Daunorubicin Powder for I.V. Injection (Daunorubicin Hydrochloride)
Daunorubicin 20mg Powder for I.V. Injection
(Daunorubicin Hydrochloride)
1. What Daunorubicin is and what it is used for
The name of your medicine is Daunorubicin 20mg Powder for I.V. Injection (called Daunorubicin in this post). 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. Before you are given 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 Daunorubicin
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 breast-feeding
• 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, nurse or pharmacist.
Take special care with Daunorubicin
Check with your doctor, nurse or pharmacist 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.
If you are not sure if any of the above apply to you, talk to your doctor, nurse or pharmacist before being given Daunorubicin.
- Using other medicines:
Special care will also be taken if you are taking any of the following medicines:
• 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
Fertility, pregnancy and breast-feeding
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.
- 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 (12 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 questions about your course of treatment ask your doctor, pharmacist or nurse.
4. Possible side effects
Like all medicines, Daunorubicin 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, nurse or pharmacist 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
• 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
Tell your doctor, nurse or pharmacist if you notice any of the following side effects:
• You feel sick (nausea) or are sick (vomit)
• You have diarrhoea
• 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
• 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
Tell your doctor, nurse or pharmacist if any of the side effects gets serious, lasts longer than a few days, or if you notice any side effects not listed in the leaflet.
After stopping treatment
After you have finished your course of treatment, you may still get side effects. Tell your doctor, nurse or pharmacist straightaway if:
• You have difficulty in breathing
• You have swelling of the feet or legs
• You get an uneven or fast heart beat
5. How to store Daunorubicin
• Keep this medicine in a safe place out of the reach and sight 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.
• Medicines should not be disposed of via waste water or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Furher information
What Daunorubicin 20mg Powder for I.V. Injection contains
The active ingredient is Daunorubicin hydrochloride. Each vial contains 20mg of Daunorubicin. Each vial also contains mannitol.
What Daunorubicin 20mg Powder for I.V. Injection looks like and contents of the pack
Daunorubicin 20mg 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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