BAVENCIO avelumab (rch) 200 mg/10 mL concentrated solution for intravenous infusion vial

Land: Australië

Taal: Engels

Bron: Department of Health (Therapeutic Goods Administration)

Werkstoffen:

avelumab, Quantity: 20 mg/mL

Beschikbaar vanaf:

Merck Healthcare Pty Ltd

farmaceutische vorm:

Injection, concentrated

Samenstelling:

Excipient Ingredients: polysorbate 20; mannitol; glacial acetic acid; sodium hydroxide; water for injections

Toedieningsweg:

Intravenous Infusion

Eenheden in pakket:

1

Prescription-type:

(S4) Prescription Only Medicine

therapeutische indicaties:

BAVENCIO is indicated for the treatment of adults and paediatric patients 12 years and older with metastatic Merkel cell carcinoma (mMCC). This indication is approved based on tumour response rate, duration of response in a single arm study.,BAVENCIO is indicated for the first-line maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) whose disease has not progressed with first-line platinum-based induction chemotherapy.,BAVENCIO in combination with axitinib is indicated for the first-line treatment of patients with advanced renal cell carcinoma (RCC).

Product samenvatting:

Visual Identification: Clear, colourless to slightly yellow solution; 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

Autorisatie-status:

Registered

Autorisatie datum:

2018-01-03

Bijsluiter

This medicine is subject to additional monitoring. This will allow
quick identification of new safety information. You can
help by reporting any side effects you may get. You can report side
effects to your doctor, or directly at www.tga.gov.au/
reporting-problems .
BAVENCIO
®
_avelumab (rch)_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about BAVENCIO.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have benefits and
risks. Your doctor has weighed the
risks of treating you with
BAVENCIO against the benefits
expected for you.
IF YOU HAVE ANY CONCERNS ABOUT
RECEIVING THIS MEDICINE, TALK TO
YOUR DOCTOR, NURSE OR THE HOSPITAL
PHARMACIST.
KEEP THIS LEAFLET IN A SAFE PLACE.
You may need to read it again.
WHAT BAVENCIO IS
USED FOR
BAVENCIO contains the active
substance avelumab, a monoclonal
antibody, which is a protein designed
to recognise and attach to a specific
target in the body to help the immune
system attack and destroy cancer
cells.
BAVENCIO is used to treat:
•
a rare type of skin cancer called
metastatic Merkel cell carcinoma
(mMCC) where the disease has
spread.
•
a type of cancer in the bladder or
urinary tract called urothelial
carcinoma, when the disease is
advanced or metastatic but has
not progressed with platinum-
based chemotherapy
•
a type of kidney cancer called
renal cell carcinoma (RCC), when
it is advanced, in combination
with another medicine, axitinib. It
is important that you also read the
Consumer Medicine Information
for axitinib. If you have any
questions about axitinib, ask your
doctor.
This medicine is available only with
a doctor's prescription.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY BAVENCIO
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
BEFORE YOU ARE GIVEN
BAVENCIO
_WHEN YOU MUST NOT BE GIVEN_
_IT_
DO NOT USE BAVENCIO:
•
if you are allergic
(hypersensitive) to avelumab or
any of the other ing

Productkenmerken

Version: a007-0722
1
Supersedes: a006-0122
This medicinal product is subject to additional monitoring in
Australia. This will allow
quick identification of new safety information. Healthcare
professionals are asked to report
any suspected adverse events at www.tga.gov.au/reporting-problems.
AUSTRALIAN PRODUCT INFORMATION – BAVENCIO
® (AVELUMAB) CONCENTRATED
SOLUTION FOR INJECTION (INTRAVENOUS INFUSION)
1.
NAME OF THE MEDICINE
avelumab
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 10 mL vial contains 200 mg of avelumab.
Each mL of concentrate contains 20 mg of avelumab.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3.
PHARMACEUTICAL FORM
Concentrate for solution for infusion (sterile concentrate).
Clear, colourless to slightly yellow solution.
4.
CLINICAL PARTICULARS
4.1. THERAPEUTIC INDICATIONS
BAVENCIO is indicated for the treatment of adults and paediatric
patients 12 years and older
with metastatic Merkel cell carcinoma (mMCC). This indication is
approved based on tumour
response rate, duration of response in a single arm study.
BAVENCIO is indicated for the first-line maintenance treatment of
patients with locally
advanced or metastatic urothelial carcinoma (UC) whose disease has not
progressed with
first-line platinum-based induction chemotherapy.
BAVENCIO in combination with axitinib is indicated for the first-line
treatment of patients with
advanced renal cell carcinoma (RCC).
4.2. DOSE AND METHOD OF ADMINISTRATION
Treatment should be initiated and supervised by a physician
experienced in the treatment of
cancer.
PREMEDICATION
Patients have to be premedicated with an antihistamine and with
paracetamol prior to the
first 4 infusions of BAVENCIO. If the fourth infusion is completed
without an infusion-related
▼
Version: a007-0722
2
Supersedes: a006-0122
reaction, premedication for subsequent doses should be administered at
the discretion of the
physician.
DOSAGE
Merkel cell carcinoma
The recommended dose of BAVENCIO as monotherapy is either 10 mg/kg
body weight or
800 mg adm