PERJETA pertuzumab (rch) 30mg/mL concentrate injection vial

מדינה: אוסטרליה

שפה: אנגלית

מקור: Department of Health (Therapeutic Goods Administration)

מרכיב פעיל:

Pertuzumab, Quantity: 420 mg

זמין מ:

Roche Products Pty Ltd

INN (שם בינלאומי):

Pertuzumab

טופס פרצבטיות:

Injection, intravenous infusion

הרכב:

Excipient Ingredients: histidine; sucrose; glacial acetic acid; water for injections; polysorbate 20

מסלול נתינה (של תרופות):

Intravenous Infusion

יחידות באריזה:

420 mg/14 mL (30 mg/mL) single-use vial

סוג מרשם:

(S4) Prescription Only Medicine

סממני תרפויטית:

Early Breast Cancer Perjeta is indicated in combination with trastuzumab and chemotherapy for:,- the neoadjuvant treatment of patients with HER2-positive inflammatory or locally advanced, or early stage (either > 2 cm in diameter or node positive) breast cancer as part of a complete treatment regimen for early breast cancer,-the adjuvant treatment of patients with HER2-positive early breast cancer at high risk of recurrence.,Metastatic Breast Cancer,Perjeta is indicated in combination with trastuzumab and docetaxel for patients with metastatic HER2-positive breast cancer who have not received prior anti-HER2 therapy or chemotherapy for their metastatic disease.

leaflet_short:

Visual Identification: Clear to opalescent, colourless to slightly brownish solution; Container Type: Vial; 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

מצב אישור:

Licence status A

תאריך אישור:

2013-05-06

עלון מידע

PERJETA
®
_Contains the active ingredient pertuzumab (rch)_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Perjeta. 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 being given Perjeta
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.
You may need to read it again.
WHAT PERJETA IS GIVEN
FOR
Perjeta contains an active ingredient
called pertuzumab.
Perjeta belongs to a group of
medicines known as anti-neoplastic
(or anti-cancer) agents. There are
many different classes of anti-
neoplastic agents. Perjeta belongs to
a class called monoclonal antibodies.
Monoclonal antibodies are proteins
made in a laboratory. These proteins
are designed to recognise and bind to
other unique proteins in the body.
Perjeta recognises and attaches to a
protein called human epidermal
growth factor receptor 2 (HER2).
HER2 is found in large amounts on
the surface of some cancer cells.
When Perjeta attaches to HER2
cancer cells it may kill them or slow/
stop the cancer cells from growing.
Perjeta is used to treat the following
stages of breast cancer;
•
metastatic (spreading) breast
cancer
•
early breast cancer, either before
or after surgery
It is only used for patients whose
tumour has tested positive for HER2.
For metastatic breast cancer Perjeta
is used with Herceptin and the
chemotherapy medicine, docetaxel.
For early breast cancer Perjeta is
used with Herceptin and
chemotherapy medicines.
For further information about
Herceptin and other chemotherapy
medicines please ask your doctor,
nurse or pharmacist for the
Consumer Medicine Information
(CMI) leaflets for these medicines.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS WHY PERJETA HAS BEEN
PRESCRIBED FOR YOU.
This medicine is available only with
a doctor's prescription

מאפייני מוצר

perjeta20210507
1
AUSTRALIAN PRODUCT INFORMATION – PERJETA
® (PERTUZUMAB)
1.
NAME OF THE MEDICINE
Pertuzumab
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Perjeta 420 mg concentrate for intravenous infusion.
For the full list of excipients, see section 6.1 List of Excipients.
3.
PHARMACEUTICAL FORM
Perjeta is supplied in a single-dose glass vial containing 14mL of
clear to opalescent, colourless to
slightly brownish solution.
Each vial contains 420 mg of pertuzumab (30 mg/mL).
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
EARLY BREAST CANCER
Perjeta is indicated in combination with trastuzumab and chemotherapy
for:
•
the neoadjuvant treatment of patients with HER2-positive inflammatory
or locally advanced,
or early stage (either > 2 cm in diameter or node positive) breast
cancer as part of a complete
treatment regimen for early breast cancer
•
the adjuvant treatment of patients with HER2-positive early breast
cancer at high risk of
recurrence.
METASTATIC BREAST CANCER
Perjeta is indicated in combination with trastuzumab and docetaxel for
patients with metastatic HER2-
positive breast cancer who have not received prior anti-HER2 therapy
or chemotherapy for their
metastatic disease.
4.2
DOSE AND METHOD OF ADMINISTRATION
DOSE
GENERAL
Detection of HER2 Protein Overexpression or HER2 Gene Amplification
Patients can only be treated with Perjeta in combination with
trastuzumab and must have a HER2-
positive tumour status, defined as a score of 3+ by
immunohistochemistry (IHC) and/or a ratio of ≥
2.0 by in situ hybridization (ISH).
To ensure accurate and reproducible results, the testing must be
performed in a specialised laboratory,
which can ensure validation of the testing procedures.
HER2 protein overexpression should be detected using an IHC-based
assessment of fixed tumour
blocks. HER2 gene amplification should be detected using ISH of fixed
tumour blocks. Examples of
perjeta20210507
2
ISH include fluorescence in situ hybridization (FISH), chromogenic in
situ hybridization (CISH) and
silver in situ hyb