Perjeta 420 mg concentrate for solution for infusion

Maa: Malesia

Kieli: englanti

Lähde: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Aktiivinen ainesosa:

PERTUZUMAB

Saatavilla:

ROCHE (MALAYSIA) SDN. BHD.

INN (Kansainvälinen yleisnimi):

PERTUZUMAB

Kpl paketissa:

1vial Vials

Valmistaja:

ROCHE DIAGNOSTICS GMBH

Valmisteyhteenveto

PACK INSERT FOR MALAYSIA
PERJETA
Pertuzumab
1.
DESCRIPTION
1.1
THERAPEUTIC / PHARMACOLOGIC CLASS OF DRUG
Antineoplastic agent, recombinant humanized IgG1 monoclonal antibody
HER2 dimerization 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 a sterile, clear to slightly
opalescent, colorless to pale brown liquid for intravenous
infusion. 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 Perjeta. _See section 4.1: List _
_of Excipients. _
_ _
2.
CLINICAL PARTICULARS
2.1
THERAPEUTIC INDICATIONS
METASTATIC BREAST CANCER
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.
EARLY BREAST CANCER
Perjeta is indicated in combination with Herceptin and chemotherapy
for the:

neoadjuvant treatment of patients with HER2-positive, locally
advanced, inflammatory, or early stage breast
cancer (either >2 cm in diameter or node positive) as part of a
complete treatment regimen for early breast cancer
(_see Dosage and Administration and Clinical Studies_).

adjuvant treatment of patients with HER2-positive early breast cancer
at high risk of recurrence (_see 3.1.2 Clinical _
_Studies_).
2.2
DOSAGE AND ADMINISTRATION
GENERAL
Patients
treated
with
Perjeta
should
have
HER2-positive
tumour
status,
defined
as
a
score
of
3+
by
immunohistochemistry (IHC) or a ratio of ≥2.0 by in situ
hybridization (ISH), assessed by a validated test.
To ensure accurate and reproducible results, the testing must be
performed in a specialized laborat