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CARDIOXANE 500 MG POWDER FOR SOLUTION FOR INFUSION

Active substance(s): DEXRAZOXANE HYDROCHLORIDE

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Read all of this leaflet carefully before you are given 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.
See section 4.
What is in this leaflet:
1. What Cardioxane is and what it is used for
2. What you need to know before you are given Cardioxane
3. How Cardioxane is used
4. Possible side effects
5. How to store Cardioxane
6. Contents of the pack and other information
1. What Cardioxane is and what it is used for
Cardioxane contains a substance called dexrazoxane. This
substance belongs to a group of medicines which protect the
heart (cardioprotective medicines).
Cardioxane is used to prevent heart damage when medicines
called d
­ oxorubicin or epirubicin are used during breast cancer
treatment in adults.
2. What you need to know before you are given
Cardioxane
You must not be given Cardioxane
– If you are under 18 years old.
– If you are allergic (hypersensitive) to dexrazoxane.
– If you are breast-feeding (see also “Pregnancy and breast-
feeding”).
− If you are given yellow-fever vaccine.
If any of the above apply, you must not be given this medicine.
Before you are given Cardioxane, tell your doctor
– If you have or have had liver or kidney problems.
– If you have or have had a heart attack, heart failure,
uncontrolled chest pain and heart valve problems.
– If you are pregnant or plan to become pregnant (see also
“Pregnancy and breast-feeding”).
– If you are allergic to dexrazoxane or razoxane.
You should also be aware that:
– Your doctor may carry out tests before and during the treatment
with Cardioxane to see how well the treatment is working and to
check the function of some of your organs, such as your heart,
kidneys or liver.
– Your doctor may carry out blood tests during the treatment with
Cardioxane to monitor your bone marrow function. If you are
receiving high-dose cancer treatment (e.g. chemotherapy or
radiation) and are also being treated with high doses of

Other medicines and Cardioxane
Please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines, including medicines obtained
without a prescription.
It is not advisable to take other medicines without telling
your doctor as there may be interactions between
Cardioxane and other medicines:
– Vaccines: you must not use Cardioxane if you will receive
yellow fever vaccine and it is not recommended that you
use Cardioxane if you will receive a vaccine containing live
virus particles.
– Phenytoin, a treatment against seizures.
– Cyclosporin or tacrolimus (both treatments lower the
body's immune system and are used to prevent organ
rejection after an organ transplant).
– Myelosuppressive medicines (decrease production of red,
white, or coagulating blood cells).



INFORMATION FOR HEALTHCARE PROFESSIONALS

CARDIOXANE®
500 mg powder for solution for infusion
Dexrazoxane
POSOLOGY AND METHOD OF ADMINISTRATION
Cardioxane is administered by a short intravenous infusion
(15 minutes), approximately 30 minutes prior to anthracycline
administration at a dose equal to 10 times the doxorubicinequivalent dose level and 10 times the epirubicin-equivalent dose.
Thus it is recommended that Cardioxane is given at a dose of
500 mg/m2 when the commonly used dosage schedule for
doxorubicin of 50 mg/m2 is employed or 600mg/m2 when the
commonly used dosage schedule for epirubicin of 60 mg/m2 is
employed.
Paediatric population
Cardioxane is contraindicated in children and adolescents up to
18 years of age.
Renal impairment
In patients with moderate to severe renal dysfunction (creatinine
clearance < 40 ml/min) the dexrazoxane dose should be reduced
by 50%.



500 mg powder for solution for infusion
Dexrazoxane

Cardioxane, your bone marrow function may be reduced. This
may affect the production of red blood cells, white blood cells,
and platelets.
– Cardioxane may increase the risk of developing leukaemia
(cancer of the blood).
– During treatment with Cardioxane, women of childbearing
potential and men should use effective contraception. Men
should continue using contraception for at least three months
after Cardioxane treatment has been stopped (see also
“Pregnancy and breast-feeding”).
– The combination of Cardioxane with your cancer treatment may
increase the risk of blood clots.
– If Cardioxane powder or solution gets on your skin, tell your
doctor straight away. You or your doctor should immediately
rinse the affected area thoroughly with water.

In case of overdose, symptomatic treatment should be provided.

Older people (over 65 years old)
The doctor may adjust your treatment with Cardioxane
according to your health condition (in case of heart, liver or
kidney problems).

