What is a Patient Information Leaflet and why is it useful?

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.

  • Keep this leaflet. You may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
  • If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

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

  • if you are hypersensitive (allergic) to doxorubicin or any of the other ingredients of Doxorubicin 2 mg/ml, or to other anthracyclines or anthracenediones (anti-cancer medicines)
  • if you are pregnant or breastfeeding

Intravenous medication must not be used if:

  • you have decreased bone marrow function or if severe oral mucositis (inflammation of the mouth) has occurred during previous cytotoxic therapy
  • you have a generalised infection
  • you have severe hepatic impairment (liver damage)
  • you have severe arrhythmia (irregular heart beat), cardiac impairment (problems with your heart function) or you have had a heart infarction (heart attack)
  • you have had prior treatment with anthracycline in excess of a certain cumulative level

Intravesical (placed directly into the bladder through a catheter) medication must not be used if:

  • you have a tumour that has penetrated the bladder wall
  • you have a urinary tract infection
  • you have a bladder infection
  • there are problems with catheterisation (insertion of a small plastic tube into the urethra)

Take special care with Doxorubicin 2 mg/ml:

  • if you have a bone marrow disease
  • if you have decreased bone marrow function
  • if you have had prior treatment with anthracycline
  • if you have had mediastinal irradiation (radiotherapy in the region between the lungs, where the heart and major blood vessels are located)
  • if you have hepatic impairment (liver damage) or blocked bile flow
  • if you have severe renal impairment (kidney damage)

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:

  • other anthracyclines
  • other preparations with cardiac toxicity (damage to the heart muscles), such as 5- fluorouracil, cyclophosphamide and paclitaxel (anti-cancer medicines)
  • preparations that have an effect on cardiac function, such as calcium antagonists
  • other preparations with hepatic toxicity, such as 6-mercaptopurine (immunosuppressive medicines)
  • cyclosporine (immunosuppressive medicine)
  • verapamil (calcium channel blocker used for heart problems)
  • digoxin (used in the treatment of abnormal heart rhythms)

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.

  • Each 5ml vial contains 10 mg Doxorubicin hydrochloride.
  • Each 10ml vial contains 20 mg Doxorubicin hydrochloride.
  • Each 25ml vial contains 50 mg Doxorubicin hydrochloride.
  • Each 50ml vial contains 100 mg Doxorubicin hydrochloride.
  • Each 100ml vial contains 200 mg 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:

Seacross Pharmaceuticals Ltd.
Bedford Business Centre
61 - 63 St Peters Street
Bedford
MK40 2PR
United Kingdom

Manufacturer in the UK:

Seacross Pharmaceuticals Ltd.
Stanmore Place
Howard Road
Stanmore
HA7 1BT
United Kingdom

Manufacturer in the IE:

Seacross Pharma (Europe) Ltd.
Regus Dublin Airport
Skybridge House
Corballis Road North
Dublin Airport Swords
Co.Dublin
K67 P6K2
Ireland

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