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2. Cytarabine 20mg/Ml Injection

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Hospira

PACKAGE LEAFLET: INFORMATION FOR THE USER

Cytarabine 20 mg/ml Injection

In this leaflet:

1.    What Cytarabine Injection is and what it is used for

2.    What you need to know before you use Cytarabine Injection

3.    How to use Cytarabine Injection

4.    Possible side effects

5.    How to store Cytarabine Injection

6.    Contents of the pack and other information

1. WHAT CYTARABINE INJECTION IS AND WHAT IT IS USED FOR

Cytarabine Injection is an anti-cancer medicine. Treatment with an anti-cancer medicine is sometimes called cancer chemotherapy.

Cytarabine Injection is used to treat some types of leukaemia (cancer affecting the blood) and lymphomas (cancer of the lymph glands). It may be used in combination with other anti-cancer medicines.

2. WHAT YOU NEED TO KNOW BEFORE YOU USE CYTARABINE INJECTION

Do not use Cytarabine Injection

•    if you have shown signs of hypersensitivity (severe allergy) to cytarabine in the past, or any of the other ingredients of this medicine (listed in section 6)

•    if your blood cell count (number of cells in your blood) is very low due to some cause other than cancer (unless your doctor decides the benefits of treatment outweigh the risks)

•    if you are feeling increasing difficulties in body coordination after radiation treatment or treatment with another anticancer medicine such as methotrexate

•    if you are pregnant

Tell your doctor if you think any of the above applies to you before this medicine is used.

Take special care with Cytarabine Injection

•    if your blood cell count is low

•    if you have any problems with your liver including jaundice (causes yellowing of the skin)

•    if you have recently received cancer medicine treatment or radiotherapy or if you are due to have radiotherapy (the side effects of radiotherapy can be made worse by cytarabine treatment)

•    Cytarabine strongly reduces blood cell production in the bone marrow and your 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.

•    if your bone marrow is still recovering from the effects of other medicines (your doctor will only consider treatment with cytarabine if absolutely necessary)

•    Serious and sometimes life-threatening side effects can occur in the central nervous system, the bowels, the lungs or the heart especially when treated with high doses of cytarabine.

•    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 certain vaccines 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.

•    During treatment with cytarabine granulocyte transfusion should be avoided as severe respiratory insufficiency has been reported. If required, consult your doctor.

Tell your doctor if any of the above applies to you before this medicine is used. Your doctor will monitor your blood to check your blood cell count, your liver and kidney functions and to monitor for raised uric acid levels.

Special care will be taken if cytarabine is to be given to a child. Cytarabine should not be used in infants.

Taking/using other medicines

Special care is needed if you are taking/using other medicines as some could interact with cytarabine.

The effectiveness of the following medicines may be reduced or increased by cytarabine:

•    digoxin or beta-acetyldigoxin tablets (heart medicine)

•    gentamicin (an antibiotic)

•    5-fluorocytosine (a medicine used to treat fungal infections)

•    medicines containing cyclophosphamide, vincristine and prednisone which are used in cancer treatment programmes

•    other medicines which decrease the activity of the immune system Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Pregnancy and breast-feeding

Tell your doctor if you are pregnant, trying to become pregnant or breast-feeding. Your doctor will decide if you should receive this medicine.

Avoid becoming pregnant while you or your partner is being treated with cytarabine. As there is a risk of birth defects, women of childbearing potential or their partner should use appropriate contraception methods during and up to 6 months after treatment with cytarabine to prevent pregnancy.

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

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Do not drive or use machines if you experience any side effect which may lessen your ability to do so.

Important information about one of the ingredients of Cytarabine Injection

This medicinal product contains 2.1 mmol sodium (48 mg) per 350 mg dose. To be taken into consideration by patients on a controlled sodium diet.

3. HOW TO USE CYTARABINE INJECTION

This medicine may be given by injection (using a syringe) under the skin (subcutaneous), into a vein (intravenous) or into the spine (intrathecal). It may also be given by infusion (drip) into a vein. If given as an infusion, Cytarabine Injection will be diluted first.

Dose

Your doctor will work out the correct dose of cytarabine for you and how often it must be given.

The dose will depend on your medical condition, your size and how well your liver is working. Your doctor will tell how well your liver is working using blood tests.