INSTRUCTIONS FOR USE
Recommendations for safe handling
Prescribers should refer to national or recognised guidelines on
handling cytotoxic agents when using Cardioxane. Reconstitution
should only be carried out by trained staff in a cytotoxic
designated area. The preparation should not be handled by
pregnant staff.

Pregnancy and breast-feeding
– You will not be given Cardioxane if you are pregnant or had
planned to become pregnant, unless your doctor decides it is
necessary.
– Women of childbearing potential should use effective
contraception during treatment with Cardioxane.
– Men should use effective contraception during treatment with
Cardioxane and for at least three months after Cardioxane
treatment has been stopped.
– Stop breast-feeding while you are receiving Cardioxane
treatment.
If you are pregnant or breast-feeding, think you may be
pregnant or are planning to have a baby, ask your doctor or
pharmacist for advice before taking this medicine.

Use of gloves and other protective clothing to prevent skin contact
is recommended. Skin reactions have been reported following
contact with Cardioxane. If Cardioxane powder or solution comes
into contact with the skin or mucosal surfaces, the affected area
should immediately be rinsed thoroughly with water.
Preparation for intravenous administration
Reconstitution of Cardioxane
For reconstitution the contents of each vial should be dissolved in
25 ml of water for injections. The vial contents will dissolve within
a few minutes with gentle shaking. The resultant solution has a pH
of approximately 1.6. This solution should be further diluted before
administration to the patient.

Driving and using machines
Tiredness has been reported with Cardioxane treatment.
Therefore if you feel sleepy, do not drive or use machines.
3. How Cardioxane is used
How Cardioxane is given to you
This medicine is prepared and given to you by your doctor or
other medical staff. The dose you will receive is decided by your
doctor.
Continued overleaf

Hepatic impairment
The dose ratio should be kept, i.e. if the anthracycline dose is
reduced the dexrazoxane dose should be reduced accordingly.
Older people (over 65 years old)
The dose may be adjusted during treatment with Cardioxane
according to health condition (in case of heart, liver or kidney
problems).



CARDIOXANE®

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Package leaflet: Information for the user

Dilution of Cardioxane
To avoid the risk of thrombophlebitis at the injection site,
Cardioxane must be diluted prior to infusion with one of the
solutions mentioned in Table 1. The final volume is proportional to
the number of Cardioxane vials used and the amount of infusion
fluid for dilution, which can be between 25 ml and 100 ml per vial.
Continued overleaf



Table 1. below summarises the final volume and the approximate
pH of reconstituted and diluted product for one vial and four vials
of Cardioxane. The minimum and maximum volumes of infusion
fluids to be used per vial are shown in Table 1.
Table 1. Reconstitution and dilution of Cardioxane vials
Infusion Volume of fluid Final
Final
pH
fluid
used to dilute volume volume (approximate)
used for
1 vial of
from
from
dilution reconstituted
1 vial 4 vials
Cardioxane
Ringer
25 ml
50 ml 200 ml
2.2
lactate
100 ml
125 ml 500 ml
3.3
0.16 M
25 ml
50 ml 200 ml
2.9
sodium
100 ml
125 ml 500 ml
4.2
lactate*

4. Possible side effects
Like all medicines, this medicine can cause side effects, although
not everybody gets them.

* Sodium lactate 11.2% should be diluted by a factor of 6 to
reach a concentration of 0.16 M
The use of larger dilution volumes (with a maximum of 100 ml of
additional infusion fluid per 25 ml reconstituted Cardioxane) is
usually recommended to increase the pH of the solution. Smaller
dilution volumes (with a minimum of 25 ml of additional infusion
fluid per 25 ml reconstituted Cardioxane) can be used if needed,
based on the haemodynamic status of the patient.



Reconstituted, diluted Cardioxane is for single use only. The
diluted solution should be used immediately or stored for not
longer than 4 hours between +2°C and +8°C and protected from
light.
Parenteral medicinal products should be inspected visually for
particulate matter whenever the solution and container permit.
Cardioxane is normally a colourless to yellow solution immediately
on reconstitution, but some variability in colour may be observed
over time, which does not indicate loss of activity if the product
has been stored as recommended. It is however recommended to
dispose of the product if the colour immediately on reconstitution
is not colourless to yellow.

