ENTYVIO vedolizumab 300 mg powder for injection vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

vedolizumab, Quantity: 331.2 mg

Available from:

Takeda Pharmaceuticals Australia Pty Ltd

INN (International Name):

vedolizumab

Pharmaceutical form:

Injection, powder for

Composition:

Excipient Ingredients: polysorbate 80; arginine hydrochloride; histidine; sucrose; histidine hydrochloride monohydrate

Administration route:

Intravenous

Units in package:

1

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Ulcerative colitis,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.,Crohn?s disease,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.,Pouchitis,Entyvio is indicated for the treatment of adult patients with moderate to severe chronic pouchitis, who have undergone proctocolectomy and ileal pouch anal anastomosis for ulcerative colitis, and have had an inadequate response with or lost response to antibiotic therapy.

Product summary:

Visual Identification: White to off-white lyophilized cake or powder; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 36 Months; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Licence status A

Authorization date:

2014-06-27

Patient Information leaflet

ENTYVIO
®
_Vedolizumab_
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.takeda.com/en-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
4
β
7
present
on certain white blood cells. Integrin
α
4
β
7
can act to increase
inflammation seen in ulcerative
colitis and Crohn’s disease.
Entyvio works by blocking
α
4
β
7
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 t

Summary of Product characteristics

ENTYVIO
®
PI V7.0 (CCDS v6.0) _ _
1
AUSTRALIAN PRODUCT INFORMATION
ENTYVIO
® (VEDOLIZUMAB)
1
NAME OF THE MEDICINE
Vedolizumab
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Intravenous infusion:
Each vial of ENTYVIO contains 300 mg of vedolizumab.
The powder is intended to be reconstituted with 4.8 mL of sterile
water for injections. After
reconstitution, each mL contains 60 mg of vedolizumab and the pH is
approximately 6.3. Five (5) mL
of the reconstituted solution is to be diluted into 250 mL sterile
0.9% sodium chloride solution or
250 mL of sterile Lactated Ringer’s solution prior to use.
Subcutaneous injection:
Each ENTYVIO pre-filled syringe or pre-filled pen contains 108 mg of
vedolizumab in 0.68 mL.
ENTYVIO 108 mg is supplied as a sterile, clear, colourless to yellow,
preservative free solution for
subcutaneous administration with a pH of 6.5.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Intravenous infusion:
ENTYVIO 300 mg powder for injection for intravenous infusion is
supplied as a white to off-white
lyophilised cake or powder for injection, in a single-use vial.
Subcutaneous injection:
ENTYVIO 108 mg solution for injection is supplied as single-dose
pre-filled syringe with needle
safety device or single-dose pre-filled pen. The solution is
colourless to yellow.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC 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 (TNFα) 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 (TNFα) antagonist.
4.2
DOSE AND METHOD OF ADMINISTRATION
ENTYVIO treatment should be initiated and supervised by specialist
healthcare professionals
experienced in the diagnosis and treatment of ulcerative co