PACLITAXEL ACT paclitaxel 150 mg/25 mL concentrated injection vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

paclitaxel

Available from:

Medis Pharma Pty Ltd

INN (International Name):

Paclitaxel

Authorization status:

Registered

Patient Information leaflet

ACTAVIS PTY LTD-VERSION 2
PAGE 1 OF 3
PACLITAXEL ACT
_PACLITAXEL _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS
LEAFLET
The medicine your doctor has
prescribed for you is called
PACLITAXEL ACT. The
information in this leaflet will
answer some questions you may
have about PACLITAXEL ACT.
This leaflet does not contain
everything about PACLITAXEL
ACT. Your doctor has been
provided with full information
and can answer any questions
you may have. Follow your
doctor's advice even if it differs
from what is in this leaflet.
You should read this leaflet
carefully before starting
PACLITAXEL ACT and keep it
in a safe place to refer to later.
WHAT PACLITAXEL
ACT IS USED FOR
PACLITAXEL ACT is used to
treat cancer of the ovary, the
breast, and non small cell cancer
of the lung. PACLITAXEL ACT
may be used alone or in
combination with other
anticancer agents. Ask your
doctor if you have any questions
about why PACLITAXEL ACT
was prescribed for you.
_HOW PACLITAXEL ACT _
_WORKS_
_ _
PACLITAXEL ACT is a new
class of anticancer agents known
as taxanes. These agents prevent
the division of cells, particularly
cancer cells. The use of
PACLITAXEL ACT to treat
your cancer can lead to side-
effects, which are discussed
below.
HOW PACLITAXEL
ACT IS USED
PACLITAXEL ACT will be
administered in a hospital clinic.
PACLITAXEL ACT may be
used alone or with other
anticancer medicines.
Dose
The dose is worked out based on
your body weight and height,
and so may be different from the
dose chosen for other people.
PACLITAXEL ACT is
administered as an intravenous
infusion over a 3 hour period.
Administration will occur at
3 week intervals.
The administration of
PACLITAXEL ACT requires all
patients to be given
premedication prior to
PACLITAXEL ACT.
The premedication consists of
three other drugs which work by
reducing the likelihood of an
allergic reaction occurring when
you receive your PACLITAXEL
ACT. They are given as tablets
12 and 6 hours before the
PACLITAXEL ACT is given
and two injections into the vein
given 30 to 60 minutes prior to
the P

Summary of Product characteristics

Paclitaxel ACT
, concentrated injection
PRODUCT INFORMATION
NAME OF THE MEDICINE
Paclitaxel ACT, concentrated injection
Active: Paclitaxel
Molecular formula: C
47
H
51
NO
14
Molecular weight: 853.929
CAS: 33069-62-4
DESCRIPTION
Each vial contains Paclitaxel, PEG-35 castor oil, anhydrous citric
acid and absolute ethanol.
Paclitaxel is a natural product with antitumour activity. It is a
white to off white crystalline
powder that is highly lipophilic and insoluble in water. It is the
first of a new class of anticancer
agents known as taxanes.
PHARMACOLOGY
Paclitaxel is a novel antimicrotubule agent that promotes the assembly
of microtubules from
tubulin
dimers.
It
stabilises
microtubules
by
preventing
depolymerisation,
resulting
in
the
inhibition of the normal dynamic reorganisation of the microtubule
network essential for cellular
functions. Paclitaxel also induces abnormal arrays or 'bundles' of
microtubules throughout the cell
cycle, and multiple asters of microtubules during mitosis. This can
result in arrest of cell division
and impaired function of nervous tissue.
PACLITAXEL ACTAVIS – Product information
Page 2 of 17
PACLITAXEL ACT/PI/052014/5
PHARMACOKINETICS
The pharmacokinetics of paclitaxel have been evaluated over a wide
range of doses (up to
300 mg/m
2
) and infusion schedules (ranging from 3 to 24 hours).
Following
intravenous
administration,
paclitaxel
exhibits
a
biphasic
decline
in
plasma
concentrations. The initial rapid decline represents distribution to
the peripheral compartment
and elimination; the later phase is due, in part, to a relatively slow
efflux of paclitaxel from the
peripheral compartment. Maximum plasma concentrations are related to
dose. In patients treated
with doses of 135 and 175 mg/m
2
given as 3 and 24 hour infusions, mean terminal half-life has
ranged from 3.0 to 52.7 hours and total body clearance has ranged from
11.6 to 24.0 L/hour/m
2
.
Mean steady state volume of distribution following single dose
infusion of 135 and 175 mg/m
2
has
ranged from 198 to 688 L/m
2
, indicatin