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DOXORUBICIN COPHARMA 2 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION

Active substance(s): DOXORUBICIN HYDROCHLORIDE

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Package Leaflet: Information for the patient

Doxorubicin Copharma2 mg/ml Concentrate for
solution for infusion
Doxorubicin Hydrochloride
Read all of this leaflet carefully, before you receive this medicine.
 Keep this leaflet. You may need to read it again.
 If you have any further questions, please ask your doctor or your pharmacist.
 This product has been prescribed for you personally. 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 Copharmais and what it is used for
2. Before you receive Doxorubicin Martindale Pharma®
3. How Doxorubicin Copharmais administered
4. Possible side effects
5. How to store Doxorubicin Martindale Pharma®
6. Further information

1. What Doxorubicin Copharmais and what it is used for
Doxorubicin Copharma– the active substance of Doxorubicin hydrochloride – belongs
to a group of medicines known as anthracyclines. These cytotoxic active substances
are used to treat cancer, they work by killing tumour and leukaemia cells. Your doctor
will be able to explain how doxorubicin might help in your particular condition.
Doxorubicin Copharmais used in the treatment of
leukaemias, a cancer that causes abnormal production of blood cells
lymphomas, a cancer affecting the immune system
myeloma, a cancer affecting the cells in your bone marrow known as plasma
cells.
sarcomas, a cancer of the supporting tissues of the body (i.e.bone)
breast and lung cancers,
cancer of the bladder.
- Advanced ovarian and endometrial cancer (a cancer of the lining of the uterus
or of the uterus)
- Malignant cancer of the kidneys tumour in children (Wilm´s tumour)
- Advanced neuroblastoma (a cancer of the nerve cells commonly found in
children)
- Cancer develops within the stomach
- Malignant renal tumour in children (Wilm´s tumour)
- Advanced neuroblastoma
Thyroid cancer

2. Before you receive Doxorubicin Copharma
You must not receive Doxorubicin Copharmain the following cases, please tell
your doctor


if you have ever had any hypersensitivity reaction to doxorubicin or any of the
other ingredients of Doxorubicin Copharmaor to other anthracyclines.










if you have been told that your blood is thin (your bone marrow is not working
well).
if you have or ever have had any heart problems.
if you have received doxorubicin or other anthracyclines, other anti-tumour drugs
or immunosuppressive drugs before.
if you tend to bleed easily.
if you suffer from any kind of infections.
if you suffer from mouth ulcers.
if your liver is not working well.
if you suffer from cystitis (inflammation of the bladder) or if you have blood in your
urine- (in case the medicine is given to you by an administration into your
bladder).

Take special care with Doxorubicin Copharmaand tell your doctor





if you have had any radiotherapy before.
if you are pregnant, trying to become pregnant, likely to want to try to become
pregnant in the future or if you want to father a child.
if you are breast-feeding.
if you are on a controlled sodium diet.

Doxorubicin Copharmashould be administered only under the supervision of a
qualified physician experienced in therapy toxic to cells. Also, patients must be
carefully and frequently monitored.
A burning sensation in the area of the infusion may be a sign of an injection error and
the infusion must be stopped immediately.
Using other medicines
Please inform your doctor if you are taking or have recently taken any other
medicines, including medicines obtained without a prescription.
The following medications can interact with Doxorubicin Copharma2 mg/ml
concentrate for solution for infusion :









Other cytostatics (medication against cancer) e.g. anthracyclines.
cyclophosphamide, cytarabine, cisplatin, fluorouracil, taxanes (e.g. paclitaxel),
mercaptopurine,methotrexate, streptozocin
Ciclosporin (used in organ and tissue transplants)
Cardioactive drugs (medications for heart diseases), e.g. calcium channel
blockers, digoxin
Cimetidine (used in the treatment of heartburn and stomach ulcers)
Live vaccines (e.g. polio(myelities), malaria)
Phenobarbital and other barbiturate ( used in the treatment of epilepsia )
Amphotericin ( medication for fungal infections )
Trastuzumab ( used in the treatment of breast cancer )
 Ritonavir (used to treat HIV)
 Clozapine (an antipsychotic)
 Sulphonamides or other diuretics

Please note that these statements may also apply to products used some time ago or
at some time in the future.

