Active ingredient
- doxorubicin hydrochloride
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 41013/0003.
Doxorubicin 2 mg/ml Concentrate for solution for infusion
PACKAGE LEAFLET: INFORMATION FOR THE USER
Doxorubicin 2mg/ml Concentrate for solution for infusion
Referred to in this leaflet as Doxorubicin 2mg/ml
Doxorubicin hydrochloride
Read all of this leaflet carefully before you start using this medicine.
In this leaflet:
1. What Doxorubicin 2 mg/ml is and what it is used for
2. Before you use Doxorubicin 2 mg/ml
3. How to use Doxorubicin 2 mg/ml
4. Possible side effects
5. How to store Doxorubicin 2 mg/ml
6. Further information
1. WHAT DOXORUBICIN 2MG/ML IS AND WHAT IT IS USED FOR
Doxorubicin, the active ingredient in Doxorubicin 2 mg/ml, is a medicine that kills cancer cells. It is used to treat several types of cancer, e.g., breast cancer, lung cancer, leukaemia (cancer of the blood or bone marrow), tumours of the thyroid gland, bladder and ovaries, and paediatric malignancy. Doxorubicin 2 mg/ml is frequently used in combination with other anti-cancer treatments.
2. BEFORE YOU USE DOXORUBICIN 2 MG/ML
Do not use Doxorubicin 2 mg/ml
Intravenous medication must not be used if:
Intravesical (placed directly into the bladder through a catheter) medication must not be used if:
Take special care with Doxorubicin 2 mg/ml:
Using other medicines
Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. In particular, inform your doctor if you have used the following medicines:
Patients should not be vaccinated during treatment with Doxorubicin 2 mg/ml, and they should avoid people who have recently received a live oral polio vaccination.
Taking Doxorubicin 2 mg/ml with food and drink:
Doxorubicin 2 mg/ml may be taken with or without food. If the medicine is administered intravesically, patients should not drink any fluids in the 12 hours prior to instillation.
Pregnancy
Doxorubicin 2 mg/ml should not be used during pregnancy. During pregnancy, cytotoxic agents (chemicals which are harmful to cells) are generally administered only after careful consideration of their benefits to the mother and the risks to the foetus.
Both men and women should use effective contraception during and up to 6 months after treatment.
Breastfeeding
Doxorubicin 2 mg/ml is excreted into breast milk. Breastfeeding should be discontinued for the duration of treatment with doxorubicin.
Driving and using machines
The effect of this medicine on the ability to drive and use machinery has not been studied.
The medicinal product contains 3.54 mg sodium per 1 ml of doxorubicin hydrochloride concentrate for solution for infusion. This should be taken into consideration by patients on a controlled sodium diet.
3. HOW TO USE DOXORUBICIN 2 MG/ML
Your doctor will prescribe the dosage and administration route on an individual basis and take care of the practical treatment arrangements.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Doxorubicin 2 mg/ml can cause side effects. Some of these are so severe that the patient should be closely monitored. Nausea and vomiting as well as hair loss occur in almost all patients.
Common (occur in 1 in 100 to 1 in 10 patients):
Blood and lymphatic tissue: Decrease in the white blood cell count, potentially resulting in systemic infections (infections which may affect different organs in the body), which can be severe. If you get a fever or experience other signs of infection after the therapy, seek immediate medical assistance.
Vascular: Cardiomyopathy (heart muscle disorder), ECG changes. Cardiomyopathy may occur a long while after discontinuation of the therapy.
Gastrointestinal: Nausea, vomiting, mucositis (inflammation of the digestive tract), loss of appetite, diarrhoea
Skin and subcutaneous tissue: Hair loss
Administration site conditions: Local reactions (bladder infection) may occur when the medicine is administered intravesically.
Uncommon (occur in 1 in 100 to 1 in 1,000 patients):
Gastrointestinal: When the medicine is used in combination with cytarabine (anti-cancer medicine), colon and particularly caecal (bowel) ulcers and necrosis (death of cells or tissue) have been reported.
Rare (occur in 1 in 10,000 to 1 in 1,000 patients):
General: Sudden allergic reactions, chills, fever, dizziness
Skin and subcutaneous tissue: Hives, rash, local redness in the vein used for the injection, skin and nail darkening and loss of nails.
Eyes: conjunctivitis
Urine may become red during the use of the medicine.
If you notice any side effects not listed in this leaflet, please tell your doctor.
5. HOW TO STORE DOXORUBICIN 2 MG/ML
Keep out of the sight and reach of children.
Store in a refrigerator (+2ºC – +8ºC).
Keep vial in the outer carton in order to protect from light.
Store in an upright position.
For single dose use only.
Any unused solution should be discarded immediately after initial use.
Do not use if deteriorated.
Do not use after the expiry date which is stated on the vial and the carton. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. FURTHER INFORMATION
What Doxorubicin 2 mg/ml contains
1 ml of Doxorubicin 2 mg/ml contains 2 mg of the active substance doxorubicin hydrochloride.
The product contains sodium chloride (3.54 mg sodium per 1 ml).
The other ingredients are sodium chloride, hydrochloric acid and water for injections.
What Doxorubicin 2 mg/ml looks like and contents of the pack
Doxorubicin 2 mg/ml is a red, clear concentrate for solution for infusion.
It is available in the following pack sizes:
Glass vial, type I glass.
Pack sizes: 5 ml, 10 ml, 25 ml, 50 ml and 100 ml.
Not all pack sizes may be marketed.
Marketing Authorisation Holder in the UK:
Manufacturer in the UK:
Manufacturer in the IE:
This medicinal product is authorised in the Member States of the EEA under the following names:
UK: Doxorubicin 2 mg/ml Concentrate for solution for infusion
IE: Doxorubicin 2 mg/ml Concentrate for solution for infusion
This leaflet was revised in 10/02/2021
uk/ie-pl-v9.0-20210210
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