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AGIDOX 2 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Agidox 2 mg/ml
concentrate for solution for infusion
Doxorubicin hydrochloride

Read all of this leaflet carefully before you start using this
medicine because it contains important information for you.
− Keep this leaflet. You may need to read it again.
− If you have any further questions, ask your doctor or
pharmacist.
− If you get any side effects, talk to your doctor or pharmacist.
This includes any possible side effects not listed in this
leaflet.
What is in this leaflet
1. What Agidox is and what it is used for
2. What you need to know before you receive Agidox
3. How Agidox is administered
4. Possible side effects
5. How to store Agidox
6. Contents of the pack and other information

1. What Agidox is and what it is used for
Agidox belongs to a group of anti-cancer medicines called
anthracyclines. Agidox is used to treat the following types of
cancer:
− Small cell lung cancer
− Bladder cancer
− Bone cancer
− Breast cancer
− Cancer of the blood
− Cancer in the lymph system (Hodgkin and Non-Hodgkin’s
lymphoma)
− Cancer of the bone marrow
− Cancer in the thyroid gland
− Cancer in soft tissue (in adult age)
− Recurrent cancer in the ovaries
− Advanced or recurrent cancer in the mucous membrane lining
the uterus
− Certain type of kidney cancer that affects children (Wilm´s
tumour)
− Certain type of advanced cancer in nerve cells that affects
children (neuroblastoma)
Agidox is also used in combination with other anti-cancer drugs.

2. What you need to know before you receive
Agidox
You must not receive Agidox
− if you are allergic to doxorubicin or any of the other
ingredients of this medicine (listed in section 6);
− if you are allergic to drugs of the class anthracyclines or
anthracendiones;
− if you are breastfeeding.
Please talk to your doctor in case any of the above applies to
you.
You must not receive Agidox intravenously
− if you have been told after previous cancer therapy that you
had persistent decrease in the production of blood cells (your
bone marrow was not working well);
− if you had after previous cancer therapy severe inflammation
or ulcers in the mouth;
− if you suffer from any kind of general infections;
− if you have serious liver problems;
− if you have some heart problems;
− if you have previously received doxorubicin or other
anthracyclines up to the maximal cumulative dose;
− if you tend to bleed easily.
Please talk to your doctor in case any of the above applies to
you.

Dimension: 360 x 320 mm

You must not receive Agidox in the bladder
if you have tumour that has grown into the bladder wall;
if you have urinary tract infection;
if you have inflammation of the bladder;
if you have problems with the instillation (e.g. urethral
obstructions);
− if you have blood in the urine.
Please talk to your doctor in case any of the above applies to
you.





Warnings and precautions
Take special care with Agidox and tell your doctor before
treatment
− if you are or might be pregnant, see also section on pregnancy
and breastfeeding below.
− if you have had any radiotherapy before;
− if you have gastrointestinal symptoms (inflammation,
ulceration or diarrhoea)
− if you are 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 have kidney problems;
− if you have or ever have had any heart problems;
− if you are having other anticancer therapies.
Doxorubicin strongly reduces blood cell production in the
bone marrow. This may make you more prone to infections
or bleeding. Tell your doctor in case of fever or other sign of
infection or in case of bleeding.
Vaccination is not recommended. Contact to persons recently
vaccinated against polio should be avoided.
Agidox should be administered only under the supervision of a
qualified physician experienced in cancer therapy.
Also, patients must be carefully and frequently monitored before
and/or during treatment e.g. blood status and function test of the
heart, liver and kidney and radiographs of the lungs and chest.
If you feel a stinging or burning sensation in the area of
the infusion tell your doctor or other health care personnel
immediately. Such a pain can occur if the medicine leaks out of
the vein and then you will need an appropriate therapy.
Other medicines and Agidox
Please tell your doctor if you are taking, have recently taken or
might take any other medicines. This is especially important in
case of:
− other medication against cancer e.g. anthracyclines
(daunorubicin, epirubicin, idarubicin, trastuzumab),
cyclophosphamide, cytarabine, cisplatin, fluorouracil, taxanes
(e.g. paclitaxel), mercaptopurine, methotrexate, streptozocin;
− ciclosporin (used in organ and tissue transplants);
− medications for heart diseases (cardioactive drugs) e.g.
calcium channel blockers and digoxin;
− medicines that lower uric acid level in your blood;
− cimetidine (used in the treatment of heartburn and stomach
ulcers);
− live vaccines (e.g. polio (myelities));
− phenytoin, phenobarbital and other barbiturate (used in the
treatment of epilepsy);
− chloramphenicol and sulfonamides (medicines for infections)
− amphotericin B (medication for fungal infections );
− medicines for viral infections, such as ritonavir (used to treat
HIV);
− clozapine (an antipsychotic);
− amidopyrine derivates (for pain and inflammation).
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant
or are planning to have a baby, ask your doctor or pharmacist for
advice before taking this medicine.
It is known that doxorubicin passes the placenta and harms the
unborn in animal experiments. Therefore you should not receive
doxorubicin if you are pregnant. Tell your doctor immediately if
you are pregnant or think you are pregnant.