Pregnancy and breast-feeding
It is known that doxorubicin passes the placenta and harms the unborn in animal
experiments. Therefore doxorubicin must not be administered if you are pregnant.
The drug also concentrates in human milk. Your doctor will decide whether nursing or
the drug should be discontinued.
Women must not get pregnant during the treatment with Doxorubicin Martindale
Pharma®. If you get pregnant during treatment with Doxorubicin Martindale Pharma®,
please inform your doctor immediately.
During the treatment and until 6 months after the treatment was stopped you should
practice effective contraception regardless of whether the male or the female partner
took Doxorubicin Martindale Pharma®.
For safety reasons, men wanting a baby should preserve unexposed sperm prior to
treatment with Doxorubicin hydrochloride.
Ask you doctor for advice before taking any medicine.

Driving and using machines
Due to the frequent occurrence of drowsiness, nausea and vomiting, you are not
advised to drive cars and operate machinery.
Important information about some of the ingredients of Doxorubicin Martindale
Pharma®
Please tell your doctor if you are on low-sodium diet. He/she will take into account
that 1 ml of Doxorubicin Copharmacontains 3.5 mg sodium.

3.

How Doxorubicin Copharmais administered

Dilute before use.
Method and routes of administration
Do not administer the medicine yourself. Your medicine will be given to you by
intravenous infusion, into a blood vessel, under the direction of specialists. You will
be monitored regularly both during and after your treatment.
If you suffer from superficial bladder cancer it is possible that you may receive your
medicine into your bladder (intravesical use).
Dosage
The dosage is usually calculated on the basis of your body surface area. 60 – 75 mg
per square metre of body surface area may be given every three weeks when used
alone. The dosage may need to be reduced to 30 – 60 mg per square metre of body
surface area and the treatment interval prolonged when given in combination with
other anti-tumour drugs. If given weekly the recommended dose is 15 – 20 mg per
square metre of body surface area.
Your doctor will advise you of how much you will need.
The dosage for intravescical administration is 30-50 mg in 25-50 ml of physiological
saline. The solution should remain in the bladder for 1-2 hours. During this period the
patient should be turned 90o every 15 minutes. To avoid undesired dilution with urine
the patient should be informed not to drink anything for a period of 12 hours before
the instillation. The instillation may be repeated with an interval of 1 week to 1 month.
Your doctor will advise you of how often you need it.

Patients with reduced liver and renal function
If your liver or kidney function is reduced, the dosage should be decreased. Your
doctor will advise you of how much you need.
Children/Elderly or patients after radiotherapy
The dosage may need to be reduced in children and the elderly or if you have
received any radiotherapy.
Your doctor will advise you of how much you need.
Patients with bone marrow suppression
The dosage may need to be reduced in patients with bone marrow suppression.
Your doctor will advise you of how much you need.
Obese patients
The starting dose may be reduced in obese patients or the dose interval may be
prolonged. Your doctor will advise you of how much you need and how often.
If you take more Doxorubicin Copharmathan you should
Acute overdosing worsens side effects like sores in the mouth, decreases the
number of white blood cells and platelets in the blood and can lead to cardiac
problems. Treatment will include administration of antibiotics, transfusions of
granulocytes and thrombocytes, and treatment of mouth sores and heart effects.

Cardiac disorders may occur up to six months after the overdosage.
4.

