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IDARUBICIN 20 MG/20 ML SOLUTION FOR INJECTION

Active substance(s): IDARUBICIN HYDROCHLORIDE

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- if you are a man, idarubicin can cause
irreversible infertility.
Patient Information Leaflet

Idarubicin 5 mg/5 ml
solution for injection
Idarubicin 10 mg/10 ml
solution for injection
Idarubicin 20 mg/20 ml
solution for injection
Idarubicin (hydrochloride)

Read all of this leaflet carefully before you are
given 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 pharmacist.
- This medicine has been prescribed for you only.
Do not pass it on to others. It may harm them,
even if their signs of illness are the same as
yours.
- If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Idarubicin Injection is and what it is used
for
2. What you need to know before you are given
Idarubicin Injection
3. How to use Idarubicin Injection
4. Possible side effects
5. How to store Idarubicin Injection
6. Contents of the pack and other information

1. What Idarubicin Injection is
and what it is used for
Idarubicin Injection belongs to a group of
medicines called as citotoxics and antimitotics
agents, which intercalate with DNA and interact
with topoisomerase II, having an inhibitory effect
on the synthesis of nucleic acid.
Idarubicin Injection is a medicine used for the
treatment :
Adults
- Acute non-lymphocytic leukaemia, for
remission induction in untreated patients or for
remission induction in relapsed or refractory
patients.
- Acute lymphocytic leukaemia as second line
treatment.
Children
- Acute non-lymphocytic leukaemia, in
combination with cytarabine, for remission
induction in untreated patients.
- Acute lymphocytic leukaemia as second line
treatment.
Idarubicin Injection may also be used in
combination with other anticancer agents.

2. What you need to know before
you are given Idarubicin
Injection
Do not take Idarubicin Injection:
- if you are allergic to idarubicin or to any of the
other ingredients in this medicine (listed in
section 6);
- if you are allergic to other anthracyclines or
anthracenediones;
- if you suffer from severe liver problems ;
- if you suffer from sever kidneys problems;
- if you suffer from heart problems;
- if you have low production of blood cells and
platelets;
- If you have previously been treated with
idarubicin and/ or other anthracyclines or
anthracenediones.
- If you are breast-feeding.
Warnings and Precautions
- if you have heart trouble. Heart function must
be assessed before starting treatment with
idarubicin and must be monitored during
treatment to minimise the risk of incurring
severe heart failure;
- if you have a reduced bone marrow blood cell
and platelet count;
- if you have a marked and permanent increase
of abnormal white cells in the blood. You may
be developing leukaemia;
- if you have gastrointestinal problems;
- if you have liver problems;
- if you have kidney problems;
- this medicine can cause vomiting, may develop
inflammation of the oral mucosa or inflammation
of the mucosal lining of the digestive tract;
- you may develop reactions at the injection site;
- if extravasation occurs during the injection, you
may feel pain and extravasation may cause
severe tissue lesions. If extravasation occurs,
administration of the medicine must be
discontinued immediately;
- as happens with other cytotoxic agents,
inflammation of a vein wall may occur, with the
formation of blood clots;
- if you have recently had or are thinking of
having a vaccine;

THE FOLLOWING INFORMATION IS
INTENDED FOR HEALTHPROFESSIONALS
ONLY:
This medicine is intended to be administered
intravenously.
Incompatibilities:
Prolonged contact with any alkaline pH solution
must be avoided, since it can give rise to drug
degradation. Idarubicin hydrochloride must not be
mixed with heparin, as it can form a precipitate.
Association with other drugs is not
recommended.
Idarubicin Injection is intended to be used once
only and any remaining drug must be discarded.
The ready-to-use solution of Idarubicin Injection
must only be administered intravenously and