You will have regular blood tests after your dose of cytarabine to check for side effects. These tests may be done more often if you are elderly, as you may be more likely to get side effects. Treatment may have to be stopped if your blood cell count drops too low.

If you are given too much or too little Cytarabine Injection

This medicine will be given to you in a hospital, under the supervision of a doctor. It is unlikely that you will be given too much or too little, however, tell your doctor or nurse if you have any concerns.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Cytarabine Injection can cause side effects, although not

everybody gets them.

If any of the following happen, tell your doctor or nursing staff

immediately:

•    sore mouth, particularly if you have a number of ulcers inside of the mouth

•    severe allergic reaction - you may experience a sudden itchy rash (hives), swelling of the hands, feet, ankles, face, lips, mouth or throat (which may cause difficulty in swallowing or breathing), and you may feel you are going to faint

•    symptoms of an infection, e.g. fever, chills, aches or soreness when swallowing

•    unexpected bleeding e.g. bleeding gums, blood in urine or vomit, unexpected bruises

•    black tarry stools which may indicate bleeding in the digestive system

•    severe pain in the chest and difficulty breathing (this may be a symptom of pericarditis)

Cytarabine 20 mg/ml Injection

The following information is intended for medical or healthcare professionals only

Further to the information included in section 3, practical information on the preparation/handling of the medicinal product is provided here.

Incompatibilities

Solutions of cytarabine have been reported to be incompatible with various drugs, i.e. carbenicillin sodium, cephalothin sodium, fluorouracil, gentamicin sulphate, heparin sodium, hydrocortisone sodium succinate, insulin-regular, methylprednisolone sodium succinate, nafacillin sodium, oxacillin sodium, penicillin G sodium. However, the incompatibility depends on several factors (e.g. concentrations of the drug, specific diluents used, resulting

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•    severe pain in the abdomen (this may be a symptom of inflammation of the pancreas)

•    loss of vision, loss of sense of touch, mental disturbance or loss of ability to move normally (this medicine may cause side effects to the brain and eyes which are usually reversible but may be very serious)

These are serious side effects. You may need urgent medical attention.

If you experience any of the following tell your doctor as soon as possible:

The side effects of cytarabine are dependent on the dose. The digestive tract is most commonly affected, but also the blood.

Common side effects which may affect up to 1 person in 10 are listed below:

•    decrease in cells responsible for providing immunity, carrying oxygen around the body and for normal blood clotting shown as a reduction in the amount of red and white cells and platelets in the blood, anaemia, shortness of breath, unexpected bleeding e.g. bleeding gums, blood in urine or vomit, unexpected bruises

•    loss of appetite

•    high levels of uric acid due to the breakdown of cancer cells during treatment with cytarabine

•    reduced consciousness, speaking difficulties, abnormal eye movements (nystagmus)

•    reversible effects on the eyes such as sore eyes with bleeding (haemorrhagic conjunctivitis), vision disturbance, sensitivity to light (photophobia), watery or burning eyes and inflammation of the cornea (keratitis)

•    feeling or being sick (this side effect may be reduced if cytarabine is given as an infusion into a vein rather than an injection into a vein), diarrhoea, sore mouth or anus (back passage), ulcers in the mouth or anus, mild pain in the abdomen

•    reversible effects on the liver such as increased enzyme levels

•    reversible effects to the skin such as reddening (erythema), blistering, rash, hives, blood vessel inflammation (vasculitis)

•    hair loss

•    impaired / disturbed kidney function, problems passing urine

•    fever

•    blood clots causing inflammation at the site of injection

Uncommon side effects which may affect up to 1 person in 100 are listed below:

•    whole body infection (sepsis) seen as a fever, vomiting, confusion, dizziness, chills

•    lung infection

•    headache

•    numbness or weakness of the arms and legs, paralysis of the legs and lower body when cytarabine is given into the space surrounding the spinal cord (intrathecal)

•    inflammation of the sac that surrounds the heart

•    shortness of breath

•    sore throat

•    inflammation of the food pipe (oesophagus), ulcers in the food pipe

•    bowel cysts (pneumatosis cystoides intestinalis), severe bowel inflammation (necrotising colitis), serious infection of the membrane that lines the abdomen (peritonitis)

•    brown/black spots on the skin (lentigo), ulceration of the skin, itching

•    painful redness and blistering on the hands and the soles of the feet

•    joint and muscle pain

•    inflammation at the injection site

Very rare side effects which may affect up to 1 person in 10,000 are listed below:

