FLUDARABINE ACTAVIS 50MG LYOPHILISATE FOR SOLUTION FOR INJECTION OR INFUSION

Active substance: FLUDARABINE PHOSPHATE

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Fludarabine Actavis 50mg
Lyophilisate For Solution
For Injection Or Infusion
Fludarabine phosphate

Read all of this leaflet carefully
before you start using this
medicine.
• Keep this leaflet. You may need to
read it again.
• If you have any further questions,
ask your doctor.
• This medicine has been prescribed
for you. Do not pass it on to others.
It may harm them, even if their
symptoms are the same as yours.
• If any of the side effects gets
serious, or if you notice any side
effects not listed in this leaflet,
please tell your doctor.
In this leaflet:
1 What Fludarabine Actavis is and
what it is used for
2 Before you use Fludarabine
Actavis
3 How to use Fludarabine Actavis
4 Possible side effects
5 How to store Fludarabine Actavis
6 Further information
1 What Fludarabine Actavis is and
what it is used for
Fludarabine Actavis is an anti-cancer drug.
Fludarabine Actavis is used to treat chronic
B-cell lymphocytic leukaemia (B-CLL) in
patients with sufficient healthy blood cell
production. This is a type of cancer of white
blood cells (the cells are called lymphocytes).
First treatment for chronic lymphocytic
leukaemia with Fludarabine Actavis should
only be started in patients with advanced
disease having disease related symptoms or
evidence of disease progression.
All cells of the body produce new cells like
themselves by dividing. For this purpose, the
cell’ genetic material (DNA) must be copied
and reproduced. Fludarabine Actavis works
by hindering the production of new DNA.
Therefore, when Fludarabine Actavis is taken
up by the cancer cells, it stops the growth of
new cancer cells.
In cancers of the white blood cells (as chronic
lymphocytic leukaemia) many abnormal
lymphocytes are produced. The abnormal
lymphocytes either do not work properly or
are too young (immature) to carry out the
normal disease fighting functions of white
blood cells. If there are too many of these
abnormal lymphocytes, they push aside
healthy blood cells in the bone marrow
where most of the new blood cells are
formed. Without enough healthy blood
cells, infections, anaemia, bruising, excessive
bleeding or even organ failure can result.

2 Before you use Fludarabine
Actavis
Do not use Fludarabine Actavis

• if you are allergic (hypersensitive) to
fludarabine phosphate or any of the other
ingredients of Fludarabine Actavis.
• if you are breast feeding
• if your kidney function is severely impaired
• if you have a low number of red blood cells
(haemolytic anaemia). Your doctor will have
told you if you have this condition.

Take special care with Fludarabine
Actavis

• If you are not feeling very well you should
tell your doctor, as your doctor may decide
not to give you this medicine, or may give
you this medicine with caution. This is
very important if your bone marrow is not
working properly or if you are susceptible
to infections.
• If you notice any unusual bruising,
excessive bleeding after injury or if you
seem to be catching a lot of infections, tell
your doctor. The number of normal blood
cells may be reduced and so you will have
regular blood tests during treatment.
• The disease itself and the therapy may
cause a reduction of the number of blood
cells and your immune system may attack
different parts of your body (autoimmune
disorder). It may also be directed against
your red blood cells (called ‘autoimmune
haemolysis’). This condition can be life
threatening. If this condition occurs you
may receive further medication such as
transfusion of blood (irradiated, see below)
and corticosteroides.
• If you need a blood transfusion and you
are being (or have been) treated with this
medicine, you should mention this to the
doctor. Your doctor will ensure that you
receive blood only, which has gone through
a special treatment (irradiation). There have
been severe complications and even death
reported when non-irradiated blood has
been given.
• If you need to have stem cells collected and
you are being (or have been) treated with
this medicine, you should mention this to the
doctor.
• If your liver does not work properly, your
doctor may give you this medicine with
caution.