Women should not get pregnant during the treatment with
Agidox or up to 6 months after treatment. Men should take
adequate precautions to ensure that their partner does not
become pregnant during the treatment with doxorubicin and up
to 6 months after the treatment. Sexually active men and women
should therefore use effective contraceptive method during and
up to 6 months after treatment.
Men should also seek advice on cryo-conservation (or
cryo-preservation) of sperm prior to treatment because of
the possibility of irreversible infertility due to therapy with
doxorubicin.
In women, doxorubicin can cause infertility and absence of
menstrual periods during the treatment. After the therapy,
ovulation and menstruation return, although premature
menopause can occur.
If you are considering becoming parents after the treatment
please discuss this with your doctor.
The drug passes into human breast milk. Do not breastfeed while
you are treated with Agidox.
Driving and using machines
Due to the frequent occurrence of nausea and vomiting, you are
not advised to drive cars and operate machinery.
Agidox contains 3.54 mg (<1 mmol) sodium per ml concentrate.
This should be taken into consideration by patients on a
controlled sodium diet.

3. How Agidox is administered
Agidox should only be given under supervision of a doctor with
experience in cancer therapy.
Method and routes of administration
Your medicine will be given to you by intravenous infusion,
into a blood vessel, under the direction of a specialist. Do
not administer the medicine yourself. 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. This medicinal product should
be diluted before use.
Intravenous administration
The dosage is usually calculated on the basis of the body surface
area. Agidox may be given e.g. once a week, every three weeks
or even with longer intervals between. The dose and frequency
also depends on other anticancer medicines used as single
agent or in combination with other cytotoxic agents or as a
part a multidisciplinary procedures that include combination
of chemotherapy, surgical procedure and radiotherapy and
hormonal treatment, in addition to the type of disease and your
general health. You doctor will decide about the dose you will
receive.
Instillation in the bladder
The dosage is 30-50 mg docorubicin in 25-50 ml of
physiological saline. The solution should remain in the bladder
for 1-2 hours. During this period you need to turn about 90°
every 15 minutes.
You should not drink anything for 12 hours before instillation
in the bladder, to avoid undesired dilution of the medicine with
urine. 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.
If you use more Agidox than you should
As a doctor will be giving you your medicine, it is unlikely that
you will receive an overdose.
However, if you have concerns you should let your doctor or
nurse know immediately.
Acute overdosing worsens side effects like sores in the mouth,
decreases the number of white blood cells and platelets in the

The following information is intended for healthcare
professionals only:
Agidox 2 mg/ml concentrate for solution for infusion
Doxorubicin is a potent cytotoxic agent which should
only be prescribed, prepared and administered by
professionals who have been trained in the safe use of the
preparation. For recommendation on posology and method
of administration see section 4.2 of the SPC and section
3 of the package leaflet for this medicinal product. The
following guidelines should be followed when handling,
preparing and disposing of doxorubicin.
For single use only.
Handling
Doxorubicin may NOT be administered by the
intramuscular, subcutaneous, oral or
intrathecal route.
Further dilution of the appropriate volume of the
concentrate with either of 0.9 % sodium chloride solution
or 5 % glucose solution is required to a final concentration
of between 0.1 mg/ml and 1 mg/ml.
Preparation
1. Cytotoxic agents should be prepared for administration
only by personnel who have been trained in the safe
handling of such preparations. Refer to local cytotoxic
guidelines before commencing.
2. Pregnant staff should be excluded from working with
this drug.
3. Personnel handling doxorubicin should wear protective
clothing; goggles, gowns, disposable gloves and masks.
4. All items used for administration or cleaning, including
gloves, should be placed in high risk waste disposal
bags for high temperature (700°C) incineration.
5. All cleaning materials should be disposed of as
indicated previously.
6. Always wash hands after removing gloves.
Do not use Agidox if the solution is not clear, red and free
of particles.
Contamination
1. In case of contact with skin or mucous membrane,
thoroughly wash the affected area with soap and water
or sodium bicarbonate solution. However, do not graze
the skin by using a scrubbing brush. A bland cream may
be used to treat transient stinging of skin.
2. In case of contact with eye(s), hold back the eyelid(s)
and flush the affected eye(s) with copious amounts of
water for at least 15 minutes or normal sodium chloride
9 mg/ml (0.9%) solution for injection. Seek medical
evaluation by a physician or eye specialist.
3. In the event of spillage or leakage treat with 1% sodium
hypochlorite solution or phosphate buffer (pH>8) until
solution is decoloured. Use a cloth/sponge kept in the
designate area. Rinse twice with water. Put all cloths
into a plastic bag and seal for incineration.
In use stability
Product diluted in 0.9% sodium chloride solution:
The chemical and physical in-use stability after dilution
to a concentration of 0.1mg/ml to 1.0mg/ml has been
demonstrated for 24 hours when stored protected from
light at 2-8°C.
From a microbiological point of view, unless the
method of dilution precludes the risk of microbiological
contamination, 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 2-8°C, unless

