CYTARABINE 20 MG/ML SOLUTION FOR INJECTION/INFUSION

Active substance: CYTARABINE

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Strides Arcolab International Ltd.

Cytarabine 20 mg/ml, solution for injection/infusion
Cytarabine 100 mg/ml, solution for injection/infusion
PILE – p. 1/9
October 2012

PACKAGE LEAFLET: INFORMATION FOR THE USER
Cytarabine 20 mg/ml, solution for injection/infusion
Cytarabine 100 mg/ml, solution for injection/infusion
Cytarabine
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 gets serious, or if you notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
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
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)
including prophylaxis and treatment of CNS involvement (meningeal leukaemia). 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.




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 feeling increasing difficulties in body coordination after radiation treatment or
treatment with another anticancer drug such as methotrexate.
 if you are pregnant.

Strides Arcolab International Ltd.

Cytarabine 20 mg/ml, solution for injection/infusion
Cytarabine 100 mg/ml, solution for injection/infusion
PILE – p. 2/9
October 2012

Take special care with Cytarabine Srides:
 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 reduce 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. 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.
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.
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.
Breast-feeding
You should stop breast-feeding before starting treatment with cytarabine because this medicine may
be harmful to infants being breast-fed.

Strides Arcolab International Ltd.

Cytarabine 20 mg/ml, solution for injection/infusion
Cytarabine 100 mg/ml, solution for injection/infusion
PILE – p. 3/9
October 2012

Fertility
Cytarabine may lead to suppression of menstrual cycles in females and lead to amenorrhea 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.
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
Cytarabine 20mg/ml: 1ml solution contains 6,8 mg of sodium chloride equivalent to 2,67 mg/ml
sodium.
To be taken into consideration by patients on a controlled sodium diet.
3. HOW TO USE CYTARABINE
Method and route of administrations
Cytarabine will be given to you 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.
You may receive Cytarabine 20mg/ml either as an injection into a vein (intravenous), into a muscle
(intramuscular), into the space surrounding the spinal card (intrathecal) or under the skin
(subcutaneous).
You may receive Cytarabine 100mg/ml as an injection into a vein (intravenous).
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:
 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 it
functions 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 you are on dialysis, the doctor may alter the time of drug administration as dialysis may
decrease the effectiveness of the medicine.

Strides Arcolab International Ltd.

Cytarabine 20 mg/ml, solution for injection/infusion
Cytarabine 100 mg/ml, solution for injection/infusion
PILE – p. 4/9
October 2012

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.
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
o a fall in white blood cells can be accompanied by chills and fever that immediately
require a medical opinion;
o 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)

Strides Arcolab International Ltd.

Cytarabine 20 mg/ml, solution for injection/infusion
Cytarabine 100 mg/ml, solution for injection/infusion
PILE – p. 5/9
October 2012

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
 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
Very rare: may affect up to 1 in 10,000 people
 inflammation of sweat glands
 irregular heartbeat (arrhythmias)
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 following symptoms may develop after intrathecal treatment (injection into the space around
the spinal cord) with cytarabine:
 inflammation and breakdown of the white matter of the brain (necrotising leukencephalopathy)
 blindness
 spinal cord injury resulting in paralysis of two or all four limbs (paraplegia and quadriplegia)
 nausea (feeling sick)
 vomiting
 headache
 fever

Strides Arcolab International Ltd.



Cytarabine 20 mg/ml, solution for injection/infusion
Cytarabine 100 mg/ml, solution for injection/infusion
PILE – p. 6/9
October 2012

other symptoms if a membrane surrounding brain and spinal cord is inflamed

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 speeking
 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 damages increases if the cytarabine treatment
 is given at high doses or at short intervals
 is combined with other treatments that are toxic to the nerves system (such as radiotherapy or
methotrexate)
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.
Lungs:
Acute, distressing breathing difficulties and water in the lungs (pulmonary edema) have been
observed particularly at high doses.

Strides Arcolab International Ltd.

Cytarabine 20 mg/ml, solution for injection/infusion
Cytarabine 100 mg/ml, solution for injection/infusion
PILE – p. 7/9
October 2012

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 store above 25 °C. Do not refrigerate or freeze.
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, glucose intravenous infusion (5 % w/v ) or sodium chloride
intravenous infusion (0.9 % w/v):
Chemical and physical in-use stability has been demonstrated for 8 days when stored at room
temperature.
From a microbiological point of view, both products 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:
Cytarabine 20mg/ml
The active substance is cytarabine. 1 ml solution for injection/infusion contains 20 mg cytarabine.
The other ingredients are Sodium Chloride, Hydrochloric Acid, Sodium Hydroxide and Water for
injection.
Cytarabine 100mg/ml
The active substance is cytarabine. 1 ml solution for injection/infusion contains 100 mg cytarabine.
The other ingredients are Hydrochloric Acid, Sodium Hydroxide and Water for injections.

Strides Arcolab International Ltd.

Cytarabine 20 mg/ml, solution for injection/infusion
Cytarabine 100 mg/ml, solution for injection/infusion
PILE – p. 8/9
October 2012

What Cytarabine looks like and contents of the pack
This medicine is a solution for injection/infusion.
The solution is clear and colourless, and is filled in a clear glass vial sealed with a rubber stopper
and aluminium cap.
Cytarabine 20mg/ml
5 vials of 5 ml , 1 vial of 25 ml, 5 vials of 25ml or 1 vial of 50ml .
Cytarabine 100mg/ml
1 vial of 20 ml .
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Strides Arcolab International Limited
Unit 4, Metro Centre,
Tolpits Lane, Watford,
Hertfordshire,
WD18 9SS
United Kingdom
Manufacturer
Strides Arcolab Polska Sp z o o
10, Daniszewska Str,
03-230 Warsaw,
Poland
This leaflet was last approved in October 2012

The following information is intended for medical or healthcare professionals only:
Instruction for Use/Handling
For single use only. Any unused solution should be discarded.
Cytarabine 20 mg/ml, solution for injection/infusion is intended for intravenous, intramuscular,
subcutaneous or intrathecal use.
Cytarabine 100 mg/ml, solution for injection/infusion is intended for intravenous use.

The diluted solution should be clear, colourless solution free, from visible particles.

Strides Arcolab International Ltd.

Cytarabine 20 mg/ml, solution for injection/infusion
Cytarabine 100 mg/ml, solution for injection/infusion
PILE – p. 9/9
October 2012

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 should for infusion be diluted with 0.9 % sodium chloride solution, or 5 % glucose
solution.
If Cytarabine comes in contact with skin, the exposed area should be rinsed with large amounts of
water and then thoroughly washed with soap and water. If the solution gets into the eyes, rinse very
carefully with large amounts of water, whereupon an eye specialist should be consulted
immediately.
Pregnant staff should be excluded from working with this drug.
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.
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.
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 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 water. Put all solutions and
sponges into a plastic bag and seal it.
Disposal:
To destroy, place in a high risk (for cytotoxics) waste disposal bag and incinerate at 1100°C. If
spills occur, restrict access to the affected area and adequate protection including gloves and safety
spectacles should be worn. Limit the spread and clean the area with absorbent paper/material. Spills
may also be treated with 5% sodium hypochlorite. The spill area should be cleaned with copious
amounts of water. Place the contaminated material in a leak proof disposal bag for cytotoxics and
incinerate at 1100°C.
Any unused product or waste material should be disposed of in accordance with local requirements.

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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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