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• If you have any form of kidney disease, your
kidney function should be checked regularly.
If it is found that your kidneys do not work
properly you may be given this medicine
at a reduced dose. If your kidneys work at
only a very low level you will not be given
this medicine at all. Patients aged 65 years
or older should have their kidney function
checked before start of treatment.
• There is little information on the effects of
Fludarabine Actavis in patients aged 75 years
and older. Your doctor will use it with caution
if you are in this age group.
• If you have very severe chronic lymphocytic
leukaemia, your body may not be able to
get rid of all the waste products from the
cells destroyed by Fludarabine Actavis. This
is called tumour lysis syndrome and may
cause dehydration, kidney failure and heart
problems. Your doctor will be aware of this
and may give you other medicines to stop
this happening.
• If you experience any unusual symptoms
from the nervous system you should mention
it to your doctor. This is because when used
in patients at doses four times greater than
the recommended dose, severe central
nervous system (brain and spinal cord) effects
including blindness, coma and death have
been reported.
• Tell your doctor if you notice any changes
to your skin either while you are receiving
this medicine or after you have finished the
course of therapy. The doctor should check
the seriousness of the skin changes. If you
have skin cancer, the damaged areas of your
skin may become worse when you use this
medicine.
• Men and women who may still be fertile,
must use a reliable form of contraception
during, and for at least 6 months after
stopping treatment.
• Check with your doctor about any
vaccinations you may need, because live
vaccinations should be avoided during and
after treatment with Fludarabine Actavis.

Using other medicines

Please tell your doctor if you are taking or have
recently taken any other medicines, including
medicines obtained without a prescription. This
is especially important if you are taking a drug
called pentostatin or deoxycoformycin (also
used to treat chronic lymphocytic leukaemia) as
a combination with Fludarabine Actavis is not
recommended. Some drugs, e.g. dipyridamole
(used to prevent excessive blood clotting) may
reduce the effectiveness of Fludarabine Actavis.

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before
taking any medicine.
Fludarabine treatment has the potential to
harm the unborn child. You should not be
given Fludarabine Actavis if you are pregnant
unless clearly necessary and when the
potential benefits justify the potential risks
to the unborn child. If you are a woman who
may still be fertile, you must avoid becoming
pregnant during treatment and for at least 6
months after stopping treatment. However, if
you do become pregnant inform your doctor
immediately.
Men who are treated with Fludarabine Actavis
and can father a child must use a reliable form
of contraception during, and for at least 6
months after stopping treatment.
It is not known if this medicine appears in the
breast milk of women treated with Fludarabine
Actavis. However, in animal studies the
medicinal product was found in breast milk.
Therefore you must not breast feed during your
treatment with this medicine.

Driving and using machines

The effect of treatment with Fludarabine
Actavis on the ability to drive or use machines
has not been evaluated. Fludarabine Actavis
may although influence the ability to drive and
use machineries since side effects like tiredness,
weakness, agitation, seizures and visual
disturbances have been observed.

Important information about some
of the ingredients of Fludarabine
Actavis

This medicine contains less than 1 mmol
sodium (23mg) per ml, i.e. essentially ‘sodiumfree’.

3 How to use Fludarabine Actavis

Fludarabine Actavis should be administered
under the supervision of a qualified doctor
experienced in cancer therapy.
The dose you are given depends on the size
of your body. It varies with your body surface
area. Technically this is measured in square
metres (m2), but actually is worked out from
your height and weight. The recommended
dose is 25mg/m2 body surface. This will be
given either as an injection or as an infusion
(with a drip) into a vein once a day for 5
consecutive days every 28 days. This five day
course of treatment will be repeated every 28
days until your doctor has decided that the
best effect has been achieved.
The dosage may be decreased or the repeat
course delayed if side effects are a problem.
If you have kidney problems you will receive
a reduced dose and you will have regular
blood tests.
The safety of this drug in children and
adolescents below age 18 has not
been established and treatment is not
recommended.

Continued on next page

The following information is intended for medical or healthcare professionals only:

Fludarabine Actavis 50mg
Lyophilisate For Solution
For Injection Or Infusion
Fludarabine phosphate

Instructions for use, handling and disposal
ANTINEOPLASTIC AGENT
A crossover from initial treatment with
fludarbine phosphate to chlorambucil for
non responders to fludarabine phosphate
should be avoided because most patients
who have been resistant to fludarabine
phoshpate have shown resistance to
chlorambucil.
Instructions for use
Reconstitution
Fludarabine Actavis should be prepared for
parenteral use by aseptically adding sterile
water for injection. When reconstituted with
2ml of sterile water for injection, the powder
should fully dissolve in 15 seconds or less.
Each ml of the resulting solution will contain
25mg of fludarabine phosphate, 25mg of
mannitol, and sodium hydroxide to adjust
the pH to 7.7. The pH range for the final
product is 7.2 - 8.2.