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Disposal
Single use only. Any unused product or waste material
should be disposed of in accordance with local
requirements. Observe guidelines for handling cytotoxic
drugs.
Note:
Posology of S-liposomal doxorubicin and (conventional)
doxorubicin as in Agidox are different. The two
formulations cannot be used interchangeably.
Incompatibilities
Doxorubicin should not be mixed with heparin, as a
precipitate may form and it should not be mixed with
5-fluorouracil as degradation may occur. Prolonged
contact with any solution of an alkaline pH should be
avoided as it will result in hydrolysis of the drug.
In the absence of compatibility studies, this medicinal
product must not be mixed with other medicinal products.

Dimension: 360 x 320 mm

blood and can lead to heart problems. In case of overdose you
should receive appropriate treatment as your doctor will decide.
Heart disorders may occur up to six months after an overdose.
If you missed a dose of Agidox
Your doctor will decide on the duration of your treatment with
Agidox. If the treatment is stopped before the advised courses
of treatment is finished, the effects of the doxorubicin therapy
might be reduced. Ask you doctor for advise if you wish to stop
the treatment.
If you have any further questions on the use of this medicine, ask
your doctor or pharmacist.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although
not everybody gets them.
Please contact your doctor or nurse immediately in case:
− you feel dizzy (rare side effect), feverish (very common
side effect), short of breath with a tight chest or throat
(frequency not known) or have an itchy rash (rare side
effect). This may be a type of allergic reaction which can be
very serious;
− you feel tired and lethargic (frequency unknown). This may
be sign of anemia (a low red blood cell count);
− you have fever or other symptoms of infection (very
common side effect). This may be sign of low white blood
cell counts;
− you bruise or bleed more easily (very common side effect).
This may be sign of low platelet count in your blood.
Very common side effects (may affect more than 1 in 10 people)
− feeling sick, being sick, abdominal pain, digestive disorders,
diarrhea
− inflammation of the mucous membranes e.g. in the mouth or
esophagus
− hair loss (normally reversible), skin redness, sensitivity of
skin to artificial or natural light (photosensitivity)
− red coloration of the urine, for one or two days after
administration. This is normal and nothing to worry about
− bone-marrow suppression (deficiency in blood cells)
including reduction in number of white blood cells (causing
infection), blood platelets (causing bleeding and bruises)
and red blood cells (anaemia; so the skin can be pale and
weakness may occur, or shortness of breath)
− severe heart complications (cardiotoxicity), like damage to
the heart muscle or fast, slow or irregular pulse. Effects can
appear shortly after the treatment is started or be observed
several years later.
− fever
Common side effects (may affect up to 1 in 10 people)
− bacterial infection
− bacterial infection in the blood
− cardiac arrhythmias (irregular heart beat, rapid heart rate,
decreased heart rate), reduced amount of blood pumped
through the heart, deterioration of the function of the heart
muscle (cardiomyopathy) that can be life threatening
− bleeding (haemorrhage)
− eating disorder (anorexia)
− local allergic reaction of the field of radiation
− itching
− difficult or painful urination, bladder inflammation following
instillation in the bladder, sometimes with irritation in the
bladder, blood in the urine, painful urination, more frequent
urination or decreased urine
Uncommon side effects (may affect up to 1 in 100 people)
− acute blood cancer (certain types of leukaemia)
− inflammation of a vein
− bleeding in the stomach or intestines
− ulcers in the mucous membranes of the mouth, pharynx,
esophagus, stomach and the intestines

