Perjeta

Land: Europeiska unionen

Språk: engelska

Källa: EMA (European Medicines Agency)

Aktiva substanser:

pertuzumab

Tillgänglig från:

Roche Registration GmbH 

ATC-kod:

L01XC13

INN (International namn):

pertuzumab

Terapeutisk grupp:

Antineoplastic agents, Monoclonal antibodies

Terapiområde:

Breast Neoplasms

Terapeutiska indikationer:

Metastatic Breast Cancer:Perjeta is indicated for use in combination with trastuzumab and docetaxel in adult patients with HER2-positive metastatic or locally recurrent unresectable breast cancer, who have not received previous anti-HER2 therapy or chemotherapy for their metastatic disease.Neoadjuvant Treatment of Breast Cancer:Perjeta is indicated for use in combination with trastuzumab and chemotherapy for the neoadjuvant treatment of adult patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer at high risk of recurrence.

Produktsammanfattning:

Revision: 22

Bemyndigande status:

Authorised

Tillstånd datum:

2013-03-04

Bipacksedel

37
B. PACKAGE LEAFLET
38
PACKAGE LEAFLET: INFORMATION FOR THE USER
PERJETA 420 MG CONCENTRATE FOR SOLUTION FOR INFUSION
pertuzumab
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START BEING GIVEN THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor or nurse.
•
If you get any side effects, talk to your doctor or nurse. This
includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
:
1.
What Perjeta
is and what it is used for
2.
What you need to know before you are given Perjeta
3.
How you are given Perjeta
4.
Possible side effects
5.
How to store Perjeta
6.
Contents of the pack and other information
1.
WHAT PERJETA IS AND WHAT IT IS USED FOR
Perjeta contains the active substance pertuzumab and is used to treat
adult patients with breast cancer
when:
•
The breast cancer has been identified to be of the “HER2-positive”
form – your doctor will
test you for this.
•
The cancer has spread to other parts of the body such as the lungs or
liver (metastasised) and
has not previously been treated with anticancer medicines
(chemotherapy) or other medicines
designed to attach to HER2, or else the cancer has come back in the
breast after previous
treatment.
•
The cancer has not spread to other parts of the body and treatment is
going to be given before
surgery takes place (treatment before surgery is called neoadjuvant
therapy)
•
The cancer has not spread to other parts of the body and treatment is
going to be given after
surgery (treatment after surgery is called adjuvant therapy)
As well as Perjeta you will also receive trastuzumab and medicines
called chemotherapy Information
about these medicines is described in separate package leaflets. Ask
your doctor or nurse to give you
information about these other medicines.
HOW PERJETA WORKS
Perjeta is a type of medicine called a “monoclonal antibody” which
attaches itself to specific targets in
your b

Produktens egenskaper

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Perjeta 420 mg concentrate for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One 14 ml vial of concentrate contains 420 mg of pertuzumab at a
concentration of 30 mg/ml.
After dilution, one ml of solution contains approximately 3.02 mg of
pertuzumab for the initial dose
and approximately 1.59 mg of pertuzumab for the maintenance dose (see
section 6.6).
Pertuzumab is a humanised IgG1 monoclonal antibody produced in
mammalian (Chinese hamster
ovary) cells by recombinant DNA technology.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate for solution for infusion.
Clear to slightly opalescent, colourless to pale yellow, liquid.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Early breast cancer
Perjeta is indicated for use in combination with trastuzumab and
chemotherapy in:
•
the neoadjuvant treatment of adult patients with HER2-positive,
locally advanced,
inflammatory, or early stage breast cancer at high risk of recurrence
(see section 5.1)
•
the adjuvant treatment of adult patients with HER2-positive early
breast cancer at high risk of
recurrence (see section 5.1)
Metastatic breast cancer
Perjeta is indicated for use in combination with trastuzumab and
docetaxel in adult patients with
HER2-positive metastatic or locally recurrent unresectable breast
cancer,
_ _
who have not received
previous anti-HER2 therapy or chemotherapy for their metastatic
disease.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_ _
Perjeta should only be initiated under the supervision of a physician
experienced in the administration
of anti-cancer agents. Perjeta should be administered by a healthcare
professional prepared to manage
anaphylaxis and in an environment where full resuscitation facilities
are immediately available.
Posology
Patients treated with Perjeta must have HER2-positive tumour status,
defined as a score of 3+ by
immunohistochemistry (IHC) and/or a ratio of ≥ 2.0 by in situ
hybridisati