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AAAE0523

Dilution
The required dose (calculated on the basis of
the patient’s body surface) is drawn up into
a syringe.
For intravenous bolus injection this dose
is further diluted in 10 ml of 0.9 % sodium
chloride. Alternatively, for infusion, the
required dose may be diluted in 100 ml of
0.9 % sodium chloride and infused over
approximately 30 minutes.
Fludarabine phosphate must not be mixed
with other drugs.
Storage after reconstitution:
The physicochemical stability of the drug
product after reconstitution in water for
injections has been demonstrated for 8
hours at 25°C ± 2°C/ 60% ± 5 %RH and for
7 days at 5°C ± 3°C. From a microbiological
point of view, the product should be used
immediately. If not used immediately, in-use
storage times and conditions prior to use are
the responsibility of the user.
Inspection prior to use
The reconstituted solution is clear and
colourless. It should be visually inspected
before use.
Only clear and colourless solutions without
particles should be used. Fludarabine Actavis
should not be used in case of a defective
container.

Continued on next page

If any of the Fludarabine Actavis solution
comes into contact with your skin or the
lining of your nose or mouth, wash the
area thoroughly with soap and water. If the
solution gets into your eyes, rinse them
thoroughly with lots of water. Try not to
breathe in any fumes coming from the
solution.

If you use more Fludarabine Actavis
than you should

In the case of an overdose your doctor will
stop the therapy and treat the symptoms.
Symptoms of an overdose can be blindness
which may not appear until later, coma
and death due to irreversible toxicity to the
central nervous system. High doses can also
lead to a severly reduced number of blood
cells.

If you forget to use Fludarabine
Actavis

Your doctor will set the times at which you
are to receive this medicine. If you think you
may have missed a dose, contact your doctor
as soon as possible.
If you have any further questions on the
use of this product, ask your doctor or
pharmacist.

4 Possible effects

Like all medicines, Fludarabine Actavis can
cause side effects, although not everybody
gets them.
If you are not sure what the adverse reactions
below are, ask your doctor to explain them to
you.
Some side effects can be life-threatening.
• If you have difficulty breathing, have a
cough, or have chest pain with or without
fever. These may be signs of an infection of
the lungs.
• If you notice any unusual bruising, more
bleeding than usual after injury or if you
seem to be catching a lot of infections.
These may be caused by a reduced number
of blood cells. This may also lead to an
increased risk of (serious) infections, caused
by organisms, that usually do not cause
disease in healthy persons (opportunistic
infections) including a late reactivation of
viruses, for example herpes zoster.
• If you notice any pain in your side, blood
in your urine, or reduced amount of urine.
These may be signs of tumour lysis syndrome
(see 2 ‘Take special care’).
• If you notice any skin and / or mucous
coat reaction with redness, inflammation,
blistering and tissue break down. These
may be signs of a severe allergic reaction
(Lyell’s syndrome, Stevens-Johnson syndrome).
• If you have palpitations (if you suddenly
become aware of your heart beat) or chest
pain. These may be signs of heart problems.
Tell your doctor immediately, if you notice
any of these effects.
Below we list possible side effects by how
common they are. The rare side effects (less
than 1 in every 1000 patients) were mainly
identified from post-marketing experience.
Very common means 1 or more in every 10
patients are likely to get these:
• infections (some serious);
• infections due to depressed immune system
(opportunistic infections);
• infection of the lungs (pneumonia) with
possible symptoms like breathing difficulties
and/or cough with or without fever;
• reduction in the number of blood platelets
(thrombocytopenia) with the possibility of
bruising and bleeding;
• lowered white blood cell count (neutropenia);
• lowered red blood cell count (anaemia);
• cough;
• vomiting, diarrhea, feeling sick (nausea);
• fever;
• feeling tired (fatigue);
• weakness.
Common means between 1 and 10 in every
100 patients are likely to get these:
• other blood related cancers (myelodysplastic
syndrome, acute myeloid leukaemia).
Most patients with these conditions were
previously, or at the same time or later
treated with other cancer drugs (alkylating
agents, topoisomerase inhibitors) or radiation
therapy);
• bone marrow depression (myelosuppression);
• severe loss of appetite leading to weight loss
(anorexia);
• numbness or weakness in limbs (peripheral
neuropathy);
• disturbed vision;
• inflammation of the inside of the mouth
(stomatitis);
• skin rash;
• swelling due to excessive fluid retention
(oedema);
• inflammation of the mucous coat of the
digestive system from the mouth to the anus
(mucositis);
• chills;
• generally feeling unwell.
Uncommon means between 1 and 10 in every
1,000 patients are likely to get these:
• autoimmune disorder (see section 2, ‘Take
special care’).
• tumour lysis syndrome (see section 2, ‘Take
special care’);
• confusion;
• lung toxicity; scaring throughout the lungs
(pulmonary fibrosis), inflammation of the
lungs (pneumonitis), shortness of breath
(dyspnoea);
• bleeding in the stomach or intestines;
• abnormal levels of the liver or pancreas
enzymes.

