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ZAVEDOS 1 MG/ML SOLUTION FOR INJECTION

Active substance(s): IDARUBICIN HYDROCHLORIDE / IDARUBICIN HYDROCHLORIDE

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Zavedos®

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Package leaflet: Information for the user

Zavedos® 1mg/mL
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Solution for Injection
idarubicin hydrochloride

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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, pharmacist or nurse.
- 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, pharmacist or nurse. This
includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet
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1. What Zavedos is and what it is used for
2. What you need to know before you are given Zavedos
3. How Zavedos will be given to you
4. Possible side effects
5. How to store Zavedos
6. Contents of the pack and other information

1. What Zavedos is and what it is used for

Zavedos contains an active ingredient called idarubicin, which belongs to a group
of medicines called anthracyclines. Zavedos interferes with ways in which the cells
of your body grow and increase in number and is used in the treatment of cancers
(chemotherapy).
Zavedos is used in adults and children for the treatment of acute non
lymphoblastic leukaemia (ANLL), also referred to as acute myeloid leukaemia
(AML).
Zavedos is also used in adults and children as a second line treatment of relapsed
acute lymphoblastic leukaemia (ALL).

2. What you need to know before you are given Zavedos
Do not use Zavedos:
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- If you have ever had an allergic (hypersensitivity) reaction to
- idarubicin or any of the other ingredients of this medicine (listed in section 6).
- other anthracyclines or anthracenediones.
- If your liver or kidneys are not working properly.
- If you have an infection which is not under control.
- If you have had a previous or current history of heart disease.
- If you have had a previous or current history of abnormal heart rhythms.

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- If you have had previous or current history of bone marrow depression caused by
previous therapy.
- If you have previously been treated with high doses of idarubicin and/ or other
anthracyclines or anthracenediones.
- If you are breast-feeding.

Warnings and precautions
Talk to your doctor, pharmacist or nurse before you are given Zavedos if you:
- Suffer from bone marrow depression caused by previous therapy.
- Have suffered from heart trouble in the past or are presently receiving treatment for
this.
- You have had a previous or current history of stomach problems (e.g. ulcer) or any
problem with your bowels.
In these cases, Zavedos might not be a suitable treatment for you, or a reduced dose
might have to be used.

Paediatric population
Babies and children are more at risk to heart problems that may be caused by taking
Zavedos. Regular checks of the heart for a longer time will be needed.

Regular checks by your doctor during Zavedos treatment
Before starting and during treatment you will need regular checks including blood tests.
Your doctor will be making regular checks of:
- Your blood, to check for low blood cell counts that may need treatment.
- Your heart function, as Zavedos can have effects upon this.
- Your liver and kidneys – again using blood tests – to check that Zavedos is not
affecting the way they function in a harmful way.
- Blood uric acid levels – Zavedos may increase uric acid levels in the blood, which
might cause gout. Another medicine may be given if your uric acid levels are too
high.
You will find more information on some of these effects in section 4.

Other medicines and Zavedos
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines, in particular, if you:
- Are given medicines or were previously given medicines such as anthracyclines or
anthracenediones that have a similar action to Zavedos. They can make the effects
of Zavedos stronger.
- Are using Zavedos with medicines like calcium channel blockers or chemotherapies
that have cardiac toxicity.
- Are receiving radiotherapy.
- Are taking oral drugs that prevent blood clots as it will require close monitoring.
- Are taking a medicine called Cyclosporin A.
You should not take live or live-attenuated vaccines (e.g. yellow fever) because of the
risk of serious infection after treatment with chemotherapy.

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 taking this medicine.
Pregnancy
Avoid becoming pregnant while you or your partner is being treated with Zavedos.
Zavedos may harm an unborn child, so it is important to tell your doctor if you think
you are pregnant. Whether you are male or female, if you are sexually active you are
advised to use effective birth control to prevent pregnancy during treatment. Males
should continue to use effective contraception up to 3 months after treatment.

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Breast-feeding
Do not breast-feed whilst receiving Zavedos, as some of the drug may get into
your milk and possibly harm your child.
Fertility
Males treated with Zavedos are advised to seek advice on sperm preservation due
to the possibility of irreversible infertility caused by the therapy.

Driving and using machines
It is not known whether Zavedos has an effect on you being able to drive or use
any tools or machines. However, special care should be taken if it is essential that
you drive or operate machinery while undergoing treatment especially if you are
lacking strength or are in a debilitated condition.

3. How Zavedos will be given to you

Zavedos will be given to you by injection into the veins. It should not be given by
injection into your spine.
- 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.
- From your height and weight the doctor will work out your body surface area;
this is necessary because the dose is usually calculated as “X milligrams per
square metre” (mg/m²), given by injection, on 3 days running.
- However, your doctor may alter the dose and number of days of treatment
depending on your condition and any other treatment you may receive.

If you receive more Zavedos than you should
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.
Heart damage can occur when high doses of Zavedos are given. This may not be
detected for several weeks, so regular tests may be required during this period.
If you have any further questions on the use of this medicine, ask your doctor,
pharmacist or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody
gets them.
Tell your doctor immediately if you experience any of the following symptoms
after you have been given this medicine. Although they are very rare, the
symptoms can be severe.
• Allergic reactions such as feeling dizzy, feverish, breathless with a tight chest,
with or without an itchy rash.
• Inflammation of the pericardium (the fibrous sac surrounding the heart),
inflammation of the heart muscle, a disease of the electrical system of the heart.
• A condition in which a blood clot that has formed inside a blood vessel or inside
the heart.
• Redness of the skin, typically over the cheeks or neck.
• Stomach ulcer (abdominal pain or burning sensation).
• Hand foot syndrome (tingling, redness, flaking, swelling or small sores on the
palms of the hands or soles of the feet).
• Anaemia (low red cells) that can leave you feeling tired and lethargic.
• Leukopenia (low white cells) leading to increased chance of infections with
symptoms of raised temperature or fever and chills (like flu).
• Thrombocytopenia (low platelets, these help the blood to clot). You may bruise
more easily or bleed more than usual if you hurt yourself.