Idarubicin must be administered only under the
supervision of a doctor with experience in
cytotoxic chemotherapy.
This medicine can cause red colouration of urine
for one to two days after its administration.
Before and during the treatment with Idarubicin
Injection, regular exams should be made to the
blood, liver, kidneys and heart. Babies and
children seem to have a greater sensitivity to
cardiac toxicity induced by anthracyclines. Thus,
in these patients, it is necessary to do regular
examination to the heart for a long period of time.
Other medicines and Idarubicin Injection
Tell your doctor if you are taking, have recently
taken, or might take any other medicines.
Idarubicin is used mainly in association with other
cytotoxic agents, and additive toxicity may occur,
especially with regard to bone marrow, blood and
gastrointestinal. The risk of cardiac toxicity may
increase in patients who have received at the
same time other medicines with toxic properties
to the heart.
Since idarubicin is extensively metabolised by the
liver, impairments in liver function caused by
other medicines may affect idarubicin
metabolism, pharmacokinetics and therapeutic
efficacy and/ or toxicity.
Anthracyclines, including idarubicin, must not be
administered in association with other cardiotoxic
agents, unless heart function is carefully
monitored.
In the case of association of oral anticoagulants
and anticancer chemotherapy, greater frequency
in monitoring the International Normalised Ratio
(INR) is recommended.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you
may be pregnant or are planning to have a baby,
ask your doctor or pharmacist for advice before
you are given this medicine.
Men subject to treatment with idarubicin must use
effective contraceptive methods up to 3 months
after treatment.
There are no adequate and controlled studies in
pregnant women. Idarubicin should only be used
during pregnancy if the potential benefits justify
the potential risks to the foetus.
Breast-feeding
It is not known if idarubicin is excreted in the
mother’s milk. Since many drugs are, mothers
must stop breast-feeding before starting
treatment.
Driving and using machines
The effect of idarubicin on the ability to drive and
use machines has not been systematically
assessed.

3. How to use Idarubicin
Injection
Always use this medicine exactly as your doctor
or pharmacist has told you. Check with your
doctor or pharmacist if you are not sure.
The dosage is normally calculated taking into
account the body surface area (mg/m2).
Administration is usually intravenous.
Acute non-lymphocytic leukaemia
Adults: In acute non-lymphocytic leukaemia, the
recommended dose is 12 mg/m2 IV a day for 3
days in combination with cytarabine. Another
dose pattern that can be used in acute
non-lymphocytic leukaemia, as a single agent or
in combination, is 8 mg/m2 IV a day for 5 days.
Children: The recommended dose range is 10-12
mg/m2 IV a day for 3 days in combination with
cytarabine.
Acute lymphocytic leukaemia
Adults: As a single agent in acute lymphocytic
leukaemia, the recommended dose is 12 mg/m2
IV a day for 3 days.
Children: As a single agent in acute lymphocytic
leukaemia, the recommended dose is 10 mg/m2
IV a day for 3 days.
All these dosage regimens must take into
account the patient’s blood condition and the
doses of the other cytotoxic agents when used in
association.
If you are given more Idarubicin Injection than
you should have received
Very high doses of idarubicin can cause acute
toxicity of the heart muscle in the first 24 hours
and severe suppression of blood cell production
through the bone marrow within one to two
weeks.
The occurrence of delayed heart failure with
anthracyclines has been observed, up to several
months after an overdose.

given through a tube where an intravenous
perfusion of 0.9% sodium chloride can flow freely
for a period of 5 to 10 minutes. This method
minimises the risks of thrombosis or perivenous
extravasation that can lead to severe cellulitis
and necrosis. Venous sclerosis can result from
injection into small veins or repeated injections
into the same vein.
The following recommendations for protection are
given because of the toxic nature of this
substance:
- The staff must be trained in the correct handling
technique.
- Pregnant women must be excluded from
working with this drug.
- The staff handling the drug must wear
protective clothing: disposable goggles, overall,
gloves and masks.

