PATIENT INFORMATION LEAFLET

Doxorubicin INN as HCl Solution for Injection

What you should know about doxorubicin solution

Please read this leaflet before receiving your medicine. This leaflet provides some useful information for you on your medicine. If you have any questions, or are not sure about anything please ask your doctor or pharmacist.

What is in your medicine?

Doxorubicin Solution is a red liquid in vials

The vials contain either

• 10mg of doxorubicin hydrochloride dissolved in 5 ml of sodium chloride (salt)solution
• 20mg of doxorubicin hydrochloride dissolved in 10 ml of sodium chloride(salt) solution
• 50mg of doxorubicin hydrochloride dissolved in 25 ml of sodium chloride (salt)solution
• 200mg of doxorubicin hydrochloride dissolved in 100 ml of sodium chloride (salt) solution

The vials also contain hydrochloric acid.

Doxorubicin is one of a group of medicines called the anthracyclines. Anthracyclines are able to kill tumour and leukaemia cells.

What is your medicine for?

Doxorubicin is used to treat a wide range of tumours, and also some leukaemias (which are a form of cancer of the blood cells). Your doctor will be able to explain how doxorubicin might help in your particular condition.

How does your medicine work?

Doxorubicin works by killing tumour and leukaemia cells.

 

Before you are given your medicine

If you can answer "YES" to any of the following questions tell your doctor;

• Have you been told your blood is thin (your bone marrow is not working well)?
• Do you have any mouth ulcers?
• Do you have or have you ever had any heart problems?
• Do you suffer from any liver problems?
• Have you received doxorubicin or other anti-tumour drugs before?
• Have you received or are you receiving radiotherapy?
• Are you pregnant, trying to become pregnant now, or likely to want to try to become pregnant in the future?
• Are you breast-feeding?
• Are you currently taking cyclosporin, which is used to suppress your immune system (e.g. after a transplant)?
• Are you currently suffering from any infections?

How your medicine will be given

Your medicine will be given to you by injection, into a blood vessel, under the direction of specialists.

You will be monitored regularly both during and after your treatment.

Dosage is usually calculated on the basis of your body surface area. 60-75mg per square metre of body surface area may be given every 3 weeks when used alone. The dosage may need to be reduced to 30-60mg per square metre of body surface area when given in combination with other anti-tumour drugs. Your doctor will advise you of how much you will need.

Alternatively the dosage may be calculated on body weight and given as either a single dose every 3 weeks or divided over 3 consecutive days (0.4 - 0.8 mg/kg or 20 - 25mg per square metre of body surface area on each day). If given weekly the recommended dose is 20mg per square metre of body surface area.

Dosage may need to be reduced in children, obese patients and the elderly. If liver function is reduced, the dosage should be decreased. Your doctor will advise you of how much you will need.

What might happen while you are being treated with this medicine?

Doxorubicin solution can cause the following side-effects:

• Your urine may be coloured red, particularly the first time that you pass urine after injection of doxorubicin solution. This is nothing to worry about and your urine will soon return to its normal colour.
• Heart problems - for example you may notice your heart beating abnormally quickly, with an increase in pulse rate. In some cases, you may notice heart problems several months or years after your medication has been completed. You may experience signs of heart failure, such as shortness of breath and build up of fluid in lungs, when taking doxorubicin
• You may also lose your hair, and your beard may stop growing. However all hair growth normally resumes after doxorubicin treatment is stopped.
• In women, doxorubicin may cause infertility during the time the drug is taken. Women may also find that their periods will stop, but their periods should return to normal after medication is stopped. In some cases early menopause can occur.
• In men, doxorubicin may cause decrease in sperm count, but this may return to normal after medication is stopped. Men taking doxorubicin should use effective contraceptive methods.
• Diarrhoea, nausea, vomiting and dehydration.
• Reduced food intake and stomach pains.
• Anaemia and loss of blood
• Skin rashes, nails and skin may appear darker than usual. Sunlight may cause excessive irritation of your skin.
• The palms of your hand and soles of your feet may become red and feel abnormal.
• Fever and hot flushes.
• Difficulty in breathing and shortness of breath
• Anaphylaxis (severe allergic reaction)
• Redness and swelling may develop at the site of injection. If this is the case during an injection you should inform the specialist oncology personnel. (The injection should be stopped and restarted at another site).
• You may suffer with inflammation of your gums and nose.
• You may be told that you have high levels of a chemical, called uric acid, in your blood.
• Doxorubicin may cause decreased activity in your bone marrow; this can make you more susceptible to serious infections, tissue damage and bleeding. These problems may be life threatening and occasionally fatal.

Your doctor will be making regular checks as follows:

• Blood tests to make sure there are enough blood cells for your blood to function properly.
• Heart tests since doxorubicin can affect your heart.
• Blood tests to check your liver is working properly.
• Blood uric acid levels, potassium, calcium phosphate and creatinine should be monitored after your initial treatment.

Doxorubicin, like similar medicines, can occasionally itself cause cancers or leukaemia, when used in combination with other anticancer agents. Please tell your doctor or pharmacist if you suffer from any other unwanted effects while receiving your medicine