ENTYVIO

Main information

  • Trade name:
  • ENTYVIO vedolizumab (rch) 300 mg powder for injection vial
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • ENTYVIO vedolizumab (rch) 300 mg powder for injection vial
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 210048
  • Last update:
  • 10-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

210048

ENTYVIO vedolizumab (rch) 300 mg powder for injection vial

ARTG entry for

Medicine Registered

Sponsor

Takeda Pharmaceuticals Australia Pty Ltd

Postal Address

GPO Box 2728,Sydney, NSW, 2001

Australia

ARTG Start Date

27/06/2014

Product category

Medicine

Status

Active

Approval area

Drug Safety Evaluation Branch

Conditions

Conditions applicable to all therapeutic goods as specified in the document "Standard Conditions Applying to Registered or Listed Therapeutic Goods

Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Standard Conditions Applying to Registered

or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Products

1. ENTYVIO vedolizumab (rch) 300 mg powder for injection vial

Product Type

Single Medicine Product

Effective date

8/06/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Treatment of adult patients with moderate to severe ulcerative colitis who have had an inadequate response with, lost response to, or are intolerant to

either conventional therapy or a tumour necrosis factor-alpha (TNF-alpha) antagonist.,Treatment of adult patients with moderate to severe Crohn's

disease who have had an inadequate response with, lost response to, or are intolerant to either conventional therapy or a tumour necrosis factor-alpha

(TNF-alpha) antagonist.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Vial

Glass Type I Clear

36 Months

Store at 2 to 8

degrees Celsius

Not recorded

Protect from Light

Do not Freeze

Pack Size/Poison information

Pack Size

Poison Schedule

(S4) Prescription Only Medicine

Components

1. ENTYVIO vedolizumab (rch) 300 mg powder for injection vial

Dosage Form

Injection, powder for

Route of Administration

Intravenous

Visual Identification

white to off-white lyophilized cake or powder

Active Ingredients

vedolizumab

331.2 mg

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 27.11.2017 at 10:04:55 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

Patient Information leaflet

ENTYVIO CMI

version 3.0

Page 1

Entyvio

®

Vedolizumab (rch)

Consumer Medicine Information (CMI)

What is in this leaflet

This leaflet answers some common

questions about Entyvio.

It does not contain all the available

information. It does not take the

place of talking to your doctor or

pharmacist.

The information in this leaflet was

last updated on the date listed on the

final page. More recent information

on the medicine may be available.

You should ensure that you speak to

your pharmacist or doctor to obtain

the most up to date information on

this medicine. You can also

download the most up to date leaflet

from https://www.ebs.tga.gov.au/.

Those updates may contain important

information about the medicine and

its use of which you should be aware.

All medicines have risks and

benefits. Your doctor has weighed

the risks of you being given this

medicine against the benefits they

expect it will have for you.

If you have any concerns about

being given this medicine, ask your

doctor or pharmacist.

Keep this leaflet with the medicine.

You may need to read it again.

What Entyvio is used

for

Entyvio contains the active substance

vedolizumab, a monoclonal antibody.

Monoclonal antibodies are proteins

that recognise and bind to certain

special proteins in the body.

Entyvio specifically binds to a

protein called integrin α

present

on certain white blood cells. Integrin

can act to increase inflammation

seen in ulcerative colitis and Crohn’s

disease.

Entyvio works by blocking α

integrins and so reduces

inflammation.

Ulcerative colitis

Ulcerative colitis is an inflammatory

disease of the large bowel. Entyvio is

used to treat the signs and symptoms

of moderate to severe ulcerative

colitis in adults who have not

responded well enough or are

intolerant to other treatments.

Crohn’s disease

Crohn’s disease is an inflammatory

disease of the bowel. It may also

affect any part of the gut. Entyvio is

used to treat the signs and symptoms

of moderate to severe Crohn’s

disease in adults who have not

responded well enough or are

intolerant to other treatments.

Ask your doctor or pharmacist if

you have any questions about why

Entyvio has been prescribed for

you.

Your doctor may have prescribed it

for another purpose.

This medicine is available only with

a doctor’s prescription.

There is not enough information to

recommend the use of this medicine

for children under the age of 18

years.

