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Ebewe Pharma
Patient Information Leaflet
Idarubicin 1 mg/ml Concentrate for Solution for Infusion
PACKAGE LEAFLET: INFORMATION FOR USER
Idarubicin 1 mg/ml Concentrate for Solution for Infusion
Idarubicin hydrochloride
Read all of this leaflet carefully before you start taking this medicine because it contains
important information for you.
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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
effect not listed in this leaflet. See section 4.
What is in this leaflet:
1.
2.
3.
4.
5.
6.
What Idarubicin is and what it is used for
What you need to know before you are given Idarubicin
How Idarubicin will be given
Possible side effects
How to store Idarubicin
Contents of the pack and other information
1. WHAT IDARUBICIN IS AND WHAT IT IS USED FOR
Idarubicin contains an active ingredient called idarubicin, which belongs to a group of medicines
called anthracyclines. Idarubicin interferes with ways in which the cells of your body grow and
increase in number and is used in the treatment of cancers (chemotherapy).
Idarubicin is used for the treatment of different types of leukaemia (cancer of the white blood cells).
Idarubicin in combination with cytarabin, is indicated for the first remission induction treatment in
previously not treated children with a blood cancer called acute mylogenous leukaemia (AML).
2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN IDARUBICIN
Do not take Idarubicin if:
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you have ever had an allergic reaction to idarubicin or any of the other ingredients of this
medicine (listed in section 6) or other anthracyclines or anthracenediones
your liver or kidneys are not working properly
you have uncontrolled infections
you have severe heart muscle disease (cardiomyopathy)
you have acute inflammatory heart disease
you suffer from severe heart failure
Ebewe Pharma
Patient Information Leaflet
Idarubicin 1 mg/ml Concentrate for Solution for Infusion
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you have had a recent heart attack
your bone marrow is not producing enough blood cells (However, in this case your doctor
might also decide to start the therapy if the benefit for you is greater than the risk.)
you have received previous treatment with other chemotherapy drugs and you already have
received the maximum dose of idarubicin and/ or any other similar medicines such as
daunorubicin or doxorubicin
you have bleeding tendency
you suffer from inflammation of the mouth
you are breast-feeding (see “Pregnancy and breast-feeding”)
you recently received a vaccination against yellow fever
Warnings and precautions
If you suffer from bone marrow depression caused by previous therapy. Idarubicin might affect your
bone marrow so that it does not produce enough blood cells. Your doctor may wish to delay your next
course of treatment until your blood has recovered. You will have regular blood tests to check this.
If you have suffered from heart trouble in the past, or are presently receiving treatment for this, please
make sure your doctor knows. Idarubicin might cause harm to your heart. Your heart function will be
examined by various tests before and throughout the treatment (ECG, MUGA scan (=special imaging
technique to show the vessels) or ECHO (= ultrasound of the heart)). Heart damage can occur
especially when high doses of Idarubicin are given. This may not be detected for several weeks, so
regular tests may be required during this period.
If you have problems with kidneys or liver, your kidney and liver function can be impaired by
Idarubicin . To monitor these changes, your blood will be checked before and on a regular basis
throughout the treatment; it is important that you do not miss these blood tests.
Before starting and during Idarubicin treatment, regular checks of your blood, liver, kidneys and heart
will be performed. Infants and children seem to be more sensitive to the cardiotoxicity of antracyclins;
therefore, it is necessary to make long-term, periodic cardiac function examination in these patients.
Your doctor will be making regular checks as follows:
- blood tests to make sure there are enough blood cells for your blood function
- blood tests to check for uric acid levels.
- blood tests to check your kidneys and liver are working properly
- heart test since Idarubicin can affect your heart.
Based on the results of these investigations, your doctor might decide that Idarubicin might not be a
suitable treatment for you, or a reduced dose might have to be used.
High doses of idarubicin can worsen side effects like sores in the mouth or may decrease the number
of white blood cells and platelets (the latter 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.
You should not receive vaccination with live vaccines (e.g. for yellow fever) as this can result in
serious and maybe even fatal infections. Please ask your doctor for advice if you would like to receive
vaccination.
Ebewe Pharma
Patient Information Leaflet
Idarubicin 1 mg/ml Concentrate for Solution for Infusion
If you have an infection, it must be controlled before therapy can be started.
Idarubicin may harm an unborn baby. Women and men should use appropriate contraception during
therapy and 3 months thereafter (see “Pregnancy and breast-feeding”).
