HERCEPTIN POWDER FOR INJECTION 440 mgvial

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

TRASTUZUMAB

Available from:

ROCHE SINGAPORE PTE. LTD.

ATC code:

L01XC03

Dosage:

440 mg/vial

Pharmaceutical form:

INJECTION, POWDER, FOR SOLUTION

Composition:

TRASTUZUMAB 440 mg/vial

Administration route:

INTRAVENOUS

Prescription type:

Prescription Only

Manufactured by:

GENENTECH INC

Authorization status:

ACTIVE

Authorization date:

1999-07-19

Patient Information leaflet

1
HERCEPTIN®  

Trastuzumab 

1. DESCRIPTION 
1.1 
THERAPEUTIC / PHARMACOLOGIC CLASS OF DRUG 
Antineoplastic agent. 

ATC code: L01 XC03 
1.2 
TYPE OF DOSAGE FORM 
Powder for concentrate for solution for infusion. 
1.3 ROUTE 
OF 
ADMINISTRATION 
Intravenous infusion. 
1.4 
STERILE / RADIOACTIVE STATEMENT 
Sterile product. 
1.5 
QUALITATIVE AND QUANTITATIVE COMPOSITION 
_Active ingredient:_ trastuzumab. 

_Dosage Preparations:_ 150 mg single dose vials, and
440 mg multidose vial containing powder for 
concentrate for solution for infusion. Reconstituted Herceptin
concentrate contains 21 mg/ml of 
trastuzumab.  
2. CLINICAL

PARTICULARS 
2.1 THERAPEUTIC 
INDICATIONS 
_Metastatic Breast Cancer (MBC) _
Herceptin is indicated for the treatment of patients
with metastatic breast cancer who have tumors 
that overexpress HER2: 
a) 
as monotherapy for the treatment
of those patients who have received one or more 
chemotherapy regimens for their metastatic disease 
b) 
in combination with paclitaxel for the treatment of those
patients who have not received 
chemotherapy for their metastatic disease 
c) 
in combination with an aromatase inhibitor for the
treatment of postmenopausal patients 
with hormone-receptor positive metastatic breast cancer, not
previously treated with 
trastuzumab. This indication is based on data from one Phase III
trial which studied the 
use of Herceptin in combination with anastrozole (see
3.1.2 Clinical/ Efficacy Studies). 
Experience with other aromatase inhibitors is limited. 
_Early Breast Cancer (EBC) _
Herceptin is indicated for the treatment of patients with HER2
positive early breast cancer. 
- 
following surgery, chemotherapy (neoadjuvant or adjuvant) and
radiotherapy (if 
applicable) (see section 3.1). 
- 
following adjuvant chemotherapy with doxorubicin
and cyclop

Summary of Product characteristics

1
Please visit www.roche.com.sg/pharma/herceptin for a printable version
of this leaflet.
INF/INJ-HER-2021 02-0
HERCEPTIN
®
Trastuzumab
1.
DESCRIPTION
1.1
THERAPEUTIC / PHARMACOLOGIC CLASS OF DRUG
Antineoplastic agent.
ATC code: L01 XC03
1.2
TYPE OF DOSAGE FORM
_Intravenous (IV) formulation (Herceptin IV):_
powder for concentrate for solution
for infusion.
_Subcutaneous (SC) formulation (Herceptin SC):_
solution for injection.
1.3
ROUTE OF ADMINISTRATION
_Herceptin IV:_
Intravenous infusion.
_Herceptin SC:_
Subcutaneous injection.
1.4
STERILE / RADIOACTIVE STATEMENT
Sterile product.
1.5
QUALITATIVE AND QUANTITATIVE COMPOSITION
_Active ingredient:_
trastuzumab.
_Herceptin IV _
_Dosage Preparations:_
440 mg multidose vial containing powder for concentrate
for solution for infusion. Reconstituted Herceptin concentrate
contains 21 mg/ml
of trastuzumab.
_Excipients:_
see 4.4 List of Excipients.
_Herceptin SC: _
_Dosage Preparations:_
600 mg/5 ml fixed dose vial containing solution for
injection (do not reconstitute or dilute).
_Excipients: _
Herceptin SC contains recombinant human hyaluronidase (rHuPH20), an
enzyme
used to increase the dispersion and absorption of co-administered
drugs when
administered subcutaneously (see 4.4 List of Excipients).
2.
CLINICAL
PARTICULARS
2.1
THERAPEUTIC INDICATIONS
_HERCEPTIN IV AND HERCEPTIN SC _
_Metastatic Breast Cancer (MBC) _
Herceptin is indicated for the treatment of patients with metastatic
breast cancer
who have tumors that overexpress HER2:
a)
as monotherapy for the treatment of those patients who have received
one or
more chemotherapy regimens for their metastatic disease
b)
in combination with paclitaxel for the treatment of those patients who
have
not received chemotherapy for their metastatic disease
c)
in
combination
with
an
aromatase
inhibitor
for
the
treatment
of
postmenopausal patients with hormone-receptor positive metastatic
breast
cancer, not previously treated with Herceptin. This indication is
based on
data
from
one
Phase III trial
which
studied
the use of
Herc