the Full Prescribing Information for more details on dosing and administration.

What is the device formulation for ENTYVIO subcutaneous for Crohn’s?

ENTYVIO SC for Crohn’s is available as a 108 mg single-dose prefilled pen, which will offer patients with Crohn's a self-administration option.

Does Takeda have clinical data on ENTYVIO subcutaneous for Crohn’s?

VISIBLE 2 was a phase 3, double-blind, placebo-controlled trial that evaluated the safety and efficacy of ENTYVIO SC. Patients who achieved clinical response following two doses of ENTYVIO administered as an intravenous infusion at Week 0 and Week 2 were randomized 2:1 at Week 6 to ENTYVIO SC or placebo.1 Download the VISIBLE 2 Trial Reprint to review the clinical data.

What were the safety results in the VISIBLE 2 trial for ENTYVIO subcutaneous?

In the VISIBLE 2 trial, the ENTYVIO SC safety profile was generally consistent with the known safety profile of ENTYVIO IV, with the exception of injection site reactions, including injection site erythema, pruritus, urticaria, pain, rash, and edema, which were reported in 3% of patients receiving ENTYVIO SC.1

Where can patients get the ENTYVIO Pen?

The ENTYVIO Pen is available to prescribe now through Takeda’s specialty pharmacy network and select qualifying on-site pharmacies.

What do I need to do to prescribe the ENTYVIO Pen?

For information on prescribing the ENTYVIO Pen, see the below Dosing and Administration section.

How can I register my patients for product support services?

Because each patient’s circumstances vary, we offer a range of programs tailored to help patients in the way they need it most after the prescribing decision has been made. Enroll patients in EntyvioConnect to help them navigate the insurance approval process, find out if they’re eligible for financial support, and get paired with a Nurse Educator.

Dosing and Administration

SC Dosing

Starting New Patients

start

Start with 300 mg IV infusions for:

Weeks 0 and 21

maintain

Starting at Week 6, begin
ENTYVIO 108 mg SC and
continue every 2 weeks1

SWITCH PATIENTS

  • Patients responding to ENTYVIO IV after Week 6 may be switched to ENTYVIO SC
  • Administer the first SC dose in place of the next scheduled IV dose and Q2W thereafter
Established IV maintenance switching to subcutaneous injection maintenance.

Discontinue ENTYVIO in patients who show no evidence of therapeutic benefit by Week 14.1

The efficacy and safety of switching from ENTYVIO SC to ENTYVIO IV have not been studied.

For complete Dosage and Administration information, please see Full Prescribing Information.

Prior to administration1

Patients should be brought up-to-date with all
immunizations prior to starting ENTYVIO.

Administration1

ENTYVIO SC is administered in a 108 mg
single-dose prefilled pen. ENTYVIO IV is administered as a 300 mg flat dose over an approximately 30-minute infusion.

Concomitant therapies1

ENTYVIO can be administered concomitantly
with aminosalicylates, steroids, and
immunomodulators.

Monitoring1

ENTYVIO IV should be administered by a
healthcare professional prepared to manage
hypersensitivity reactions, including anaphylaxis,
if they occur. Appropriate monitoring and
medical support measures should be available
for immediate use. Observe patients during
infusion and until the infusion is complete.

Injection education1

After proper training on correct subcutaneous
injection technique, a patient or caregiver may
administer the ENTYVIO Pen if a healthcare
professional determines it is appropriate.
Patients and caregivers should be instructed to
follow the directions for administration of the
ENTYVIO Pen in the Instructions For Use section
of the Full Prescribing Information.

Q2W=every 2 weeks.

IMPORTANT SAFETY INFORMATION

Contraindications

ENTYVIO is contraindicated in patients who have had a known serious or severe hypersensitivity reaction to ENTYVIO or any of its excipients.

WARNINGS AND PRECAUTIONS

  • Infusion-Related and Hypersensitivity Reactions: Infusion-related reactions and hypersensitivity reactions including anaphylaxis, dyspnea, bronchospasm, urticaria, flushing, rash, and increased blood pressure and heart

IMPORTANT SAFETY INFORMATION

Contraindications

ENTYVIO is contraindicated in patients who have had a known serious or severe hypersensitivity reaction to ENTYVIO or any of its excipients.

Warnings and precautions

  • Infusion-Related and Hypersensitivity Reactions: 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.
  • Infections: 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): 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 typically only occurs in patients who are immunocompromised. One case of PML in an ENTYVIO-treated patient with multiple contributory factors has been reported. Although unlikely, a risk of PML cannot be ruled out. Monitor patients for any new or worsening neurological signs or symptoms that may 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 neurologist; if confirmed, discontinue ENTYVIO dosing permanently.
  • Liver Injury: 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.
  • Live and Oral Vaccines: 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.

Adverse reactions

The most common adverse reactions (incidence ≥3% and ≥1% higher than placebo) were: nasopharyngitis, headache, arthralgia, nausea, pyrexia, upper respiratory tract infection, fatigue, cough, bronchitis, influenza, back pain, rash, pruritus, sinusitis, oropharyngeal pain, pain in extremities, and injection site reactions with subcutaneous administration.

Drug interactions

Because of the potential for increased risk of PML and other infections, avoid the concomitant use of ENTYVIO with natalizumab products and with TNF blockers. Upon initiation or discontinuation of ENTYVIO in patients treated with CYP450 substrates, monitor drug concentrations or other therapeutic parameters, and adjust the dosage of the CYP substrate as needed.

INDICATIONS

Adult Ulcerative Colitis (UC):

ENTYVIO is indicated in adults for the treatment of moderately to severely active UC.

Adult Crohn’s Disease (CD):

ENTYVIO is indicated in adults for the treatment of moderately to severely active CD.

Dosage forms & strengths:

  • ENTYVIO Intravenous (IV) Infusion: 300 mg vedolizumab
  • ENTYVIO Subcutaneous (SC) Injection: 108 mg vedolizumab

Please click for Full Prescribing Information.

Reference:

  1. ENTYVIO (vedolizumab) prescribing information. Takeda Pharmaceuticals.