Prescribing Entyvio SC

Entyvio (vedolizumab) is available in both subcutaneous and intravenous formulations,1,2 allowing you the flexibility to choose the route of administration that best fits your patient’s needs.

The administration of Entyvio (vedolizumab) SC should be initiated and supervised by specialist healthcare professionals experienced in the diagnosis and treatment of UC or CD.1

Please click here to refer to the Entyvio Summary of Product Characteristics for full dosing and administration guidance in UC and CD.1

Patients should be given the package leaflet and the patient alert card.1

Select from the options below for further information:

The recommended dose of Entyvio SC as a maintenance treatment, following at least two IV infusions, is 108 mg once every 2 weeks.1

The first SC dose should be administered in place of the next scheduled IV dose and every 2 weeks (Q2W) thereafter.1

In patients who have responded to treatment with Entyvio SC, corticosteroids may be reduced and/or discontinued in accordance with standard of care.1

If treatment with Entyvio SC is interrupted or if a patient misses a scheduled dose(s), they should be advised to inject the next SC dose as soon as possible and then every 2 weeks thereafter.1

Entyvio SC dosing1

Maintenance chart

The recommended dose of Entyvio SC as a maintenance treatment, following at least two IV infusions, is 108 mg once every 2 weeks.1

The first SC dose should be administered in place of the next scheduled IV dose and every 2 weeks (Q2W) thereafter.1

In patients who have responded to treatment with Entyvio, corticosteroids may be reduced and/or discontinued in accordance with standard of care.1

If treatment with Entyvio SC is interrupted or if a patient misses a scheduled dose(s), they should be advised to inject the next SC dose as soon as possible and then every 2 weeks thereafter.1

Entyvio SC dosing1

Maintenance chart

Homecare information

Entyvio SC will be provided through a Takeda-funded national homecare delivery service.

Takeda has commissioned the service through two homecare providers in the UK: Healthcare at Home and HealthNet Homecare. Homecare pharmacists should either contact their local homecare representative, or their national homecare representative:

Healthcare at Home
Ian Morgan, General Manager – NHS
ian.morgan@hah.co.uk
07730 092946

HealthNet Homecare
Rachel Farmer, Head of Sales & Client Contract Management
rachel.farmer@healthnethomecare.co.uk
07827 886825

Administration

Entyvio solution for injection (in a pre-filled syringe or a pre-filled pen) is for subcutaneous injection only.1

After proper training on correct SC injection technique, a patient or caregiver may inject with Entyvio SC if their physician determines it is appropriate. Comprehensive instructions for administration using the pre-filled syringe or the pre-filled pen are given in the respective package leaflet.1

An Entyvio SC training device is available to order by clicking here.

Instructions for administration:1

1

After removing the pre-filled syringe or pre-filled pen from the refrigerator, wait 30 minutes before injecting to allow the solution to reach room temperature.

2

Do not leave the pre-filled syringe or pre-filled pen in direct sunlight.

3

Do not freeze. Do not use if it has been frozen.

4

Inspect the solution visually for particulate matter and discoloration prior to administration. The solution should be colourless to yellow. Do not use pre-filled syringe or pre-filled pen with visible particulate matter or discoloration.

5

Each pre-filled syringe or pre-filled pen is for single use only.

6

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

Instructions for storage and shelf life

Entyvio SC has a shelf life of 24 months.1

Store in a refrigerator (2–8°C). Keep the pre-filled syringe or pre-filled pen in the outer carton in order to protect from light. Do not freeze.1

If needed, the pre-filled syringe and pre-filled pen can be left out of the refrigerator in its original carton at room temperature (up to 25 °C) for up to 7 days. Do not use the pre-filled syringe or pre-filled pen if left out of the refrigerator for more than 7 days.1

Entyvio SC administration guide and video

Entyvio subcutaneous pen: How-to inject video

 

Entyvio subcutaneous pen instructions

 

Entyvio subcutaneous syringe: How-to inject video

 

Entyvio subcutaneous syringe instructions

 

If treatment with Entyvio SC is interrupted or if a patient misses a scheduled dose(s), they should be advised to inject the next SC dose as soon as possible and then every 2 weeks thereafter.1

The treatment interruption period in clinical trials extended up to 46 weeks with no evident increase in adverse reactions or injection site reactions during re-initiation of treatment with Entyvio SC.1

Please refer to the Entyvio Summary of Product Characteristics for full safety information.

Contraindications

Entyvio SC is contraindicated in patients with hypersensitivity to the active substance vedolizumab or to any of the following excipients: Citric acid monohydrate, sodium citrate dihydrate, L-histidine, L-histidine monohydrochloride, L-arginine hydrocholoride, and polysorbate 80 and water for injections.1

Entyvio SC should not be used in patients with:1

  • Active severe infections, such as tuberculosis (TB), sepsis, cytomegalovirus, listeriosis
  • Opportunistic infections, such as progressive multifocal leukoencephalopathy (PML)

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Special Warnings and Precautions for Use

Traceability

In order to improve the traceability of biologics, the name and the batch number of the administered product should be clearly recorded.1

Hypersensitivity reactions

Hypersensitivity reactions have been reported in clinical studies in Entyvio SC, with the majority being mild to moderate in severity. If an anaphylactic reaction, or other severe reaction occurs, administration of Entyvio SC must be discontinued immediately and appropriate treatment initiated.1

Infections

Vedolizumab is a gut-selective integrin antagonist with no identified systemic immunosuppressive activity.1

Physicians should be aware of the potential increased risk of opportunistic infections or infections for which the gut is a defensive barrier. Entyvio SC treatment is not to be initiated in patients with active, severe infections until the infections are controlled, and physicians should consider withholding treatment in patients who develop a severe infection while on chronic treatment with Entyvio SC. Caution should be exercised when considering the use of vedolizumab in patients with a controlled chronic severe infection or a history of recurring severe infections.1