Before you are given

Entyvio

When you must not be given

it

You should not be given Entyvio if

you:

are allergic to vedolizumab or

any of the other ingredients

listed at the end of this leaflet.

Symptoms of an allergic reaction

may include wheezing, difficulty

breathing, hives, itching, swelling

or dizziness.

have an active severe infection,

such as for example tuberculosis,

blood poisoning, serious

abscesses.

Do not receive it after the expiry

date printed on the pack or if the

packaging is damaged or shows

signs of tampering.

If it has expired or is damaged return

it to your pharmacist for disposal.

Before you are given it

Tell your doctor if:

you have an infection, or think

you have an infection.

are going to receive any

vaccination or have recently

had a vaccination.

Entyvio may affect the way you

respond to a vaccination

you have any allergies to any

other medicines, foods,

preservatives or dyes.

Tell your doctor if you are

pregnant or intend to become

pregnant.

The effects of Entyvio in pregnant

women are not known. Therefore,

this medicine is not recommended

for use during pregnancy unless you

and your doctor decide that the

benefit to you clearly outweighs the

potential risk to your baby.

Your doctor can discuss the risks and

benefits involved.

If you are a woman of childbearing

potential, you should use adequate

contraception to avoid falling

pregnant and continue to use it for at

least 4.5 months after the last

treatment with Entyvio.

Tell your doctor if you are

breastfeeding or intend to

breastfeed.

It is not known whether Entyvio

passes into breast milk and if so what

ENTYVIO CMI

version 3.0

Page 2

effect this may have on your baby. If

you are breastfeeding, your doctor

may advise you to stop breastfeeding

while you are using this medicine.

If you have not told your doctor

about any of the above, tell them

before you are given Entyvio.

Taking other medicines

Tell your doctor or pharmacist if

you are taking any other

medicines, including any that you

buy without a prescription from

your pharmacy, supermarket or

health food store.

Entyvio should not be given with

other biologic medicines that

suppress your immune system as this

combination has not been studied in

clinical trials.

If you have previously taken

natalizumab (TYSABRI) or

rituximab (MABTHERA) for

other conditions, tell your doctor

who will decide if you can be given

Entyvio.

How Entyvio is given

Entyvio will be given to you by your

doctor or nurse in a hospital or a

clinic, through a drip in one of the

veins in your arm (intravenous

infusion) over about 30 minutes.

Your healthcare provider will

monitor you during and after the

Entyvio infusion for side effects to

see if you have a reaction to the

treatment.

If you have any questions about

how this medicine is given, ask

your doctor or nurse who is giving

you the infusion.

How much to take

Treatment with Entyvio is the same

for ulcerative colitis and Crohn’s

disease.

The recommended dose of Entyvio is

300 mg per infusion. You will get

additional infusions at 2 and 6 weeks

and be assessed by your treating

doctor 6 to 8 weeks after you’ve

completed the initial treatment doses

to see how you have responded. If

there has been an adequate response

to the first 3 doses you may continue

treatment with further doses every 8

weeks.

How long to take it

Continue receiving your medicine

for as long as your doctor tells you.

You should not stop using Entyvio

without talking with your doctor first.

If you forget or miss an

appointment

If you forget or miss an

appointment to receive the

infusion, make another

appointment as soon as possible.

If you are not sure what to do, ask

your doctor.

If you are given too much

(overdose)

As Entyvio is given to you by

infusion under the supervision of a

doctor or nurse, it is unlikely that you

will receive too much.

However, if you experience any

side effects after being given

Entyvio, tell your doctor or nurse

immediately.

While you are being

given Entyvio

Things you must do

When you first receive this

medicine and during the course of

the treatment, also between doses,

tell your doctor or nurse

immediately if you:

experience blurred, loss of or

double vision, difficulty

speaking, weakness in an arm

or a leg, a change in the way

you walk or problems with your

balance, persistent numbness,

decreased sensation or loss of

sensation, or memory loss or

confusion. These may all be

symptoms of a serious and

potentially fatal brain condition

known as progressive

multifocal leukoencephalopathy

(PML).

Your doctor or nurse will provide

you with a Patient Alert Card, that

you should keep with you at all

times. This card will remind you to

tell all other health professionals that

you are being given Entyvio.

