Fludarabine phosphate 50mg powder for solution for injection or infusion

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

FLUDARABINE PHOSPHATE

Available from:

Fresenius Kabi Oncology PLC Lion Court, Farnham Road, Bordon, Hampshire, GU35 0NF, United Kingdom

ATC code:

L01BB05

INN (International Name):

FLUDARABINE PHOSPHATE 50 mg

Pharmaceutical form:

POWDER FOR SOLUTION FOR INFUSION OR INJECTION

Composition:

FLUDARABINE PHOSPHATE 50 mg

Prescription type:

POM

Therapeutic area:

ANTINEOPLASTIC AGENTS

Authorization status:

Withdrawn

Authorization date:

2013-03-08

Patient Information leaflet

 
Page 1 of 11 
PACKAGE LEAFLET: INFORMATION FOR THE USER 

FLUDARABINE PHOSPHATE 50 MG POWDER FOR SOLUTION FOR
INJECTION/INFUSION 

fludarabine phosphate 

READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS 
IMPORTANT INFORMATION FOR YOU. 
-  Keep this leaflet. You may need to read it again. 
-  If you have any further questions, ask your doctor or nurse. 
-  If you get any side effects, talk to your doctor or nurse.
This includes any possible side effects 
not listed in this leaflet. 

WHAT IS IN THIS LEAFLET:  
1.   What Fludarabine is and what it is used for 
2.   What you need to know before you use Fludarabine 
3.   How to use Fludarabine 
4.   Possible side effects 
5.   How to store Fludarabine 
6.   Contents of the pack and other information 

1.  WHAT FLUDARABINE IS AND WHAT IT IS USED FOR 

The name of your medicine is ‘Fludarabine phosphate 50 mg powder
for solution for 
injection/infusion’ but in the rest of the leaflet it will be
called ‘Fludarabine’. It contains the active 
ingredient fludarabine phosphate. This medicine is an anti-cancer
medicine that inhibits the growth 
of cancer cells.  It is used in the treatment of B-cell chronic
lymphocytic leukaemia (B-CLL), a 
cancer of the lymphocytes (white blood cells), in patients who have a
sufficient amount of healthy 
blood cells in their bone marrow. 

First treatment for chronic lymphocytic leukaemia with fludarabine
should only be started in 
patients with advanced disease having disease related symptoms
or evidence of disease progression. 

This medicine works by stopping the growth of new cancer cells.  

2.   WHAT YOU NEED TO KNOW BEFORE YOU USE FLUDARABINE 

DO NOT USE FLUDARABINE 
-  if you are allergic to fludarabine or any of the other
ingredients of this medicine (listed in 
section 6). 
-  if your kidney function is severely reduced. Your doctor will
decide, based on your kidney 
func

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS 

1 
NAME OF THE MEDICINAL PRODUCT 
Fludarabine phosphate 50 mg powder for solution for injection or
infusion 
2 
QUALITATIVE AND QUANTITATIVE COMPOSITION 
Each vial contains 50 mg of fludarabine phosphate.  

1 ml of reconstituted solutions contains 25 mg of fludarabine
phosphate.  

Excipient with known effect: 

Each vial of fludarabine 50 mg powder for solution for injection
/infusion contains less than 
1 mmol sodium (23 mg), i.e. essentially 'sodium-free'.  

For the full list of excipients, see section 6.1. 
3 PHARMACEUTICAL 
FORM 
Powder for solution for injection/ infusion.  

Sterile lyophilized white or almost white powder or cake. 
4 CLINICAL 
PARTICULARS 

4.1 THERAPEUTIC 
INDICATIONS 
Treatment of B cell chronic lymphocytic leukaemia (CLL) in patients
with sufficient bone 
marrow reserves.  

First line treatment with fludarabine should only be initiated in
patients with advanced 
disease, Rai stages III/IV (binet stage C), or Rai stages I/II
(Binet stage A/B) where the 
patient has disease related symptoms or evidence of progressive
disease. 
4.2 
POSOLOGY AND METHOD OF ADMINISTRATION 
Fludarabine should be administered under the supervision of a
qualified physician 
experienced in the use of antineoplastic therapy.  

Intravenous administration 

Fludarabine must be administered only intravenously.  
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No cases have been reported in which paravenously administered
fludarabine led to severe 
local adverse reactions. However, unintentional paravenous
administration must be avoided.  

Adults 

The recommended dose of fludarabine is 25 mg/m2 body surface area
given daily for 5 
consecutive days every 28 days by the intravenous route.  Each vial
is to be made up in 2 ml 
water for injections. Each ml of the resulting solution for
injection /infusion contains 25 mg 
fludarabine phosphate (see section 6.6).  

The required dose (calculated on the basis of the patient's bo