Your urine may have a red colour for 1 to 2 days after treatment with Idarubicin. Please check with
your doctor in case you have any questions or are worried about the colour of your urine.
Please tell your doctor also if you are receiving radiotherapy at the same time or have received it 2-3
weeks before starting treatment.
Other medicines and Idarubicin
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines,
including medicines obtained without a prescription.
In particular, you should tell your doctor if you are taking or have recently taken/received any of the
following medicines:
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medical drugs against cancer affecting the bone marrow function.
drugs that influence the function of your kidneys and / or liver
drugs that might damage the heart (e.g. cyclophosphamide)
drugs for a pre-existing heart disease (calcium-channel blockers)
received any vaccination during the last few months
immunosuppressant medicines (such as cyclosporine or tacrolimus)
medicines that prevent your blood from clotting (e.g. phenprocoumon or acenocumarol)
Pregnancy, breast-feeding and fertility
You should not be treated with Idarubicin unless clearly indicated by your doctor. Tell your doctor if
you are pregnant, think you might be pregnant or plan to become pregnant and also if you are breastfeeding. Your doctor will need to consider any possible risks to you or your child.
Avoid becoming pregnant while you or your partner is being treated with Idarubicin. If you are
sexually active, you are advised to use effective birth control to prevent pregnancy during treatment
and 3 months thereafter, whether you are male or female. Idarubicin may harm an unborn child, so it is
important to tell your doctor if you think you are pregnant.
If you wish to have children after the end of the therapy, please talk to your doctor about the
opportunities of genetic counselling.
Treatment with Idarubicin can result in irreversible infertility in men, please talk to your doctor about
the possibilities of sperm conservation if you wish to father a child in the future.
You should not breast-feed whilst receiving Idarubicin as some of the drug may get into your milk and
possibly harm your child.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Ebewe Pharma
Patient Information Leaflet
Idarubicin 1 mg/ml Concentrate for Solution for Infusion
No studies have been performed on the effects of Idarubicin on the ability to drive and use machines.
Please check with your doctor before you drive or operate machinery.
3. HOW IDARUBICIN WILL BE GIVEN
Idarubicin will be given to you by intravenous infusion (a drip).
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Your doctor will prescribe the required amount (the dose). The dose is decided by taking into
account your condition being treated, your height and weight.
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From your height and weight the doctor will work out your body surface area; this is
necessary because the dose is usually calculated as "... milligrams per square metre" (mg/m²),
given on 3 days running.
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However, your doctor may alter the dose and number of days of treatment depending on your
condition and any other treatment you may be receiving.
AML
If the child is receiving idarubicin plus other antileukemic medicines (cytarabine) the recommended
dosage is in the range of 10-12 mg /m², administered slowly into a vein once a day for3 subsequent
days. This is repeated every three weeks.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Idarubicin can cause side effects, although not everybody gets them.
You should tell your doctor or nurse immediately:
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If you get a stinging or burning sensation where the medicine goes into your vein while
idarubicine is being given to you. It may mean the rest of the dose should be given into a
different vein.
If you get a feverish chill (like flu) or skin rashes, as you may be allergic to your medicines.
If you get a sore throat or temperature after treatment or you notice any bleeding or bruising,
because the product may reduce the number of cells in your blood.
Side effects can occur with the following frequencies:
Very common (affects more than 1 per 10 users)
- Infections
- Low numbers of the following blood cells:
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low red blood cells (anaemia) that can leave you feeling tired and lethargic.
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low white blood cells (leukopenia or neutropenia) increasing the chance of infections, a
raised temperature or fever and chills (like flu). Severe infections can occur after
treatment with idarubicin alone or in combination, and may be fatal.
Ebewe Pharma
Patient Information Leaflet
Idarubicin 1 mg/ml Concentrate for Solution for Infusion
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low platelets (thrombocytopenia) making you bruise more easily, or bleed more than
usual if you hurt yourself.
Reduced number of all types of blood cells (pancytopenia)
Loss of appetite (anorexia)
Feeling sick (nausea) being sick (vomiting) or diarrhoea
Soreness or ulcers in the mouth (stomatitis) which may not appear until 3-10 days after
treatment
Inflammation of mucous membranes (mucositis)
Abdominal pain
Heartburn
You may lose all or part of your hair, which usually grows back after treatment has finished.
A stinging or burning sensation at the injection site (local toxicity)
Red colour may appear when you pass water for a few days after treatment. This is quite
normal and should not be cause for concern.