Patients should be monitored closely for infections before, during and after treatment. Entyvio SC is contraindicated in patients with active tuberculosis (TB). Before starting treatment with vedolizumab, patients must be screened for TB according to the local practice. If latent TB is diagnosed, appropriate treatment must be started with anti-TB treatment in accordance with local recommendations, before beginning vedolizumab. In patients diagnosed with TB whilst receiving vedolizumab therapy, then vedolizumab therapy should be discontinued until the TB infection has been resolved.1

Some integrin antagonists and some systemic immunosuppressive agents have been associated with progressive multifocal leukoencephalopathy (PML), which is a rare and often fatal opportunistic infection caused by the John Cunningham virus. By binding to the α4β7 integrin expressed on gut-homing lymphocytes, vedolizumab exerts an immunosuppressive effect on the gut. Although no systemic immunosuppressive effect was noted in healthy subjects the effects on systemic immune system function in patients with inflammatory bowel disease patients is not known.1

Healthcare professionals should monitor patients on Entyvio SC for any new onset or worsening of neurological signs and symptoms as outlined in physician education materials, and consider neurological referral if they occur. The patient is to be given a Patient Alert Card. If PML is suspected, treatment with Entyvio SC must be withheld; if confirmed, treatment must be permanently discontinued.1

Malignancies

The risk of malignancy is increased in patients with UC and CD. Immunomodulatory medicinal products may increase of malignancy.1

Prior and Concurrent Use of Biologic Products

No vedolizumab clinical trial data are available for patients previously treated with natalizumab or rituximab. Caution should be exercised when considering the use of Entyvio SC in these patients.1

Patients previously exposed to natalizumab should normally wait a minimum of 12 weeks prior to initiating therapy with Entyvio SC, unless otherwise indicated by the patient’s clinical condition.1

No clinical trial data for concomitant use of vedolizumab with biologic immunosuppressants are available. Therefore, the use of Entyvio SC in such patients is not recommended.1

Live and Oral Vaccines

In a placebo-controlled study of healthy volunteers, a single 750 mg dose of vedolizumab did not lower rates of protective immunity to hepatitis B virus in subjects who were vaccinated intramuscularly with three doses of recombinant hepatitis B surface antigen. Vedolizumab-exposed subjects had lower seroconversion rates after receiving a killed, oral cholera vaccine. The impact on other oral and nasal vaccines is unknown.1

It is recommended that all patients be brought up to date with all immunisations in agreement with current immunisation guidelines prior to initiating therapy with Entyvio SC.1

Patients receiving Entyvio SC treatment may continue to receive non-live vaccines.1

There are no data on the secondary transmission of infection by live vaccines in patients receiving vedolizumab.1

Administration of the influenza vaccine should be by injection in line with routine clinical practice. Other live vaccines may be administered concurrently with Entyvio SC only if the benefits clearly outweigh the risks.1

Induction of Remission in Crohn’s Disease

Induction of remission in CD may take up to 14 weeks in some patients. The reasons for this are not fully known and are possibly related to the mechanism of action. This should be taken into consideration, particularly in patients with severe active disease at baseline not previously treated with TNFα antagonists.1

Exploratory subgroup analyses from the clinical trials in CD suggested that vedolizumab administered in patients without concomitant steroid treatment may be less effective for induction of remission in CD than in those patients already receiving concomitant steroids (regardless of use of concomitant immunomodulators).1

Sodium content

This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free’.1

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Adverse Events1

1 in 10 People or More

Very Common

  • Arthralgia
  • Headache
  • Nasopharyngitis

1 in 10 People
or Less

Common

  • Abdominal distension
  • Acne
  • Anal abscess
  • Anal fissure
  • Back pain
  • Bronchitis
  • Constipation
  • Cough
  • Eczema
  • Erythema
  • Dyspepsia
  • Fatigue
  • Flatulence
  • Gastroenteritis
  • Haemorrhoids
  • Hypertension
  • Influenza
  • Injection site reactions
  • Muscle spasms
  • Muscular weakness
  • Nasal congestion
  • Nausea
  • Night sweats
  • Oropharyngeal pain
  • Pain in the extremity
  • Paraesthesia
  • Pharyngitis
  • Pruritus
  • Pyrexia
  • Rash
  • Sinusitis
  • Upper respiratory tract infection

1 in 100 People
or Less

Uncommon

  • Chills
  • Feeling cold
  • Infusion related reaction
  • Infusion site reaction (including infusion site pain and infusion site irritation)
  • Oral candidiasis
  • Redness and tenderness of hair follicle
  • Respiratory tract infection
  • Throat and mouth yeast infection
  • Vaginal infection
  • Vulvovaginal candidiasis
  • Shingles (herpes zoster)

1 in 10,000 People or Less

Very rare

  • Pneumonia
  • Blurred vision
  • Sudden, severe allergic reaction which can cause
    breathing difficulty, swelling, fast heartbeat,
    sweating, drop in blood pressure, light-headedness,
    loss of consciousness and collapse (anaphylactic
    reaction and anaphylactic shock)

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Entyvio SC dosing guide

 

Entyvio SC pen: How-to inject video (for patients)

 

Entyvio SC pen instructions

 

Entyvio SC syringe: How-to inject video (for patients)

 

Entyvio SC syringe instructions

 

Entyvio SC Carer Booklet

 

Adverse events should be reported. In the United Kingdom, reporting forms and information can be found at www.mhra.gov.uk/yellowcard.

Adverse events should also be reported to Takeda by e-mail at

AE.GBR-IRL@takeda.com