If you experience any of the

symptoms in this card, you should

contact your doctor immediately.

have an infection, or think you

have an infection, such as if you

develop chills, shivering,

persistent cough or a high

fever.

Some infections may become

serious and possibly even life-

threatening if left untreated

experience signs of an allergic

reaction or other reaction to the

infusion such as wheezing,

difficulty breathing, hives,

itching, swelling or dizziness.

These could occur during or after

the infusion.

are going to receive any

vaccination or have recently

had a vaccination.

Entyvio may affect the way you

respond to a vaccination

If you are about to be started on

any new medicine, remind your

doctor that you are taking Entyvio.

If you become pregnant while you

are taking this medicine, tell your

doctor immediately.

Things you must not do

Do not use this medicine to treat

any other complaints unless your

doctor tells you to.

Do not give this medicine to anyone

else, even if they have the same

condition as you.

Do not stop taking Entyvio without

checking with your doctor.

Things to be careful of

Be careful driving or operating

machinery until you know how

Entyvio affects you.

This medicine may have a minor

influence on your ability to drive or

use tools or machines. A small

number of patients have felt dizzy

after receiving Entyvio.

If you feel dizzy, do not drive or

use tools or machines.

ENTYVIO CMI

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Page 3

Side effects

Tell your doctor or pharmacist as

soon as possible if you do not feel

well while you are taking Entyvio.

Entyvio helps most people with

ulcerative colitis or Crohn’s disease,

but it may have unwanted side effects

in a few people.

All medicines have some unwanted

side effects. Sometimes they are

serious, but most of the time they are

not. You may need medical attention

if you get some of the side-effects.

Do not be alarmed by this list of

possible side effects. You may not

experience any of them.

Ask your doctor or pharmacist to

answer any questions you may

have.

Tell your doctor or nurse if you

notice any of the following and

they worry you:

headache

fever

common cold

flu (influenza)

nose or throat infection

bronchitis

chest infection

cough

throat pain

nausea

itching

rash and redness

pain in the extremities

back pain

joint pain

tiredness

The above list includes the more

common side effects of your

medicine. They are usually mild and

short-lived.

Tell your doctor as soon as possible

if you notice any of the following:

high fever

rash

dark urine, yellowing of the eyes

and skin (jaundice)

The above symptoms could be a sign

of infection or liver injury. Some

infections may become serious and

possibly even life-threatening if left

untreated.

If any of the following happen, tell

your doctor immediately or go to

Accident and Emergency at your

nearest hospital:

wheezing or difficulty breathing

hives

itching of the skin

swelling

rapid heart beat

vomiting

chills or shivering

The above list includes very serious

side effects. You may need urgent

medical attention. These side effects

are rare.

Tell your doctor or pharmacist if

you notice anything else that is

making you feel unwell.

Other side effects not listed above

may occur in some people.

Storage

If you need to store Entyvio before

taking it to hospital or clinic, the

unopened vial should be stored in

the refrigerator at 2°C to 8°C

(Refrigerate. Do not freeze).

Protect from light. Keep the vial in

the original carton.

Do not store it or any other

medicine in the bathroom, near a

sink, or on a windowsill.

Do not leave it in the car.

Heat and damp can destroy some

medicines.

Keep it where children cannot

reach it.

Product description

What it looks like

Entyvio is a white to off-white

powder provided in a glass vial.

Each pack of Entyvio contains one

vial.

Ingredients

Active ingredient:

Each vial of Entyvio contains 300 mg

of vedolizumab.

After reconstitution each mL of

solution contains 60 mg of

vedolizumab.

Other ingredients:

histidine

histidine hydrochloride

monohydrate

arginine hydrochloride

sucrose

polysorbate 80

Supplier

Entyvio is supplied in Australia by:

Takeda Pharmaceuticals

Australia Pty Ltd

Level 5

2 Chifley Square

Sydney NSW 2000

Ph: 1800 675 957

Trademark

This leaflet was prepared in

December 2016.

Australian Registration Number

AUST R 210048

27-8-2018

Entyvio (Takeda Pharma A/S)

Entyvio (Takeda Pharma A/S)

Entyvio (Active substance: vedolizumab) - PSUSA - Modification - Commission Decision (2018)5712 of Mon, 27 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/10186/201711

Europe -DG Health and Food Safety