Fever and chills
Headache
Common (affects 1 to 10 per 100 users)
- Heart is not strong enough to pump blood efficiently (congestive heart failure)
- Damage to the heart muscle (cardiomyopathies), characterised by shortness of breath, swelling
of the lungs, swelling, that changes its position with different body postures, enlargement of
the heart and liver, decreased urine production, fluid retention in the abdominal cavity, fluid
accumulation next to the lungs, abnormal heart beat (gallop rhythm)
- Heart damage and irregularities (beating too slow or too quick, changes in rhythm, heart not
working effectively)
- Local inflammation of the vein where the infusion is administered (phlebitis)
- Vein inflammation related to a blood clot (thrombophlebitis)bleeding from different sites
(haemorrhage)
- Bleeding in stomach or guts
- Itching
- Skin that has been damaged by radiation therapy might become very sensitive
- Elevated liver enzymes and bilirubin (blood values)
- Skin rash
- bellyache
Uncommon (affects 1 to 10 per 1,000 users)
- Blood poisoning (sepsis, septicaemia)
- Blood cancer after end of treatment (secondary leukaemias)
- complications that can occur after cancer treatment caused by break-down products of dying
cancer cells (tumor lysis syndrome)
- High level of uric acid in the blood (maybe leading to gout)
- Loss of water (dehydration)
- Changes in the ECG
- Heart attack (myocardial infarction)
- Shock
- Inflammation of oesophagus and large intestines (can be severe and lead to perforation)
- Colour change of nails and skin
- Itchy rash
- Severe tissue lesion (cellulitis and necrosis)
Rare (affects 1 to 10 per 10,000 users)
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Patient Information Leaflet
Idarubicin 1 mg/ml Concentrate for Solution for Infusion
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Bleeding in the brain
Very rare (affects less than 1 per 10,000 users)
- Severe allergic reactions (anaphylaxis), symptoms include faintness, skin rash or hives,
itching, , swelling of lips, face and airway with difficulty in breathing, loss of consciousness
- Inflammation of the sac surrounding the heart (pericarditis)
- Inflammation of the heart muscle (myocarditis)
- Defects in the electrical conduction system of the heart
- Occlusion of a blood vessel due to a blood clot in the circulatory system, (thromboembolic
events), including the possibility of occlusion of the lung vessels (pulmonary embolism)
- Redness of the skin (flush)
- Stomach ulcers
- Numbness, swelling and painful redness on palms and soles
Frequency not known, according to the available data
- local reaction at administration site
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 the Yellow Card Scheme
(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
Keep out of the sight and reach of children.
Do not use this medicine after the expiry date, which is stated on the vial.
The expiry date refers to the last day of that month.
Store in a refrigerator (2°C – 8°C).
Keep the container in the outer carton in order to protect from light.
The diluted solution is chemically stable when stored for at least 14 days at 2-8°C and 24 hours at
room temperature (20°C - 25°C); however, it is recommended that, in line with good pharmaceutical
practice, the solution should not normally be stored for longer than 24 hours at 2-8°C.
The product does not contain any antibacterial preservative. Therefore if aseptic preparation cannot be
ensured, the product must be prepared immediately before use and any unused portion discarded.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Idarubicin contains
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The active substance is idarubicin hydrochloride.
Each ml of concentrate for solution for infusion contains 1mg idarubicin hydrochloride.
Ebewe Pharma
Patient Information Leaflet
Idarubicin 1 mg/ml Concentrate for Solution for Infusion
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The other ingredients are glycerol, hydrochloric acid dilute (for pH-adjustment), sodium
hydroxide 10% (for pH-adjustment), water for injections.
What Idarubicin looks like and contents of the pack
Clear red to orange solution
Pack of 1 vial, 5 or 10 vials containing 5 ml, 10 ml or 20 ml of sterile solution of idarubicin
hydrochloride 1 mg/ml with or without a protective plastic overwrap (ONCO-SAFE).
5 ml clear glass vial (class I) with fluoropolymer coated halobutyl rubber stopper containing 5mg
idarubicin hydrochloride.
10 ml clear glass vial (class I) with fluoropolymer coated halobutyl rubber stopper containing 10mg
idarubicin hydrochloride.
20 ml clear glass vial (class I) with fluoropolymer coated halobutyl rubber stopper containing 20mg
idarubicin hydrochloride.
