BEVACIPTIN bevacizumab 100 mg/4 mL concentrated solution for infusion vial

Land: Australia

Språk: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv ingrediens:

Bevacizumab, Quantity: 25 mg/mL

Tilgjengelig fra:

Cipla Australia Pty Ltd

Legemiddelform:

Injection, concentrated

Sammensetning:

Excipient Ingredients: monobasic sodium phosphate monohydrate; water for injections; trehalose dihydrate; dibasic sodium phosphate; polysorbate 20

Administreringsrute:

Intravenous

Enheter i pakken:

1 vial

Resept typen:

(S4) Prescription Only Medicine

Indikasjoner:

Metastatic colorectal cancer Bevaciptin (bevacizumab) in combination with fluoropyrimidine-based chemotherapy is indicated for the treatment of patients with metastatic colorectal cancer. Locally recurrent or metastatic breast cancer Bevaciptin (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 Clinical trials). Advanced, metastatic or recurrent non-squamous non-small cell lung cancer (NSCLC) Bevaciptin (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 Bevaciptin (bevacizumab) in combination with interferon alfa-2a is indicated for treatment of patients with advanced and/or metastatic renal cell cancer. Grade IV glioma Bevaciptin (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 Bevaciptin (bevacizumab) in combination with carboplatin and paclitaxel, is indicated for first- line 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 Bevaciptin (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. Bevaciptin (bevacizumab) in combination with 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 Bevaciptin (bevacizumab) in combination with paclitaxel and cisplatin is indicated for the treatment of persistent, recurrent or metastatic carcinoma of the cervix. Bevaciptin (bevacizumab) in combination with paclitaxel and topotecan is an acceptable alternative where cisplatin is not tolerated or not indicated.

Produkt oppsummering:

Visual Identification: 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

Autorisasjon status:

Registered

Autorisasjon dato:

2021-11-02

Informasjon til brukeren

BEVACIPTIN
_CONCENTRATED FOR SOLUTION FOR INFUSION_
_Bevacizumab_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
Bevaciptin 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 Bevaciptin 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 BEVACIPTIN IS USED FOR
Bevaciptin 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
®
).
Bevaciptin contains the active
ingredient bevacizumab.
Bevaciptin belongs to a group
of medicines known as anti-
neoplastic (or anti-cancer)
agents. There are many
different classes of anti-
neoplastic agents. Bevaciptin
belongs to a class known as
anti-angiogenic agents.
Anti-angiogenic agents inhibit
angiogenesis (the process of
forming new blood vessels in
your body).
Bevacizumab 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 bevacizumab 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 h

Preparatomtale

AUSTRALIAN PRODUCT INFORMATION
BEVACIPTIN (BEVACIZUMAB) CONCENTRATE FOR SOLUTION FOR INFUSION
1.
NAME OF THE MEDICINE
Bevacizumab
Bevaciptin is a biosimilar medicine to Avastin
®
The evidence for comparability supports the use of
Bevaciptin for the listed indications.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Bevaciptin is available in 100 mg and 400 mg single dose vials
containing 4 mL and 16 mL,
respectively, of bevacizumab (25 mg/mL).
For the full list of excipients, see section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Concentrate for solution for infusion.
Bevaciptin (bevacizumab) is a clear to slightly opalescent, colourless
to pale brown, sterile
solution for intravenous (IV) infusion. Bevaciptin is not formulated
for intravitreal use (see section
4.4 Special warnings and precautions for use).
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Metastatic colorectal cancer
Bevaciptin (bevacizumab) in combination with fluoropyrimidine-based
chemotherapy is indicated
for the treatment of patients with metastatic colorectal cancer.
Locally recurrent or metastatic breast cancer
Bevaciptin (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 Clinical trials).
Advanced, metastatic or recurrent non-squamous non-small cell lung
cancer (NSCLC)
Bevaciptin (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
Bevaciptin (bevacizumab) in combination with interferon alfa-2a is
indicated for treatment of
patients with advanced and/or metastatic renal cell cancer.
Grade IV glioma
Bevaciptin (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.