情報リーフレット
HERCEPTIN
®
_Contains the active ingredient trastuzumab (rch)_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about HERCEPTIN. 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
HERCEPTIN 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 HERCEPTIN IS
GIVEN FOR
HERCEPTIN contains an active
ingredient called trastuzumab.
HERCEPTIN belongs to a group of
medicines known as anti-neoplastic
(or anti-cancer) agents. There are
many different classes of anti-
neoplastic agents. HERCEPTIN
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.
HERCEPTIN binds selectively 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 HERCEPTIN binds to HER2
it stops the growth and spread of the
cancer cells.
HERCEPTIN is used to treat breast
and gastric cancer. It is only used in
patients whose tumour has tested
positive to HER2.
HERCEPTIN may be used alone or
with other medicines that treat breast
cancer, such as an aromatase
inhibitor (hormone receptor positive
breast cancer) or a taxane (e.g.
paclitaxel or docetaxel).
For the treatment of gastric cancer
HERCEPTIN is used with
chemotherapy medicines cisplatin
and capecitabine (or 5FU).
For further information about the
other medicines you are receiving
with HERCEPTIN, please ask your
doctor, nurse or pharmacist for the
Consumer Medicine Information
(CMI) leaflet.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS WHY HERCEPTIN HAS
BEEN PRESCRIBED FOR YOU.
This medicine is available only with
a docto
完全なドキュメントを読む
製品の特徴
Herceptin
PI 120810
1 of 33
CDS 12.0
NAME OF THE MEDICINE
HERCEPTIN
®
_trastuzumab _
CAS-180288-69-1
HERCEPTIN (trastuzumab) is a recombinant DNA-derived humanized
monoclonal antibody that
selectively targets the extracellular domain of the
human epidermal growth factor receptor 2 protein
(HER2). The antibody is an IgG
1
kappa that contains human framework regions with the
complementarity-determining regions of a murine anti-p185 HER2
antibody that binds to HER2.
Trastuzumab is composed of 1,328 amino acids and
has a molecular weight of ~148 kDa.
The humanized antibody against HER2 is produced
by recombinant mammalian cells (Chinese
hamster ovary (rch)) in suspension
culture in a nutrient medium and purified by affinity
chromatography and
ion exchange, including specific viral inactivation and
removal procedures.
DESCRIPTION
HERCEPTIN is a sterile, white to pale
yellow, preservative-free lyophilized powder for intravenous
(IV) infusion.
HERCEPTIN is available as a single-dose
vial containing 60 mg or 150 mg of trastuzumab with the
following excipients: histidine hydrochloride, histidine, trehalose dihydrate and polysorbate 20.
Reconstitution of the 60 mg vial with 3.0
mL of sterile water for injection yields 3.1 mL of a single-
dose solution containing approximately 21 mg/mL trastuzumab,
at a pH of approximately 6.0. A
volume overage of 7.5% ensures that the labelled dose can be
withdrawn from each vial.
Reconstitution of the 150 mg vial with 7.2
mL of sterile water for injection yields 7.4 mL of a single-
dose solution containing approximately 21 mg/mL trastuzumab,
at a pH of approximately 6.0. A
volume overage of 4% ensures that the labelled dose can be
withdrawn from each vial.
PHARMACOLOGY
PHARMACODYNAMICS
The HER2 (or c-erbB2) proto-oncogene encodes for
完全なドキュメントを読む
情報リーフレット 