Continued on top of next column
AAAE0523

Rare means less than 10 in every 10,000
patients are likely to get these:
• disorders of the lymph system due to a viral
infection (EBV-associated lymphoproliferative
disorder);
• coma;
• seizures;
• agitation;
• blindness;
• inflammation or damage of the nerve of the
eyes (optic neuritis; optic neuropathy);
• heart failure;
• irregular heart beat (arrhythmia);
• skin cancer;
• skin and/or mucous coat reaction with
redness, inflammation, blistering and tissue
break down (Lyell’s syndrome, Stevens-Johnson
syndrome);

Frequency not know

• inflammation of the bladder, which can cause
pain when passing urine, and can lead to
blood in the urine (haemorrhagic cystitis).
• bleeding in the brain
• bleeding in the lungs
If any side effects get serious, or if you notice
any side effects not listed in this leaflet, please
tell your doctor.

5 How to store Fludarabine Actavis

Keep out of the reach and sight of children.
Store below 25°C.
Do not use Fludarabine Actavis after the
expiry date which is stated on the carton and
vial after EXP.

6 Further information

What Fludarabine Actavis contains
• The active substance is fludarabine
phosphate
• The other ingredients are mannitol and
sodium hydroxide.

What Fludarabine Actavis looks like
and contents of the pack
Each vial contains 50mg fludarabine
phosphate as a powder for injection or
infusion. The powder will be made up into
a solution before it is given to you. 1 ml
of reconstituted solution contains 25mg
fludarabine phosphate.
Pack sizes
1 x 50mg vial
5 x 50mg vial
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Actavis Group PTC ehf
Reykjavíkurvegur 76-78
IS-220 Hafnarfjörður
Iceland
Manufacturer
S. C. Sindan Pharma S.R.L.
11 Ion Michalache Blvd.
11171 Bucharest
Romania

This medicinal product is authorised
in the Member States of the EEA
under the following names:
Belgium

Fludarabin Actavis 50 mg
poeder voor oplossing
voor injectie
Czech Republic Fludarabin Actavis 50 mg
Germany
Fludarabin-Actavis 50 mg
Pulver zur Herstellung
einer

Injektions- oder
Infusionslösung
Denmark
Fludarabin Actavis
Spain
Fludarabina Actavis 50 mg
polvo para solución para
inyectable o perfusión
Finland
Fludarabin Actavis
Ireland
Fludarabine Actavis 50mg
Lyophilisate For Solution
For Injection Or Infusion
Iceland
Fludarabin Actavis
Fludarabina Actavis
Italy
Netherlands
Fludarabinefosfaat Actavis
50 mg
Norway
Fludarabin Actavis
Portugal
Fludarabina Actavis
Sweden
Fludarabin Actavis
United Kingdom Fludarabine Actavis 50mg
Lyophilisate For Solution
For Injection Or Infusion
This leaflet was last revised in July 2012.

If you would like
a leaflet with
larger text, please
contact
01271 311257.

Actavis, Barnstaple, EX32 8NS, UK

Handling and disposal
Fludarabine Actavis should not be handled
by pregnant staff.
Procedures for proper handling should be
followed according to local requirements
for cytotoxic drugs. Caution should be
exercised in the handling and preparation
of the Fludarabine Actavis solution. The
use of latex gloves and safety glasses is
recommended to avoid exposure in case
of breakage of the vial or other accidental
spillage.
If the solution comes into contact with the
skin or mucous membranes, the area should
be washed thoroughly with soap and water.
In the event of contact with the eyes, rinse
them thoroughly with copious amounts
of water. Exposure by inhalation should be
avoided.
The medicinal product is for single use only.
Any unused product or waste material
should be disposed of in accordance with
local requirements for cytotoxic agents.

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AAAE0523

Actavis, Barnstaple, EX32 8NS, UK

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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