Read all of this leaflet carefully before you start taking 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 nurse
If you get any side effects talk to your doctor or nurse.
This includes any possible side effects not listed in this leaflet (see section 4).
What is in this leaflet:
1. What Daunorubicin is and what it is used for
2. What you need to know before you take Daunorubicin
3. How you will be given Daunorubicin
4. Possible side effects
5. How to store Daunorubicin
6 Contents of the pack and other information
1. WHAT DAUNORUBICIN IS AND WHAT IT IS USED FOR
The name of your medicine is Daunorubicin 20 mg Powder for I.V. Injection (called daunorubicin in this leaflet). It belongs to a group of medicines used to treat acute leukaemia.
Daunorubicin works by attacking and destroying the abnormal white blood cells which are present in a person with leukaemia.
Information about Leukaemia
Leukaemia is the name for a number of diseases of the white blood cells, which form part of your blood.
These cells are produced in your bone marrow. In leukaemia, the white blood cells multiply in an uncontrolled and abnormal way.
The most common signs of leukaemia are:
Increased number of white cells in the blood.
This causes easy bruising and nose bleeds
Feeling tired, faint, dizzy, having pale skin. These could be symptoms of anaemia
Extreme tiredness (exhaustion), and headaches
Bone and joint pain
Severe infection and fever
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DAUNORUBICIN
Before treatment, you should discuss the risks and benefits of this medicine with your doctor.
Do not have daunorubicin if:
You are sensitive to, or allergic to, daunorubicin or other anthracyclines or any of the other ingredients of this medicine (listed in section 6)
Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue
You have chicken pox or shingles, or you have been in recent contact with anyone who has chicken pox or shingles
You have an infection, fever or high temperature
You have any heart problems
You are pregnant or breastfeeding
You have a lot of mouth ulcers
Do not have daunorubicin if any of the above applies to you. If you are not sure, talk to your doctor or nurse.
Warnings and precautions
Talk to your doctor or nurse before you are given daunorubicin if:
You have had radiation treatment to the chest
You have had any other medicines to treat leukaemia (or cancer)
You have or have ever had gout
You have or have ever had kidney stones or any other kidney problems
You have any liver problems
You are sexually active, you are advised to use effective birth control to prevent pregnancy during treatment, whether you are male or female.
Before each treatment with daunorubicin, your doctor will do blood tests to check that you have enough white blood cells (which are important for fighting infection) to receive daunorubicin. If you feel you have a fever, please contact your doctor immediately.
Talk to your doctor or nurse during the use of daunorubicin:
If you notice any pain in your side, blood in your urine or reduced amount of urine. When your disease is very severe, your body may not be able to clear all the waste products from the dying cancer cells. This is called tumour lysis syndrome and can cause kidney failure and heart problems soon after the first dose of daunorubicin. Your doctor will be aware of this and may give you other medicines to help prevent it.
If you have abdominal pain as a result of inflammation of the bowels (colitis).
A neurological disorder called PRES has been reported when treatment with daunorubicin has been used in combination with other cancer treatments. PRES can cause symptoms such as headache, seizures, lethargy, confusion and disturbed vision. If you experience any of these symptoms you should contact your doctor If you are not sure if any of the above apply to you, talk to your doctor or nurse before being given daunorubicin.
Other medicines and daunorubicin
Tell your doctor or pharmacist if you are taking, have recently taken or might take any:
Other medicines that may affect your heart for example, medicines to treat cancer such as 5-fluorouracil, cyclophosphamide, cisplatin, taxanes, calcium channel blockers used to control high blood pressure, chest pain, and irregular heartbeats and if you are receiving chest radiotherapy.
Other medicines that may affect the bone marrow for example, other cancer treatments, sulphonamide, chloramphenicol (used to treat infection), diphenylhydantoin (used to treat epilepsy), amidopyrine-derivative (used to relieve pain), antiretroviral agents (used to treat HIV infection) may alter the formation of blood cells
Other medicines that may affect your liver e.g barbiturates (drugs used in epilepsy or sleep disorders) and rifampicin (a drug used to treat TB - Tuberculosis)
Live attenuated vaccines
Pregnancy, breast-feeding and fertility
Do not have daunorubicin if you are pregnant, might become pregnant or think you might be pregnant as daunorubicin can be very damaging to your unborn baby (embryo). If pregnancy occurs during treatment this should be discussed with your doctor.
Both female and male patients must take special precautions in their sexual activity if there is any possibility for pregnancy to occur:
For a girl or woman of childbearing age:
You must have a negative pregnancy test before treatment and each month during treatment. This should be discussed with your doctor.
Do not have sex with a pregnant woman unless you use a condom. This will lessen the possibility for daunorubicin to be left in the woman’s body.
You and your female partner must each use an effective contraceptive during the time you are taking daunorubicin and for 6 months after stopping treatment.
This should be discussed with your doctor.
Men who wish to father children in the future should seek advice about freezing sperm before treatment with daunorubicin is started.
If you are a woman who is breast-feeding, you must not take daunorubicin. Discontinue breast-feeding before starting to take daunorubicin.
Driving and using machines
You may feel and/or be sick after being given this medicine, therefore special care should be taken when driving or using machines.