If you forgot to use Idarubicin Injection
Do not take a double dose to make up for a
forgotten dose.
If you have any further questions on the use of
this medicine, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, this medicine can cause side
effects, although not everybody gets them.
The following side effects can occur very
commonly: - infections; decrease in number of
red blood cells, white blood cells and platelet
counts in circulatory blood; marked reduction or
loss of appetite; nausea, vomiting, diarrhoea,
abdominal pain, burning sensation, inflammation
of mucosa in the mouth; hair loss; reddish
colouring of urine 1-2 days after taking the
medicine: fever, headache and chills.

Marketing Authorisation Holder:
Accord Healthcare Limited
Sage House
319 Pinner Road
North Harrow
Middlesex, HA1 4HF
United Kingdom
Manufacturer:
Accord Healthcare Limited
Sage House
319 Pinner Road
North Harrow
Middlesex, HA1 4HF
United Kingdom
This leaflet was last approved in 11/2016

The following side effects can occur commonly:
- increase or decrease in heart rate, increase and
irregular heart rhythm, heart function
impairment; inflammation of the vein,
inflammation of the vein associated with
thrombosis, bleeding; haemorrhage of the
gastrointestinal tract, stomach ache; increase in
liver enzymes and bilirubin; skin rash, itching,
hypersensitivity of irradiated skin.
The following side effects can occur
uncommonly:
- general infection; secondary leukaemia;
increase in blood uric acid concentration;
electrocardiogram irregularities; shock;
inflammation of the oesophagus, inflammation
of the colon, hyperpigmentation of skin and
nails, cellulitis, tissue necrosis.
The following side effects can occur rarely:
- brain haemorrhage.
The following side effects can occur very rarely:
- general severe allergic reaction; heart infection
and other disorders, occlusion of a blood
vessel, redness, gastric ulcers, skin reddening
particularly in the limbs.
Cases of pancytopoenia, tumourallysis syndrome
and local reaction have also been reported.
Reporting side effects
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side
effects not listed in this leaflet.
You can also report side effects directly via
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 Idarubicin
Injection
Keep this medicine out of the sight and reach of
children.
Do not use this medicine after the expiry date
which is stated on the label or carton after EXP.
The expiry date refers to the last day of that
month.
Store in a refrigerator (2°C - 8°C). Store in the
original package in order to protect from light.
Do not throw away any medicines via wastewater
or household waste. Ask your pharmacist how to
throw away medicines you no longer use. These
measures will help protect the environment.

6. Contents of the pack and
other information
What Idarubicin Injection contains
- The active substance is idarubicin
hydrochloride.
- One ml of solution contains 1 mg idarubicin
hydrochloride.
- Each vial of 5 ml contains 5 mg of idarubicin
hydrochloride.
- Each vial of 10 ml contains 10 mg of idarubicin
hydrochloride.
- Each vial of 20 ml contains 20 mg of idarubicin
hydrochloride.
- The other ingredients are: glycerol, hydrochloric
acid concentrate, sodium hydroxide (for pH
adjustment) and water for injection.
What Idarubicin Injection looks like and contents
of the pack
Solution for injection
Clear, orange red solution, free of visible
suspended particles.
Each vial of Type I colourless glass for injection
contains ready to use solution of 5 mg, 10 mg or
20 mg of idarubicin hydrochloride for injection
solution.
Vials of 5 ml or 10 ml or 20 ml of solution. Box of
1 vial.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer:

- A reconstitution area should be set up
(preferably under a vertical laminar air flow).
The work area should be protected with
plastic-backed absorbent paper.
- All tools used for reconstitution, administration
or cleaning, including gloves, must be placed at
high-risk, in containers to be disposed of at
high-temperatures in incinerators.
Spillages or leaks must be treated with diluted
(1% chlorine) sodium hypochlorite and then with
water.
All cleaning material must subsequently be
treated as described above.
Accidental contact with skin and eyes must be
treated immediately by washing thoroughly with
water, or soap and water, or sodium bicarbonate
solution; medical attention may be necessary.

Dispose of any unused solution.

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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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