Possible Side Effects

Like all medicines Doxorubicin Copharmacan cause side effects, although not
everybody gets them.
Please contact your doctor or nurse immediately if you notice any of the
following side effects:
• Feeling dizzy, feverish, short of breath with a tight chest or throat or have an itchy
rash. This type of allergic reaction can be very serious.
• Anaemia (a low red blood cell count) that can leave you feeling tired and lethargic.
• White blood cell counts (which fight infection) can also drop, increasing the chance
of infections and a raised temperature (fever).
• Platelets (these are cells that help the blood to clot) can be affected which could
make you bruise or bleed more easily. It is important to seek medical advice if this
happens. Your doctor should test your blood cell count during treatment.
• Doxorubicin may cause decreased activity in your bone marrow
Doxorubicin Copharmamay cause a red colouration of the urine for one or two days
after administration. This is normal and nothing to worry about.
Frequency:
Very common (more than 1 in 10 patients)
Common (more than 1 in 100 patients, but less than 1 in 10 patients)

Uncommon (more than 1 in 1,000 patients, but less than 1 in 100 patients)
Rare (more than 1 in 10,000 patients, but less than 1 in 1,000 patients)
Very rare (less than 1 in 10,000 patients)
Not known (cannot be estimated from the available data)
Common











Uncommon










Rare












Not known













cardiomyopathy (heart muscle disease)
ECG (electrocardiogram) changes
bone-marrow suppression (deficiency in blood cells causing
infection and bleeding)
nausea (feeling sick)
vomiting (being sick)
mucositis (inflammation of membranes in digestive tract)
anorexia (eating disorder)
diarrhoea – may result in dehydration
chemical cystitis ((bladder inflammation) sometimes haemorrhagic
(with blood in the urine) following administration into the bladder
alopecia (hair loss) normally reversible
sepsis ( bacterial infection )
septiciaemia ( bacterial infection of blood )
ulceration and necrosis (death of cells/tissues) of the colon
(intestine) in combination with cytarabine.

phlebitis
gastrointestinal bleeding
abdominal pain
local hypersensitivity reaction of the field of radiation
dehydration
secondary leukaemia ( blood cancer developed after treatment for
another cancer ) when in combination with anti-neoplastic drugs
which damage the DNA.
tumor lysis syndrome ( complications of having chemotherapy )
conjunctivitis (inflammation of the outermost layer of the eye)
urticaria (hives)
exanthema (type of rash)
erythematous reactions (rash-like symptoms) along the vein used
for the injection
hyperpigmentation (darkened areas) of skin and nails
onycholysis (loosening of the nails)
anaphylactic reactions (severe allergic reactions with or without
shock including skin rash, pruritis (itching), fever and chills)
shivering
fever
dizziness
thrombophlebitis ( vein inflammation under the skin )
thromboembolism ( clot formed in a blood vessel )
arrhythmia ( irregular heartbeat )
heart failure ( loss of cardiac function )
acute renal failure ( loss of renal function )
hyperuricaemia ( high uric acid level in blood )
bronchospasm ( coughing or difficulty in breathing because of
narrowing sudden of airways )
pneumonitis ( inflammation of lung tissue )








amenorrhoea ( absence of menstruation )
oligospermia ( low sperm volume )
azoospermia ( lack of sperm )
Anaemia (reduction in red blood cells)
A stinging or burning sensation at the administration site in relation
to extravasation. Extravasation can lead to local death of cells of
the tissue which may require surgical measures.
Transient increase of liver enzymes

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.

5.

How to store Doxorubicin Copharma

Keep out of the reach and sight of children.
Do not use Doxorubicin Copharmaafter the expiry date which is stated on the label
and carton. The expiry date refers to the last day of that month.
Store the unopened vials in a refrigerator (2-8°C). Keep the container in the outer
carton in order to protect from light.
The product should be used immediately after opening the vial.
For Single Dose Use Only. Any unused solution should be discarded immediately
after initial use.
Do not use Doxorubicin Copharmaif you notice that the solution is not clear, red and
practically free of particles.
Medicines should not be disposed of via wastewater or household waste in order to
protect the environment.

6.

Further information

What Doxorubicin hydrochloride contains
Doxorubicin Martindale Pharma 2 mg/mL is a concentrate for solution for infusion
containing doxorubicin hydrochloride, which is the active substance.
The other ingredients are sodium chloride, hydrochloric acid (for pH adjustment) and
water for injections.