There is no information available about how daunorubicin might affect your ability to drive or use machines.
3. HOW YOU WILL BE GIVEN DAUNORUBICIN
How daunorubicin is given
Daunorubicin is a medicine used in hospitals
It will be given to you by a doctor or nurse as an injection into one of your veins
It will be given over about 20 minutes (this is called an intravenous infusion)
It should never be given as a single injection under the skin or into a muscle
The site of injection should not be covered or bandaged
Tell your doctor or nurse straight away if:
You have any pain, swelling or warmth around the vein where daunorubicin is being injected
You notice that your face is red while the injection is being given to you. This may be a sign that the injection is being given too quickly
How much daunorubicin will be given
The exact dose will be determined by your doctor.
It will depend on your age, height, weight and your general medical condition. The usual dose for a person weighing 70kg (11 stone) would be about 80mg
Your course of treatment may be altered, depending on how your body reacts to the medicine
Daunorubicin may be given alone or in combination with other medicines to treat or prevent side effects
Tests while having daunorubicin
Your condition will be closely monitored during treatment. This may involve blood, urine tests or heart monitoring (called ECG).
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 who is given this medicine will be affected in the same way. If you are worried about side effects you should discuss them with your doctor, who will explain the risks and benefits of your treatment.
Some of the side effects can be lessened or treated by other medicines or therapy.
Tell your doctor or nurse straight away if:
You have pain, swelling or warmth in or around the vein where daunorubicin is being injected
You have a red face while daunorubicin is being injected. This may be a sign that the injection is being given too quickly
You get fevers, chills or other signs of infection, which sometimes can be fatal
You have any severe infections, such as those of the blood (sepsis), which may also cause low blood pressure (septic shock, a life-threatening form of sepsis) or inflammation of the lungs (pneumonia)
You have difficulty in breathing
You have swelling of the feet or legs
You have an uneven or fast heart beat
You have black or tarry bowel motions
You are being sick (vomiting) and bring up blood or dark brown coffee-coloured granules
You notice any unusual bleeding or bruising
You develop a neurological disorder called Posterior Reversible Encephalopathy Syndrome (PRES, also known as Reversible Posterior Leukoencephalopathy Syndrome, RPLS) Symptoms include a severe or persistent headache, abnormal vision (such as blurred vision or vision loss), seizures (fits), confusion or memory loss or abnormal behaviour.
Tell your doctor or nurse if you notice any of the following side effects:
You feel sick (nausea) or are sick (vomit)
You have diarrhoea
You have inflammation of the bowel
You have a skin rash
You have sores in the mouth or on the lips
Other side effects include:
Decreased numbers of different types of blood cells (granulocytopenia, leukopenia and neutropenia, anaemia) which may cause tiredness, fever or increased risk of bleeding
Leukaemia (a type of blood cancer) and other cancers may occur in patients who are treated with daunorubicin together with certain other anticancer treatments
Reduced number of white blood cells (which are important for fighting infection) associated with fever, including fatal cases
Changes in metabolism caused by dying cancer cells releasing their contents into the bloodstream (tumour lysis syndrome)
Feeling very dry and thirsty (dehydration)
Inflammation of mucous membranes (mucositis), of the mouth with areas of painful erosions, ulceration and bleeding (stomatitis) and of the oesophagus (oesophagitis)
Loss of appetite
Increased pigmentation (hyperpigmentation) of skin and nails
Daunorubicin can make your urine turn red for a couple of days after each dose
Medicines like daunorubicin often cause temporary loss of hair. After your treatment finishes your hair should grow back
Disease of the bone marrow
Infections, which sometimes can be fatal
There have been reports of secondary tumours (secondary leukaemia) following use of daunorubicin in combination with other anti-cancer drugs.
After stopping treatment
After you have finished your course of treatment, you may still get side effects. Tell your doctor or nurse straightaway if:
You have difficulty in breathing
You have swelling of the feet or legs
You get an uneven or fast heart beat
Reporting of 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 the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search from MHRA Yellow Card in the Google Play or Apple App Store.
By reporting side effects, you can help provide more information on the safety of this medicine.
5. HOW TO STORE DAUNORUBICIN
Keep this medicine out of the sight and reach of children.
Daunorubicin should not be used after the expiry date which is stated on the carton. The expiry date refers to the last day of the month.
The vials of powder should be kept at room temperature and protected from light.
The daunorubicin solutions made up from the powder should be stored at between 2 - 8°C, protected from light and used within 24 hours.
Following the injection, daunorubicin will be disposed of carefully by the doctor or nurse.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Daunorubicin 20 mg Powder for I.V. Injection contains:
The active ingredient is daunorubicin hydrochloride.
Each vial contains 20 mg of daunorubicin. Each vial also contains mannitol.
What Daunorubicin 20 mg Powder for I.V. Injection looks like and contents of the pack:
Daunorubicin 20 mg Powder for I.V. Injection comes as a vial containing a red powder. The solution prepared with this powder is also red.
The vials are available in packs of 1 and 10 vials.
Marketing Authorisation Holder and Manufacturer
Marketing authorisation holder
Zentiva Pharma UK Limited 12 New Fetter Lane London EC4A 1JP United Kingdom