Cardioxane 500 mg powder for solution for infusion

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• If you get any side effects talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

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 given
4. Possible side effects
5. How to store Cardioxane
6. Contents of the pack and other information

• If you are under 18 years old and your planned dose of anthracycline is considered low – talk to your doctor about this.
• 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.

Talk to your doctor, pharmacist or nurse before you are given Cardioxane:

• 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.

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 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. Women and men should continue using contraception for at least six 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.

The long-term benefits and risks of this medicine in children and adolescents are not yet clear. Your doctor will advise on benefits and risks of this medicine.

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

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

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).

• 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 and men should use effective contraception during treatment with Cardioxane and for at least six 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 you are given this medicine.

Tiredness has been reported with Cardioxane treatment. Therefore if you feel sleepy, do not drive or use machines.

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.

• 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 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”.

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 level 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.

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

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 or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

• The active substance is dexrazoxane (as dexrazoxane hydrochloride).
• Each vial contains 500 mg of dexrazoxane. Cardioxane contains no other ingredients.

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.