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• Tumour lysis syndrome (the breakdown and release of tumour cell contents), a
potentially-life threatening condition, in which you may experience decreased or
cloudy urination, weakness, irritability and confusion, vomiting, nausea, muscle
cramps or joint discomfort, shortness of breath, irregular heartbeat and seizures.
These symptoms can be associated with abnormal laboratory test results (high
potassium, uric acid and phosphorous levels and low calcium levels in the
blood) that can lead to changes in kidney function and acute renal failure.
• Severe infections which can occur after treatment with idarubicin alone or in
combination with other medicines, and may be fatal.
Very common side effects (may affect more than 1 in 10 people)
• Infections.
• Decrease in number of red blood cells, reduced numbers of white blood cells,
abnormally low amount of platelets.
• A lack or loss of appetite for food.
• Feeling sick or being sick, the painful inflammation and ulceration of the mucous
membranes lining the digestive tract, diarrhoea, stomach ache.
• Hair loss.
• Red colouration of urine.
• Fever (rise in temperature).
• Headache.
• Chills.
Common side effects (may affect up to 1 in 10 people)
• Increase or decrease in heart rate, irregular heart beat/pulse, heart failure, heart
attack.
• Inflammation of the vein, swelling (inflammation) of a vein caused by a blood
clot.
• Bleeding from the intestines, pain in the stomach or abdomen.
• Liver enzyme elevation.
• Rash, itch.
• Haemorrhages.
• Increased sensitivity of irradiated skin ‘radiation recall reaction’.
Uncommon side effects (may affect up to 1 in 100 people)
• Blood infection, bacteria in the blood.
• Cancers of blood such as secondary leukaemia or unfavourable leukaemia
(acute myeloid leukaemia (AML) or myelodysplastic syndrome (MDS)).
• Painful joints due to increased uric acid levels in your blood (gouty arthritis).
• ECG changes.
• Shock.
• Inflammation of the oesophagus, inflammation of the colon.
• Darkening of the skin and nails.
• Excessive loss of body fluid.
• Spreading of bacterial infection below the skin surface and tissue damage.
• Heart attack.
• Hives.
Rare side effects (may affect up to 1 in 1,000 people)
• Stroke.
Very rare side effects (may affect up to 1 in 10,000 people)
• Serious allergic reaction.
• Inflammation of the pericardium (the fibrous sac surrounding the heart), defect in
the heart’s electrical system.
• Minor ulceration of the gastric mucosa.
• Hand foot syndrome.
• Inflammation of heart muscle.
• Thromboembolism.
• Flush.

Additional side effects experienced, (frequency cannot be estimated from the
available data)
• Change in certain chemicals in the blood.
• Abnormally low levels of all blood cells produced by the bone marrow.
• Local skin reaction.

Additional side effects in children
Side effects seen in children are similar to those seen for adults. Children have a
higher risk for heart problems that could be caused by taking Zavedos.

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
(see details below). By reporting side effects you can help provide more information
on the safety of this medicine.
United Kingdom
Yellow Card Scheme website: www.mhra.gov.uk/yellowcard
Ireland
HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2;
Tel: +353 1 6764971; Fax: +353 1 6762517.
Website: www.hpra.ie; E-mail: medsafety@hpra.ie.

Marketing Authorisation Holder
PL Holder: Pfizer Limited
Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK
PA Holder: Pfizer Healthcare Ireland
9 Riverwalk, National Digital Park, Citywest Business Campus,
Dublin 24, Ireland.

Manufacturer:
Pfizer Service Company BVBA
Hoge Wei, 10
B-1930 Zaventem
Belgium

Company Contact Address:
For further information on this medicine, please contact Medical Information at
Pfizer Limited in Walton Oaks, Tadworth, Surrey, Tel: 01304 616161.
This leaflet was last revised in
UK: 09/2016
IE: MM/YYYY
Ref: ZD 1_1

5. How to store Zavedos

Zavedos is for single use only. It should be used immediately after opening and any
unused portion should be discarded.
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 vial label and
carton after EXP. The expiry date refers to the last date of that month.
Zavedos should be stored in a refrigerator (2°C -8°C) and the vial kept in the outer
carton in order to protect it 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 Zavedos contains
The active substance is idarubicin hydrochloride. Each mL of solution for injection
contains 1 mg idarubicin hydrochloride.
Each vial of 5 mL of solution for injection contains 5 mg of idarubicin hydrochloride.
Each vial of 10 mL of solution for injection contains 10 mg of idarubicin hydrochloride.
Each vial of 20 mL of solution for injection contains 20 mg of idarubicin hydrochloride.
The other ingredients are glycerol, hydrochloric acid and water for injection

What Zavedos looks like and the contents of the pack
Zavedos is supplied as a clear orange-red aqueous solution in polypropylene vials
which are closed with a rubber stopper and sealed with an aluminium cap with
plastic flip off top. The vials are packed singly in cartons.
Zavedos is available in 5 ml, 10 mL and 20 mL vials. Not all pack sizes may be
marketed.

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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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