Not all pack sizes may be marketed
Marketing Authorisation Holder & Manufacturer
EBEWE Pharma
Ges.m.b.H. Nfg. KG
4866 Unterach
Austria
This leaflet was last revised in 03/2014.
--------------------------------------------------------------------------------------------------------------------The following information is intended for medical or healthcare professionals only:
Special precautions for disposal and other handling
The following protective recommendations are given due to the toxic nature of this substance:
• This product should be handled only by personnel who have been trained in the safe handling of
such preparations.
• Pregnant staff should be excluded from working with this drug.
• Personnel handling Idarubicin should wear protective clothing (e.g. gowns, disposable gloves,
safety goggles and a protective mask).
• All handling should take place in a safety cabinet or an isolator.
• The work surface should be covered by an absorptive underpacking with a liquid-leakproof foil for
single use.
• All items used for administration or cleaning, including gloves, should be placed in high risk,
waste disposal bags for high temperature incineration.
• Spillage or leakage should be treated with dilute sodium hypochlorite (1% available chlorine)
solution, preferably by soaking, and then with water. Discolouration shows the loss of cytostatical
potency.
Ebewe Pharma
Patient Information Leaflet
Idarubicin 1 mg/ml Concentrate for Solution for Infusion
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All cleaning materials should be disposed of as indicated previously.
Accidental contact with the skin and eyes should be treated immediately by copious lavage with
water, or sodium bicarbonate solution, medical attention should be sought.
Discard any unused solution.
Idarubicin is intended for single use only!
Only clear solutions should be used.
Before administration the solution should be brought to room temperature.
Idarubicin shall be prepared not more than 24 hours before administration.
Mind the risk of bacterial contamination due to manipulation.
Intravenous administration:
Idarubicin must be administered only by the intravenous route.
The infusion can be prepared by diluting Idarubicin with 0.9% sodium chloride or 5% glucose.
Alternatively the required volume of the undiluted product can be slowly administered over 5 to 10
minutes via the tubing of a freely running intravenous infusion of 0.9% sodium chloride or glucose
5%.
A direct push injection is not recommended due to the risk of extravasation, which may occur even in
the presence of adequate blood return upon needle aspiration,.
Disposal
Remnants of the medicinal product as well as all materials that have been used for reconstitution, for
dilution and administration must be destroyed according to hospital standard procedures applicable to
cytotoxic agents with due regard to current laws related to the disposal of hazardous waste.
Incompatibilities
This medicinal product must not be mixed with other medicinal products except for 0.9% sodium
chloride or glucose 5%.
Posology and method of administration
For intravenous use only.
Not for intrathecal use.
Dosage is calculated on the basis of body surface area.
Posology
Acute myelogenous leukaemia (AML)
Adults
- 12 mg/m2/day i.v. daily for 3 days in combination with cytarabine.
or
- 8 mg/m2/day i.v. daily for 5 days with/without combination.
Paediatric population
Combination therapy:
In children with AML the recommended dose range of idarubicin, in combination with cytarabin, is
10-12 mg/m2 body surface daily for 3 days by slow intravenous injection.
Ebewe Pharma
Patient Information Leaflet
Idarubicin 1 mg/ml Concentrate for Solution for Infusion
NOTE: These are general guidelines. Refer to individual protocols for exact dosage.
A maximum total dose of 120 mg/m² body surface area should not be exceeded.
Acute lymphoblastic leukaemia (ALL)
Adults
The suggested dose in adults is 12 mg/m2 i.v. daily for 3 days in adequate combination regimens.
Paediatric population
10 mg/m2 i.v. daily for 3 days, in adequate combination regimens.
These dosage schedules should, however, take into account the haematological status of the patient
and the dosages of other cytotoxic drugs when used in combination.
Administration of the second course should be delayed in patients who develop severe mucositis until
recovery from this toxicity has occurred and a dose reduction of 25% is recommended.
A maximum total dose of 120 mg/m² body surface area should not be exceeded.
Patients with hepatic and / or renal impairment
A dosage adjustment may be required in patients with impaired renal or liver function.
Shelf life
2 years.
Chemical and physical in-use stability has been demonstrated for 14 days at 2-8°C and 24 hours at
25°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 and would normally not be longer than 24 hours at 2 to 8°C, unless dilution has taken place in
controlled and validated aseptic conditions.
Special precautions for storage
Store in a refrigerator (2°C – 8°C)
Keep the container in the outer carton in order to protect from light.