− ulcers and possible death of cells/tissues of the colon when
Agidox is given in combination with the medicinal product
cytarabine
− dehydration
Rare side effects (may affect up to 1 in 1,000 people)
− inflammation of the outermost layer of the eye (conjunctivitis)
− hives; skin rash and redness
− darkened areas of skin and nails; loosening of the nails
(onycholysis)
− severe allergic reactions with or without shock, including skin
rash, itching, fever and chills (anaphylactic reactions)
− shivering
− dizziness
− secondary leukaemia (blood cancer developed after treatment
for another cancer ), when Agidox is used in combination
with other anticancer drugs which damage the DNA
− tumour lysis syndrome (complications of having
chemotherapy due to break-down products of dying cancer
cells which for example can affect the blood and kidneys)
− injection site reactions including redness, rash and pain,
inflammation of the vein (phlebitis), thickening or hardening
of the wall of the vein (flebosclerose)
− a stinging or burning sensation at the administration site in
relation to the medicine leaking out of the vein. This can lead
to death of local tissue cells and needs appropriate treatment,
in some cases surgical measures
Very rare side effects (may affect up to 1 in 10,000 people)
− flushing of the face
− changes in the heart function (unspecified ECG changes),
isolated cases of life-threatening irregular heart beat
(arrhythmias), heart failure, inflammation of the pericardium /
myocardium, loss of nerve impulses in the heart
− clot formation in a blood vessel
− discoloration (pigmentation) of the oral mucosa
− swelling and numbness of the hands and feet (acral
erythema), blistering, tissue damage especially of the hands
and feet, causing redness, swelling, blisters, tingling or
burning sensation were leakage of the drug in the tissues
occur (palmarplantar erythrodysesthesia syndrome)
− acute kidney failure
− abnormally high uric acid levels in the blood
− absence of menstrual period
− fertility problems in men (reduction or absence of active
sperm)
Side effects where frequency is not known (cannot be estimated
from the available data)
− increased tear production
− coughing or difficulty in breathing because of sudden
narrowing of airways
− lung inflammation
− liver toxicity, which sometimes can progress to permanent
damage of liver tissue (chirrhosis)
− transient increase of liver enzymes
− fat, bald or crusty patches of skin (actinin keratosis).
− severe pain and swelling in the joints
− weakness
− radiation damage (on the skin, lungs, throat, esophagus,
stomach and intestinal mucosa, heart) already healing, may
reappear following administration of doxorubicin
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist.
This includes any possible side effects not listed in this leaflet.
You can also report side effects directly via the Yellow Card
Scheme at: www.mhra.gov.uk/yellowcard. By reporting side
effects you can help provide more information on the safety of
this medicine.

5. How to store Agidox
Keep this medicine out of the sight and reach of children.
Do not use Agidox after the expiry date which is stated on the
vial and outer carton after EXP. The expiry date refers to the last
day of that month.
Storage conditions
Before opening:
Store in a refrigerator (2-8°C).
After opening:
The product should be used immediately after opening the vial.
After dilution:
Chemical and physical in-use stability after dilution to a
concentration of 0.1 mg/ml to 1.0 mg/ml in 9 mg/ml (0.9%)
sodium chloride solution for infusion or in 50 mg/ml (5%)
glucose solution for infusion has been demonstrated for 24 hours
when stored protected from light at 2-8°C.
From a microbiological point of view, unless the method of
dilution precludes the risk of microbiological contamination, 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 to 8°C, unless dilution has taken place in controlled
and validated aseptic conditions.
Do not use this medicine if you notice any precipitate in the
vials.
Do not throw away any medicines via wastewater or household
waste. Ask your pharmacist how to throw away medicines you
no longer use. These measures will help protect the environment.

6. Contents of the pack and other information
What Agidox contains
− The active substance is doxorubicin hydrochloride. Each
ml of concentrate for solution for infusion contains 2 mg
doxorubicin hydrochloride.
• Each vial with 5 ml contains 10 mg doxorubicin
hydrochloride.
• Each vial with 10 ml contains 20 mg doxorubicin
hydrochloride.
• Each vial with 25 ml contains 50 mg doxorubicin
hydrochloride.
• Each vial with 100 ml contains 200 mg doxorubicin
hydrochloride.
− The other ingredients are sodium chloride, hydrochloric acid
(E507) and water for injection.
What Agidox looks like and contents of the pack
Agidox is a clear, orange red solution. The solution is supplied
in type I glass vials closed with a bromobutyl rubber closure
with a flip off aluminium seal. Agidox is available in vials of 5
ml, 10 ml, 30 ml and 100 ml. Each package contains 1 injection
bottle.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation holder
Strides Arcolab International Ltd.
Unit 4, Metro Centre, Tolpits Lane,
Watford, Hertfordshire WD 18 9SS,
United Kingdom
Manufacturer
Agila Specialties Polska Sp.Z.o.o.
10, Daniszewska Str
03-230 Warsaw
Poland

1xxxxxx

reconstitution/dilution has taken place under controlled
and validated aseptic conditions.
Product diluted in 5% Glucose solution:
The chemical and physical in-use stability after dilution
to a concentration of 0.1mg/ml to 1.0mg/ml has been
demonstrated for 24 hours when stored protected from
light at 2-8°C.
From a microbiological point of view, unless the
method of dilution precludes the risk of microbiological
contamination, 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 2-8°C, unless
reconstitution/dilution has taken place under controlled
and validated aseptic conditions.

This leaflet was last approved in 09/2014

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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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