ENTYVIO vedolizumab 108 mg/0.68 mL solution for injection pre-filled pen

Country: Ավստրալիա

language: անգլերեն

source: Department of Health (Therapeutic Goods Administration)

active_ingredient:

vedolizumab, Quantity: 119 mg

MAH:

Takeda Pharmaceuticals Australia Pty Ltd

pharmaceutical_form:

Injection, solution

composition:

Excipient Ingredients: citric acid monohydrate; sodium citrate dihydrate; histidine; histidine hydrochloride monohydrate; arginine hydrochloride; polysorbate 80; water for injections

administration_route:

Subcutaneous

units_in_package:

1 pen, 6 pens, 2 pens

prescription_type:

(S4) Prescription Only Medicine

therapeutic_indication:

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.

leaflet_short:

Visual Identification: Colourless to yellow solution; Container Type: Syringe; Container Material: Glass Type I Clear; Container Life Time: 24 Months; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

authorization_status:

Registered

authorization_date:

2020-05-12

PIL

ENTYVIO
® PRE-FILLED PEN
E
N
T
Y
V
I
O
®
P
R
E
-
F
I
L
L
E
D
P
E
N
C
M
I
V
2
.
0
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING ENTYVIO?
Entyvio pre-filled pen for subcutaneous injection contains the active
ingredient vedolizumab. Entyvio is used to treat the signs and
symptoms of moderate to severe ulcerative colitis or moderate to
severe Crohn’s disease in adults who have not responded well
enough or are intolerant to other treatments.
For more information, see Section 1. Why am I using Entyvio? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE ENTYVIO?
Do not use if you have ever had an allergic reaction to vedolizumab or
any of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING OR PLAN TO BREASTFEED.
For more information, see Section 2. What should I know before I use
Entyvio? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Entyvio and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE ENTYVIO PRE-FILLED PEN?
•
Entyvio solution for injection is given by injection just under the
skin (subcutaneous injection).
More instructions can be found in Section 4. How do I use Entyvio? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING ENTYVIO?
THINGS YOU
SHOULD DO
•
Read this leaflet carefully before you start using this medicine. It
contains important information for you.
•
Keep this leaflet. You may need to read it again.
•
Your doctor or nurse will also give you a Patient Alert Card when you
first start treatment with Entyvio.
Keep it with you at all times.
•
If you have any questions, ask your doctor, pharmacist or nurse.
THINGS YOU
SHOULD NOT DO
•
Do not stop using Entyvio without checking

SPC

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