CYTARABINE 100 MG/ML SOLUTION FOR INJECTION OR INFUSION

Active substance: CYTARABINE

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Cytarabine - Pack Insert - Bordon - GBR+IRL

Driving and using machinery
Cytarabine does not affect your ability to drive or use machinery.
However, cancer treatment in general can affect the ability of some
patients to drive or operate machines. If you are affected, you should
not drive or use machines.
Important information about some of the ingredients of
Cytarabine
This medicinal product contains less than 1 mmol sodium (23 mg)
per dose, i.e. essentially ’sodium- free’.
3. HOW TO USE CYTARABINE
Method and route of administrations
Cytarabine will be given to you by infusion into a vein (through a
‘drip’) or by injection under the direction of specialists in hospital.
Your doctor will decide what dose to give and the number of days
treatment you will receive depending on your condition.
Dosage
Based on your condition, your doctor will decide the dose of
cytarabine, whether you are in induction or maintenance therapy and
your body surface area. Your body weight and height will be used to
calculate your body surface area.
During treatment you will need regular checks including blood tests.
Your doctor will tell you how often this should be done. He/she will
be making regular checks of:

Black

Uncommon : may affect up to 1 in 100 people
• Sore throat
• Headache
• Serious allergic reactions (anaphylaxis), causing for instance
difficulty in breathing or dizziness
• Blood-poisoning (sepsis)
• Inflammation and ulcers of the gullet

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Fertility
Cytarabine may lead to suppression of menstrual cycles in females
and lead to amenorrhoea and may suppress sperm production in
male patients. Male patients undergoing cytarabine treatment should
use a reliable contraceptive method.
Ask your doctor or pharmacist for advice before taking any medicine.

Instruction for Use/Handling
For single use only.
Cytarabine is intended for intravenous
or subcutaneous use only.
The diluted solution should be clear,
colourless solution, free from visible
particles.
Parenteral drugs should be inspected
visually for particulate matter and
discolouration, prior to administration,
whenever solution and container
permit.
If the solution appears discoloured or
contains visible particles, it should be
discarded.
Cytarabine injection can be diluted
with sterile water for injections,
glucose intravenous infusion (5 %
w/v) or sodium chloride intravenous
infusion (0.9 % w/v).
The dilution compatibility study has
been carried out in polyolefin infusion
bags.
The concentration over which
the physico-chemical stability of
cytarabine has been demonstrated is
0.04 - 4 mg/ml.

Take special care with cytarabine:
• If your bone marrow is in low state, therapy should be initiated
under close medical supervision.
• If you have problem with your liver.
• Cytarabine strongly reduces blood cell production in the bone
marrow. This can make you more prone to infection or bleeding.
The blood cell numbers can continue to fall for up to a week after
stopping treatment. Your doctor will test your blood regularly and
examine your bone marrow if required.
• Serious and sometimes life-threatening side effects can occur in
the central nervous system, the bowels or lungs.
• Your liver and kidney function should be monitored during
cytarabine therapy. If your liver is not working well before
treatment, cytarabine should be given only under strict control.
• The levels of uric acid (showing that the cancer cells are destroyed)
in your blood (hyperuricaemia) may be high during treatment.

Breast-feeding
You should stop breast-feeding before starting treatment with
cytarabine because this medicine may be harmful to infants being
breast-fed.

4. POSSIBLE SIDE EFFECTS
Like all medicines, cytarabine injection can cause side effects,
although not everybody gets them.
The side effects of cytarabine are dependent on the dose. The
digestive tract is most commonly affected, but also the blood.
Common : may affect up to 1 in 10 people
• Fever
• Not enough white and red blood cells or blood platelets, which
may make you more prone to infection or bleeding
- a fall in white blood cells can be accompanied by chills and
fever that immediately requires a medical opinion;
- a fall in the platelet count can be accompanied by bleeding that
immediately requires a medical opinion,
• Abnormal blood cells (megaloblastosis)
• Loss of appetite
• Swallowing difficulty
• Belly ache (abdominal pain)
• Nausea (feeling sick)
• Vomiting
• Diarrhoea
• Inflammation or ulceration of the mouth or anus
• Reversible effects on the skin such as reddening (erythema),
blistering, rash, hives, blood vessel inflammation (vasculitis), hair
loss
• Reversible effects on the liver such as increased enzyme levels
• Reversible effects on the eyes such as sore eyes with bleeding
(haemorrhagic conjunctivitis) with vision disturbance, sensitivity
to light (photophobia), watery or burning eyes and inflammation
of the cornea (keratitis)
• Reduced consciousness (at high doses)
• Speaking difficulties (at high doses)
• Abnormal eye movements (nystagmus at high dose)
• Inflammation of the vein at the site injection
• Abnormal high blood uric acid levels (hyperuricaemia)

