Daunorubicin 20 mg Powder for I.V. Injection

• 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).

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

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

• 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.

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.

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

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.

• For men:

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.

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.

• 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

• 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

• 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

Your condition will be closely monitored during treatment. This may involve blood, urine tests or heart monitoring (called ECG).

• 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.

• 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

• 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 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

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.

The active ingredient is daunorubicin hydrochloride. Each vial contains 20 mg of daunorubicin. Each vial also contains mannitol.

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.

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