– Cardioxane is given as a drip (infusion) into a vein over about
15 minutes.
– This will start approximately 30 minutes before your cancer
treatment (doxorubicin and/or epirubicin).
If you think you have been given more Cardioxane than you
should
If you are given too much Cardioxane, tell your doctor or nurse
straight away. You may experience some of the side effects listed
in section 4, “Possible side effects”.

Incompatibilities
Cardioxane must not be mixed with any products other than the
solutions for dilution mentioned above.
Storage
Do not use Cardioxane after the expiry date which is stated on the
pack.
Before opening
Do not store above 25°C. Store Cardioxane vials in the original
package in order to protect from light.
After reconstitution and dilution
The diluted solution of Cardioxane is physically and chemically
stable for 4 hours at 25°C.
From a microbiological point of view, the readily prepared infusion
solution should be used immediately. If not used immediately,
in-use storage times and conditions prior to use are the
responsibility of the user. These must not exceed 4 hours at 2°C
to 8°C (in a refrigerator), protected from light.



Disposal
Any unused medicinal product or waste material should be
discarded in accordance with local requirements. Adequate care
and precaution should be taken in the disposal of items used to
reconstitute and dilute Cardioxane.

Some side effects can be serious and need immediate
medical attention:
Very common (may affect more than 1 in 10 patients):
– Frequent infections, fever, sore throat, unexpected bruising and
bleeding (signs of blood disorders such as low red blood cell
counts, low white blood cell counts, low level of platelets and
low levels of granulocytes. Your blood counts may however
return to normal after each treatment cycle).
Common (may affect up to 1 in 10 patients):
– Swelling and reddening of a vein.
Uncommon (may affect up to 1 in 100 patients):
– Leukaemia (cancer of the blood).
– Sudden loss of consciousness.
– Swelling and pain in one part of the body that can be caused by
blood clotting within vein.
– Tissue swelling in limbs.
The following side effects have been reported in very few patients
during treatment with Cardioxane:
– Allergic reactions including itching, rash, facial/throat swelling,
wheezing, breathlessness or difficult breathing, changes in
levels of consciousness, hypotension. 
– Sudden onset of shortness of breath, coughing up blood and
chest pain (signs of blood clot in the lung).
If you get any of the above, tell your doctor straight away or
go to the nearest emergency unit.
Other side effects include:
Very common (may affect more than 1 in 10 patients):
– Hair loss.
– Vomiting, mouth sores, nausea.
– Weakness.
Common (may affect up to 1 in 10 patients):
– Diarrhoea, stomach pain, constipation, fullness in stomach and
loss of appetite.
– Decreased heart muscle function, fast heart beat.
– Pain, redness and swelling of the moist lining of the internal
passageways such as the airways or food pipe.
– Nail disorders such as blackening.
– Skin reaction such as swelling, redness, pain, burning
sensation, itching at the site of injection.
– Tingling or numbness of the hands or feet, dizziness, headache.
– Tiredness, generally feeling unwell.
– Slight fever, chest pain, elevated/increased heart rate,
shortness of breath or rapid breathing.
– Abnormal liver function test results.
Uncommon (may affect up to 1 in 100 patients)
– Increase in blood cell counts.
– Vertigo, ear infection.
– Bleeding, tender or enlarged gums, oral thrush.
– Thirst.
− Redness, hotness and tenderness caused by inflammation
under the skin.

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or
nurse. This includes any possible side effects not listed in this
leaflet.
You can also report side effects directly via the Yellow Card
Scheme: 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 Cardioxane
– Do not store above 25°C. Store in the original package in order
to protect from light.
– Do not use Cardioxane after the expiry date which is stated on
the pack.
– 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. Contents of the pack and other information
What Cardioxane contains
– The active substance is dexrazoxane (as dexrazoxane
hydrochloride).
– Each vial contains 500 mg of dexrazoxane. Cardioxane contains
no other ingredients.
What Cardioxane looks like and contents of the pack
Cardioxane is a white to off-white powder for solution for infusion
available in packs of one vial and packs of four vials. Not all pack
sizes may be marketed in your country.
Marketing Authorisation Holder
Clinigen Healthcare Ltd.
Pitcairn House, Crown Square
First Avenue, Burton-on-Trent, Staffordshire,
DE14 2WW, United Kingdom
Manufacturer
Cenexi Laboratoires Thissen S.A.
Rue de la Papyrée 2-4-6
1420 Braine-l'Alleud
Belgium
This leaflet was last revised in 02/2015.

5204500/B  GB

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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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