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2. BEFORE YOU ARE GIVEN CYTARABINE
Do not use cytarabine if you:
• Are allergic (hypersensitive) to cytarabine, or any of the other
ingredients of Cytarabine.
• If the cell count in your blood report is very low due to some cause
other than cancer or as decided by your doctor
• If you are having increasing difficulties in body coordination after
radiation treatment or treatment with another anticancer drug such
as methotrexate.

Pregnancy, breast-feeding and fertility
Pregnancy
Avoid becoming pregnant while you or your partner is being treated
with cytarabine. If you are sexually active, you are advised to
use effective birth control to prevent pregnancy during treatment,
whether you are male or female. Cytarabine may cause birth defects,
so it is important to tell your doctor if you think you are pregnant.
Men and women have to use effective contraception during and up
to 6 months after treatment.

If you receive high doses of cytarabine:
High doses can worsen side effects like sores in the mouth or may
decrease the number of white blood cells and platelets (these help
the blood to clot) in the blood. Should this happen, you may need
antibiotics or blood transfusions. Mouth ulcers can be treated to
make them less uncomfortable as they heal.
If you have any further questions on the use of this product, ask your
doctor or pharmacist.

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1. WHAT CYTARABINE IS AND WHAT IT IS USED FOR
• Cytarabine is used in adults and children. The active ingredient is
cytarabine.
• Cytarabine is one of a group of medicines known as cytotoxics,
these medicines are used in the treatment of acute leukaemias
(cancer of blood where you have too many white blood cells).
Cytarabine interferes with the growth of cancer cells, which are
eventually destroyed.
• Remission induction is an intensive treatment to force leukaemia
into retreat. When it works, the balance of cells in your blood
becomes more normal and your health improves. This relatively
healthy period is called a remission.
• Maintenance therapy is a milder treatment to make your remission
last as long as possible. Quite low doses of cytarabine are used to
keep the leukaemia under control and stop it flaring up again.

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

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Dimension: 280 x 320 mm

In this leaflet:
1. What Cytarabine is and what it is used for
2. Before you are given Cytarabine
3. How to use Cytarabine
4. Possible side effects
5. How to store Cytarabine
6. Further information

Using other medicines
Please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines, including medicines obtained
without a prescription.
• Given medicines containing 5-fluorocytosine (a medicine used to
treat fungal infections).
• Taking medicines containing digitoxin or beta-acetyldigoxin
which are used to treat certain heart conditions.
• Taking gentamicin (an antibiotic used to treat bacterial infections).
• Given medicines containing cyclophosphamide, vincristine and
prednisone which are used in cancer treatment programmes.

Contamination:
(a) In the event of contact with the skin
or eyes, the affected area should be
washed with copious amounts of
water or normal saline. A bland

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, please ask your doctor or
pharmacist.
-- If any of the side effects get serious, or if you notice any side effects
not listed in this leaflet, please tell your doctor or pharmacist.

Preparation (Guidelines):
1. Chemotherapeutic agents should be
prepared for administration only by
professionals trained in the safe use
of the preparation.
2. Operations such as dilution and
transfer to syringes should be carried
out only in the designated area.
3. The personnel carrying out these
procedures should be adequately
protected with clothing, gloves
and eye shield.
4. Pregnant personnel are advised not
to handle chemotherapeutic agents.

Cytarabine

• Your blood, to check for low blood cell counts that may need
treatment.
• Your liver —again using blood tests —to check that cytarabine is
not affecting the way it functions in a harmful way.
• Your kidneys —again using blood tests —to check that cytarabine
is not affecting the way they function in a harmful way.
• Blood uric acid levels - cytarabine may increase uric acid levels in
the blood. Another medicine may be given if your uric acid levels
are too high.
• If your are on dialysis, the doctor may alter the time of drug
administration as dialysis may decrease the effectiveness of the
medicine.

Cytotoxic Handling Guidelines
Administration:
Should be administered by, or under
the direct supervision of, a qualified
physician who is experienced in the
use of cancer chemotherapeutic agents.

