FLUDARA ORAL fludarabine phosphate 10mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

fludarabine phosphate, Quantity: 10 mg

Available from:

Sanofi-Aventis Australia Pty Ltd

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: microcrystalline cellulose; lactose monohydrate; colloidal anhydrous silica; croscarmellose sodium; magnesium stearate; hypromellose; purified talc; titanium dioxide; iron oxide yellow; iron oxide red

Administration route:

Oral

Units in package:

15 tablets, 20 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Indicated for use as second-line tharapy in patients with chronic lymphocytic leukaemia (CLL). INDICATIONS AS AT 6 APRIL 2004: For the treatment of B-cell chronic lymphocytic leukaemia.

Product summary:

Visual Identification: Salmon coloured oval shaped tablets with "LN" indented in a regular hexagon on one side.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

2002-05-27

Patient Information leaflet

FLUDARA ORAL
®
_Fludarabine phosphate_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Fludara Oral. 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 taking Fludara Oral
against the benefits they expect it
will have for you.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT FLUDARA ORAL IS
USED FOR
This medicine is an anti-cancer drug
approved to treat a form of leukaemia
known as B-cell chronic lymphocytic
leukaemia (B-CLL). This is a cancer
of a type of white blood cells called
lymphocytes.
Patients with B-CLL have too many
abnormal white blood cells
(lymphocytes) and lymph nodes start
to grow in various parts of the body.
The abnormal white blood cells
cannot carry out their normal disease
fighting functions, and may push
aside healthy blood cells. This can
result in infections, a decreased
number of red blood cells (anaemia),
bruising and/or bleeding.
Fludara is a medication that stops the
growth of new cancer cells. All cells
of the body produce new cells like
themselves by dividing. To do this,
the cells’ genetic material (DNA)
must be copied and reproduced.
Fludara is taken up by the cancer
cells and hinders the production of
new DNA.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
There is not enough information to
recommend the use of this medicine
for children.
BEFORE YOU TAKE
FLUDARA
_WHEN YOU MUST NOT BE GIVEN_
_IT_
DO NOT HAVE ANY FLUDARA IF YOU
HAVE AN ALLERGY TO:
•
any medicine containing
fludarabine
•
any of the ingredients listed at the
end of this leaflet.
Some of the symptoms of an allergic
reaction may include:
•
shortness of breath
•
wheezing or difficulty breathing
•
swelling of the face, lips, tongue
or other parts of the body
•
rash, itching or hives on the skin
DO NOT HAVE FLUDARA IF YOU
•
are pregnant

Summary of Product characteristics

fludara-ccdsv26-piv3-27jul20
Page 1
AUSTRALIAN PRODUCT INFORMATION – FLUDARA
(FLUDARABINE PHOSPHATE) TABLETS
1
NAME OF THE MEDICINE
Fludarabine phosphate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Fludara contains fludarabine phosphate, a fluorinated nucleotide
analogue of the antiviral agent
vidarabine, (9-β-D-arabinofuranosyladenine) that is relatively
resistant to deamination by
adenosine deaminase.
Each Fludara tablet contains 10 mg of fludarabine phosphate.
Excipients with known effect: sugars (lactose monohydrate). For the
full list of excipients, see
Section 6.1, List of Excipients.
3
PHARMACEUTICAL FORM
Film coated tablets (salmon coloured oval shaped tablets with "LN"
indented in a regular hexagon
on one side).
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Fludara is indicated for the treatment of B - cell chronic lymphocytic
leukaemia.
4.2
DOSE AND METHOD OF ADMINISTRATION
_ADULTS _
Fludara tablets should be prescribed by a qualified physician
experienced in the use of
antineoplastic therapy.
The recommended dose is 40 mg fludarabine phosphate/m
2
body surface given daily for 5
consecutive days every 28 days by the oral route. Fludara tablets can
be taken either on an empty
fludara-ccdsv26-piv3-27jul20
Page 2
stomach or together with food. The tablets are to be swallowed whole
with water, and must not be
chewed or broken.
The duration of treatment depends on the treatment success and the
tolerability of the drug.
Fludara should be administered up to achievement of best response
(complete or partial remission,
usually 6 cycles) and then the drug should be discontinued.
TOXICITY
Dosage may be decreased or delayed based on evidence of haematological
and non
haematological toxicity. Physicians should consider delaying or
discontinuing the drug if toxicity
occurs.
_IMPAIRED STATE OF HEALTH _
A number of clinical settings may predispose to increased toxicity
from Fludara. These include
advanced age, renal insufficiency and bone marrow impairment (refer to
Section 4.4.6 Use in
specialised groups). Such