Perjeta concentrate for solution for infusion

Nazione: Armenia

Lingua: inglese

Fonte: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Principio attivo:

pertuzumab

Commercializzato da:

Roche Diagnostics GmbH

Codice ATC:

L01XC13

INN (Nome Internazionale):

pertuzumab

Dosaggio:

30mg/ml

Forma farmaceutica:

concentrate for solution for infusion

Confezione:

(1) glass vial 14ml

Tipo di ricetta:

Prescription

Stato dell'autorizzazione:

Registered

Data dell'autorizzazione:

2019-12-20

Foglio illustrativo

PERJETA
®
10223257
PERJETA
®
10223257
10223257 FE
Artwork
Creator
Date
Version
Signature
Proofreader
Date
Signature
Perigord / MAH
31 Jan 2020
1
Genisys-No.
10223257
make-up code:
FE
Type size:
9 pt
Printing colour:
Pantone Black
Format:
450x500 mm folded: 47x60 mm
Drawing Norm:
NP9357 17.08.10 10.114
PERJETA
®
Pertuzumab
1. DESCRIPTION
1.1 THERAPEUTIC / PHARMACOLOGIC CLASS OF DRUG
Antineoplastic agent, recombinant humanised IgG1 monoclonal
antibody
HER2 dimerisation inhibitor
ATC code: L01XC13 pertuzumab
1.2 TYPE OF DOSAGE FORM
Concentrate for solution for infusion.
1.3 ROUTE OF ADMINISTRATION
Intravenous (IV) infusion.
1.4 STERILE / RADIOACTIVE STATEMENT
Sterile product.
1.5 QUALITATIVE AND QUANTITATIVE COMPOSITION
_Active ingredient: _
Pertuzumab.
_Dosage preparations:_
Perjeta is supplied as a single-use vial
containing 14 ml preservative-free liquid concentrate, at
a concentration of 30 mg/ml. Each vial of Perjeta drug product
contains a total of 420 mg pertuzumab.
_Excipients:_
As registered locally.
2. CLINICAL PARTICULARS
2.1 THERAPEUTIC INDICATION
Perjeta is indicated in combination with Herceptin and docetaxel
for 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.
2.2 DOSAGE AND ADMINISTRATION
GENERAL
Patients treated with Perjeta should have HER2-positive tumour
status, defined as a score of 3+ by IHC or a ratio of ≥ 2.0 by ISH
assessed by a validated test.
To ensure accurate and reproducible results, the testing must be
performed in a specialised laboratory, which can ensure validation
of the testing procedures.
For full instructions on assay performance and interpretation
please refer to the package inserts of validated HER2 testing
assays.
Substitution by any other biological medicinal product requires
the consent of the prescribing physician.
In order to prevent medication errors, it is important to check the
vial labels to ensure that the drug being prepared and

Scheda tecnica

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