Cytarabine 100 mg/ml
solution for injection or infusion

Your doctor will tell you if you need to take any medicine to
control this.
• During treatment with cytarabine, administration of live or
attenuated vaccine is not advised. If required, consult your doctor.
Use of killed or inactivated vaccine may not have the desired
effect due to suppressed immune system while on cytarabine.
• Do not forget to tell you doctor if you have received radiotherapy.

If crystallization is observed
as a result of exposure to low
temperatures, redissolve the crystals
by warming up to 55°C for no longer
than 30 minutes and shake until the
crystals are dissolved. Allow to cool
to room temperature before use.
Once opened, the contents of each
vial must be used immediately and not
stored.
Infusion fluids containing cytarabine
should be used immediately.

PACKAGE LEAFLET: INFORMATION FOR THE USER
­­

Last modified: 6 June 2013 3:47 PM

Cytarabine - Pack Insert - Bordon - GBR+IRL

Your doctor may prescribe corticosteroids (anti-inflammatory
medicines) to prevent or treat these symptoms. If they are effective,
treatment with cytarabine may be continued.
Central nervous system:
The following symptoms, which are usually reversible, may develop
in up to one third of patients after treatment with high cytarabine
doses:
• Personality changes
• Changed alertness
• Difficulty in speaking
• Problems of coordination
• Tremor
• Abnormal eye movements (nystagmus)
• Headache
• Confusion
• Sleepiness
• Dizziness
• Coma
• Convulsions
These side effects may occur more often:
• In elderly patients (>55 years of age)
• In patients with impaired liver and kidney function
• After previous cancer treatment to the brain and spinal cord for
instance radiotherapy or injection of cytostatic
• With alcohol abuse
The risk of nervous system damage increases if the cytarabine
treatment
• Is given at high doses or at short intervals
• Is combined with other treatments that are toxic to the nervous
system (such as radiotherapy or methotrexate)

Lungs:
Acute, distressing breathing difficulties and water in the lungs
(pulmonary oedema) have been observed particularly at high doses.
Others:
• heart muscle disease (cardiomyopathy)
• abnormal muscle breakdown (rhabdomyolysis)
If any of the side effects gets serious, or if you notice any
side effects not listed in this leaflet, please tell your doctor or
pharmacist. These disorders can occur even when treatment has
a positive effect
5. HOW TO STORE CYTARABINE
Keep out of the reach and sight of children.
Do not refrigerate or freeze. Store between 15°C to 25°C.
Do not use cytarabine injection after the expiry date which is stated
on the vial or carton. The expiry date refers to the last day of that
month. The product should be used immediately after opening the
vial.
After dilution in the following diluents, sterile water for injections,
glucose intravenous infusion (5 % w/v) or sodium chloride
intravenous infusion (0.9 % w/v):
Chemical and physical in-use stability have been demonstrated for 8
days below 25 °C. From a microbiological point of view, the product
should be used immediately. If not used immediately, in-use storage
times and conditions are the responsibility of the user and would
normally not be longer than 24 hours at 2-8°C, unless dilution has
taken place in controlled and validated aseptic conditions.
Do not use cytarabine injection if you notice that the solution is not
clear, colourless and free of particles.
Medicines should not be disposed of via wastewater or household
waste. Ask your pharmacist how to dispose of medicines no longer
required. These measures will help to protect the environment.
6. FURTHER INFORMATION
What Cytarabine contains:
The active ingredient is cytarabine.
Each ml of solution contains 100 mg of cytarabine.
Each 1 ml vial contains 100 mg of cytarabine.
Each 5 ml vial contains 500 mg of cytarabine.
Each 10 ml vial contains 1 g of cytarabine.
Each 20 ml vial contains 2 g of cytarabine.

Marketing Authorisation Holder and Manufacturer
Fresenius Kabi Oncology Plc.
Lion Court, Farnham Road, Bordon
Hampshire, GU35 0NF
United Kingdom
This medicinal product is authorised in the Member States of
the EEA under the following names:
Belgium
Czech
Republic
Germany
Denmark
Estonia
Spain
Finland
France
Hungary
Ireland
Iceland
Italy
Latvia
Malta
Lithuania
Luxemburg
Netherlands
Norway
Poland
Portugal
Romania
Sweden

The other ingredients are hydrochloric acid, sodium hydroxide and
water for injections.

