ABEVMY bevacizumab 100 mg/4 mL concentrate injection for solution vial

Land: Australia

Språk: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv ingrediens:

Bevacizumab, Quantity: 100 mg

Tilgjengelig fra:

Maxx Pharma Pty Ltd

Legemiddelform:

Injection, concentrated

Sammensetning:

Excipient Ingredients: dibasic sodium phosphate; polysorbate 20; monobasic sodium phosphate dihydrate; water for injections; trehalose dihydrate; sodium hydroxide; phosphoric acid

Administreringsrute:

Intravenous Infusion

Enheter i pakken:

1 vial

Resept typen:

(S4) Prescription Only Medicine

Indikasjoner:

Metastatic Colorectal Cancer,ABEVMY (bevacizumab) in combination with fluoropyrimidine-based chemotherapy is indicated for the treatment of patients with metastatic colorectal cancer.,Locally recurrent or metastatic Breast Cancer,ABEVMY (bevacizumab) in combination with paclitaxel is indicated for the first-line treatment of metastatic breast cancer in patients in whom an anthracycline-based therapy is contraindicated (see section 5.1 PHARMACODYNAMIC PROPERTIES, Clinical Trials).,Advanced, metastatic or recurrent non-squamous Non-Small Cell Lung Cancer (NSCLC),ABEVMY (bevacizumab), in combination with carboplatin and paclitaxel, is indicated for firstline treatment of patients with unresectable advanced, metastatic or recurrent, non-squamous, non- small cell lung cancer.,Advanced and/or metastatic Renal Cell Cancer,ABEVMY (bevacizumab) in combination with interferon alfa-2a is indicated for treatment of patients with advanced and/or metastatic renal cell cancer.,Grade IV Glioma,ABEVMY (bevacizumab) as a single agent, is indicated for the treatment of patients with Grade IV glioma after relapse or disease progression after standard therapy, including chemotherapy.,Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer,ABEVMY (bevacizumab) in combination with carboplatin and paclitaxel, is indicated for firstline treatment of patients with advanced (FIGO stages IIIB, IIIC and IV) epithelial ovarian, fallopian tube, or primary peritoneal cancer.,Recurrent Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer,ABEVMY (bevacizumab) in combination with carboplatin and paclitaxel or in combination with carboplatin and gemcitabine, is indicated for the treatment of patients with first recurrence of platinum-sensitive, epithelial ovarian, fallopian tube, or primary peritoneal cancer who have not received prior bevacizumab or other VEGF-targeted angiogenesis inhibitors.,ABEVMY (bevacizumab) in combination with paclitaxel, topotecan or pegylated liposomal doxorubicin is indicated for the treatment of patients with recurrent, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received no more than two prior chemotherapy regimens, and have not received any prior anti-angiogenic therapy including bevacizumab.,Cervical Cancer,ABEVMY (bevacizumab) in combination with paclitaxel and cisplatin is indicated for the treatment of persistent, recurrent or metastatic carcinoma of the cervix. ABEVMY (bevacizumab) in combination with paclitaxel and topotecan is an acceptable alternative where cisplatin is not tolerated or not indicated.

Produkt oppsummering:

Visual Identification: A clear to slightly opalescent, colourless to pale brown, sterile solution; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 30 Months; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Autorisasjon status:

Registered

Autorisasjon dato:

2021-09-06

Informasjon til brukeren

ABEVMY
®
_bevacizumab (rch)_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about ABEVMY infusion.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking ABEVMY
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT ABEVMY IS USED
FOR
ABEVMY is used to treat;
•
brain tumours resistant to
previous treatments
•
metastatic (spreading) cancer of
the large bowel (i.e. in the colon
or rectum), breast or cervix in
combination with chemotherapy
agents
•
lung cancer and cancer of the
ovaries and fallopian tubes
(which can extend to the lining of
surrounding organs such as
stomach, liver) in combination
with chemotherapy agents
•
kidney cancer (renal cell cancer)
in combination with interferon
therapy (Roferon-A
®
).
ABEVMY contains the active
ingredient bevacizumab.
ABEVMY belongs to a group of
medicines known as anti-neoplastic
(or anti-cancer) agents. There are
many different classes of anti-
neoplastic agents. ABEVMY belongs
to a class known as anti-angiogenic
agents.
Anti-angiogenic agents inhibit
angiogenesis (the process of forming
new blood vessels in your body).
ABEVMY selectively binds to
vascular endothelial growth factor
(VEGF), a protein found on the cells
that line blood vessels. Tumours
produce high levels of VEGF, which
stimulates blood vessels to grow,
thereby providing the tumour with
nutrients and oxygen.
When ABEVMY blocks VEGF it
disrupts the blood supply to the
tumour, stopping or slowing down its
growth.
There are many different types of
medicines used to treat brain tumours
and metastatic cancer of the large
bowel, breast, lung, kidney and
cervix.
Your doctor may have prescribed
ABEVMY for another purpose.
ASK YOUR DOCTOR IF YOU HAVE ANY

Preparatomtale

AUSTRALIAN PRODUCT INFORMATION
ABEVMY
®
_Bevacizumab (rch) Injection_
_ _
_ _
_ _
1
NAME OF THE MEDICINE
Bevacizumab (rch).
ABEVMY is a biosimilar medicine to Avastin. The evidence for
comparability supports the use of ABEVMY
for the listed indications.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Bevacizumab is the active ingredient.
For the full list of excipients, see
SECTION 6.1 LIST OF EXCIPIENTS
.
3
PHARMACEUTICAL FORM
ABEVMY (bevacizumab) is available in 100 mg and 400 mg single dose
vials containing 4 mL and 16 mL,
respectively, of bevacizumab (25 mg/mL).
ABEVMY is a clear to slightly opalescent, colourless to pale brown,
sterile solution for intravenous (IV)
infusion. ABEVMY is not formulated for intravitreal use (see
SECTION 4.4 SPECIAL WARNINGS AND
PRECAUTIONS
FOR
USE
,
SEVERE
EYE
INFECTIONS
FOLLOWING
COMPOUNDING
FOR
UNAPPROVED
INTRAVITREAL USE
).
4
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
METASTATIC COLORECTAL CANCER
ABEVMY (bevacizumab) in combination with fluoropyrimidine-based
chemotherapy is indicated for the
treatment of patients with metastatic colorectal cancer.
LOCALLY RECURRENT OR METASTATIC BREAST CANCER
ABEVMY (bevacizumab) in combination with paclitaxel is indicated for
the first-line treatment of metastatic
breast cancer in patients in whom an anthracycline-based therapy is
contraindicated (see
SECTION 5.1
PHARMACODYNAMIC PROPERTIES, CLINICAL TRIALS
).
ADVANCED, METASTATIC OR RECURRENT NON-SQUAMOUS NON-SMALL CELL LUNG
CANCER (NSCLC)
ABEVMY (bevacizumab), in combination with carboplatin and paclitaxel,
is indicated for first-line treatment
of patients with unresectable advanced, metastatic or recurrent,
non-squamous, non- small cell lung cancer.
ADVANCED AND/OR METASTATIC RENAL CELL CANCER
ABEVMY (bevacizumab) in combination with interferon alfa-2a is
indicated for treatment of patients with
advanced and/or metastatic renal cell cancer.
ABEVMY
®
– PRODUCT INFORMATION
2
GRADE IV GLIOMA
ABEVMY (bevacizumab) as a single agent, is indicated for the treatment
of patients with Grade IV