JAVLOR vinflunine ditartrate 100mg/4mL concentrated injection vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

vinflunine ditartrate

Available from:

Pierre Fabre Australia Pty Ltd

INN (International Name):

Vinflunine ditartrate

Authorization status:

Registered

Patient Information leaflet

CONSUMER MEDICINE INFORMATION
Version: A04-090818
1
Supercedes: A03-0914
JAVLOR 25 MG/ML CONCENTRATED INJECTION
_vinflunine ditartrate _
_ _
_ _
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
Javlor.
It does not contain all the
available information.
It does not take the place
of talking to your doctor or
pharmacist.
All medicines have
benefits and risks. Your
doctor has weighed the
risks of you taking Javlor
against the benefits this
medicine is expected to
have for you.
IF YOU HAVE ANY
CONCERNS ABOUT TAKING
THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE
MEDICINE. You may need
to read it again.
WHAT JAVLOR IS USED
FOR
Javlor is used to treat
cancer of the bladder and
urinary tract at an
advanced stage. Javlor is
given if previous therapy
with a platinum-containing
medicine has failed.
Javlor belongs to a group
of medicines called
antineoplastic or cytotoxic
medicines. You may also
hear of these medicines
being called
chemotherapy.
Javlor contains the
medicine, vinflunine which
belongs to a family of
medicines called vinca
alkaloids. Javlor works by
stopping cancer cells from
growing and multiplying
causing the cells to die.
Your doctor may have
prescribed Javlor for
another purpose.
Ask your doctor if you
have any questions about
why Javlor has been
prescribed for you.
This medicine is available
only with a doctor’s
prescription.
BEFORE YOU ARE GIVEN
JAVLOR
_WHEN YOU MUST NOT BE _
_GIVEN IT _
DO NOT TAKE JAVLOR IF YOU
HAVE AN ALLERGY TO THE
ACTIVE SUBSTANCE,
VINFLUNINE OR TO THE OTHER
VINCA ALKALOIDS,
(VINBLASTINE, VINCRISTINE,
VINDESINE, VINORELBINE).
Symptoms of an allergic
reaction to Javlor may
include:
•
shortness of breath
•
wheezing, difficulty
breathing or a tight
feeling in your chest
•
swelling of the face,
lips, tongue or other
parts of the body
•
rash, itching, hives or
flushed, red skin.
DO NOT TAKE JAVLOR IF YOU
HAVE OR HAVE HAD (WITHIN
THE LAST TWO WEEKS), A
SEVERE INFECTION.
Tell your doctor if you
have or have had a
severe infection i

Summary of Product characteristics

Version: A06-090818
Page 1 of 21
Supercedes: A05-0914
PRODUCT INFORMATION
JAVLOR
®
25 MG/ML CONCENTRATED INJECTION
NAME OF THE MEDICINE
vinflunine ditartrate
N
H
N
F
N
H
H
N
C
H
3
OCOCH
3
OH
F
H
H
3
COOC
COOCH
3
CH
3
O
. 2 (C
4 H
6 O
6
)
CAS number: 194468-36-5
DESCRIPTION
Vinflunine ditartrate is a white to off-white powder with the
molecular formula
C
53
H
66
F
2
N
4
O
20
and a molecular weight of 1117.09. Vinflunine ditartrate is freely
soluble in water, soluble in ethanol and practically insoluble in
dichloromethane. It is
very hygroscopic with a pKa value of 5.67 and 8.17 in water at 26
o
C – 27
o
C.
Javlor Concentrated Injection is presented as a clear, colourless to
pale yellow
solution. It is supplied as a sterile, endotoxin-free aqueous solution
intended for
dilution with a suitable parenteral fluid (sodium chloride 0.9%
solution or glucose 5%
solution). One mL of Javlor contains 25 mg of vinflunine (as
vinflunine ditartrate).
Javlor also contains the excipient, water for injections.
PHARMACOLOGY
PHARMACODYNAMICS
Vinflunine is an antineoplastic drug. Vinflunine binds to tubulin at
or near to the
vinca binding sites inhibiting its polymerisation into microtubules,
which results in
treadmilling suppression, disruption of microtubule dynamics, mitotic
arrest and
apoptotic cell death.
Version: A06-090818
Page 2 of 21
Supercedes: A05-0914
_In vivo_, vinflunine displays significant antitumour activity against
a broad spectrum of
human xenografts in mice both in terms of survival prolongation and
tumour growth
inhibition.
PHARMACOKINETICS
Vinflunine pharmacokinetics is linear up to 400 mg/m
2
in cancer patients. Blood
exposure to vinflunine (AUC) significantly correlated with severity of
leucopenia,
neutropenia and fatigue.
Distribution
Vinflunine is moderately bound to human plasma protein (67.2 ± 1.1%)
with a
plasma/blood concentration ratio of 0.80 ± 0.12. Protein binding
mainly involves high
density lipoproteins and serum albumin and is non-saturable in the
range of
vinflunine concentrations observed i