Slovak
Republic
United
Kingdom

Cytarabine Fresenius Kabi 100 mg/ml Oplossing
voor injectie of infusie
Cytarabin Kabi 100 mg/ml, Injekční a infuzní
roztok
Cytarabin Kabi 100 mg/ml Injektions-oder
Infusionslösung
Cytarabin Fresenius Kabi
Cytarabine Kabi
Citarabina 100 mg/ml solución inyectable o para
perfusión
Cytarabin Fresenius Kabi 100 mg/ml injektio-/
infuusioneste, liuos
Cytarabine Kabi 100 mg/ml, solution injectable ou
pour perfusion
Cytarabine Kabi 100 mg/ml oldatos injekció vagy
infúzió
Cytarabine 100 mg/ml Solution for Injection or
Infusion
Cytarabin Fresenius Kabi 100 mg/ml stungulyf/
innrennslislyf, lausn
Citarabina Kabi
Cytarabine Kabi 100 mg/ml šķīdums injekcijām
vai infūzijām
Cytarabine 100 mg/ml Solution for Injection or
Infusion
Cytarabine Kabi 100 mg/ml injekcinis/
infuzinis tirpalas
Cytarabin Kabi 100 mg/ml Injektions- oder
Infusionslösung
Cytarabine Fresenius Kabi 100 mg/ml Oplossing
voor injectie of infusie
Cytarabin "Fresenius Kabi" 100 mg/ml
Injeksjons-/infusjonsvæske, oppløsning
Cytarabine Kabi
Citarabina Kabi
Citarabina Kabi 100 mg/ml soluţie injectabilă sau
perfuzabilă
Cytarabin Fresenius Kabi 100 mg/ml injektions-/
infusionsvätska, lösning
Cytarabin Kabi 100 mg/ml, injekčný a infúzny
roztok,
Cytarabine 100 mg/ml Solution for Injection or
Infusion

This leaflet was last revised on 03/2013

What Cytarabine looks like and contents of the pack
The medicinal product is presented as a clear, colourless solution
for injection or infusion. This medicine is presented in a clear
colourless, type I glass vials with bromobutyl rubber stopper and
sealed with flip-off aluminium overseal. Green (2 ml), blue (5 ml),
red (10 ml) and yellow (20 ml).

7220131752

Other side effects:
The cytarabine syndrome may occur 6-12 hours after the start of
treatment. The symptoms include:
• Fever
• Bone and muscle pain
• Occasional chest pain
• Rash
• Sore eyes (conjunctivitis)
• Nausea (feeling sick)

The package contains 1 vial of 1 ml, 5 ml, 10 ml and 20 ml,
respectively.

Disposal:
Syringes,
container,
absorbent
materials, solution and any other
contaminated material should be
placed in a thick plastic bag or other
impervious container and incinerated
at 1100°C.
Any unused product or waste material
should be disposed of in accordance
with local requirements.

Not all pack sizes may be marketed.

cream may be used to treat the
transient stinging of skin. Medical
advice should be sought if the eyes
are affected.
(b) In the event of spillage, operators
should put on gloves and mop up
the spilled material with a sponge
kept in the area for that purpose.
Rinse the area twice with w a t e r .
Put all solutions and sponges into
a plastic bag and seal it.

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Dimension: 280 x 320 mm

Very rare : may affect up to 1 in 10,000 people
• Inflammation of sweat glands
• Irregular heartbeat (arrhythmias)

Digestive tract:
Especially in treatment with high doses of cytarabine more severe
reactions may appear in addition to the common symptoms.
Perforation, death (necrosis) and obstruction of the bowel and
inflammation of the inner belly lining have been reported. Liver
abcesses, liver enlargement, blockage of liver veins and inflammation
of the pancreas have been observed after high-dose therapy.
The side effects on the digestive tract are less if cytarabine is given
by infusion.

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Severe bowel inflammation (necrositing colitis)
Bowel cysts
Ulceration of the skin
Itching
Inflammation at the site of injection
Brown/black spots on the skin (lentigo)
Yellowish skin and eye balls (jaundice)
Lung infection (pneumonia)
Breathing difficulty
Paralysis of the legs and lower body can occur when cytarabine is
given into the space surrounding the spinal cord
Muscle and joint pain
Inflammation of the lining that surrounds the heart (pericarditis)
Impaired kidney function
Inability to pass urine (urinary retention)
Chest pain
Burning pain of palms and soles

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Times New Roman

9 pt

Ver.: 01

Last modified: 6 June 2013 3:47 PM

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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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