•    irregular heart beat (arrhythmia)

•    redness and itchy bumps on hands or legs, associated with inflammation of the sweat glands (neutrophilic eccrine hidradenitis)

Not known (cannot be estimated from available data) side effects are listed below:

•    bone marrow suppression, low counts of pre-stages of red cells in the blood (reticulocytopenia), abnormal blood cells (megaloblastosis)

•    dizziness, inflammation of a nerve or part of the nervous system, damage to nerve tissues and pain

•    sore or itchy eyes

•    black tarry stools which may indicate bleeding in the digestive system

•    impaired liver function

•    yellowing of the skin or yellowing of the whites of the eyes (jaundice)

•    skin rash, pigmented spots on the skin (freckles), skin bleeding

•    kidneys may not work properly

•    chest pain

•    irritation or severe blood infection (sepsis) at the site of injection, mucosal bleeding

Severe and at times fatal side effects on the blood, eyes, lungs, nervous system, liver, digestive or genital system have been reported after using experimental dose schedules. The side effects have included severe bone marrow suppression, reversible effects on the cornea (front of the eye), effects on the brain (usually reversible), drowsiness and convulsion, ulcers in the digestive system which may lead to the infection of your abdominal fluid (peritonitis), inflammation of the pancreas, abscess or blood clots in a vein in the liver, blood infection, fluid in the lungs, absence of menstrual periods in women or complete lack of sperm in the ejaculate in men, heart muscle disease or abnormal muscle breakdown, which may lead to kidney problems (rhabdomyolysis).

The side effects on the digestive tract are less if cytarabine is given by infusion. Your doctor may prescribe local corticosteroids (anti-inflammatory medicines) to prevent effects on the eyes such as sore eyes with bleeding (haemorrhagic conjunctivitis).

Cytarabine may lead to changes in your blood cells. Your doctor will take blood samples to monitor for these and also to check how well your liver and kidneys are working.

Sometimes the following side effects can occur together, usually 6-12 hours after receiving cytarabine:

•    feeling generally unwell with a high temperature

•    pain in bone, muscle and occasionally the chest

•    rash

•    sore eyes

This is known as ‘cytarabine syndrome' and it can be treated. If you experience these side effects please tell your doctor or nurse as soon as possible.

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

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.

You can also report side effects directly via:

United Kingdom

Yellow Card Scheme

Website: www.mhra.gov.uk/yellowcard

By reporting side effects you can help provide more information on the safety of this medicine.

5. HOW TO STORE CYTARABINE INJECTION

Keep out of the reach and sight of children Expiry

This medicine must not be used after the expiry date which is stated on the vial label and carton after ‘EXP'. Where only a month and year is stated, the expiry date refers to the last day of that month.

Storage

The vial should be kept in the outer carton, in order to protect from light, and stored at a temperature not above 25°C.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Cytarabine Injection contains

The active substance is cytarabine. Each millilitre (ml) of solution contains 20 milligrams (mg) of cytarabine.

The other ingredients are sodium chloride and Water for Injections. See section 2 ‘Important information about one of the ingredients of Cytarabine Injection' for further information about the sodium content.

What Cytarabine Injection looks like and contents of the pack

Cytarabine Injection is a clear, colourless solution for injection which comes in glass containers called vials.

It may be supplied in packs containing:

5, 25 or 50 x 100 mg/5 ml vials 5, 25 or 50 x 500 mg/25 ml vials 5, 25 or 50 x 1 g/50 ml vials Not all packs may be marketed.

Marketing authorisation holder and manufacturer responsible for batch release in Europe

Hospira UK Limited, Queensway, Royal Leamington Spa, Warwickshire,

CV31 3RW

Manufacturer

Hospira Australia Pty Ltd, Lexia Place, Mulgrave, Victoria 3170, Australia This leaflet was last approved in 03/2014

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pH, temperature). Specialised references should be consulted for specific compatibility information.

Use and handling

Cytarabine 20 mg/ml Injection is a ready to use solution but it can be diluted with sterilised Water for Injections BP, Glucose Intravenous Infusion BP or Sodium Chloride Intravenous Infusion BP.

Chemical and physical in-use stability has been demonstrated for 7 days at room temperature.

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 and would normally not be longer than 24 hours at 2-8°C, unless dilution has taken place in controlled and validated aseptic conditions.

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