What Doxorubicin Copharmalooks like and contents of the pack
Doxorubicin Copharma2 mg/ml Concentrate for solution for infusion
solution which is practically free of particles.
 Each 5 ml vial of Doxorubicin Copharmacontains 10 mg
hydrochloride
 Each 10 ml vial of Doxorubicin Copharmacontains 20 mg
hydrochloride
 Each 25 ml vial of Doxorubicin Copharmacontains 50 mg
hydrochloride
 Each 75 ml vial of Doxorubicin Copharmacontains 150 mg
hydrochloride
 Each 100 ml vial of Doxorubicin Copharmacontains 200 mg
hydrochloride

is a clear, red
of doxorubicin
of doxorubicin
of doxorubicin
of doxorubicin
of doxorubicin

Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
For any information about this medicine, please contact the local representative of
the Marketing Authorisation Holder:
Marketing Authorisation Holder:
Manufacturer:
COPHARMA ApS
Oncotec Pharma Jægersborg
Allé 164DK-2820 Gentofte
Am Pharmapark
DK-2820 Gentofte
D-06861 Dessau-Roβlau
Germany
This leaflet was approved in .
This medicinal product is authorised in the Member States of the EEA under
the following names:
Denmark
Finland
Norway
United Kingdom
Sweden

Doxorubicin ”Copharma”
Doxorubicin Copharma 2 mg/ml infuusiokonsentraatti, liuosta
varten
Doxorubicin Copharma 2mg/ml Infusjonsvæske
Doxorubicin COPHARMA 2 mg/ml Concentrate for solution for
infusion
Doxorubicin Copharma, 2mg/ml koncentrat till infusionsvätska,
lösning

------------------------------------------------------------------------------------------------------------Technical Prescribing Information

Doxorubicin Copharma2 mg/ml Concentrate for
solution for infusion
The following information is intended for medical or healthcare professionals only:
Doxorubicin Copharmamay be further diluted in Sodium Chloride 0.9% or Glucose
5% and administered as an intravenous infusion. The infusion solution should be
prepared immediately before use.
The injection solution contains no preservative and any unused portion of the vial
should be discarded immediately.
Incompatibilities
Contact with any solution of an alkaline pH should be avoided as it will result in hydrolysis of the drug. Doxorubicin should not be mixed with heparin and 5-fluorouracil
since a precipitate may form, and it is not recommended that doxorubicin be mixed
with other drugs until specific compatibility data are available.
In use stability
Chemical and physical in-use stability has been demonstrated in Sodium Chloride
0.9 % or Glucose 5 % for up to 48 hours at 2 – 8°C and for up to 24 hours at 25°C
when prepared in PVC infusion bags and polypropylene syringes protected from
light.
From a microbiological point of view, the product should be used immediately. If not
used immediately, in-use storage times and conditions prior to use are the
responsibility of the user and would normally not be longer than 24 hours at 2°C to
8°C, unless dilution has taken place in controlled and validated aseptic conditions.
Guidelines for the safe handling and disposal of cytotoxic agents
For single use only.
Observe guidelines for handling cytotoxic drugs.
The following protective recommendations are given due to the toxic nature of this
substance:
- Personnel should be trained in good technique for handling.
- Pregnant staff should be excluded from working with this drug.
- Personnel handling doxorubicin should wear protective clothing: goggles, gowns
and disposable gloves and masks.
- All items used for administration or cleaning, including gloves, should be placed in
high risk waste disposal bags for high temperature (700°C) incineration.
Accidental contact with the skin should be treated immediately by copious lavage
with water or soap and water. In an accidental contact, the eyes should be rinsed
copiously with water or sodium bicarbonate solution. Medical attention should be
sought.
Spillage or leakage should be treated with dilute sodium hypochlorite (1 % available
chlorine) solution, preferably soaking overnight and then rinse with water.

All cleaning materials should be disposed of as indicated previously.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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